TORONTO and SAN DIEGO, May 01, 2017 (GLOBE NEWSWIRE) -- Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announces they have completed pre-IND and pre-CTA discussions with both the United States Food and Drug Administration (FDA) and Health Canada. These discussions clear the way for the company to pursue its early clinical development strategy for the investigational product TRPH-222 for the treatment of patients with lymphoma.
“Our discussions with both FDA and Health Canada provided clear direction regarding the data needed for a successful IND and Clinical Trial Application to initiate lymphoma clinical trials in the US and Canada, respectively,” said Mohit Trikha, Ph.D., president and CSO of Triphase Accelerator. “We believe that the outcomes of these meetings diminish the risk of early regulatory setbacks and will make for a faster development process for TRPH-222, and allow us to help accelerate drug development and bring important potential treatments to those patients in need.”
TRPH-222 is a novel, site-specific antibody-drug conjugate (ADC) targeting CD22, a B-cell-restricted sialo-glycoprotein that is an important modulator of B-cell signaling and survival, and is expressed on nearly all B-cell malignancies. CD22 is a clinically validated ADC target with potential in Non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). The compound itself combines a site-specific modified humanized antibody conjugated to a cytotoxic payload using Hydrazino-Pictet-Spengler (HIPSTM) chemistry and a proprietary 4AP linker.
Pre-clinical data have shown that this optimization of payload placement and linker composition, combined with the stability afforded by HIPS chemistry, leads to better tolerability and expanded therapeutic index. TRPH-222 is currently in IND enabling GLP studies.
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, high-quality model that is faster and more cost-effective than traditional pharmaceutical and biotech industry drug development approaches. Triphase Accelerator was spun out of the Ontario Institute for Cancer Research (OICR), with support from the Fight Against Cancer Innovation Trust (FACIT), MaRS Innovation and MaRS. For more information, visit www.triphaseco.com or LinkedIn.