Friday, September 29, 2023
ImmunoGenesis has recently announced the initiation of its Phase 1a/1b clinical trial for its lead candidate, IMGS-001, at The University of Texas MD Anderson Cancer Center in Houston, Texas. IMGS-001 is a groundbreaking antibody engineered to simultaneously target programmed cell death 1 ligand 1 (PD-L1) and programmed cell death 1 ligand 2 (PD-L2) with cytotoxic capabilities, aiming to address the challenge of treating immune-resistant cold tumors.
The Phase 1a/1b clinical trial, identified as NCT06014502, is an open-label, multicenter study that includes both dose escalation and expansion phases. It seeks to assess IMGS-001's safety, pharmacokinetics, and initial anti-tumor efficacy in adult patients with locally advanced or metastatic solid tumors unresponsive to standard-of-care treatments. The initial phase of the study will encompass patients with ovarian, colorectal, and triple-negative breast cancer.
James Barlow, President and CEO of ImmunoGenesis, highlighted the pressing need for improved treatments for tumors that are unresponsive to current immunotherapies. He expressed the company's vision of expanding the benefits of immunotherapy to a broader patient population by targeting critical mechanisms of immune resistance. Barlow anticipates that this study will provide an initial proof of concept for their innovative approach, which involves using a single molecule to tackle both immunosuppression and PD-1 pathway blockade.
Dr. Jeremy Barton, Acting Chief Medical Officer at ImmunoGenesis, provided insight into the rationale behind IMGS-001's design. He emphasized that PD-L1 and PD-L2 are not only present on tumor cells but also on immunosuppressive cells within the tumor microenvironment. IMGS-001 is specifically engineered to target these immunosuppressive cells, potentially enhancing the effectiveness of PD-1 pathway blockade. This Phase 1a/1b clinical trial represents a critical initial step in validating this approach as a potential solution for the treatment of cold tumors that typically resist immunotherapy.
IMGS-001 is a dual-specific monoclonal antibody that uniquely targets both PD-L1 and PD-L2 while possessing cytotoxic capabilities. It is the first candidate in clinical testing to address PD-L2 alongside PD-L1, potentially improving PD-1 pathway blockade. Preclinical studies have demonstrated that IMGS-001 achieved higher response rates when compared to existing immunotherapies. This innovative approach could establish IMGS-001 as a foundational therapy with its multitasking mechanism, combining superior blockade and cytotoxic effector function. The development of IMGS-001 has received support from the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094 and an investment from the Cancer Focus Fund, LP.
