Phanes Therapeutics Inc. has announced that the US Food and Drug Administration has granted Fast Track designation to PT886 for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.

PT886 was also granted orphan drug designation for the treatment of pancreatic cancer by the FDA in 2022.

PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47, is being developed for the treatment of patients with gastric, gastroesophageal junction, and pancreatic adenocarcinomas. PT886 was assembled using Phanes' proprietary bispecific antibody platforms PACbody and SPECpair.

Pancreatic cancer is an aggressive form of cancer characterized by high mortality rates and significant morbidities. For patients who present with metastasis at the time of diagnosis, the 5-year survival rate is only 3 percent. Projections for 2024 estimate that approximately 51,000 Americans will die of pancreatic cancer this year and by 2030, it is projected to exceed breast, prostate, and colorectal malignancies as the leading cause of cancer-related deaths in the US.

"PT886 has the potential to be a transformative treatment option for patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, for which current standard of care is insufficient", said Ming Wang, Founder and CEO of Phanes Therapeutics.

"PT886 is a product of Phanes' ingenious innovation in the creative design of both novel therapeutic approaches and practical technologies", he added.

The multi-center Phase I 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.