FDA Grants Fast Track Designation to PT886 for the Treatment of Pancreatic Cancer


PT886 (Phanes Therapeutics) received fast track designation 2 years after receiving orphan drug designation by the FDA.

PT886, a novel immunoglobulin G (IgG)-like bispecific antibody (bsAb), received fast track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma, according to a Phanes Therapeutics press release. The IgG-like bsAb received this designation 2 years after first receiving orphan drug designation.1

"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, PhD, founder and CEO of Phanes Therapeutics, in the press release.1

PT886 is undergoing evaluation in the TWINPEAK study (NCT05482893), a multi-center phase I trial that aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy endpoints of PT886 in patients with locally advanced or metastatic pancreatic cancers. Patients with gastric and gastroesophageal junction cancers are also eligible, according to a press release. All patients have either progressed past the standard of care (SOC), or the SOC is ineffective, intolerable, or inappropriate for them.1,2

About The TWINPEAK Trial

Trial Name: PT886 For Treatment of Patients With Metastatic/​Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT05482893

Sponsor: Phanes Therapeutics

Completion Date (Estimated): April 2026

The IgG-like bsAb kills tumor cells by inducing phagocytosis in natural killer cells and targeting claudin 18.2 and CD47, which are overexpressed on the surface of tumor cells. PT886 may induce adaptive immune response by indirectly activating T cells to kill claudin 18.2 low or negative tumor cells. This therapeutic teaches the T cells to recognize these overexpressed proteins as tumor neoantigens, according to a press release.Comparatively, PT886 targets and binds to CD47 on tumor cells without heavily binding to human red bloods cells.2

"PT886 targets a validated tumor associated antigen in claudin 18.2 with enhanced anti-tumor activity and broadened tumor killing spectrum through a best-in-class anti-CD47 arm,” Wang said in a separate news release.2

In 2024, approximately 51,000 individuals in the United States will die from pancreatic cancer, an aggressive cancer linked with high mortality and morbidities. Patients with metastatic disease only have a 3% chance of survival at 5 years, and this type of cancer is likely to become the number 1 cause of cancer-related deaths in the United States by 2030.1

PT886 product assembly was done using the company’s proprietary bispecific antibody platforms PACbody and SPECpair. Phanes also has a a clinical collaboration agreement with Merck to evalaute PT886 in combination with pembrolizumab (Keytruda) for the treatment of claudin 18.2 positive gastric or gastroesophageal junction (GEJ) adenocarcinomas with or without chemotherapy.3

  1. Phanes Therapeutics' PT886 granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma by the FDA. Phanes Therapeutics, Inc. News Release. March 20, 2024. Accessed on March 21, 2024. https://prnmedia.prnewswire.com/news-releases/phanes-therapeutics-pt886-granted-fast-track-designation-for-the-treatment-of-patients-with-metastatic-claudin-18-2-positive-pancreatic-adenocarcinoma-by-the-fda-302095196.html
  2. Phanes Therapeutics Announces First Patient Dosed in Phase 1 Study of PT886 for Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinomas. Phanes Therapeutics, Inc. News Release. March 20, 2023. Accessed on March 21, 2024. https://www.prnewswire.com/news-releases/phanes-therapeutics-announces-first-patient-dosed-in-phase-1-study-of-pt886-for-advanced-gastric-gastroesophageal-junction-and-pancreatic-adenocarcinomas-301776427.html
  3. Phanes Therapeutics, Inc. Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate PT886 in Combination with KEYTRUDA (pembrolizumab). Biospace. News Release. October 16, 2023. Accessed on March 21, 2024. https://www.biospace.com/article/releases/phanes-therapeutics-inc-announces-clinical-trial-collaboration-and-supply-agreement-with-merck-to-evaluate-pt886-in-combination-with-keytruda-pembrolizumab-/
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