NextGen Biomed 2027

At LifeArc we have a strong track record of antibody engineering. This talk delves into two case studies;understanding the process from: humanisation design, through screening to lead candidate panel characterisation
Highlighting how high throughput techniques and data science have developed our antibody engineering processes
Discussing how engineering therapeutic antibodies is a balance between function, developability and reduced immunogenicity

- Ion channels are a broad class of membrane proteins with clear involvement in a wide variety of human diseases. Development of drugs targeting such ion channels are often precluded by difficulties in generating functional, potent and selective molecules with limited off-target side effects.
- Maxion Therapeutics and its co-founders have sought to solve this problem by the development of the KnotBody platform – fusing cysteine-rich, ion-channel targeting peptides derived from animals, plants and yeast into the CDR of antibody scaffolds. The resulting KnotBody molecules are potent, selective ion channel modulators with the strong biophysical properties and high developability profile of an antibody.
- This talk will discuss the development of the KnotBody platform, the progression of Maxion’s lead autoimmunity program (MAX001) and the future outlook for the company.

When generating CHO based production clones, a significant amount of time is spent selecting clones and creating an optimal bioprocess. Our research indicates that these steps can be entirely skipped by employing a recombinase-based targeted gene integration strategy. The clones generated this way, all behave very similarly in bioprocess suggesting that a one-time pre-optimized bioprocess will drastically reduce development times.

- New tools to study trafficking of ADCs
- Real-time analysis of payload release
- Quantitative AI-guided imaging for rational design of advanced therapeutics

• Are emerging analytical tools closing the gap between R&D and QC?
• The strategic role of quality analytics in regulatory & commercial success

Benchmarking: Evaluating open-source tools using in-house antibody-antigen data to assess their effectiveness in an industrial context •Enhancing Capabilities: Adapting & extending Boltz-2 to address the unique challenges of antibody & ADC design •Democratising Structure Prediction: Improving usability to empower broader access to structure prediction & fostering collaboration within the open-source community.

We engineer logic-gated multispecific T cell engagers that activate only in defined tumor contexts. Our Logibody platform combines precision targeting with potent cytotoxicity to improve safety in cancer immunotherapy.

Alzheimer’s disease remains a major unmet medical challenge driven by pathological tau spread. We developed S1D12, a potent anti-tau monoclonal antibody that slows disease progression and prevents neuropathology by 97% in animal models, with therapeutic potential across Alzheimer’s disease and other tauopathies.

How to make your work GLP appropriate & aligned with regulations to produce your drug

The need for efficacious, potent, and developable biologic drugs for patients remains undiminished. Applying in silico Machine Learning (ML) tools and generative AI to augment biologics discovery has the potential to revolutionise biologics drug discovery. Mark’s presentation describes how AstraZeneca is deploying a paradigm-shifting, ultra high throughput in vitro “Deep Screen” platform to identify rare candidate drugs.
The Deep Screen Platform simultaneously screens millions of candidate biologics for their ability to bind to a therapeutically relevant target protein (phenotype) and uniquely links each binder to its cognate gene sequence (genotype). The unparalleled screening power of the Deep Screen Platform, coupled with routine application of in silico ML tools, is allowing AstraZeneca to identify and prioritise biologic molecules with the desired affinity, developability and target specificity characteristics. The augmented biologics discovery workflow described, increases the probability that a candidate molecule will progress from the bench and into the clinic to treat patients.

Next-gen cell line engineering (e.g. CRISPR)
AI for close screening

FcRn functions as a recycling receptor to maintain levels of IgG and albumin.
Efgartigimod (Vyvgart™) is a FcRn antagonist approved for treatment of IgG driven diseases. In this talk the engineering of a next-generation FcRn blocker with prolonged duration of effect will be discussed. Moreover, we describe the development of an anti-IgA monoclonal antibody that can actively remove IgA from the circulation by leveraging the backbone of Efgartigimod.

• ADCs outside cancer
• Payload innovation & new indications
• Preclinical models & translational hurdles

A key platform developed for high-throughput protein generation
-Process from construct design to protein expression
-Automated data collection for AI/ML

•Why do we establish clinical collaborations with external companies?
•Industry Clinical Collaborations (ICC) at Roche
•Drugs combinations in ICC
•Successes & challenges with commercial drugs & novel combinations

Rapid and robust characterization of complex biologics using affinity LC-MS (aLC-MS)
Stability and biotransformation of ADCs in biological matrices
Kay learning from the development of aLC-MS workflow

•Compatibility with administration
component
•Mitigating incompatibility risks: implementing material selection & early compantibility assessments
•Regulatory allignment: risk assessments & bracketing strategies

• Platform vs. product: what will drive success in the multi-specifics & engagers market?
• Emerging modalities meet real-world demand
• Immuno-safety
• Enhancing the activity of T cell engagers in solid tumours

• TORCH technology enables unprecedented visualization of ADC trafficking and payload release with minimal background.

• The parameters receptor density and intracellular drug release were evaluated with regards to ADC efficacy.

• The improved FlexTORCH platform offers modular design through orthogonal click chemistry and different linker types.

• A high-throughput workflow combining modular cloning of complex membrane proteins with the TagBlock system.
• Construct screening and systematic solubilizing reagent evaluation by automated purification on the CyBio FeliX.
• Shortened development timelines and de-risking by screening to scale up.

Explore how chemically aware, atom-precise macromolecule representations bridge the chemisttry and biology, enabling collaborative workflows, accurate sequence/struture integration, and accelrated biologics therapeutics discovery using some modern features and advanced data management tool

PUREfrex® is a rebuilt, cell-free protein
expression system that redefines how
proteins are produced and explored. Its
modular architecture offers researchers
precise control at the molecular level,
making it exceptionally adaptable to
a wide range of applications—from
expressing challenging biologics to
enabling high-throughput workflows.
Whether you’re working on therapeutic
proteins, novel modalities, or synthetic
biology prototypes, PUREfrex® provides
a flexible and efficient foundation. When
paired with AI/ML platforms, it becomes
a powerful accelerator for innovation in
protein engineering and discovery

• Review of antibody therapeutics first approved in 2025 and those currently under regulatory review
• Forecast of antibodies likely to enter regulatory review by the end of 2026
• Comparative analysis of antibody therapeutic development in the US/Europe versus China

AI/ML for biotherapeutics is constrained by the
scale and quality of training data. In this session, Twist Bioscience will present multiple workflows for strategies to bridge this gap using highfidelity synthetic DNA platforms and bespoke data outputs that integrates next-generation synthesis, production and characterisation directly into the Design-Make-Test-Learn cycle. Case studies will illustrate how LLMs are validated using Twist “off-the-shelf” data sets, how high-throughput iterations of make-test cycles can be used to compare and train new models, and when in silico (de novo) designed libraries coupled with wet-lab panning and screening can simultaneously generate lead
therapeutic candidates while also validating and
training generative models. Learn how scalable
and innovative antibody services transform ML
into a powerful engine for rapid biotherapeutic
discovery.

• Introduction to AZDiff, our in house diffusion based generative model for designing antibody H3 loops and exploring sequence–structure relationships in biologics design.
• How H3 loop grafting guided by AZDiff enables antibody repurposing, allowing antibodies with promising biology to be redirected toward new targets or improved interfaces.
• Hybrid ML–physics design workflow with in vitro experimental validation demonstrating that ML designed H3 loop variants can form viable antibody candidates.

