On September 9, 2024 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of PT886 in combination with chemotherapy (Press release, Phanes Therapeutics, SEP 9, 2024, View Source [SID1234646449]). Dosing has been completed in two cohorts: one for first-line treatment of pancreatic cancers and another for second-line treatment of gastric, gastroesophageal junction cancers.

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PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study PT886 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655).