PTT-4256 / Pathios Therap - LARVOL DELTA

Pathios Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of GPR65 Inhibitor PTT-4256 in Patients with Advanced Solid Cancers (PRNewswire) - "Pathios Therapeutics...announced dosing of the first patient in the initial module of a Phase 1/2 clinical trial evaluating PTT-4256, the company's investigational first-in-class GPR65 inhibitor....The RAISIC-1 trial (Relief of Acidic Immune Suppression in Cancer) is a modular multi-part, multi-arm open-label study being conducted in Australia. The study's first module is designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of PTT-4256 monotherapy in patients with a range of advanced solid tumours."

Trial status • Oncology • Solid Tumor

PTT-4256-01: An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1). (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Pathios Therapeutics Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours. (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Pathios Therapeutics Pty Ltd

New P1/2 trial • Oncology • Solid Tumor

Pathios Therapeutics Raises $25M in First Close of Series B Financing to Advance First-in-Class Immunotherapy Approach into Clinic (PRNewswire) - "Pathios Therapeutics Limited...today announced that the company has raised $25 million in the first close of a Series B financing. The financing consists of a new strategic investment from Bristol Myers Squibb, as well as support from existing investors including Canaan and Brandon Capital. Proceeds from the raise will be used to support the continued development of Pathios' unique approach to cancer immunotherapy focused on the inhibition of GPR65, a novel target that has been genetically associated with a range of immunologically-mediated diseases. As part of these efforts, the company expects to advance PTT-4256, its lead internally discovered, oral, highly potent, and selective small molecule inhibitor of GPR65, into human clinical trials in advanced solid cancers by the end of 2024."

Financing • Oncology

PTT-4256 is a first-in-class small molecule inhibitor of GPR65 that counteracts the low pH-dependent immunosuppressive effects on immune cells and displays pronounced anti-tumor activity in mice (SITC 2023) - "Conclusions GPR65 is a key checkpoint on tumor-infiltrating immune cells that links the chronically acidic TME to tumor-promoting immunosuppression. The GPR65 inhibitor PTT-4256 restores anti-tumor immunity and demonstrates pronounced single-agent efficacy in mice, and is therefore being advanced towards clinical development."

Immune cell • IO biomarker • Preclinical • Oncology

Pathios Therapeutics Unveils PTT-4256, a Highly Potent and Selective Inhibitor of GPR65, in Presentation at American Association for Cancer Research (AACR) Annual Meeting 2023 (PRNewswire) - "Pathios Therapeutics Limited...announced the presentation of the latest preclinical data from the company's GPR65 discovery program at the American Association for Cancer Research (AACR) Annual Meeting 2023....In preclinical experiments, PTT-4256 was shown to be highly effective in counteracting the effects of low pH (i.e. high acidity) that polarizes human and mouse macrophages toward an immunosuppressive state. This PTT-4256-induced relief of immune suppression was associated with dose-dependent increases in a range of pro-inflammatory genes that are consistent with an anti-tumor immune response, evidence of an infiltration of T cells and natural killer (NK) cells into the TME, and prevention of the activation of immunosuppressive cytokines....'Based on these latest data, we are now focused on completing the toxicology program that will support initiation of clinical trials in 2024'."

Preclinical • Oncology