•Over the last few years SCIEX have
been developing new tools to enable
Scientists to dig deeper and more
quickly and accurately profile impurities
in protein biotherapeutics. In this
short talk you will discover how Native
Fluorescence has been developed by
SCIEX and how it is improving fragment
and charge impurity detection in
capillary electrophoresis providing
a more sensitive detection than UV
without the need for derivatisation
•When a deeper understanding of the
impurities is required, LCMS is used
and, in this presentation, you will
learn how the ZenoTOF 8600 system is
enhancing peptide mapping using both
CID and electron-activated dissociation
(EAD) to confidentiality characterize
low level impurities. With its new ion
transmission also discover how this
system improves intact native analysis
of large protein biotherapeutics

AJICAP® enables site-specific chemical conjugation with precise DAR control. We present non-human primate toxicology data for AJICAPbased ADC and in vivo efficacy of AOC, demonstrating its versatility and potential as a platform for nextgeneration antibody conjugates.

First-in-class mechanism to directly
trigger tumour-selective apoptosis:
IMV-M is a novel MUC16×DR5
bispecific antibody that induces
potent death receptor clustering
selectively on tumour cells through
multivalent engagement of MUC16
•Strong efficacy with favourable safety
profile: IMV-M demonstrated robust
single-agent anti-tumour activity in
multiple preclinical models without
requiring secondary crosslinking and
showed no detectable toxicity in a
pilot nonhuman primate study
•Potential platform for safer and
more effective cancer therapies:
By eliminating cytotoxic payloads,
IMV-M overcomes key limitations
of ADCs and has broad applicability
across major solid tumours, including
ovarian, pancreatic, and lung cancers,
that express MUC16

Cutting-edge computational tools and proprietary data platforms
Can we predict multiple conformations? Data strategies and predictive modelling approaches

• Reviewing and understanding the drivers of on
and off target ADC toxicities
• Understanding best practices to minimise the
translational mismatch observed with ADC
toxicity characterisation
• Leveraging learnings to mitigate clinical toxicity
and maximise ADC therapeutic index

• Where does AI truly move the needle? From discovery and early R&D through translation toward CMC, manufacturing, and commercial viability—what delivers real impact today, and what still needs to change
• What really limits scale? Data quality, biological validation, regulatory acceptance, talent, and infrastructure—why most bottlenecks sit beyond discovery
• Who wins the 2030s? AI-native platforms vs asset-led companies, and the organisational models that will define long-term advantage

This topic explores the revolutionary potential of the genome-edited mouse, where endogenous VH and VL genes are replaced by fully human VH and VL genes in situ, enabling the generation of fully human antibody molecules. When combined with Biointron’s AbDrop microfluidic technology-enhanced single B cell screening, this approach allows for the high-throughput and efficient discovery of antibody drug molecules

o The rationale for combining TNF targeting with site-directed JAK inhibition in a single, targeted drug conjugate.
o The SDC is designed to concentrate pathway modulation at inflamed tissue while reducing systemic JAK exposure and broadening the therapeutic window
o ELN28 demonstrates preclinical translation and developable path to clinic, with robust in vitro/in-vivo efficacy, and PK/PD profile

• LabGenius Therapeutics has pioneered the development of EVA™, an ML-driven, closed-loop antibody discovery engine. EVA™ generates large volumes of biologically rich experimental data, which are used to train computational models. These models can then be used to co-optimise molecules across multiple therapeutic parameters, including potency, efficacy, selectivity and developability
• By integrating high-throughput experimentation and computational learning in this way, LabGenius is able to identify novel, high-performing antibody molecules, often with non-intuitive designs
• Using EVA™, LabGenius has built a growing oncology pipeline focused on addressing on-target, off-tumour toxicity; a key challenge for solid tumour-targeted T-cell engagers. The company’s lead programme, LGTX-101, is a selectivity-enhanced Nectin-4 x CD3 T-cell engager featuring a novel 3+1 molecular architecture. In preclinical studies, LGTX-101 has demonstrated robust tumour-killing activity with minimal activity against Nectin-4–expressing healthy cells

• Optimising novel therapeutic platforms
• Overcoming development bottlenecks through engineering
» Automation
» Microfluidics
» Synthetic biology

• At GSK, we are enhancing our antibody discovery platform by bringing Function First screening into our in vivo discovery platform using the Beacon.
• This allows for more informed mining of our NGS B cell repertoire mining and leads to improved project outcomes.

Development of microtubule inhibitor hemiasterlins for ADC
SAR and optimisation of a payload series with sub-nanomolar in vitro potency
Potency of Her2-ADCs in in vitro and in vivo efficacy models

•High-throughput screening methods for the screening cascade of antibodies
•How soon should developability be assessed in the screening cascade?
•Could data science help in the future for reducing the number of
antibodies needed to be screened?

Automation in BRC
Concept of shared analytics for optimized resource use
End-to-end integrated solution for SEC-MALS

• Where is the biggest up and coming market for
modalities?
• Where specific therapeutic areas amplify—
or break—modality viability (oncology, rare
disease, immunology, CNS)
• How modality choice shapes development risk,
cost, and long-term platform value
• Patient, payer & physician risk vs reward

The oral presentation will outline hybrid LC‑MS/MS methods for ADC bioanalysis to support novel candidate development.
It will detail an immunocapture–enzymatic LC‑MS/MS method for conjugated payloads.
It will discuss intact mass analysis (Orbitrap) in in vitro and in vivo samples for stability and biotransformation assessment.

What defines a best-in-class ADC in 2025 & beyond?
Strategic collaborations & market shifts: who's driving the future of ADC development?

Advancing multi-specifics for autoimmune & infectious diseases
Hurdles in design & clinical translation

We present a physics-based generative AI framework for the de novo design of cyclic peptides that exhibit both passive membrane permeability and high target affinity. As a case study, we describe the application of Menten AI’s design platform to generate cyclic peptides against a difficult protein–protein interaction target.

• In silico discovery & optimisation
• Structure prediction
• Future directions
» Generative AI
» De novo antibody creation

• What new sources of data are required to training AI
• Data generation, integration & data sharing, how do we provide equitable access from public data.

Antibody-drug conjugates which combine the specificity of mAb and the toxicity of payload have showed promising anti-tumour effects in clinic. Due to the complex structure and MOA, preclinical development of ADC can be challenging and shall be scrutinised. The presentation will cover the following aspects:

1. In vitro Pharmacodynamics
2. In vivo Efficacy and Pharmacokinetics
3. Drug Resistance and Solutions

-There is a great need for novel ADC payloads with a different mode of action
-Novel payloads can be used to treat ADC-resistant patients and expand patient populations
-This talk will show the discovery of a novel PLK1/BET degrader payload and its application in a TROP2-targeting degrader antibody conjugate with excellent in vivo activity

Translating discovery to application
Bridging the gaps
Data & knowledge sharing

• Platform differentiation in a crowded field
• How the competitive landscape is shifting with new entrants and modalities
• Latest technological development
• Importance of CDMO partnerships

• IL-2 is a clinically validated immunotherapy. However, toxicity limits its use and despite years of research, the optimal approach to deliver IL-2 has yet to be achieved.
• AZD6750 applies cis-guiding to deliver a modified IL-2 mutein preferentially to CD8+ T cells. This approach potentially limits the side effects of Aldesleukin, typically attributed to the broad effects of IL-2R signalling, which should result in a safer, more effective IL-2.

•The benefits of combination trials
•How to navigate the collaboration for
combination trials

Regulators increasingly emphasize total process
understanding from development to commercial
scale. With 75% of FDA rejections tied to CMC
shortcomings, LC-MS-based HCP impurity
analysis is key to a regulatory-ready, data-driven
purification strategy.

While modern immunotherapy has pushed the limits of drug efficiency, these advancements often come with increased risks of immunogenicity (unwanted immune responses) that can derail clinical trials.
The presentation emphasizes pre-clinical in vitro and in vivo data to identify immunogenicity drivers in complex multi-specific antibodies, which traditional sequence analysis might miss.
Sharing key insights into the underlying biological mechanisms of immune reactions may help drug developers to avoid "immunogenic transformations" and create safer, more effective therapeutics.

