FDA has granted orphan drug designation (ODD) to Phanes Therapeutics, Inc., PT217, a first-in-class bispecific antibody for treating neuroendocrine carcinoma (NEC).
Phanes’ lead product candidate, PT217—a first-in-class bispecific antibody targeting DLL3 and CD47—was evaluated in the phase 1 SKYBRIDGE trial for advanced or refractory DLL3-expressing cancers like NEC.
Phanes Therapeutics is a clinical-stage biotechnology company focused on discovering and developing novel therapies for oncology which now offers a step ahead for patients with NEC.
The therapy received FDA ODD for SCLC in 2022 and Fast Track Designation in 2024 for extensive-stage SCLC patients progressing after platinum chemotherapy.
To accelerate the development of PT217 for NEC, Phanes entered into a clinical supply agreement with Roche earlier this year to evaluate the combination of PT217 with Roche’s anti-PD-L1 therapy, atezolizumab.
Source: Phanes Therapeutics’ PT217 receives Orphan Drug Designation for Neuroendocrine Carcinoma from the FDA
https://www.prnewswire.com/news-releases/phanes-therapeutics-pt217-receives-orphan-drug-designation-for-neuroendocrine-carcinoma-from-the-fda-302224570
