Home Regulatory The FDA Designated PT886 from Phanes Therapeutics as an Orphan Drug for the Treatment of Pancreatic Cancer.

The FDA Designated PT886 from Phanes Therapeutics as an Orphan Drug for the Treatment of Pancreatic Cancer.

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FDA approves

Synopsis :

  • The U.S. Food and Medication Administration (FDA) has designated PT886 as an orphan drug for the treatment of pancreatic cancer, according to Phanes Therapeutics, Inc. (Phanes), an up-and-coming pioneer in breakthrough discovery research and clinical development in oncology.
  • The FDA designated the company’s PT217 for the treatment of small cell lung cancer as an orphan medication earlier this month.

About PT886


PT886 Structure

  • Description : PT886 is a first-in-class bispecific antibody targeting claudin 18.2 (CLDN18.2) and cluster of differentiation 47 (CD47) being developed for patients with pancreatic cancer as well as gastric and gastroesophageal cancers. Pancreatic cancer is an aggressive form of cancer characterized by high mortality rates and significant morbidities.
  • Class : Antineoplastics; Bispecific antibodies; Immunotherapies
  • Mechanism of Action: Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status :Yes – Pancreatic cancer

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.

“PT886 has the potential to be a transformative treatment option for pancreatic cancer patients whose current standard of care is severely limited.” said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. “This orphan drug designation comes in the same month with our recent IND clearance for PT886, which we are rapidly progressing into the clinic. These important milestones the company has achieved in Q2 this year follow the March IND clearance for PT199, an anti-CD73 monoclonal antibody for the treatment of multiple solid tumors.”

About Phanes Therapeutics
Phanes Therapeutics, Inc. is a biotech company focused on innovative drug discovery in immuno-oncology. Based in San Diego, California, the company’s management team members previously held senior managerial and R&D positions in leading global pharmaceutical and biotech companies with extensive experience in R&D and commercialization. The company’s bispecific antibody platform is PACbody™, a proprietary approach for constructing native IgG-like bispecific antibodies without using protein engineering so that the antibody molecules maintain native structures with superb CMC characteristics, ATACCbody™, a proprietary technology for targeting solid tumors using immuno-oncology molecules with minimal risk of cytokine release syndrome, and SPECpair™, which allows mAb-like manufacturability of bispecific antibodies with native IgG-like structures.

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