• Ensuring product stability across the lifecycle
• Making complex methods scalable, transferable & regulatory-ready
• Identification of critical attributes for stability & characterisation

Harnessing the tumor microenvironment offers powerful opportunities for next-generation antibody therapeutics. By exploiting stromal, immune, and metabolic cues for conditional activation, emerging antibody formats enhance tumor selectivity, expand the therapeutic window, and enable more efficacious and durable cancer immunotherapies.

We demonstrate highly accurate developability prediction for VHHs using a model fine-tuned on both sequence and structure, to produce a scalable sequence-only predictor. This approach outperforms protein language models and inverse-folding methods, identifies developability issues, and accelerates the DMTA cycle by improving hit selection, guiding optimization, and de-risking development.

Strategies for optimising key components of ADC design to further enhance the efficacy and tolerability
Discussing a novel prodrug-linker with a unique mechanism of action
Improving tumour distribution to enhance efficacy

- Overview Masked antibodies
- Case study Masked ADC
- Functionality and toxicity
- Process development

Vaccination the cornerstone of public health, can result in poor protection to individuals with compromised immune systems. Neutralising monoclonal antibodies can provide immediate, passive immunity to protect these populations. I will discuss the advances in the identification, development, and deployment of neutralising antibodies targeted against human respiratory viral infections.

This session will discuss ligand design leveraging multivalent binding principles that can be used to improve binding affinity and selectivity for target proteins and enzymes. Applications will include: protein purification, targeted drug delivery, and modulating enzyme activity.

• At UCB we are enhancing our antibody platform with both wet and dry lab capabilities to efficiently deliver high quality antibodies to all targets
• This talk will feature our recent investment in an updated end-to-end robotics platform to deeply mine the immune repertoire to isolate rare antibodies
• The talk will also highlight examples of hit expansion and optimisation using NGS and in silico predictions to ensure antibody hits are as drug-like as possible, enabling a smooth transition through lead optimisation and development

• TCR directed bispecific T cell engagers enable us to target the rich and mostly untapped universe of peptide MHC complexes
• Our Optimus mouse platform yields an unprecedented diversity of starting TCRs for further optimisation
• We combine yeast affinity maturation with in silico optimisation and directed positive/negative selection to rapidly discover highly specific pM binders. This requires minimal mutations in the CDR regions, and the resulting TCRs are developable and highly potent in our proprietary T-Bridge T cell engager format

· The SGC is an international public-private partnership with a mission to accelerate the discovery of new medicines through open science.

· Target 2035 aims to develop pharmacological modulators for every human protein by 2035 to provide tools to enable a better understanding of biology.

· In the next 5 years, SGC will generate and share protein-ligand datasets, enabling AI and machine learning to expedite the mission of Target 2035 more effectively and efficiently.

Integrating advanced analytical platforms with developability data to enable predictive control of critical quality attributes.

• Systematic Framework: Learn how AQbD, risk assessment, and DoE reduce potency assay development time
• Overcoming Challenges: Discover strategies to manage variability, ensure reproducibility, and meet regulatory requirements using RTU cell banks
• Real-World Insights: Gain actionable takeaways from Immunocore's ImmTAAI case study and method transfer

AI & big data driving faster antibody discovery
New platforms enabling advanced bi-and multispecifics

• Using QC-driven strategies to improve early candidate selection
• Applying developability assessments to prioritise molecules with the greatest chance of downstream success

- Supervised property optimization: Where does the "standard" workflow require improvements?
- Diverse candidates: What does it mean to truly explore the protein space - and why it matters?
- Public resources: How do we leverage public resources, and what is needed for internal adoption?

• Potency assays are essential for GMP release of mAb and ADC drugs; faster cell line selection can accelerate assay development.
• Imaging-based internalisation-cytotoxicity assay enables rapid cell-line triaging.
• Plate-based internalisation technology enables faster, sensitive uptake detection.

•Applying structural insights to guide stability and solubility engineering
•Experimental approaches for identifying and mitigating developability risks
•Balancing potency, specificity, and manufacturability in protein design

• IgA activates myeloid cells via FcαRI (CD89), driving tissue damage in chronic inflammation and autoimmunity.
• Novel therapies that aim to unleash FcαRI’s potential in cancer or block its activity in autoimmunity, offer innovative strategies for immune modulation and disease treatment.

•The value of adopting (academic) open source tools in industry and associated challenges
•Fostering open-source community from within the industry
•Paths for bidirectional knowledge transfer and how to initiate it
•Comparison of open-source initiatives to other transfer approaches

• Digitally Programmable 3D platforms mimicking natural ECM to support satellite cell growth
• High throughput nanofibre based human iPSC derived skeletal muscle models
• High throughput nanofibre based human iPSC derived neuromuscular junction models for drug discovery

• FDCs are tailored for solid tumours and promise many advantages over conventional ADCs including rapid tumour penetration & faster systemic clearance
• A novel approach using engineered single-chain Fvs with the capacity for high drug loading from proprietary libraries and tailored payload-linker chemistry
• ANT-045 demonstrates superior tumour cure efficacy across high-low CDX and PDX gastric cancer models with better safety and tolerability compared to Emrelis

• Next-gen AI approaches shaping antibody discovery
• Future opportunities & challenges beyond 2026

We developed a rapid (<5 min), simple, radiation compatible identity test for Actinium 225 drug products using Bio Layer Interferometry (BLI). Custom antigen-coated biosensors enable real-time binding detection, replacing slower, waste intensive ELISA methods. The BLI assay shows strong specificity, precision, and 12 month sensor stability. It enables reliable DP release within tight shelf life constraints, reduces radioactive waste, and has been accepted by regulators

This presentation highlights automated
and high throughput solutions for
upstream AAV processing, including
cell seeding, transfection, titration,
and harvest using the Biomek i7
automated liquid handling system,
enabling reproducible operations while
significantly reducing hands on time
and operator variability. Cell density
and viability are monitored using the
Vi CELL BLU automated cell viability
analyzer, supporting consistent process
performance and data driven decision
making. Functional vector assessment
is further supported by CytoFLEX Flow
Cytometer, enabling rapid evaluation
of transduction efficiency and cell
population responses.

Lonza’s latest advances in the GS
Gene Expression System® technology
platform showcase how multifaceted
vector optimisation, bespoke promoter
design, and high performance CHO
hosts can be intelligently combined
to improve the expression of
diverse protein biotherapeutics.
This presentation highlights how
technologies such as GS piggyBac®
transposon technology and the
GSquad® Pro vector system with
the LHP 1 promoter enable higher
productivity, outstanding expression
stability, and streamlined progression
from discovery to manufacturing.
Using both R&D and commercial data
we will show how these integrated
innovations de risk development and
support reliable performance across
diverse molecule formats, paving the
way for more efficient and successful
biomanufacturing. We will also look
into the future direction of the GS
Gene Expression System® technology
platform and consider where further
vector-based solutions may arise.

Next-generation genetic medicines
require differentiated antibodies that
serve as both therapeutics and targeted
delivery vehicles. Alloy Therapeutics
enables this through an integrated,
AI-driven discovery platform that
accelerates progression from immune
repertoire to optimised candidate. By
combining AI/ML-guided selection,
in silico optimisation, and predictive
developability modeling, we survey
billions of sequences to prioritise
diverse, high-affinity, manufacturable
leads from transgenic mice, human VHH
libraries, or partner-derived parentals—
validated via high-throughput functional
screening. We highlight early data from
antibody–oligonucleotide conjugates
using transferrin receptor-binding
antibodies to deliver genetic payloads,
achieving potent knockdown and
demonstrating precise delivery to
challenging tissues.

