Acquisition Strengthens “Cold” Tumor Targeting Pipeline

  • ImmunoGenesis acquires rights to evofosfamide; Phase 2 clinical testing in combination with checkpoint blockade is planned for 2021
  • Evofosfamide is the only known reducer of solid tumor hypoxia, a driver of therapeutic resistance in immunologically “cold” tumors such as pancreatic & prostate cancer

HOUSTON, December 8, 2020 — ImmunoGenesis, Inc., a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers such as prostate, colorectal and pancreatic cancer, today announced that it has acquired the rights to the hypoxia-reducing agent evofosfamide. The company plans to initiate a Phase 2 clinical trial in 2021 investigating evofosfamide in combination with both CTLA-4 and PD-1 blockade in patients with castration-resistant prostate cancer (CRPC), pancreatic ductal adenocarcinoma (PDAC) and HPV-negative head and neck cancer (HNSCC).

Evofosfamide, a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM), was originally developed as a hypoxia-activated prodrug. Dr. Michael A. Curran, founder of ImmunoGenesis, discovered that evofosfamide can reduce hypoxia in solid tumors. Dr. Curran demonstrated in pre-clinical models that evofosfamide could restore T cell function and synergize with checkpoint inhibition.

Based on Dr. Curran’s work as Associate Professor of Immunology at The University of Texas MD Anderson Cancer Center, ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent (HRA) which could synergize with checkpoint blockade to drive efficacy in tumor types where checkpoint blockade monotherapy is ineffective. Dr. Curran’s financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

The planned Phase 2 trial is supported by data from a Phase 1 trial, both led by David S. Hong, M.D., Professor of Investigational Cancer Therapeutics at MD Anderson. The Phase 1 study investigated evofosfamide in combination with the CTLA-4 inhibitor, ipilimumab, in four tumor types where hypoxia is believed to be a major source of immune resistance. The combination treatment drove an overall response rate of 17 percent and a disease control rate of 83 percent across four different dose levels in 21 heavily pre-treated patients.

“Overcoming resistance to immunotherapy in immunologically cold tumors will likely require a multi-faceted approach to address diverse mechanisms of host immune suppression,” said Dr. Curran, “Evofosfamide is the first drug to demonstrate success in reversing hostile tumor metabolism through reduction of hypoxia. Restoration of tumor oxygen supply facilitates T cell infiltration and persistence allowing these otherwise poorly immune checkpoint sensitive cancers to become therapeutically sensitized.”

In addition to the clinical efficacy demonstrated in the Phase 1 trial, a clear biomarker picture has emerged. Pre-existing immune gene signatures predicted response to therapy, while hypermetabolic tumors predicted progression. Responders also showed improved cellular signatures of anti-tumor immunity.

“Our vision at ImmunoGenesis is to develop a pipeline of drugs that synergize to address the critical ingredients necessary for effective immunity against the particularly difficult-to-treat cold tumors, including the generation of sufficient anti-tumor T cells, the protection and expansion of those cells in the tumor, and finally the reduction in hostile tumor metabolism” said James Barlow, ImmunoGenesis President and CEO. “Coupled with the PD-L1/PD-L2 dual specific antibody and STING agonist the company previously licensed from Dr. Curran’s lab, the addition of evofosfamide creates an integrated suite of molecules with extraordinary potential to address the unmet therapeutic need in cold cancers.”

About ImmunoGenesis, Inc.
ImmunoGenesis is a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically “cold” cancers such as prostate, colorectal, and pancreatic cancer. These tumor types represent more than half of all cancers, and current immunotherapies have shown limited to no efficacy here. As a result, there is a high unmet need for efficacious therapies.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “could,” “believe,” “plan,” “expect,” “target,” “continue,” “to,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements regarding the development and/or effectiveness of evofosfamide and the ability of evofosfamide to achieve the desired results whether as a monotherapy or in combination with other therapies. We may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in the forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

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Bill Tanner
Chief Financial Officer