On October 8, 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 Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Phanes Therapeutics, OCT 8, 2024, View Source [SID1234647089]). The dosing was conducted in a cohort of gastric and gastroesophageal junction cancers.

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As previously announced, Phanes is conducting this study under a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada). 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 Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. PT886 is currently being evaluated as monotherapy and in combination with pembrolizumab, or with chemotherapy, either alone or in combination with 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. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.