•Measure bsAb antibody aggregation without
columns or method development
•Identify high affinity binders and determine
binding stoichiometry in solution
•Increase speed (1 min) and sample economy
(nanograms)

Ailux is an AI-native biologics
innovation company advancing the
next generation of biotherapeutics
through the seamless integration
of data, artificial intelligence,
and experimental science. In this
presentation, we will describe our
end-to-end biologics design platform,
anchored on AtlaX, our biologics data
powerhouse, and driven by state-ofthe-
art AI models working in concert
with specialised wet lab capabilities.
We will also showcase how highthroughput
experimental data and
curated synthetic data can fuel our AIdriven
approach to complex antibody
discovery and engineering challenges,
including bispecific antibody design
and developability optimisation.

This presentation explores why linker
design is critical to ADC success and
how an orthogonal analytical toolbox
verifies structural integrity, controls
impurities, confirms conjugation
consistency, and assesses release
under physiological conditions to
support performance, reduce risk, and
guide development decisions.

We present an analytical workflow to address
GLP-1 aggregation at high concentration. GLP1 oligomers form ordered nanosheets with
assembly rates correlating with kD. The screening
of co-solutes provided strategies to control selfassociation with selected pH-conditions

Stability screening of biologics is like
an obstacle course, especially when
testing many candidates. Most lab
tools are either inflexible one-hit
wonders that don’t give the full stability
picture or seriously low-throughput,
creating major bottlenecks. Aunty’s
throughput, speed and resolution
break out of the pack. Load 8 µL of
your sample into its 96-well quartz
plate and let Aunty power through
melting & aggregation experiments
- reading fluorescence, SLS and DLS
of the whole plate every minute of
the experiment. Join my presentation
to see how Aunty characterizes
monoclonal antibodies and ADCs
in different formulations and how
excipients tune stability.

What if the limitation in antibody discovery isn’t the target, but the platform? HUGO-Ab is a genomically humanized antibody mouse system integrating immune-background engineering to unlock conserved targets and expand biologically accessible antigen space.

Accelerating CMC development is
essential to meet the demand for rapid
clinical entry of biologics. Conventional
processes are limited by long cell line
and upstream development cycles. In
this presentation, we will introduce
ProBio’s new Express CMCTM
service, which delivers toxicology
batch materials within 4 months
from a single clone, and highlight
the technology enablers that drive
faster development timeline without
compromising

Antibody numbering and segmentation are
powerful algorithms that allow one to quickly
deduce how a particular sequence aligns with
what we know about antibody structure. At
ENPICOM, we have developed an ultra-fast
algorithm for antibody segmentation that also
enables extremely robust machine learning
pipelines. Egor will tell what we have built, why
we decided to make it available for everyone in
open-source, and how we use it in a universal
machine learning algorithm for antibody property
prediction.

Generative AI is redefining what’s possible in
biologics discovery - enabling scientists to explore
protein sequence space more efficiently, design
higher-performing molecules, and accelerate
the path from concept to candidate. At Cradle,
we are developing intuitive software tools that
allow protein engineers to directly leverage
generative AI models within their existing
workflows. This presentation will showcase
how Cradle’s technology enables scalable and
reproducible protein design, combining advanced
AI architectures with user-centered design to
reduce cycle times and ultimately create better
biologics.

We present advancements in chromatography
resins, focusing on engineered recombinant
Protein A with enhanced alkaline stability
and DBC for the sequential purification of
a nanobody-Fc fusion biomolecule for the
treatment of SFTS virus.

This workshop explores the sophisticated interplay between antibody engineering, receptor clustering, and Fc-mediated effector functions. As the industry moves beyond simple monoclonal antibodies, understanding how to control secondary interactions—whether through bispecific architectures or programmable synthetic motifs—is critical for enhancing tumor selectivity and de-risking clinical development.

Session 1: Targeting Death Receptor 5 with Mono- and Bispecific Antibodies: Fc Receptor–Dependent Effects on Tumor and Normal
Cells
Speaker: Victor Goldmacher, Ph.D., Chief Scientific Officer, ImmuVia

Session 2: Deep Fc Profiling of HER2-Targeting Antibodies: Derisking Linker Strategies for Synthetic Motif Conjugates and
Uncovering Mechanistic Insights for Approved ADCs
Speaker: Shashi Jatiani, Ph.D, Director of Strategic Partnerships,
SeromYx Systems

Examples will show how modelling of protein and antibody
structure and properties using a range of computational tools
provides insight into how to optimise their therapeutic activity and
developability.

This Schrödinger workshop will demonstrate how physics-based computational modeling (BioLuminate, FEP+) and collaborative enterprise informatics (LiveDesign) work together to accelerate modern biologics design. This workshop will be suitable for both new and experienced Schrodinger users. We will cover:
• Learn how BioLuminate, FEP+, and LiveDesign work together to accelerate biologics design
• Explore an end-to-end workflow from early structural assessment to structure-guided engineering
• Analyze developability and liability risks using physics-based
modeling • Apply advanced free-energy methods to support rational variant design
• Combine in silico predictions with experimental data for faster, data-driven decision

Carterra transformed high-throughput
surface plasmon resonance (SPR)–based
antibody discovery with the launch
of its one-on-384 array LSA platform
in 2018. The newly developed Vega
platform substantially increases analyte
throughput to 48 channels, with each
channel containing two ligand spots
and a reference. This presentation
will introduce Carterra Vega and
demonstrate its functionality through
two case studies. The first case study
describes the use of Vega’s 48-channel
injections to simultaneously characterise
binding kinetics and specificity of 48
monovalent antibodies against human
and cynomolgus forms of a dimeric
receptor. The second case study
highlights high-throughput screening
of a small-molecule library against a
target and a counter-target, with rapid
confirmation of hit compounds through
titration experiments.

The rapid diversification of biotherapeutics has
increased structural complexity across modalities
such as monoclonal antibodies, bispecifics,
engineered variants, and antibody-drug conjugates,
requiring robust analytical strategies for
thorough characterisation. Multi-level approaches
enabled by enzymatic tools like LysCERATOR™
simplify workflows and provide detailed insights
into structure, function, and heterogeneity,
supporting discovery through analytical control.
Additionally, GlyCLICK® technology enables sitespecific conjugation to generate homogeneous
antibody conjugates with controlled payload
attachment. Together, these enzymatic platforms
deliver deep molecular insight and precise
engineering to accelerate development of complex
biotherapeutics.

Bispecific antibodies (BsAbs) are at the forefront
of therapeutic innovation, but their production
remains challenging, especially for bsAbs with two
distinct light chains, as chain mispairing constrains
throughput, yield, and purity. This presentation
introduce Quick ‘n’ Clean, an HTP platform for
producing diverse bsAb formats, automating steps
from expression to purification. The platform
rapidly generates bsAbs in both double-tag and
tagless formats with high purity and yield. Tagless
bsAbs suit ADC conjugation, in vitro assays, and in
vivo studies. Quick ‘n’ Clean enables rapid optimal
pairing screening and streamlines downstream
workflows, establishing a next-gen platform for
bsAb R&D.

Presenting a direct method for anti-idiotype mAb
discovery, which generates high-affinity and highly
specific antibodies quickly. These antibodies
outperformed the best commercially available
mAbs. We show isolation of isolated blocking and
non-blocking mAbs, and a variety of kinetic profiles.

