8:00 am Registration & Morning Coffee

8:25 am Chair’s Opening Remarks

Improving the First Generation of Approved ADCs to Propel Treatments to Patients

8:30 am The Race to the Next Approval: Outlining the Exciting Clinical Progress in the ADC Field

Synopsis

  • Exploring exciting new clinical data in the ADC field and outlining the best path of progression to approval
  • Providing a late-stage clinical development overview of the most exciting clinical therapeutics

9:00 am Versatile & Robust Chemical Site-Specific Conjugation Platform: AJICAP® Technology

Synopsis

  • AJICAP® Conjugation: Examining how site-specific technologies are being employed in many of the next-generation ADCs due to the enhancement of clinically relevant biological properties observed in various preclinical studies
  • AJICAP® Linker: Demonstrating a novel hydrophilic linker technology that enables the versatile synthesis of homogenous DAR = 1, 2, 4, 8, and higher.
  • Demonstration of Bispecific and Trispecific antibodies produced by fully-chemical conjugation technology

9:30 am Expanding the Potential of ADCs: Bicyclic Peptide (Bicycle) Toxin Conjugates Offer Advancements Over Traditional ADCs

Synopsis

  • Bicycles are a unique therapeutic modality combining the pharmacology usually associated with a biologic with the manufacturing and PK properties of a small molecule
  • Bicycles are fully synthetic constrained peptides that bind with high affinity and selectivity that have a short systemic exposure with tumour retention
  • Bicycles can be used to deliver key pharmacological activity for solid tumours using cytotoxic payloads and are currently being explored in the clinic as Bicycle toxin conjugates® (BTCs)

10:00 am Session Reserved for ICL Dover

10:30 am The Next Big Step: Perfecting ADC Design to Improve Clinical Outcome

  • Olga Ab Director, Product Team Lead, ImmunoGen

Synopsis

  • Mirvetuximab soravtansine (ELAHERE) has been recently approved by the FDA for the treatment of Folate Receptor alpha (FRα) positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 
  • Learning from mirvetuximab clinical experience to design a next generation FRα targeting ADC with improved activity against a broader patient population
  • Discussing scientific rationale, design and preclinical activity 

11:00 am Morning Networking Break & Refreshments

Discovery Stream

Discovery stream

 

Tailoring Your ADC Design to a Specific Target to Maximise Efficacy

 

11.30 Exploring How ATACs Overcome Resistance Mechanisms & Provide New Treatment Options for Difficult to Treat Cancers

• Amanitin based ADCs (ATAC®s) introduce a new mode of action into oncology therapy
• Exploring how the inhibition of RNA polymerase II offers new treatment options for difficult to treat cancers and high-risk patients by killing dormant tumour cells (CSCs, TICs)
• Reviewing how the unique MoA in combination with a biomarker for patient selection with high therapeutic needs could open ways for accelerated development

Torsten Heckler, Vice President, ADC Research, Heidelberg Pharma

 

12.00 Translational Considerations in the Development of CS5001, a PBD-Based ADC Against ROR1, a Low- Density Target in Solid Tumours

• Analysing CS5001, which is an ADC targeting ROR1 with a density of ~103 molecules/cell, armed with a potent payload (PBD) to enable efficient killing of both hematological and solid tumour cells
• Investigating the ROR1-dependency of CS5001 efficacy in human solid tumour cell lines (n=294) and animal models (CDX and TNBC PDX) with varying ROR1 levels relevant to its expression in human
• Providing further insights into the development of ADCs with a potent payload against low-density targets in solid tumour

Ying Pan, Senior Director, Translational Science & Biomarkers, CStone Pharmaceuticals

 

12.30 Designing ADCs With Efficient Tissue & Cellular-Level Distribution to Maximise the Therapeutic Window: Tailoring the Antibody, Linker, & Payload for Specific Targets

• ADCs have shown great success in the clinic over the past few years, but they are challenging drugs to develop given their complexity
• Using data from clinical and preclinical studies, learn how the features of effective ADCs can be optimised for a particular target to maximise efficacy at clinically tolerable doses
• Gain insight into how the tissue and cellular distribution of ADCs can be used to guide drug design from early in preclinical development to better predict clinical success

Greg Turber, Associate Professor, University of Michigan

 

