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Glenmark Initiates Global Phase 3 Trial for Subcutaneous PD-L1 Inhibitor Envafolimab in Stage III Lung Cancer

Oncology
  • Glenmark Pharmaceuticals has received approval from India's DCGI to begin a multi-country Phase 3 clinical trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III non-small cell lung cancer.
  • The randomized, multi-center trial will expand to Russia, Brazil, and Mexico, assessing the drug's efficacy and safety in Stage IIIA and IIIB NSCLC patients where five-year survival rates remain poor at 36% and 26% respectively.
  • Envafolimab's unique subcutaneous administration allows for faster delivery within 30 seconds, potentially making immunotherapy more accessible in resource-constrained healthcare settings.
  • The drug is already approved in China for advanced solid tumors with MSI-H/dMMR and has benefited over 40,000 cancer patients, representing a significant advancement in convenient immunotherapy delivery.

Predictive Oncology Partners with Every Cure to Accelerate AI-Driven Drug Repurposing for Cancer Treatment

AIOncology
  • Predictive Oncology and Every Cure have formed a strategic collaboration to identify and prioritize existing drugs for repurposing in cancer treatment using AI-driven platforms.
  • The partnership leverages Predictive Oncology's biobank of over 150,000 tumor samples across more than 130 cancer types and their PEDAL AI platform, which predicts tumor drug response with 92% accuracy.
  • Every Cure's AI models utilize knowledge graphs, large language models, and real-world medical data to identify potential connections between existing drugs and diseases for rigorous evaluation.
  • The collaboration aims to accelerate the delivery of life-saving treatments to cancer patients worldwide by combining machine learning capabilities with extensive tumor sample databases.

Merck KGaA Appoints David Weinreich as Global Head of R&D to Revitalize Healthcare Pipeline

Oncology
  • Merck KGaA has appointed David Weinreich as Global Head of R&D and Chief Medical Officer for its Healthcare business sector, bringing over 20 years of experience and leadership in developing 15 approved drugs worldwide.
  • The appointment comes as Merck faces pressure to revitalize its pipeline following recent setbacks including the failure of multiple sclerosis candidate evobrutinib and cancer therapy xevinapant in phase 3 development.
  • Weinreich joins from Foresite Labs & Foresite Capital Management and will lead R&D strategy from the company's Billerica, Massachusetts site, with responsibility for advancing early and late-stage drug development programs.
  • The company has been actively pursuing external partnerships and acquisitions, including a $3.9 billion SpringWorks takeover and $2 billion Skyhawk alliance, to strengthen its mature product portfolio.

OGRD Alliance Announces PLPC-DB Non-Cellular Oncology Immunotherapy Platform for Global Acquisition

Oncology
  • OGRD Alliance introduces PLPC-DB, a lyophilized phospholipoproteic complex that remains stable for over 18 months at room temperature, eliminating cold-chain dependency and reducing infrastructure costs by over 60%.
  • The platform coordinates innate and adaptive immune responses, enhancing NK and CD8+ effector activity while reducing inhibitory cytokines, supported by five PubMed-indexed publications and eleven oncology congress presentations.
  • PLPC-DB is anchored in the Structured Immunophenotypic Traceability Platform (STIP) with Network Access Module (NAM), validated through over a decade of patient monitoring in Latin America.
  • The platform enters a global acquisition window with valuation floor secured at USD 350M+, targeting the USD 120B oncology immunotherapy market growing at approximately 10% CAGR.

Parabilis Medicines Appoints Fawzi Benzaghou as Chief Medical Officer to Advance "Undruggable" Cancer Targets

Oncology
  • Parabilis Medicines has appointed Fawzi Benzaghou, M.D., as Chief Medical Officer to lead clinical and regulatory strategy for its pipeline targeting historically "undruggable" cancer proteins.
  • The company is preparing for data disclosures at ESMO Congress for FOG-001, the first direct inhibitor of β-cateninTCF4, a breakthrough targeting pathway involved in colorectal cancer and desmoid tumors.
  • Benzaghou brings extensive oncology leadership experience from Ipsen, where he oversaw regulatory approvals for Cabometyx across multiple solid tumor indications and Onivyde in pancreatic cancer.
  • Parabilis' proprietary Helicon platform uses stabilized, cell-penetrant alpha-helical peptides to modulate intracellular protein-protein interactions inaccessible to traditional drug modalities.