AI is accelerating candidate generation, but uncertainty is moving downstream. With more modalities and fewer clear answers, industry must rethink how research connects to manufacturing to avoid losing the right molecules on the path to patients. We’ll cover:

· How increasing complexity is challenging traditional, standardized approaches

· Why early decisions have a disproportionate impact on downstream outcomes

· How intentional design choices can reduce risk and improve scalability

• MD simulations provide dynamic information that we covert to
thermodynamic insight with CodeEntropy
• CodeEntropy provides information about solvent entropy as well
as the solute
• CodeEntropy is open source software available from the
CCPBioSim network

The talk will focus on typical gaps in the drug
product development of biologics and how
computational tools help to asses molecular
properties to select excipients data-driven
excipient.
Topics discussed in the talk are:
•Key challenges in biopharmaceutical formulation
development
•How computational tools support formulation
decision-making
•Combining computational insights with
experimental formulation strategies

Designing Cell Line Screening processes to optimise yield and scalability – Cell lines are ready for manufacturing
Modern Design of Experiments and Statistical Strategies to Predict “winning” cell lines and optimal process parameters earlier and across scales

The process of ligative oligonucleotide synthesis will be presented with particular attention being placed on the critical impurities that track through the process. The role of fragment quality in the ligation reaction will also be explored to minimize side reactions during the process.

- Rigid vs Gel Type of Solid Supports
- Green Solvents to replace DMF
- Getting rid of PFAS
- Tag-Assisted LPPS vs SPPS

•Ethical considerations
•Regulatory compliance
•Streamlining benefits

GSK has recently filed the regulatory package for Bepirovirsen, an ASO gapmer for the treatment of Chronic Hepatitis B.
This presentation will
• outline the ADME package assembled for the file
• review the learnings encountered on the way
• Introduce the new methodologies developed during the process

The molecular structure of Bicycle® molecules present CMC development challenges
Analysis has a number of challenges
Novel approaches to structural elucidation

•GLP-1
•Knob domain peptides
•Peptide-Drug conjugates

The global rise in peptide demand, driven by accelerated clinical development and speed to market pressures, requires a rethinking of traditional peptide manufacturing. Process Intensification (P.I.) provides a structured approach to increasing output, minimizing costs, with a focus on flexibility and sustainability.

This presentation will highlight some P.I. tools as single-unit operations or in combinatorial scenario with other technologies under evaluation.

- A novel NGS-based in vivo screening platform utilizes chemically modified RNA barcodes to enable the simultaneous evaluation of diverse delivery conjugates within a single animal.
- By distinguishing between total sequestration and cytosolic entry, the workflow provides a quantitative method for measuring endosomal escape kinetics and identifying potent ligands.

While the powder form offers many advantages, it adds an extra production step that must be
qualified in terms of product quality, time, and cost. Electrostatic drying was developed to address these challenges. TIDES case studies will be presented.

The presentation will touch upon some key aspects of why new modalities incl. SiRNA therapeutics are needed, their potential and some hurdles that need to be solved to reach the full clinical potential.

Increasing demand for high product throughput led to the development of quick, efficient, and controlled nucleation processes using external stimuli such as templated nucleants. Template-assisted nucleation is explored for TIDES to improve their downstream processing and enhancing dry particle attributes opening new avenues for novel formulations.

- Drug discovery and peptide design
- New process technologies
- Photochemical C-terminal -amidation of peptides and proteins

Cytolytix is developing a second generation, oncolytic peptide for treatment of cancers with high unmet clinical need. Our primary indication is Triple Negative Breast Cancer. The peptide is formulated to avoid systemic toxicity for IV administration and leverages both direct anti-tumoral activity as well as potential host immune activation.

•Delivering oligos outside the liver (to the muscles, brain etc)
•Crossing the blood-brain barrier – strategies & methods

Oligonucleotide-based therapies are a promising class of drugs that target disease by modulating mRNA or DNA. Oligonucleotides exhibit poor membrane permeability due to their high molecular weight and pronounced charge and require delivery methods such as conjugation involving targeting ligands to promote cellular internalization. A major hurdle after endocytosis, the oligonucleotide is often trapped within endosomes, preventing it from reaching its intracellular target. Efficient therapeutics must facilitate the escape of the oligonucleotide from the endosome to function correctly. This work focuses on overcoming this challenge by developing linkers for conjugation with the oligonucleotide, designed for improved uptake and subsequent release.

This presentation covers analytical strategies for oligonucleotides, from early-stage characterisation
and method development to validation, stability studies, and GMP-compliant commercial release
testing, ensuring quality, safety, and regulatory compliance.

• Oligonucleotide chemistry has played a key role in enabling drug-like properties.
• Protein binding and interactions with pattern recognition receptors cause off-target effects.
• Chemical engineering of oligonucleotides has facilitated the development of spatial transient cyclic structures with specific features.
• Cyclic structured oligonucleotides have wide applicability in developing RNA-targeted therapeutics.

Knob domain peptides are derived from a subset of bovine antibodies with an ultra-long CDR H3 loop and represent the smallest autonomous antibody fragments (3-6 kDa). We present a platform for modular engineering of knob domain peptide fusions based on the substitution of natural β-ribbon stalk with antiparallel coiled-coil dimers. We were able to generate the world’s smallest bi- and tri-specific antibody fragments with molecular weights of 14.5 and 22 kDa respectively. Artificial coiled-coil stalks can also be used to achieve high-yield recombinant production of individual knob domain peptides.

• Peptide hit-to-lead optimisation is traditionally a time-consuming process, requiring many iterative design-make-test-analysis (DMTA) cycles and multi-year investment to achieve candidate nomination. We have developed a novel high throughput synthesis platform that combines barcode-free, split-pool synthesis of artificial intelligence-enhanced combinatorial peptide libraries with pooled affinity-selection mass spectrometry (ASMS) to significantly reduce hit-to-lead optimisation timelines from years-months to weeks.

• Using AI to design and optimise peptide sequences
• Enhancing stability and delivery through predictive modeling
• Overcoming data limitations in peptide ML applications

Modeling nucleic acids, particularly RNA, presents challenges due to their dynamic nature, with biologically relevant conformations often differing significantly between unbound and bound states. This variability complicates predictions in silico, making efficient conformational sampling crucial. In this presentation, we investigate the efficacy of the LowModeMD method for enhancing conformational sampling in DNA and RNA systems compared to traditional molecular dynamics approaches.By focusing on low-frequency vibrational modes, LowModeMD enables rapid exploration of conformational space, facilitating the identification of biologically relevant structures. We demonstrate the utility of LowModeMD in analyzing bulged residues, sampling terminal and internal loops, cryptic pockets and large conformational changes caused by complexation

As demand of peptide-based therapeutics continues to grow, there is increasing pressure on industry to improve process efficiency and ensure consistent product quality while reducing environmental impact and operational complexity. This presentation will discuss several innovation process developments in the context of peptide manufacturing, with a focus on research and development activities that aim to enable efficient and scalable production. The talk will address key stages of peptide production, including solid-phase peptide synthesis (SPPS), purification and isolation of the product, with particular emphasis on the design of environmental friendly and sustainable approaches that are compatible with future scale-up. Selected examples will be used to illustrate practical adjustment and optimization of the process. Overall, the presentation aims to provide insight into how innovation in peptide manufacturing process can lay a strong foundation for future sustainable and efficient manufacturing.

•Advanced labeling techniques
•Real-time imaging tools to assess delivery efficiency and cellular uptake

•Current applications in therapy and imaging
•Choice of the most suitable radionuclide
•Optimal design of peptide vector for various properties

AmbioPharm presents three innovative strategies for peptide manufacturing built on a fragmentbased hybrid approach that integrates solid phase and liquid phase peptide synthesis to improve
yield, purity, and sustainability when compared to traditional Solid Phase Peptide Synthesis.

