Pre-Conference Seminar Day

As the ADC landscape become increasingly crowded around established payload mechanisms and targets, leveraging chemistry and technological innovation is crucial to pursue novel ADC payloads and targeting moieties to develop differentiated ADCs that provide long-term patient benefit

Join this popular seminar day to stay ahead of the ADC design curve across discovery and performance of non-cytotoxic payloads, bispecific and fragment-conjugates, and dual payload ADCs

• Breaking down the exciting landscape of novel drug conjugate design and mechanism of action
• Exploring emerging trends across conjugate design and targets
• Spotlighting novel conjugate innovation across multi payload ADCs, bispecific ADCs, and degrader antibody conjugates

• Examining CEACAM6 as a tumour-specific target in hard-to-treat solid tumours
• Leveraging cutting edge ADC design to achieve precise targeting with broad therapeutic potential
• Building state-of-the-art ADC constructs targeting CEACAM6

• Showcasing SMARTag® Enhanced Conjugates , designed to improve efficacy and potency through cytotoxic and non-cytotoxic dual payloads combined in a single ADC using our industry-recognised stable linkers
• Presenting novel in vitro and in vivo efficacy, PK, and tolerability data highlighting Enhanced Conjugate impacts on overcoming common barriers to effective treatment
• Highlighting applications of Enhanced Conjugates to Catalent’s ADC pipeline

• Explaining how bispecific ADCs improve efficacy by engaging two antigens, reducing the risk of escape from antigen loss or tumour heterogeneity
• Pursuing a “Two-Hit” Approach: Combining complementary payloads (e.g., DNA-damaging + DDRi) to deliver a “two-hit” attack, heightening tumour kill and resistance barriers
• Optimising bispecific ADC dual binding to improve tumour specificity, internalisation, and safety by balancing antigen engagement

• Undergoing development of RB-601, a bispecific nano ADC
• Highlighting RRB-601 advantages against classical bispecific ADCs across tumour tissue penetration, improved anti-tumour activity and superior tolerability profile
• Exploring ongoing biomarker and clinical trial with potential across solid tumour indications

• Exploring the FORCETM modular drug delivery approach to enable widespread distribution of AOCs and chemically diverse therapeutic payloads to muscle and the CNS
• Assessing clinical data from DYNE-101 ACHIEVE trial in patients with DM1 and DYNE-251 DELIVER trial against DMD
• Contextualising how the encouraging clinical data and preclinical efficacy in FSHD and Pompe models supports the potential of FORCETM and AOCs to address neuromuscular disorders with high unmet medical needs

• Understanding AOC novel therapeutic approaches for targeted oligonucleotide delivery to skeletal and cardiac tissues
• Showcasing early clinical promise of AOCs in treating rare muscle diseases like DM1, FSHD, and DMD
• Explaining AOC platform extension to precision cardiology, expanding the potential of oligonucleotide-based therapies

Even with 2025 seeing ADCs rival oncology standard of care performance and multiple new regulatory approvals, clinical toxicity still remains the largest hurdle to widen ADC therapeutic index and accomplish widespread impact for patients

Don’t miss this important seminar spanning the breadth of ADC toxicity including in vivo and in vitro model to predict clinical tolerability, harnessing masked payload technology to improve off-target toxicity and clinical mitigation strategies to deliver safer, more effective ADCs

• Contextualising the field’s prioritisation of novel ADC payloads and design in next-generation ADC development
• Understanding toxicity challenges and opportunities for novel and dual payload ADCs
• Exploring ongoing development, promise and opportunities of bispecific ADC programmes

• Recapitulating clinically relevant ADC toxicity in an acute rodent IV infusion model to increase efficiency and reduce costs within payload discovery screening
• Utilising infusion models to better understand potential species-specific sensitivities to ADCinduced toxicities
• Giving merit for infusion models to inform anticipated ADC payload PK exposures, respective of SOC or comparator drugs, to aid risk benefit analysis for ADC approaches

• Overviewing biomarkers for ADC-Induced pulmonary toxicities
• Defining responsibility by discussing who should lead clinical ADC sample-based translational research for safety
• Addressing the gap between preclinical toxicity teams and clinical safety teams
• Case study: Exploring ILD concerns in HER2- targeted ADCs – how are biomarkers in blood helping refine prediction and how can we monitor and treat ADC toxicities?

• Identifying and addressing off-target toxicities caused by ADCs
• Laying out experience of ocular toxicity in the clinic, including prevention strategies to mitigate patient impact
• Exploring an example of ongoing efforts to address the mechanistic understanding of ocular keratopathy and prophylactic approaches to mitigate severity

• Exploring mechanistic insights across cellular and molecular pathways driving ADC-induced interstitial lung disease in preclinical and clinical contexts
• Overviewing emerging translational biomarkers for early detection and patient risk stratification
• Intervention strategies: Exploring preventive and therapeutic approaches to mitigate pulmonary toxicity and improve clinical safety

• Demonstrating rationale to develop masked ADCs to overcome challenges with target-mediated toxicity
• Highlighting development of ADCs leveraging masking technology including preclinical efficacy and safety profiles
• Looking ahead: What is the potential for masked ADC technology to deliver improved safety performance and therapeutic index?

