TORONTO and SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Triphase Accelerator, a private drug development company dedicated to advancing novel compounds through clinical proof-of-concept, today announced positive results from its ongoing Phase 1 multi-center, open-label, monotherapy study of TRPH-222 in heavily pre-treated patients with relapsed and/or refractory (R/R) B-cell lymphoma. The study results were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) in San Diego, California.
“TRPH-222 appears to be a very well-tolerated novel antibody-drug conjugate (ADC). The unique molecular design allows a higher delivery of the cytotoxic agent in the tumor bed with a mild and manageable side effect profile. Of interest, clinical activity has been observed even at the lowest dose tested, and six complete remissions had been achieved in previously treated lymphoma patients,” stated Dr. Hernandez-Ilizaliturri, MD, Chief of the Lymphoma Section at Roswell Park, and lead investigator for the TRPH-222-100 study. “Together, our preliminary findings suggest that TRPH-222 is an active targeted agent in B-cell malignancies, which given its’ very good tolerability could be combined with a range of therapeutic modalities to improve outcomes for our patients.”
“The feedback from our investigators regarding the overall safety profile of TRPH-222 is very encouraging, and the current and emerging clinical data confirm our preclinical observations of an excellent safety profile for this molecule,” commented Nancy Levin, Ph.D., Vice President of Development, Triphase Accelerator and TRPH-222 program lead. “Given that heavily pretreated patients are not usually treated with a monotherapy, the observed deep and durable responses together with its impressive safety profile makes us feel very excited about the continued clinical development of TRPH-222 in Non-Hodgkin Lymphoma,” she added.
TRPH-222 Oral Presentation (Session 623)
A Phase I Pharmacokinetic (PK) and Safety Study of TRPH-222 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL): Dose-Escalation Results
Key Results:
- TRPH-222 monotherapy is well tolerated through dose-escalation to 10 mg/kg, with a low incidence of AEs commonly associated with ADCs such as thrombocytopenia, neutropenia, liver transaminase increases, and peripheral neuropathy.
- Six complete responses (CR: 4 FL, 1 DLBCL, 1 MCL) and two partial responses (PR: 1 FL, 1 TFL) have been observed at doses from 0.6 to 7.5 mg/kg at the end of cycle 6. Five patients with CRs confirmed at the end of cycle 9 are now off treatment for up to 15 months while they continue to be in CR; patients are continuing to be followed for safety and response durability.
- The observed data, together with 100% CD22 receptor occupancy observed at all dose levels, and CRs/PRs observed at doses levels less than 10 mg/kg, support further assessment of TRPH-222 monotherapy in an expansion cohort currently enrolling R/R FL and DLBCL patients.
- These results also support further clinical studies of TRPH-222, including combinations with other antitumor agents in B-cell lymphoma patients.
More information about this study can be found at www.clinicaltrials.gov, identifier NCT03682796.
About TRPH-222
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. The approval of Besponsa in 2017, an anti-CD22 ADC for the treatment of relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL), supports the rationale for CD22 targeting in these diseases.
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) and FACIT, in partnership with Toronto Innovation Acceleration Partners (TIAP) and MaRS. It has a strategic relationship with Bristol Myers Squibb for oncology-focused drug development opportunities. For more information, visit www.triphaseco.com.