Key Findings:
- A single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcomes.
- Chemically induced pancreatic failure (a model for type-1 diabetes) could be partially reversed when mice were transplanted with beta-cell islet allografts and treated with mPTX-35.
- Disease protection in preclinical models was correlated with a significant expansion of Tregs and protection of the allograft, resulting in euglycemia and a graft survival benefit.
- Long-term surviving grafts showed a marked increase in Treg infiltration which directly correlated with mPTX-35 agonist activity.
PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. PTX-35 is the Company's first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors.
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Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the partially reversing chemically induced pancreatic failure (a model for type-1 diabetes) when mice were transplanted with beta-cell islet allografts and treated with mPTX-35, PTX-35 contributing to achieving lasting immunological tolerance in organ transplantation, the potential of PTX-35 to modulate immunological responses and facilitate minimization or withdrawal of immunosuppression post-transplant, which supports further clinical evaluation in the context of inflammatory disease, expected filing for HS-110 for an End of Phase 2 meeting with the FDA this quarter, and the potential Phase 3 registration pathways for HS-110. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates including a Phase 3 registration pathway for HS-110 or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the
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