ImmunoGenesis and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Trial of IMGS-001 for Relapsed or Refractory Advanced Solid Tumors

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

Phase 1b will focus on tumors that are resistant to existing immunotherapy, which may include ovarian, colorectal, and triple negative breast cancers

HOUSTON, June 27, 2023 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotechnology company developing 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 cancer therapies, today announced that Cancer Focus Fund plans to invest $4.5 million to support the Phase 1a/1b clinical trial of ImmunoGenesis' lead candidate, IMGS-001. IMGS-001 is a dual-specific PD-L1/PD-L2 antibody designed to treat immune-excluded tumors, which are resistant to existing immunotherapy. The investment will support the portion of the IMGS-001 Phase 1a/1b multi-site clinical trial being conducted at MD Anderson. It coincides with ImmunoGenesis' Series A financing, which is expected to close in the third quarter.

"Overcoming the widespread resistance to immunotherapy in immune-excluded tumors requires re-envisioning the starting point for treatment," said Dr. Michael A. Curran, Founder of ImmunoGenesis. "We are addressing this challenge by developing a novel, dual–specific PD–L1/PD–L2 inhibitor engineered to include tumor-killing effector function – essentially addressing tumor pathology at the roots. Based on the results of preclinical studies, we believe that IMGS–001 has the potential to significantly improve clinical response over currently approved checkpoint inhibitors for patients with immune-excluded tumors."

IMGS-001 is based on discoveries made by the laboratory of Dr. Curran, Associate Professor of Immunology at MD Anderson, and by the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson's Therapeutics Discovery division. The technology was licensed to ImmunoGenesis in 2019.

"The Cancer Focus Fund Scientific Advisory Board is made up of expert scientists and clinicians and to be recommended for an investment by this group is an honor that we believe provides validation of the clinical potential for IMGS-001," said James Barlow, ImmunoGenesis President and CEO. "We believe that IMGS-001 has the potential to become the foundational treatment for immune-excluded tumors where there is both significant unmet need and tremendous market opportunity. This funding, combined with our upcoming Series A financing, will provide the opportunity to establish the initial proof of concept for this groundbreaking approach and bring hope, and potentially life-saving treatments, to the patients battling these difficult tumors." 

"Cancer Focus Fund was founded with the goal of assuring that innovative early-stage cancer therapies had the opportunity to undergo the rigorous clinical testing needed for advancement," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "We are thrilled at the opportunity to invest in the exciting new approach to cancer immunotherapy pioneered by Dr. Curran – our first investment in a discovery made at MD Anderson and developed by a biotechnology company located here in Houston. Immune-excluded tumors are thought to represent more than half of all cancers and contribute to the high failure rates that limit the potential of cancer immunotherapy for too many patients. We welcome the opportunity to support ImmunoGenesis by investing in this promising candidate and look forward to the results of this important clinical trial."

About the IMGS-001 Phase 1a/1b Clinical Trial
This funding will support a Phase 1a/1b, 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 antitumor activity of IMGS-001. Dr. David S. Hong, Professor of Investigational Cancer Therapeutics at MD Anderson, will serve as Principal Investigator of the trial.

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 inhibitor with engineered cytotoxic effector function. IMGS-001 is the first molecule to target PD-L2 in addition to PD-L1. This means that IMGS-001 has the potential to shut down the entire PD-1 pathway and provide a superior blockade compared to other PD-1 or PD-L1 inhibitors. The engineered effector function enables IMGS-001 to kill immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, which may enable it to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove substantially higher response rates in head-to-head studies vs. currently available immunotherapies. With its innovative multi-tasking mechanism of superior blockade and killing function, IMGS-001 may provide a new foundation for combination therapies.

About ImmunoGenesis
ImmunoGenesis is a clinical-stage immuno-oncology biopharmaceutical company re-envisioning the treatment of immune-excluded tumors. Immune-excluded tumors, which account for more than half of all cancers, are characterized by having mechanisms of resistance that suppress the immune response. ImmunoGenesis is creating therapies based on the pathology of these immune-excluded tumors that are rationally designed to overcome immune exclusion and thereby drive an effective immune response. For more information, visit www.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 by supporting significant advances in cancer treatments. In collaboration with partner 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
Dr. Curran's financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

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 Cancer Focus Fund or ImmunoGenesis, have 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.

SOURCE Cancer Focus Fund and ImmunoGenesis