• Overview of internal mRNA platform to discover novel peptides
• Case study of peptides enabling drug-discovery on challenging targets.
• FXX489 a peptide based RLT targeting fibroblast activation protein (FAP)

• Exploring greener synthesis methods
• Innovative technologies and tools
• Scaling green peptide manufacturing
• Regulatory and commercial considerations

• Antimicrobial resistance as a priority clinical threat: why current options are failing, and where antimicrobial peptides (AMPs) fit (and typically fall short) as a new modality.
• The central translational barrier for AMPs: loss of activity in serum due to binding, proteolysis, and host-environment effects—why standard in vitro potency often does not translate.
• The solution and results: AI-predicted peptide down-selection followed by screening directly in serum to identify serum-synergistic AMPs (SeSy-AMPs) with high activity against MDR E. coli.

A fast-paced discussion on how cross-modality partnerships — spanning peptides, oligonucleotides, and conjugates — are transforming therapeutic discovery and development. Panellists will share perspectives on integrated science, manufacturing, entrepreneurship, and the role of consultancy in accelerating innovation from concept to clinic.

• Regulatory environment
• Technologies & platforms
• Scaling oligo therapeutics
• Reaching the patient

The primary goal in greening peptide synthesis is decreasing Process Mass Intensity (PMI) and
improving Atom Economy (AE) and Ideality Factor (IF). To this purpose, synthesis in flow, development
of coupling reagents avoiding side-chain protection and replacement of TFA based cleavage cocktails
represent main challenges to achieve eco-friendly peptide synthesis.

• Highlights microbial systems in biopharma production
• CASPON® as a versatile development platform
• High-throughput process development for peptide production process
• CASPON® technology as a solution for therapeutic peptide manufacturing
• Future prospects: sustainability, scalability, and competitiveness in peptide manufacturing

This talk highlights CPC Scientific’s innovative peptide manufacturing approaches, advanced process
development, and scalable capabilities that enable reliable supply, quality, and speed from early
development to commercial production.

Learn how Aralez Bio’s platform enables the diverse, scalable, and sustainable production of
noncanonical amino acids (ncAAs), along with the latest advancements on their technology roadmap.

•Oligonucleotides are emerging new therapeutic entities and reliable selective analytical methods
to determine their purity and related impurities are critical. Strong anion exchange (SAX) liquid chromatography (LC) methods are often used as an orthogonal method to well established ionpairing reversed phase (IP-RP) methods, particularly for phosphorothioate oligonucleotides. However,
the non-volatile eluents of SAX methods deem them not MS-compatible and are hindering direct
peak purity analysis
•In this presentation, a novel 2D-LC-MS approach developed at Bachem will be described that allows
the evaluation of peak purity by using SAX methods in combination with IP-RP and high-resolution
MS

Peptides are increasingly important. Jiuzhou Pharma offers SPPS, LPPS and hybrid synthesis
technologies. With vast production capacity and upcoming expansions, we can handle large-scale
peptides. Recent developments, including facility expansions and new technologies, are covered

This presentation highlights new microwave instrumentation for fully automated walk-away production of peptides up to 1KG/batch (including liraglutide/semaglutide). This includes the latest performance in crude purity, wash solvent, amino acid equivalents, and total synthesis time.

•Peptide macrocycles offer a unique opportunity as key modulators for targeting protein/protein
interactions and receptors on cells for payload delivery
•At Curium Pharma, a global leader in nuclear medicine, we are looking at peptides as a “modality of choice” for radiopharmaceutical applications for curing cancer

•Project background
•ASO identification and optimisation process in the ARHGEF6 project
•Disclosure of in vitro and in vivo data

This talk describes a novel approach to dissolve Fmoc-amino acids in water to enable aqueous-based
solid phase peptide synthesis. Critical to the successful application is the development and use of a highly hydrophilic solid support. Together this approach enables the most green and sustainable chemical peptide production.

We describe a human-centric R&D paradigm integrating multi-omics to increase translatability across target discovery, clinical development, and franchise expansion, demonstrated through the discovery of SEZ6, a first-in-class tumor antigen target for small cell lung cancer (SCLC). Through an in-silico drug screening platform, we identified subtype-specific therapeutic vulnerabilities using a digital twin approach that connects preclinical insights with virtual patient modeling, integrating internal clinical trial data with large-scale real-world evidence. This precision clinic-omics paradigm successfully translated discovery to clinical proof-of-concept and strategic franchise expansion across next-generation modalities.

· Designing a TCR-based library and optimising the format for stable and robust phage display
· Generating diverse panels of TCRs to pHLA and monitoring specificity during affinity maturation
· Discovery and engineering of TCR mimics and the potential benefits of TCRs and TCRm

• Prediction of response
• Patient selection & stratification in IO
• Case studies from:
» Immuno-oncology
» Autoimmune diseases
» Other

* AI-driven cancer vaccine development based on Dark Genome targets
* Off-the-shelf vaccine for the treatment of Acute Myeloid Leukemia

Clinical translation of microbial immunotherapy – first steps in bladder cancer
Building a programmable platform at the crossroads of synthetic biology and immuno-oncology
Tumour-restricted, logic-gated payload delivery

Outlining genO-BRGSF-HIS mice: a CD34+-reconstituted model with functional human lymphoid and myeloid compartments, without side effects
Evidencing the recruitment of human immune cells to tumor microenvironment, as well as their activation status
Highlighting the key role of myeloid compartment in the translatable assessment of biologic’s safety in humanised models

PLT012 targets CD36-mediated lipid uptake to simultaneously disarm immunosuppressive features and boost anti-tumor immunity
PLT012 addresses difficult-to-treat cancer while providing durable efficacy that limits metastasis and recurrence.
The success of PLT012 open a new avenue for immunotherapy that extends beyond classic immunological signal 1, 2, and 3.

Next generation immune humanized mouse models from JAX will be discussed, focused on improved recapitulation of human immune cell development and function, and their use in mechanistic and translational immuno oncology drug research

Gold-Standard 3D Epitope Mapping data is now available within weeks on a routine basis and suitable budgets.
Main advantages of cryo-EM based 3D Epitope Mapping compared to orthogonal methods
How reliable, 3D structure-based epitope data enables more rational lead selection and design decisions across Therapeutic Antibodies modalities, from monoclonal antibodies, bi-specifics and ADCs
The critical role of empirical 3D Epitope Data in the development and validation of reliable AI models for antibody discovery

T cell engagers are an exciting new therapeutic modality which has seen multiple approvals in recent years
In solid tumours progress has been slower due to difficulties in finding the right balance between activity and toxicity
The design and affinities of T cell engagers need to the modulated to find the right therapeutic window and unlock this class of therapeutics in solid tumours

• Scancell’s non-personalised ImmunoBody® DNA vaccine platform induces CD8 and CD4 T cell responses that mediate tumour therapy in preclinical models.
• SCIB1 and iSCIB1+ demonstrate broad T cell responses in patients and show favourable safety profile.
• SCIB1 and iSCIB1+ demonstrate clinical benefit with evidence of durable disease control and extended PFS in advanced melanoma patients compared to historical checkpoint therapy data.

Overview of novel CAR T-cell therapies targeting CD1 for treatment-resistant T-ALL.
Discussion of preclinical findings and emerging strategies in CD1-directed immunotherapy development.
How to speed up a clinical development program for CAR-T therapies in a rare indication.
Clinical and regulatory challenges.

