SAN DIEGO - Triphase Accelerator and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced interim results for Triphase Accelerator's multi-center, open-label, monotherapy study of TRPH-222 in heavily pre-treated patients with relapsed and/or refractory B-cell lymphoma.
The primary aim of the study is to determine the maximum tolerated dose of TRPH-222, with secondary aims of assessing safety, anti-tumor activity, and pharmacokinetics of the drug.
In the ongoing two-stage study, TRPH-222 is administered once every three weeks. To date, results in 19 heavily pre-treated patients with non-Hodgkin's lymphoma have been evaluated, with five confirmed to have had a complete response at TRPH-222 doses of 0.6 to 5.6 mg/kg. Tumor reductions have been observed in patients with both indolent and aggressive disease, and durable responses to date have been observed in follicular, diffuse large cell, and mantle cell lymphoma patients. The trial is currently ongoing with a 10 mg/kg dose cohort.
Throughout the trial, which began in February 2019, TRPH-222 has been well-tolerated, with an overall benign safety profile. Notably, no peripheral neuropathies, which are typically observed with ADCs containing microtubule-interfering payloads, were observed in the patients to date. Similarly, elevations in liver enzymes and alterations in blood cell parameters, also commonly observed with ADCs, have been infrequent and mild and have reversed in all patients.
'The feedback from our investigators regarding the overall safety profile of TRPH-222 is very encouraging,' commented Nancy Levin, Ph.D., Vice President of Development, Triphase Accelerator and TRPH-222 program lead. 'We find that the current and emerging clinical data provide additional support for our preclinical observations of an excellent safety profile for this molecule,' she added.
Dr. Hernandez-Ilizaliturri, MD, Chief of the Lymphoma Section at Roswell Park, and lead investigator for the TRPH-222-100 study, stated that 'These interim results indicate that TRPH-222 is a very well-tolerated novel antibody-drug conjugate in this clinical study. The unique molecular design allows a higher delivery of the cytotoxic agent in the tumor bed, and, at the current doses tested, side effects have been mild and manageable. Of interest, clinical activity has been observed even at the lowest dose tested, and five complete remissions have been achieved in previously treated lymphoma patients. Together, our preliminary findings support our hypothesis that TRPH-222 is an active and safe novel targeted agent in B-cell malignancies.'
'Given the fact that heavily pretreated patients are not usually treated with a monotherapy, the observed responses together with the demonstrated safety profile make us feel very excited about the molecule and the SMARTag technology,' added Mathias Schmidt, Ph.D., Executive Vice President and Head of Research & Development of Triphase Accelerator.
'This is an important interim milestone for the program, and the data are important not only in the context of TRPH-222 but also because they signal broader opportunities for the general application of SMARTag technology to improve ADC tolerability and expand its therapeutic index,' said Penelope Drake, Ph.D., Director, Research & Development at Catalent Biologics.
TRPH-222 was originally developed by Catalent's subsidiary Redwood Bioscience, Inc. using its proprietary SMARTag platform, which provides optimized site-specific protein-modification and linker technologies.
TRPH-222 is a novel antibody-drug conjugate (ADC) composed of an anti-CD22 monoclonal antibody modified to allow site-specific conjugation of a maytansine payload via a non-cleavable linker. The drug, formerly called CAT-02-106, was developed by Catalent Biologics using its proprietary SMARTag technology and was licensed to Triphase Accelerator. CD22 is a cell surface protein expressed across all subtypes of B-cell lymphomas.
ABOUT TRIPHASE ACCELERATOR
Triphase Accelerator is a private drug development company with a primary focus on oncology and with operations in Toronto and San Diego. Triphase Accelerator is dedicated to advancing novel compounds through Phase 2 proof-of-concept clinical studies using a unique, science-based model that is faster and more cost-effective than traditional pharmaceutical and biotech industry drug development approaches. Triphase Accelerator was founded by the Ontario Institute for Cancer Research (OICR), in partnership with Toronto Innovation Acceleration Partners (formerly MaRS Innovation) and MaRS. It has a strategic relationship with Bristol Myers Squibb for oncology-focused drug development opportunities. In 2016, Celgene (now a Bristol Myers Squibb company) acquired the company's assets related to its proteasome inhibitor, marizomib (MRZ), which is currently in Phase 3 development for glioblastoma.
ABOUT CATALENT BIOLOGICS
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx cell line development technology, and 35+ commercially approved products. Catalent has recently acquired MaSTherCell, a technology-focused cell therapy development and manufacturing partner with expertise in autologous and allogeneic cell therapy that complements Catalent's industry-leading expertise and commercial success in gene therapy development, manufacturing and adeno-associated virus (AAV) vector production. Together, Paragon Gene Therapy and MaSTherCell have produced over 100 GMP batches across 60+ clinical and commercial programs.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.
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