Phanes Therapeutics announces FDA IND clearance for PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction, and pancreatic cancers

On June 15, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology reported that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT886, its anti-claudin18.2/anti-CD47 bispecific antibody being developed for patients with gastric, gastroesophageal junction (GEJ) and pancreatic cancers (Press release, Phanes Therapeutics, JUN 15, 2022, View Source;an-anti-claudin18-2anti-cd47-bispecific-antibody-being-developed-for-patients-with-gastric-gastroesophageal-junction-and-pancreatic-cancers-301568015.html [SID1234616022]).

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"The clearance of our second IND this year is an important milestone for Phanes and the opportunity to bring this potential first-in-class bispecific antibody to cancer patients who have such a high unmet medical need is what drives us every day," said Dr. Ming Wang, Founder and CEO. "We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file one additional IND with PT217, an anti-DLL3/anti-CD47 bispecific antibody for the potential treatment of small cell lung cancer and other neuroendocrine cancers. This continues to be a transformational year for Phanes as we now progress two programs into the clinic".

PT886 is a native IgG-like bispecific antibody assembled with Phanes’ proprietary PACbody and SPECpair platforms. Its advancement into clinical stage further validates Phanes’ bispecific antibody technology platforms.

Gastric, gastroesophageal junction (GEJ) and pancreatic cancers are considered as some of the most incurable cancers worldwide. In patients with advanced or metastatic gastric or GEJ adenocarcinoma, the median overall survival is no more than 10 months and that for pancreatic cancers is equally dismal with a median overall survival of 6-11 months. The multi-center, Phase I clinical trial of PT886 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT886 in adult patients with metastatic gastric adenocarcinoma, GEJ adenocarcinoma, and pancreatic ductal adenocarcinoma (PDAC) that have progressed after available standard therapy or for which standard therapy has proven to be ineffective, intolerable or is considered inappropriate.