On September 28, 2023 ImmunoGenesis, a clinical-stage biotechnology company developing science-driven immunotherapies, reported the first patient has been dosed in the company’s Phase 1a/1b clinical trial of its lead candidate, IMGS-001, at The University of Texas MD Anderson Cancer Center in Houston, Texas (Press release, ImmunoGenesis, SEP 28, 2023, View Source [SID1234635509]). IMGS-001 is a dual-specific programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 ligand 2 (PD-L2) antibody engineered with cytotoxic function designed to treat cold, immune-excluded tumors, which are resistant to existing immunotherapy.

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The Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment. Anticipated tumor types in the dose escalation portion of the study include ovarian, colorectal and triple-negative breast cancer.

"Many tumors are not responsive to the current immunotherapies, representing a significant unmet need," said ImmunoGenesis President and CEO James Barlow. "Our vision is to unlock the potential of immunotherapy for a broader group of patients by targeting key mechanisms of immune resistance. We believe that this study will deliver initial proof of concept for our groundbreaking multitasking approach of using a single molecule to address immunosuppression and PD-1 pathway blockade."

"PD-L1 and PD-L2 are widely expressed not only on various tumors but also on immunosuppressive cells in the tumor microenvironment," said ImmunoGenesis Acting Chief Medical Officer Dr. Jeremy Barton. "IMGS-001 is designed to remove these immunosuppressive cells and potentially improve PD-1 pathway blockade. This Phase 1a/1b clinical trial is an important first step towards validating this approach as potentially effective in treating cold, immune-excluded cancers."

About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor
IMGS-001, the lead program at ImmunoGenesis, is a PD-L1/PD-L2 dual-specific monoclonal antibody with engineered cytotoxic effector function. IMGS-001 is the first molecule in clinical testing to target PD-L2 in addition to PD-L1, potentially improving blockade of the PD-1 pathway. The engineered effector function may enable IMGS-001 to eliminate immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, providing the potential to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove higher response rates in head-to-head studies compared to currently available immunotherapies. IMGS-001 may provide a new foundational therapy with its innovative multitasking mechanism of superior blockade and cytotoxic effector function. This work was conducted with support from the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094 as well as an investment from the Cancer Focus Fund, LP.