• Current successes
• Where AI has already delivered impact
• Key challenges
• Data quality
• Model interpretability
• Regulatory acceptance
• Integration into existing R&D pipelines

• Overview of the development of CARKey platform technology with multi-receptor targeting
• Identification of combinatorial target proteins through bioinformatic analysis
• Strategic development of clinical candidate via high throughput in vitro screening

• Benchmarking technologies across different therapeutic areas –
oncology & autoimmune diseases
• Real-world examples of targeting strategies that succeeded or
failed - and why

-Biomarkers can inform drug development
-Patient enrichment strategies in early clinical development
-Target engagement informing POM and dose selection
-Biomarker driven decisions

• Barriers within the TME
• Strategies to re-programme the TME
• Translational challenges

Why neoadjuvant IO strategies are much more effective that adjuvant strategies
Work with and expand T-cell clones in primary tumors and lymph node metastases
Essential learning elements from Melanoma to MSI-high to MSS tumors

- HLA-associated peptides (immunopeptides) presented at the cell surface are promising targets for immunotherapies. - Mass spectrometry (MS) enables direct identification of these low-abundance targets but has historically required large sample input. - Recent advances in MS sensitivity and speed now support in-depth, high-throughput immunopeptidomics from progressively smaller amount of material enabling novel target discovery and accelerating translational research.

Introduction to Gamma Delta T cells
Rationale for activating Gamma Delta T cells in oncology indications
Overview of Cytospire's strategy to develop novel Gamma Delta T cell engagers

Impact of repeated doses on cytokine release and mitigation strategies
CRS prediction from in vitro assays
FIH dose selection for T-cell Bispecifics

Immunocore’s ImmTAX platform (Immune Modulating Therapeutics against X disease) leverages engineered bispecifics to redirect patient’s own T cells to kill cancer (ImmTAC) and infected cells (ImmTAV) via an anti-CD3 effector arm or to elicit targeted and local suppression of immune responses via an agonist anti-PD1 effector arm (ImmTAAI). We will discuss the first ImmTAAI molecule targeting a monomorphic antigen presenting molecule, CD1a, for localised immunosuppression in the skin.

Historical perspective on combination approaches in autoimmune disease
New emerging clinical data
Next wave of bispecific molecules

• The cancer Immunotherapy of yesterday and today
• What happened with the development of Therapeutic Cancer Vaccine (TCV)?
• Are TCV Back to the Future?

Why combining an APC activator with immune checkpoints?
Why eftilagimod alfa (soluble LAG-3)?
Journey to phase 3 and how to manage collaborations with big pharma as a small biotech

• Enara’s proprietary EDAPT® platform interrogates the dark genome to discover and validate novel,
cancer-specific peptide-HLA and cell surface antigens with the hallmarks of optimal cancer targets
• DARKFOX is a previously undescribed alternative open reading frame (alt-ORF) contained in the
exonic sequence of FOXM1. DARKFOX alt-ORF encodes a short (<100 amino acids) polypeptide, from
which we identified several Class I HLA peptides on primary tumours, but not on benign tissues, by
immunopeptidomics
• DARKFOX is an attractive cancer antigen for peptide-HLA targeted bispecific T cell engagers

A general-purpose conversational AI, like ChatGPT, can assist in early-stage molecular ideation and design. This will be demonstrated on three in silico tasks are considered: QSAR guided design of molecules targeting EGFR, de novo inhibitor design for EGFR, and non-covalent inhibitor design for MCL1.

The development of potency assays for cancer vaccines presents
unique scientific and regulatory complexities, particularly as these
products often target diverse and patient-specific tumour antigens.
This presentation explores the critical role of potency testing in
the development lifecycle of cancer vaccines, highlighting the
intersection of technical feasibility, regulatory expectations, and
commercial applicability.

-- Combining frontier AI and frontier bio to design TCR-guided therapies
-- Platform generates ultra high-throughput molecular interactions data to train models
-- Our lab-in-the-loop approach designs precision therapies in oncology and immunology

Introduction of an engineered mouse line with fully humanised cytotoxic T lymphocyte immune synapse.
Demonstration of its use as a platform for identifying therapeutic T cell receptors

T cell engagers are a very potent type of drug but there are relatively few good disease specific targets, limiting the potential of this class of drug..

Peptide-MHC-complexes (pMHC) are a compelling class of targets. Their presence on cell surface enables access to targets from the entire proteome, expanding the cell surface accessible druggable genome

However, the low density of pMHC targets, the promiscuity of their natural ligands (TCRs) as well as the ability to build TCEs that work effectively with pMHC targets has limited the development of TCR-TCEs with just a single approved drug on the market.

T-Therapeutics has developed unique technology solutions which address all of the challenges inherent in targeting pMHC as a class. These have been amalgamated and collectively solve all of the challenges of pMHC directed TCEs.

Further, by pan-indication analysis of target relevance across multiple diseases we have identified highly specific pMHC disease-driver targets that are relevant in multiple diseases, thereby also overcoming market-size concerns inherent in drugs that have MHC allele specificity.

Tag-assisted LPPS
PMO synthesis

Optimized workflow of PBMC-humanized mice:
- welfare scoring
- in vitro graft-versus-tumour screen to refine donor selection
- multi-donor block designs to improve robustness, generalizability and ethical standards while reducing animal use.

PBMC-humanized mice data resource:
- database of 3,000+ PBMC-humanized mice across 80 studies, informing welfare outcomes, engraftment variability, and efficiency drivers to enable evidence-based refinements

• MAIT engagers target uniquely the abundant population of highly cytotoxic Mucosal Associated Invariant T-cells (MAITs)
• MAIT engagers induce efficient MAIT-mediated elimination of cancer cells in vitro and ex vivo, in fresh human tumor samples
• Superior safety (no CRS) and anticipated tumor activity (no Treg activation) from MAIT engager vs CD3 engagers leading to a substantial therapeutic window

Vγ9Vδ2-T cells constitute a homogeneous population of pro-inflammatory immune effector cells. This presentation will focus on the development of bispecific Vγ9Vδ2-T cell engagers as an approach for cancer immunotherapy

Novel vaccine technologies & platforms
AI analysis methods
Regulatory updates

Humanised mouse models – Platforms to precisely manipulate the tumour microenvironment (TME) for translational cancer research.
Cold vs hot Tumours – Replicating immune-infiltrated (“hot”) and immune-excluded (“cold”) tumours across adult and paediatric cancers.
Therapeutic insights – Using these models to guide immunotherapy development and precision medicine strategies.

How can patients be involved in clinical research.

• Discussion of clinical experience developing therapeutics targeting TGFb pathway, including review
of efficacy and biomarker data
• Thoughts on advantages and disadvantages of next-generation modalities targeting TGFb

This talk maps the evolution of ATMP immunotherapies for autoimmune diseases from TNF-α–targeted biologics to emerging immune cell and pathway targets, and highlights ACROBiosystems’ integrated solutions enabling development from discovery to clinic.

This presentation will cover how CAR-T and targeted biologics, originally developed for an oncology
indication, are now being employed to deplete autoreactive cells, enabling controlled immune reset.
The approach aims to restore tolerance & deliver durable remission in autoimmune disease.

Targeted depletion of defined cell populations is a powerful therapeutic strategy across oncology, autoimmunity, and transplantation. Some of the first antibodies used in the clinic acted to eliminate pathogenic T cells and since then the field has expanded rapidly to include diverse mechanisms of action to drive target cell depletion. Strategies currently include enhancing effector cell mediated cytotoxicity (for example, through check-point inhibition), ADCC driving antibodies and antibody-drug-conjugates (ADC), T cell engagers, and cellular therapies. Many of these strategies are now moving beyond oncology back into autoimmune indications. As these depletion-based modalities continue to grow, robust human primary cell in vitro systems are essential to improve the translational reliability of preclinical findings.
This talk will outline assay approaches that enable evaluation of therapeutic depletion across disease areas, covering both oncology and autoimmune models, and spanning simple 2D formats through to more physiologically relevant 3D system

This talk will cover concepts of Prior knowledge and utilization of Platform approaches in CMC unit operations to fast forward development process to bring medicines faster to patients

Individualized cancer vaccines target patient- & tumor-specific genetic alterations that can be recognized by the immune system. Nykode Therapeutics has developed a proprietary DNA-based neoantigen vaccine. Here we describe the complexity of manufacturing individualized vaccines and highlight clinical biomarker data showing robust induction of cancer-specific immune responses in patients.

