PT217

The FDA fast-tracked PT217 for metastatic neuroendocrine prostate cancer. PT217, a DLL3/CD47-targeting antibody, is in the SKYBRIDGE trial for DLL3-expressing cancers like SCLC, LCNEC, and EP-NEC, either as monotherapy or with atezolizumab. The trial's primary endpoints include safety, tolerability, and PFS, with biomarkers as exploratory endpoints. PT217 also received fast-track designation for ES-SCLC in 2024 and orphan drug designations for SCLC and NEC.

The FDA granted fast track designation to PT217, a DLL3- and CD47-targeting antibody for metastatic neuroendocrine prostate cancer. PT217 also received orphan drug designation for neuroendocrine carcinoma in August 2024. The phase 1/2 SKYBRIDGE trial is evaluating PT217's safety, tolerability, and efficacy in neuroendocrine cancers, including neuroendocrine prostate cancer and small cell lung cancer. The trial, set to complete by December 2027, involves 203 patients across 7 US sites and includes combination therapy phases with atezolizumab and chemotherapy.

Phanes Therapeutics announced FDA Fast Track designation for PT217 in metastatic neuroendocrine prostate cancer (NEPC), marking the second such designation for PT217. PT217, a first-in-class bispecific antibody targeting DLL3 and CD47, is also being developed for small cell lung cancer (SCLC) and neuroendocrine carcinoma, with orphan drug designations granted for both. The SKYBRIDGE study, a Phase I/II trial, is evaluating PT217's safety and efficacy in advanced cancers expressing DLL3.

Phanes Therapeutics' PT217 granted Fast Track designation by FDA for metastatic neuroendocrine prostate cancer (NEPC). PT217 is a first-in-class bispecific antibody targeting DLL3 and CD47, also granted orphan drug designations for small cell lung cancer and neuroendocrine carcinoma.

Phanes Therapeutics announces FDA Fast Track designation for PT217 in metastatic neuroendocrine prostate cancer (NEPC), the second such designation for PT217. PT217, a first-in-class bispecific antibody targeting DLL3 and CD47, is also being developed for small cell lung cancer (SCLC) and neuroendocrine carcinoma, with orphan drug designations granted for both. A Phase I/II clinical trial (SKYBRIDGE study) is ongoing to evaluate PT217's safety and efficacy in advanced cancers expressing DLL3.

CD47 inhibitor drugs in clinical trials aim to enhance cancer immunotherapy by targeting the CD47 surface checkpoint, which inhibits cancer proliferation. Despite no commercial approvals, several therapies are expected to enter the market soon, driven by increasing clinical trials and research, with the U.S. leading and China rapidly advancing in this field.

Phanes Therapeutics announced the first patient dosed in the PT886 clinical study, a first-in-class bispecific antibody targeting claudin 18.2 and CD47, combined with chemotherapy for pancreatic and gastric cancers. PT886 has received orphan drug and Fast Track designations from the FDA.