13.00 Clickable ADCs at Scale by Functional Droplet Screening & Site-Specific Conjugation

• Functional antibodies are rare: VERAXA can screen entire B-cell repertoires fast and identify highly specific mAbs that internalize.
• Precise positioning: utilizing positional intelligence combined with site-specific conjugation we are learning how to modulate pharmacokinetics and efficacy.
• Target to Lead: Scaled and early generation of optimized ADC candidates on multiple targets within the year

Christoph Antz, Chief Executive Officer, Veraxa Biotech

Translational Stream
Clinical Lessons Stream
Process & Analytical Development Stream
Manufacturing & Supply Chain Stream

1:30 pm Lunch Break & WuXi’s Hosted Lunch Presentation: From Concept to Market: Accelerating ADC Development with WuXi XDC’s Fully Integrated Discovery & CMC Platforms

  • Jimmy Li Chief Executive Officer, WuXi XDC

Synopsis

• One-stop integrated discovery service platform focusing on bioconjugate lead selection that includes mAb/protein generation, payload linker synthesis, bioconjugate preparation, in vitro and in vivo characterization
• Fully integrated ADC CMC development and manufacturing with industry leading DNA to IND timeline of 15 months; mAb/payload-linker/conjugation DS & DP all by in-house team and facilities
• Vast ADC experience with 250+ discovery projects, 75+ CMC projects, 27+ INDs

Discovery Stream

Discovery stream

 

Novel Technologies in ADC Design

 

14.30 Is There a Need/Role for Radiolabeled Antibody for Non-Invasive Imaging in  ADC Development?

• Outlining radiolabeled antibody as immuno-PET agent for non-invasive imaging

• Exploring radiolabeled antibodies applied in preclinical and clinical ADC development

• Discussing Regeneron’s efforts in radiolabeled antibody non-invasive imaging in antibody therapeutic development

Dangshe Ma, Senior Director, Regeneron

 

15.00 “Total”, “Free”, & “Active” ADC Concentrations: Challenges to Pick the Right PK Assay

• Strategy to assess “total”, “free”, and “active” ADC concentrations

• Picking the right bioanalytical assay: What needs to be measured?

• Preclinical PK en human PK (prediction)

Benno Ingelse, Director Bioanalysis & Protein Interaction, Byondis

Translational Stream
Clinical Lessons Stream
Process & Analytical Development Stream
Manufacturing & Supply Chain Stream

3:30 pm Afternoon Networking Break & Technology Slam

Synopsis

As you enjoy your afternoon refreshments, you will also have the chance to be face-to-face with the field’s most innovative and exciting technology providers.

Join our dedicated technology slam to identify your next technology provider and progress your antibody-drug conjugate pipeline smoothly and efficiently.

Outlining the Options for ADCs Outside of Oncology

4:15 pm Industry Leaders’ Panel Discussion: Discussing the Possibility of Expanding ADCs to Alternative Indications

Synopsis

  • Discussing the potential of using of ADCs and novel formats in wholly new therapeutic areas including DLBCL, CAR-T cell therapy, and autoimmune diseases
  • Highlighting current efforts to develop ADCs effective in viral and bacterial infections
  • Outlining the limitations of the wider use of ADCs including cost, complexity of manufacturing, and supply chain challenges

4:45 pm Developing an Antibody-Antibiotic Conjugate for Melioidosis

  • Adam Taylor Senior Scientist, Defence Science & Technology Laboratory - DSTL

Synopsis

  • Discussing antibody selection based on in vitro cell infection assays
  • Developing a proof of concept antibody-antibiotic conjugate to deliver antibiotic to an intracellular site of infection
  • Analysing an in vitro assessment of the antibody-antibiotic conjugate activity

5:15 pm ZW191 – A FRa-Targeted ADC Employing Zymework’s TOPO1-Inhibitor Platform

  • Sam Lawn Director - Preclinical Programs & Antibody Drug Conjugates Therapeutic Development, Zymeworks

Synopsis

  • ZW191 integrates a highly effective FRa-targeting antibody with Zymework’s novel camptothecin-based TOPO1 inhibitor platform
  • Overview of preclinical studies demonstrating ZW191’s favorable activity and tolerability profiles
  • Discussing the potential for a differentiated ADC to deepen and expand responses in patients with tumors expressing a range of FRa levels

5:45 pm End of Conference Day Two