ImmunoGenesis to present IMGS-001 Phase 1a/1b Clinical Study Updates at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

IMGS-001 is first dual-specific PD-L1/PD-L2 antibody with cytotoxic killing function and is designed to treat the many "immune-excluded" cancers that are resistant to existing immunotherapies

HOUSTON, May 30, 2025 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, announced today that a Trial in Progress poster for its first-in-human, Phase 1a/1b clinical trial of IMGS-001 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois from May 30 to June 3, 2025.

This Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) includes a dose escalation and an 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. The study will enroll approximately 25 patients in Phase 1a and up to 250 in Phase 1b. The first three of five planned dose cohorts have completed without any dose limiting toxicities (DLTs), with cohort 4 (10 mg/kg) now enrolling.

"This clinical trial is an important first step to understand how IMGS-001 may potentially remove immunosuppressive cells while improving PD-1 pathway blockade to treat otherwise immunoresistant tumors that represent a significant unmet medical need," stated Charles Schweizer, PhD, Senior Vice President of Clinical Development at ImmunoGenesis. "We are pleased to discuss the study plan and progress at this important conference as we look ahead to sharing results."

"We are encouraged by the early performance of IMGS-001 as we proceed with Phase 1 dose escalation in patients with a variety of advanced solid tumors," said James Barlow, President and CEO of ImmunoGenesis. "Initial low doses administered to date have been well-tolerated with no dose-limiting toxicities, and we are seeing promising early signs of anti-tumor activity in patients who have failed prior treatments. IMGS-001 has the potential to be a foundational therapy for immune-excluded tumors, addressing a major unmet need."

ASCO Poster Presentation

Title: A Phase 1a/1b study to evaluate the safety, tolerability, Pharmakokinetics, and anti-tumor activity of IMGS-001 in Patients with relapsed or refractory advanced solid tumors.
Abstract: TS2686 | Poster Bd #: 324a
Track: Developmental Therapeutics—Immunotherapy
Location: Hall A -Posters and Exhibits | On Demand
Time: June 2, 2025, 1:30 PM – 4:30 PM CDT

About ImmunoGenesis

ImmunoGenesis is a clinical-stage biotech company dedicated to transforming immuno-oncology by targeting key mechanisms of immune resistance. The company's lead product, IMGS-001, is a cytotoxic, dual-specific PD-L1/PD-L2 antibody currently in a Phase 1a/b clinical trial for the treatment of immune-excluded ("cold") tumors, which account for more than half of all cancers. In addition to its lead program, the company is developing a number of novel approaches to overcome immune resistance in cold tumors. ImmunoGenesis designs therapies to address the pathology of these tumors, overcoming immune exclusion to elicit a robust immune response. For more information, visit www.immunogenesis.com. 

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. IMGS-001 is being developed with support from the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094 as well as an investment from the Cancer Focus Fund, LP.

Contact

ImmunoGenesis

Investors: 
James Barlow   President and CEO 
[email protected]

SOURCE Immunogenesis Inc.