Palifosfamide Tromethamine

Data reported in Clinical Cancer Research support the efficacy of evofosfamide in combination with checkpoint inhibition in advanced, immunologically "cold" tumors Gene expression analysis highlights potential correlation with therapeutic response [16-June-2021] HOUSTON, June 16, 2021 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers, announced the publication in Clinical Cancer Research of results from a Phase 1 trial of evofosfamide, the only known reducer of solid tumor hypoxia, combined with an immune checkpoint inhibitor, ipilimumab, in patients with advanced cancer. The journal article, "A Phase 1 Dose Escalation Study to Evaluate the Safety and Tolerability of Evofosfamide in Combination with Ipilimumab in Advanced Solid Malignancies," highlights an overall response rate of 17% and a disease control rate of 83% across four dose levels in 21 heavily pre-treated patients. In addition, a clear biomarker picture emerged with pre-existing immune gene signatures correlating with response to therapy and hypermetabolic signatures predicting progression. Responders also showed improved cellular signatures of anti-tumor immunity. "A hostile tumor metabolism is a major source of immune resistance in certain tumors," said James Barlow, ImmunoGenesis President and CEO. "Evofosfamide, with the demonstrated ability to reduce tumor hypoxia, can be a critical component of facilitating immunotherapy efficacy in these tumors. With these compelling results in hand, we look forward to advancing our development pipeline." "Along with others in the field, I had identified tumor hypoxia as a barrier to effective tumor immunity in certain tumors," said Michael Curran, PhD, founder of ImmunoGenesis. "These exciting Phase 1 data support preclinical observations in which evofosfamide reversed tumor hypoxia and facilitated the efficacy of checkpoint inhibition. The efficacy of the combination in these heavily pre-treated patients appears superior to checkpoint monotherapy and provides strong rationale for the use of evofosfamide as a tumor conditioning agent." The study was led at The University of Texas MD Anderson Cancer Center by Curran, Associate Professor of Immunology and David S. Hong, M.D., Professor of Investigational Cancer Therapeutics. Dr. Curran has a personal financial relationship with ImmunoGenesis, which is managed and monitored by the MD Anderson Conflict of Interest Committee. About the Phase 1 Study The Phase 1 (NCT03098160), dose-escalation study tested evofosfamide in combination with ipilimumab administered in four three-week cycles in heavily pre-treated patients with castration-resistant prostate cancer, advanced pancreatic cancer, immunotherapy-resistant melanoma, and advanced HPV-negative head and neck cancer. The combination regimen was well-tolerated, with most drug–related-adverse events being grade 1–2. There were no unexpected safety signals. About Evofosfamide Evofosfamide is a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM) originally developed as a hypoxia-activated prodrug. Through his research, Dr. Curran discovered that evofosfamide can reduce hypoxia in solid tumors. In pre-clinical models, evofosfamide restored T cell function and synergized with checkpoint inhibition. ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent that can condition tumors to respond to checkpoint inhibition. About ImmunoGenesis 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, resulting in high unmet need for efficacious therapies. For more information about the company, visit . 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. Contacts Bill Tanner Chief Financial Officer 203-517-8577 bill.tanner@immunogenesis.com Jennifer Guinan Sage Strategic Marketing 610-410-8111 jennifer@sagestrat.com