Treeline Biosciences Initiates Three Phase 1 Trials Targeting BCL6, KRAS, and EZH2 with $1.1B in Total Funding

Oncology
  • Treeline Biosciences has launched Phase 1 clinical trials for three oncology programs: TLN-121 (BCL6 degrader), TLN-372 (pan-KRAS inhibitor), and TLN-254 (EZH2 inhibitor) targeting lymphomas and solid tumors.
  • The company secured an additional $200 million in Series A extension funding, bringing total funding to $1.1 billion to support its clinical development programs.
  • TLN-372 addresses a significant unmet need as approximately one in four adult cancers harbor KRAS alterations, with most variants lacking targeted therapy options beyond G12C mutations.
  • The trials represent the clinical debut for the company co-founded by Josh Bilenker, who previously founded Loxo Oncology and developed three FDA-approved medicines.

A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma

NCT06733441RecruitingPhase 1
Treeline Biosciences, Inc.
Posted 12/16/2024

TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

NCT07082803RecruitingNot Applicable
Treeline Biosciences, Inc.
Posted 6/23/2025

BostonGene's AI Model Identifies Five Novel Subtypes to Predict Immunotherapy Response in Kidney Cancer

AITargeted TherapyPrecision MedicineOncology
  • BostonGene published a study in Cell Reports Medicine introducing the largest harmonized transcriptomic and clinical dataset in kidney cancer, analyzing over 3,600 patient samples.
  • Researchers developed a multimodal AI foundation model that identified five novel Harmonized Immune Tumor Microenvironment (HiTME) subtypes in clear cell renal cell carcinoma.
  • The AI model generated clinically interpretable responder scores that correlated with survival outcomes for both immune checkpoint inhibitors and VEGF inhibitors across independent cohorts.
  • The framework revealed a therapy-resistant subgroup characterized by immune-desert phenotypes and angiogenic signaling, highlighting new therapeutic opportunities.

Ryvu Therapeutics Partners with BioNTech to Accelerate Cancer Immunotherapy Trials in Poland

Oncology
  • Ryvu Therapeutics has entered a strategic agreement with BioNTech to support clinical trial site activation and patient recruitment for multiple investigational cancer immunotherapies in Poland.
  • The partnership will leverage Ryvu's clinical network and operational expertise to streamline Polish patient access to BioNTech's priority oncology programs across lung, breast, and colorectal cancers.
  • BioNTech will design and fund clinical trials for priority programs in Poland, with Ryvu providing specialized oncology clinical operations support through its established trial site network.

Glenmark Launches First Generic Eribulin Mesylate Injection in $66.3 Million Market

Oncology
  • Glenmark Pharmaceuticals Inc., USA announced the September 2025 launch of its generic Eribulin Mesylate Injection, marking the company's first complex generic product entry.
  • The generic formulation is bioequivalent and therapeutically equivalent to Eisai's Halaven injection, targeting a market worth approximately $66.3 million annually.
  • This launch represents Glenmark's strategic expansion into the institutional channel and commitment to providing affordable cancer treatment alternatives for patients in need.

OBI Pharma Initiates Phase 1/2 Trial for Novel TROP2-Targeted ADC OBI-902 in Advanced Solid Tumors

Oncology
  • OBI Pharma has launched a Phase 1/2 clinical trial for OBI-902, the first antibody-drug conjugate utilizing their proprietary GlycOBI® ADC enabling technology platform.
  • The study will evaluate OBI-902's safety, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors expressing TROP2 antigen.
  • OBI-902 demonstrated superior antitumor activities and favorable pharmacokinetics compared to other TROP2 ADCs in preclinical studies presented at AACR 2025.
  • The FDA cleared the investigational new drug application for OBI-902 in April 2025, with MD Anderson Cancer Center leading the clinical investigation.

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