The VIP Blueprint: Examining how the UK Vaccine Innovation Pathway, the first 'Clinical Trials Delivery Accelerator' transformed timelines for infectious disease vaccine and mRNA therapeutic clinical trials.
Strategic Policy Alignment: Integrating research infrastructure with the Life Sciences Sector Plan, 10-Year Health Plan, and National Cancer Plan to prioritise national research delivery.
The NIHR Industry Hub: Establishing a 'Single Front Door’ to restore predictability in trial setup, featuring bespoke pathways for MedTech, Biotech, and HealthTech to ensure the UK remains a competitive global destination for clinical innovation.

Antigen-specific immune tolerance (ASIT) offers targeted autoimmune therapy without broad immunosuppression.
Nykode Therapeutics is advancing a modular dimeric protein platform that targets disease-specific antigens to antigen-presenting cells (APCs) for precision immune modulation and durable tolerance.
Preclinical data show promising tolerogenic effects in Experimental Autoimmune Encephalomyelitis and Non-Obese Diabetic mouse models.

This presentation highlights the growing demand for responsibly sourced alternatives to traditional animal-derived ingredients, focusing on fermentation-derived non-animal-origin (NAO) squalene. It addresses the significant environmental concerns associated with sourcing squalene from shark liver oil and explores how NAO squalene can serve as a sustainable alternative, particularly in vaccine adjuvant formulation.

•Use LLM and AI to identify and annotate experimentally verified protective antigens and vaccine adjuvants and their mechanisms.
•Develop machine Learning methods for protective antigen and adjuvant prediction.
•Various bacterial and viral use case demonstrations

Developing analytical tools for pandemic vaccines.
Using assays to assess vaccine immunogenicity and immune response

CMC requirements specific to DNA-based vaccines, including manufacturing, characterisation, and control strategy considerations
Application of CMC principles through a development case example
Key regulatory considerations to support successful progression of DNA-based vaccines

- Manufacturing, especially CMC, plays a crucial role in enabling fast vaccine development.
- New technologies can help overcome CMC challenges, making vaccine production quicker, more scalable, and accessible to all who need them.
- An overview of CEPI-funded innovations that accelerate the development of protein-based vaccines is presented.

We have growing knowledge of mRNA sequence-function relationships, which is encoded both in traditional mechanistic models and in recent AI models
These sequence-function relationships enable us to control various aspects of mRNA Therapeutic function, including efficacy and safety
The presentation will outline our work on the design and validation of software that implements standardised design principles based on known sequence-function relationships

• What regulators expect at different phases of clinical development
• The challenges around classification and how these definitions impact regulatory strategy
• Analytical requirements and their implications for compliance
• Case studies where lack of regulatory clarity delayed or redirected development
• How to engage proactively with regulators to avoid roadblocks
• How to optimise clinical trial delivery?
• Working with industry and making the UK a better place to bring more clinical trials

• The AI-Immunology™ platform identified novel B‑cell and T‑cell antigen candidates relevant for CMV immune control
• Serum against AI-predicted novel B-cell antigens demonstrated in vitro protection against HCMV, reducing both cell infection and cell‑to‑cell viral spread
• AI-identified T-cell epitopes from novel targets elicited protective T-cell responses in MCMV infection models

Rapid vaccine turnaround

Personalized neoantigen discovery powered by AI

Preclinical success across major cancers

Our mission is to develop high-performing lipid nanoparticles for delivering therapeutics and vaccines. I will discuss our digital-first approach to designing novel ionizable lipids, optimizing formulations, and planning experiments to meet customer needs, with a focus on molecular modeling and integrated high-throughput experimentation in our labs.

· Microalgae extracellular vesicles (MEVs) can be used for the oral delivery of selected payloads to the intestinal epithelium and gut-associated lymphoid tissue (GALT), enabling the induction of IgA-rich immune responses.

· Design-first principle: AGS’s MEV-based delivery platform was engineered from the outset around downstream constraints — including route of administration, manufacturability, payload class, loading strategy, and regulatory expectations — in order to avoid the failure modes observed in prior delivery systems.

• Key lessons learned from the evolution of the six major vaccine platforms—from Jenner and Pasteur to mRNA and AI designed vaccines
• The transition from preventive to therapeutic vaccines targeting infectious diseases and chronic conditions
• Emerging hot topics in vaccines and anti infection disease innovation

• AI-driven approaches in vaccine discovery
o Antigen and epitope discovery
o Rational vaccine design
• AI-driven approaches in vaccine development
o Product optimisation / manufacturing
o Clinical design and execution
o Regulatory considerations

Innate immune models that mirror clinical reactogenicity by profiling TLR and RLR activation and forecasting dose‑dependent inflammatory signatures consistent with clinical biomarkers.
Adaptive human immune assays that reconstruct vaccine outcomes by driving class switching, affinity maturation, and functional T‑cell responses within T/B‑cell cocultures and germinal‑center analogs.

• The T cell receptor (TCR) repertoire holds huge amounts of information on past, present and future immune responses of an individual
• Unlocking this potential is possible using in-depth TCR data analytics and TCR-epitope annotations, with ImmuneWatch DETECT as demonstrated best-in-class software solution
• We present concrete applications of this technology, which include immune monitoring of T cell responses after vaccination or immunotherapy, TCR biomarker identification, characterising adoptive T cell
therapies, and patient stratification

Carbene Footprinting is a novel technique to map the binding sites of proteins with their binding partners
Advanced bottom-up proteomic workflows are used to analyse samples
High resolution spatial data to inform drug development

Vixen Bio’s framework replaces standard buffer screening with physiologically relevant environments to accurately predict clinical performance.
• Early Physiological Insight: Testing in serum or plasma reveals antibody behaviors and critical flaws that conventional buffers miss.
• Rapid Effector Profiling: Patent-pending assays deliver ADCC, ADCP, and CDC results in under 2 hours without the need for target cells.
• Precision Patient Matching: By testing candidates directly in patient blood, we assess both drug efficacy and immune fitness to optimize clinical inclusion/exclusion

Red Peak Therapeutics is advancing next-generation immunotherapies by identifying clinically relevant immunogenic epitopes. Conventional antibody discovery approaches often fail to capture native protein conformations, limiting their ability to identify effective targets.

Our proprietary Maxitope platform overcomes this limitation by discovering peptides that mimic native protein structure, enabling efficient prioritisation of high-value targets prior to experimental validation. This is complemented by human B-cell repertoire mining, allowing the generation of fully human monoclonal antibody candidates with enhanced clinical relevance.

Our lead programme focuses on selectively targeting Epstein–Barr virus–infected cells in multiple sclerosis, offering a more precise alternative to broad immunosuppression. Proof-of-concept studies in SARS-CoV-2 further demonstrate the platform’s versatility and potential across multiple disease areas.

• CMC requirements specific to DNA-based vaccines, including manufacturing, characterisation, and control strategy considerations
• Application of CMC principles through a development case example
• Key regulatory considerations to support successful progression of DNA-based vaccines

• Is the western world developed enough?
• What are the challenges that vaccines could overcome?
» Cost of manufacturing
» Impact on global health