To close out the seminar day, re-group with the Toxicity Day presenters for a final panel discussion. Bring your unanswered questions across in vivo and in vitro prediction of clinical toxicities, innovative methods to improve tolerability through ADC design, and best practices to identify and mitigate ADC-induced adverse events.

As ADCs become more prevalent in a busy clinical landscape, the role of ADC combinations and sequencing is increasingly important to deliver enhanced therapeutic benefit to patients

Take part in the Combination Seminar Day to delve into clinical combination design and performance, understand the potential of dual-payload conjugates and sequencing to combat payload resistance, and discover science-driven approaches to select the optimal combination partner to optimise your ADC combination strategy and performance

• Overviewing enfortumab vedotin (EV) and combining with pembrolizumab
• Reflecting on previous clinical data of EV in combination with pembrolizumab in locally advanced or metastatic urothelial cancer
• Exploring recent clinical combination data of EV-pembrolizumab combinations with pembrolizumab in muscle-invasive bladder cancer

This is your opportunity to present newly published ADC combination data in front of our specialised audience of industry experts. Data must be published and available to be presented ahead of the deadline of Friday, 31st January.

Please email [email protected] to register your interest.

• Bringing in the clinician perspective to understand the efficacy performance from ADCs administered sequentially
• Assessing real-world data to analyse the impact of current ADC sequence therapies
• ADCs biomarkers: Exploring data demonstrated so far and connection to ADC sequences

• Assessing preclinical combination thesis: What are the best agents to combine with ADCs?
• Breaking down preclinical investigation and use of models to understand ADC combination mechanism and rationale
• Contextualising the landscape and future perspectives of ADC-therapeutic agent combinations

• Laying out rational-driven opportunities to improve ADC combinations through knowledge of ADC design and targeting
• Understanding the role of epitope selection and antibody affinity in ADC immune agonists combination performance
• Incorporating ADC design principles and applications to enhance ADC combinations

• Understanding rationale and synergy considerations for dual payload ADC development to overcome payload resistance challenges
• Highlighting development and reasoning for dual payload ADC products with different payload mechanisms
• Delving into preclinical data of two dual payload ADC products

Re-join your expert speakers in a closing panel discussion as they explore the impact of ADC combination on the oncology treatment landscape, best rationale to select appropriate ADC combination partners, ability to combat ADC payload resistance.

Make sure to come with your thoughts and questions prepared!

By blending small and large molecule components, and more complex conjugates on the horizon, ADCs present additional hurdles and considerations to ensure a robust regulatory CMC strategy and best set up ADC regulatory submissions for success Exploring sponsor and regulator perspectives, don’t miss these important sessions laying out ADC regulatory CMC fundamentals, providing technical insights for impurity control strategy, and assessing regulator expectations and feedback to elevate your ADC regulatory CMC knowledge base

• Understanding the core principles of ADCs from a regulatory CMC perspective
• Understanding the need for ADC-specific regulatory guidance as complex biologic and small molecules
• Identifying the gaps in ADC regulatory CMC guidance and the need for further clarity and regulatory legislation

• Issuing guidance for industry sponsors and regulatory agencies to assess safety of impurities in drug-linker intermediates used to produce ADCs in oncology
• Evaluating conjugatable impurities in ADC drug-linkers for potential toxicological risks for all clinical stage and approved ADCs
• Developing a methodology to assess the level of concern and justify specifications for non-conjugatable organic impurities
• Qualification divergence: drug-linker impurities versus small molecule API impurities

• Understanding the NCA´s perspective to ADC regulatory CMC as a promising emerging modality
• Offering scientific advice and principles for ADC regulatory CMC strategy
• Laying out commonly asked questions raised by sponsors in Clinical Trial Applications for ADCs

Aligning on interpretation of regulatory expectations and maintaining beneficial communication between regulators and sponsors is crucial to set up ADC regulatory submissions for success and put forward future topics to prioritise.

Join individual table discussions moderated by ADC regulatory CMC experts to delve into pre-prepared discussion points surrounding the opportunities and setbacks of ADC regulatory CMC guidance. Make sure you come with your thoughts and questions prepared!

Discussion Highlights Include:

• Must-have versus nice-to-have: Is it clear what needs to be included in ADC data packages for regulatory submissions?
• Sharing experiences and takeaways from regulatory body interactions to maximise clarity and best action feedback on ADC programmes
• Putting forward top priorities and clarifications for ADC-specific regulatory CMC guidance
• Looking to the future: Anticipating how ADC regulatory CMC principles apply to emerging novel ADC modalities

• Leveraging agency feedback focusing on clinical submissions, highly relevant for sponsors navigating evolving requirements for ADCs
• Providing case examples of successful navigation or challenge resolution in early-phase ADC CMC filings
• Breaking down takeaways from case study analyses to aid sponsor interpretation and application of global regulatory standards for ADCs

Join this closing roundtable session with leaders in ADC regulatory CMC field to break down the key learnings from the seminar day. With your fellow speakers and attendees, discuss, debate and evaluate the opportunities and challenges in ADC regulatory CMC guidance, analytical control strategy, creating development packages, and more.