On April 1, 2019 Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, and Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, reported that Triphase Accelerator’s TRPH-222, an anti-CD22 antibody-drug conjugate (ADC) for the treatment of patients with lymphoma, has been dosed in the first patient in a Phase 1 clinical trial (Press release, Catalent, APR 1, 2019, https://www.catalent.com/index.php/news-events/news/Triphase-Accelerator-Initiates-Phase-1-Clinical-Trial-of-TRPH-222-in-B-cell-Lymphoma-Next-Generation-Antibody-Drug-Conjugate-Developed-Using-Catalent-s-SMARTag-R-ADC-Technology [SID1234534806]). TRPH-222 was originally developed by Catalent’s subsidiary Redwood Bioscience, Inc. using the proprietary SMARTag platform, which provides optimized site-specific protein-modification and linker technologies. Triphase Accelerator obtained the worldwide rights to further develop this program and subsequently announced that Celgene had obtained the option to acquire all rights to the program as part of an expanded strategic collaboration.
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The Phase 1 clinical trial is a multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell non-Hodgkin lymphoma (NHL), which will be conducted in two stages, dose-escalation and dose-expansion. The study is currently enrolling patients at sites in the U.S. and Canada, including Roswell Park Cancer Center, University of Pennsylvania, Ohio State University, Sarah Cannon Research Institute, Princess Margaret Cancer Centre and Jewish General Hospital. Additional sites are planned to support the dose-expansion stage. More information about this study can be found at www.clinicaltrials.gov, Identifier NCT03682796.
"We are thrilled to advance the first SMARTag ADC into human clinical trials and evaluate its potential for better tolerability and an expanded therapeutic index as compared to conventional ADCs" said Dr. Mathias Schmidt, Executive Vice President and Head of Research & Development of Triphase Accelerator. "We look forward to assessing the potential clinical benefit of TRPH-222 in patients with relapsed/refractory B-cell lymphoma and remain convinced that this molecule can play an important role in the future treatment of lymphoma."
"We are excited to see Triphase Accelerator reach this important milestone with TRPH-222," added Mike Riley, Vice President and General Manager, Catalent Biologics. "The SMARTag technology has the potential to create ADCs with significantly higher tolerability and expanded therapeutic index. The improved conjugate stability and biophysical characteristics of TRPH-222 has translated to improved tolerability in preclinical testing, and we look forward to further validation in the clinic."