PT886
- Generic Name
- PT886
- Drug Type
- Biotech
- Background
PT886 is a bispecific antibody against Claudin 18.2 and cluster of differentiation 47 (CD47)
Robust Pipeline of 220+ Drugs Advancing for Gastric Cancer Treatment, Led by Major Pharmaceutical Companies
• DelveInsight's comprehensive analysis reveals over 200 companies actively developing 220+ pipeline therapies for gastric cancer treatment, indicating significant industry investment in addressing this disease.
• Key players including BeiGene, Bristol-Myers Squibb, and AstraZeneca are advancing promising candidates like tislelizumab, relatlimab-nivolumab combination, and trastuzumab deruxtecan through clinical trials.
• Multiple therapeutic approaches are being explored, from monoclonal antibodies to small molecules, with several drugs in late-stage development including Catumaxomab in Phase III and Tivumecirnon in Phase II trials.
First Patient Dosed in Peluntamig Combination Therapy Trial for Small Cell Lung Cancer
• Phanes Therapeutics has initiated dosing in a clinical trial evaluating peluntamig (PT217), a first-in-class bispecific antibody targeting DLL3 and CD47, in combination with chemotherapy for small cell lung cancer and neuroendocrine carcinoma.
• The drug has received multiple FDA designations, including Orphan Drug Designation for SCLC and NEC, and Fast Track status for extensive-stage SCLC and metastatic neuroendocrine prostate cancer.
• The SKYBRIDGE study, a multi-center Phase I/II trial, will assess peluntamig's safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced DLL3-expressing cancers.
EPCORE NHL-2 Trial Shows Promise Combining Chemotherapy and Immunotherapy for DLBCL
• A phase Ib/II clinical trial led by Mount Sinai researchers demonstrates successful outcomes in combining chemotherapy with immunotherapy for diffuse large B-cell lymphoma treatment.
• The groundbreaking research, published in Blood journal, was conducted under the leadership of Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute.
• The study represents a significant advancement in lymphoma treatment, supported by the Leukemia & Lymphoma Society's research initiatives, which have invested over $600 million in hematologic oncology research.
FDA Grants Fast Track Designation to Phanes Therapeutics' PT217 for Neuroendocrine Prostate Cancer
• The FDA has granted Fast Track designation to Phanes Therapeutics' PT217 for metastatic neuroendocrine prostate cancer (NEPC), marking its second Fast Track designation.
• PT217, a first-in-class bispecific antibody targeting DLL3 and CD47, is under development for small cell lung cancer (SCLC) and neuroendocrine carcinoma.
• A Phase I/II clinical trial (SKYBRIDGE study) is ongoing to assess PT217's safety and efficacy in advanced DLL3-expressing cancers.
• Phanes Therapeutics has a clinical supply agreement with Roche to study PT217 in combination with Roche's anti-PD-L1 therapy, atezolizumab.
Novel Therapies Show Promise in Melanoma, Breast, and Prostate Cancers
• Fianlimab plus cemiplimab demonstrates durable efficacy and a better-tolerated safety profile compared to ipilimumab and nivolumab in advanced melanoma, showing promise in ongoing adjuvant and frontline metastatic studies.
• Inavolisib, combined with palbociclib and fulvestrant, receives FDA approval for HR+, HER2–, PIK3CA-mutated breast cancer, uniquely targeting and degrading the PI3K target to prevent cellular adaptation.
• Talazoparib plus enzalutamide shows meaningful overall survival improvement in metastatic castration-resistant prostate cancer, offering hope for patients with limited effective treatment options.
Phanes Therapeutics Doses First Patient in PT886 Combination Trials for Advanced Cancers
• Phanes Therapeutics has dosed the first patient in a clinical study evaluating PT886 combined with chemotherapy for pancreatic and gastric cancers.
• The TWINPEAK Phase I/II trial (NCT05482893) assesses PT886's safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced solid tumors.
• PT886, a first-in-class bispecific antibody, targets claudin 18.2 and CD47, and has received FDA Orphan Drug and Fast Track designations for pancreatic cancer.
• A separate cohort in the TWINPEAK study is evaluating PT886 in combination with pembrolizumab for gastric and gastroesophageal junction cancers.
FDA Grants Fast Track Designation to Phanes Therapeutics' PT217 for Advanced Small Cell Lung Cancer
• The FDA has granted Fast Track designation to PT217 for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
• PT217 is a first-in-class bispecific antibody targeting DLL3 and CD47, designed to enhance antitumor activity and stimulate the adaptive immune system.
• The Fast Track designation aims to expedite the development and review of PT217, addressing a critical unmet need in SCLC treatment.
• A Phase 1 clinical trial (SKYBRIDGE) is currently evaluating PT217's safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced cancers.
Drug Development Updates
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