Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company, announced on Wednesday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its PT886 product to treat metastatic claudin 18.2-positive pancreatic adenocarcinoma.

The product also received orphan drug designation for the treatment of pancreatic cancer by the FDA in 2022. It is the first-in-class native IgG-like bispecific antibody (bsAb) aimed at claudin 18.2 and CD47 and is being produced for the treatment of subjects with gastric, gastroesophageal junction and pancreatic adenocarcinomas. It was assembled using the company's proprietary bispecific antibody platforms PACbody(R) and SPECpair(R).

The multi-centre Phase one clinical trial of PT886 (NCT05482893), named as the TWINPEAK study, is testing the products safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in subjects 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 considered inappropriate.