ImmunoGenesis Expands Phase 1a/b Trial of IMGS-001 for Advanced Solid Tumors to Ochsner MD Anderson Cancer Center

First dual-specific PD-L1/PD-L2 antibody with cytotoxic killing function is designed to treat the many “immune-excluded” cancers that are resistant to existing immunotherapies

Promising early signals of activity seen as Phase 1 dose escalation proceeds

HOUSTON, May 01, 2025 (GLOBE NEWSWIRE) -- ImmunoGenesis, a clinical-stage biotechnology company developing innovative, science-driven immune therapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising clinical therapies, today announced expansion of the Phase 1a/b clinical trial of ImmunoGenesis’ lead candidate, IMGS-001, to Ochsner MD Anderson Cancer Center in southeastern Louisiana. IMGS-001 is a novel dual-specific PD-L1/PD-L2 antibody with cytotoxic killing function designed to treat immune-excluded, cold tumors that are resistant to existing immunotherapy. The Phase 1a/b trial is being partially funded by a previously announced investment from Cancer Focus Fund.

/EIN News/ -- “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’re seeing promising signs of clinical activity in patients who have failed prior treatments. Expanding our trial to Ochsner MD Anderson, with its excellent clinical research staff, will accelerate our progress toward establishing initial proof-of-concept and offering more patients access to this potentially groundbreaking approach.”

While first-generation PD-(L)1 checkpoint inhibitors have become a mainstay of cancer treatment, more than half of all cancers are “cold” immune resistant tumors that do not respond to these immunotherapies. IMGS-001 is designed to unlock the potential of immunotherapy for a broader group of patients by targeting key mechanisms of immune resistance, using a single engineered molecule to overcome immunosuppression through cytotoxic killing function and optimizing the PD-1 pathway blockade. In preclinical studies, IMGS-001 demonstrated superior survival benefit and tumor growth inhibition compared to currently approved checkpoint inhibitors.

The Phase 1a/b 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. Anticipated tumor types in the dose expansion portion of the study include ovarian, colorectal, and triple-negative breast cancer.

Daniel Johnson, MD, director of the Center for Innovative Cancer Therapies (Phase 1) at Ochsner MD Anderson and lead investigator of the IMGS-001 Phase 1a/b trial at Ochsner, noted, “My research focuses on advancing new strategies to combat immune checkpoint inhibitor resistance while minimizing immunotherapy-related side effects. IMGS-001 has a novel mechanism that has the potential to overcome the key resistance mechanisms in immune-excluded tumors. Based on the results of preclinical studies and the promising signals seen in trial participants to date, we believe IMGS-001 may have the potential to improve clinical response for patients with these difficult-to-treat cancers. We welcome the opportunity to participate in this trial and to make it available to eligible patients in our care.”

Ochsner MD Anderson is part of a collaborative network of hospitals and health care systems dedicated to advancing MD Anderson’s mission to end cancer. Ochsner MD Anderson patients in southeastern Louisiana receive care based on the same protocols and practice standards provided at MD Anderson in Houston, Texas. Ochsner MD Anderson experts provide access to a full range of multidisciplinary cancer care options, as well as to clinical trials of investigational drugs, when appropriate. Ochsner’s Center for Innovative Cancer Therapies has been leading first-in-human Phase 1 oncology clinical trials since 2016.

Ross Barrett, a founder and Managing Partner of Cancer Focus Fund, said, “We believe that IMGS-001 has the potential to treat the many tumors that are resistant to current immunotherapies, and we are delighted that the Phase 1a/b trial is expanding to Ochsner MD Anderson. At Cancer Focus Fund we are proud to work collaboratively with leading institutions whose efforts to advance innovative new cancer therapies are generating promising results.”

About the IMGS-001 Phase 1a/b Clinical Trial
The IMGS-001 Phase 1a/b trial is a first-in-human, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumor activity of IMGS-001. Phase 1a is a dose-escalation study that aims to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to appropriate standard-of-care treatments. Phase 1b is an open-label, dose-expansion cohort study of patients with prespecified tumors intended to further assess the safety and preliminary anti-tumor activity of IMGS-001.

About IMGS-001
IMGS-001 is a PD-L1/PD-L2 dual-specific inhibitor with engineered cytotoxic effector function. It is the first molecule to target PD-L2 in addition to PD-L1, potentially shutting down the entire PD-1 pathway and providing a superior blockade compared to other PD-1 or PD-L1 inhibitors. Its engineered effector function enables IMGS-001 to kill 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 superior survival rates and tumor growth inhibition in head-to-head studies compared to currently available immunotherapies. With its cytotoxic killing function and superior blockade, IMGS-001 may provide a new foundation for combination immuno-oncology therapies. This Phase 1a/b study is being conducted with support from an investment from the Cancer Focus Fund, LP and the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094.

About Ochsner MD Anderson Cancer Center
Ochsner MD Anderson Cancer Center provides patients in the South Gulf region with access to cancer treatments that are among the most advanced in the nation. As Louisiana’s leader in cancer care, Ochsner Health has joined forces with MD Anderson, the nation’s leader in cancer care, to bring an enhanced level of comprehensive cancer care to patients. Ochsner is the first and only provider in Louisiana with a fully integrated cancer program based on MD Anderson’s standards and treatment plans. It offers customized treatment plans with access to cutting-edge technology, a multidisciplinary approach, and potential access to clinical trials.

About Ochsner Health
Ochsner Health delivers health to the people of Louisiana, Mississippi and the Gulf South with a mission to Serve, Heal, Lead, Educate and Innovate. It is the leading nonprofit healthcare provider in the Gulf South, delivering expert care at its 46 hospitals and more than 370 health and urgent care centers. In 2024, Ochsner Health cared for more than 1.6 million people from every state in the nation and 63 countries, and for 13 consecutive years, U.S. News & World Report has recognized Ochsner as the No. 1 hospital in Louisiana. Ochsner Health is innovating healthcare by investing in new technologies and research to make world-class care more accessible, affordable, convenient and effective.

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 immunogenesis.com

About Cancer Focus Fund
The Cancer Focus Fund LP is a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center. The fund provides investment support to advance promising cancer therapies that are close to being tested in humans or are in early clinical development, along with the clinical trial expertise and infrastructure of MD Anderson and strategic partners Ochsner Health System Precision Cancer Therapies Program New Orleans and the LSU Feist Weiller Cancer Center Shreveport. The Fund's objective is to leverage this unique combination to provide investors with superior risk-adjusted returns. In collaboration with MD Anderson, the Cancer Focus Fund provides both capital and translational research expertise with the goal of accelerating the development of novel cancer therapies that result in better outcomes for patients while generating returns for investors.

Disclosures
The University of Texas MD Anderson Cancer Center’s relationships with Cancer Focus Fund and ImmunoGenesis, and all research conducted at MD Anderson related to these relationships, has been identified as institutional financial conflicts of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore are managed under Institutional Conflict of Interest Management and Monitoring Plans.

Contacts

ImmunoGenesis
Corporate
James Barlow
President and CEO
James.barlow@immunogenesis.com

Cancer Focus Fund
Corporate:
Ross Barrett
Managing Partner
ross@cancerfocusfund.com

Media:
Barbara Lindheim
BLL Partners for Cancer Focus Fund
blindheim@bllbiopartners.com
(917) 355-9234