TRPH-222 Preclinical Development and Interim Phase I Data: Enhancing Clinical Safety and Overcoming ADC Manufacturing Challenges with SMARTag® Technology
Maximizing the therapeutic window and manufacturing well-defined antibody-drug conjugates (ADCs) are major challenges in the clinical development of ADCs. While higher doses of an ADC are considered desirable to improve tumor penetration and enhance therapeutic efficacy, this strategy has often failed to maintain a therapeutic window due to an undesired release of the payload to non-tumor tissues and organs. Further, non-site specific attachment of linkers to the antibody can lead to manufacturing challenges, poorly defined ADCs, and batch-to-batch variation, which can negatively impact regulatory filings and clinical outcomes.
What to Expect
During this webinar, experts from Triphase Accelerator and Catalent Biologics will discuss their collaboration to develop TRPH-222, the first ADC to reach the clinic using the SMARTag® site-specific conjugation technology from Catalent. TRPH-222 is a CD22-targeted ADC for the treatment of patients with B-cell lymphoma. Preclinical development and interim Phase Ia safety and efficacy data will be presented from Triphase’s multi-center, open-label, monotherapy study of TRPH-222 in heavily pretreated patients with relapsed and/or refractory B-cell lymphoma (NCT03682796).
Register and watch this webinar program On-Demand to learn about:
- TRPH-222, a novel ADC composed of an anti-CD22 mAb carrying a maytansine payload that is attached via the SMARTag® linker technology
- Phase I data in subjects with relapsed and/or refractory B-cell non-Hodgkin lymphoma
- Ongoing dose escalation, with current dosing at 10 mg/kg every 3 wk
- SMARTag® technology for site-specific conjugation and enhanced safety and tolerability of ADCs
Robyn Barfield, Ph.D.Group Leader, Chemical Biology, Catalent Biologics
Robyn Barfield received her Ph.D. in Cell and Molecule Biology from the University of Pennsylvania and did her postdoctoral work at the University of California, Berkeley. Robyn joined Redwood Bioscience in 2009 as one of their first scientists and helped build the bioconjugation team generating aldehyde-specific antibody drug conjugates. Since the acquisition of Redwood by Catalent in 2014, Robyn has continued to lead the bioconjugation group and is also involved in process development and partner collaboration.
Peter Hofland, Ph.D.Executive Editor, ADC Review | Journal of Antibody-drug Conjugates
Peter Hofland is the Executive Editor of ADC Review | Journal of Antibody-drug Conjugates, a comprehensive digital news platform and peer-reviewed publication focusing on innovative therapies in the treatment of cancer and hematological malignancies as well as research and development of ADCs Beyond Cancer®. Hofland contributes articles on the advances in ADCs, from initial discovery to approved and commercially available therapeutic agents. He is also the executive editor of Onco'Zine and a co-host of The Onco'Zine Brief, a radio/podcast show made for public radio.
Nancy Levin, Ph.D.Vice President, Development, Triphase
Nancy Levin joined Triphase in 2015 with more than 20 years’ experience in the biotechnology industry, and technical expertise in clinical and translational pharmacology and nonclinical development. Nancy was Vice President of Therapeutics Product Design Group at Intrexon Corporation (2013-2014), where she oversaw the conception and development of novel therapeutic partnering opportunities enabled by Intrexon’s proprietary cell- and DNA-based technologies. Prior to this, Nancy held positions of increasing responsibility at Pfizer (CovX Research, 2005-2013), X-Ceptor Therapeutics (2003-2004), MitoKor (2001-2003), and Trega Biosciences (1999-2001). Nancy’s biotechnology experience began at Genentech (1993-1996), followed by Amgen (1996-1999), where she led multiple discovery and target validation projects. Her breadth of therapeutic area expertise includes oncology, metabolic and cardiovascular diseases, dermatology, inflammation, endocrinology, and rare/ultra-rare genetic diseases. She has led programs from discovery into clinical proof-of-concept employing multiple therapeutic modalities including small molecules, antibody-drug and -peptide conjugates, peptides, proteins, and antibodies. Nancy’s development experience includes 19 IND/CTA filings, and 11 Phase 1 and 6 Phase 2 clinical proof-of-concept studies, responsible for clinical PK and biomarker study design and execution, PK modeling, clinical efficacy and safety data analysis and presentation, clinical protocol design and development, IND and Orphan Drug applications and annual reports, and complete IND-enabled submission packages for small and large molecules. She earned a Ph.D. in Endocrinology at the University of California San Francisco, followed by post-doctoral training in the Fishberg Research Center for Neurobiology at The Mount Sinai School of Medicine in New York, NY.