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Mabwell Initiates First US Clinical Trial of Nectin-4 ADC in Previously Treated Triple-Negative Breast Cancer

Oncology
  • Mabwell has dosed the first patient in a US clinical study of Bulumtatug Fuvedotin (BFv), a novel nectin-4-targeting ADC, at Memorial Sloan Kettering Cancer Center for triple-negative breast cancer patients previously treated with ADCs.
  • The multicenter trial (NCT06908928) addresses significant unmet medical needs in TNBC, where treatment options remain limited and many patients progress after topoisomerase inhibitor-based ADC therapy.
  • BFv utilizes next-generation site-specific conjugation technology with MMAE payload, demonstrating superior characteristics including lower toxin release in plasma and enhanced intratumoral drug concentration.
  • The drug has already received multiple FDA Fast Track designations and Orphan Drug designation, with Phase III studies ongoing in urothelial carcinoma and cervical cancer indications.

A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

NCT06908928RecruitingPhase 1
Mabwell (Shanghai) Bioscience Co., Ltd.
Posted 8/11/2025

Rakovina Therapeutics and NanoPalm Form Joint Venture to Advance AI-Discovered Cancer Drug kt-3283

AIOncology
  • Rakovina Therapeutics and Saudi-based NanoPalm have signed a non-binding Letter of Intent to form a joint venture focused on developing AI-discovered oncology therapeutics using advanced lipid nanoparticle delivery systems.
  • The collaboration will initially focus on kt-3283, a dual PARP-HDAC inhibitor that has demonstrated enhanced cytotoxicity in preclinical models of Ewing sarcoma, breast cancer, and ovarian cancer compared to currently approved inhibitors.
  • The joint venture will be domiciled in Saudi Arabia with global development rights, combining Rakovina's AI-powered drug discovery platform with NanoPalm's precision patterned lipid nanoparticle technology.
  • This partnership represents the first pLNP-oncology-focused biotech venture co-founded in Saudi Arabia, aligning with the Kingdom's National Biotechnology Strategy for local biotech development.

Amphastar Pharmaceuticals Expands Pipeline with $453 Million Licensing Deal for Three Novel Peptide Therapeutics

Oncology
  • Amphastar Pharmaceuticals has entered into an exclusive licensing agreement with Nanjing Anji Biotechnology for three proprietary peptide therapeutics targeting oncology and ophthalmology indications in the US and Canada.
  • The deal includes an endogenous peptide for cancer growth suppression, a peptide-docetaxel conjugate designed to reduce toxicity, and an anti-VEGFR peptide eye drop for wet age-related macular degeneration.
  • The agreement involves $6 million in upfront payments and potential milestone payments totaling up to $453 million, with 5% royalties on net sales capped at $60 million per product.
  • The licensing terms extend for ten years from first commercial sale with potential extension for an additional decade, strengthening Amphastar's proprietary peptide pipeline.

Compass Therapeutics Reports Promising Clinical Data Across Bispecific Antibody Pipeline

Oncology
  • Compass Therapeutics' tovecimig met its primary endpoint in Phase 2/3 biliary tract cancer trial, with fewer deaths observed than projected suggesting potential overall survival benefit.
  • CTX-8371 bispecific antibody demonstrated deep responses in post-checkpoint inhibitor setting, including complete resolution of lung cancer lesions and >90% reduction in breast cancer tumors.
  • CTX-10726 showed superior tumor control and PD-1 inhibition compared to ivonescimab in preclinical studies, with IND filing planned for Q4 2025.
  • The company maintains strong financial position with $101 million in cash providing runway into 2027.

A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)

NCT05506943Active, Not RecruitingPhase 2
Compass Therapeutics
Posted 1/9/2023

SEED Therapeutics Receives FDA Clearance for First-in-Human Trial of RBM39 Degrader ST-01156

Orphan DrugOncology
  • The FDA has cleared SEED Therapeutics' IND application for ST-01156, a molecular glue degrader targeting RBM39, enabling a Phase 1 trial in advanced solid tumor and hematological malignancies.
  • ST-01156 demonstrated complete tumor regression in preclinical models of Ewing sarcoma, neuroblastoma, and KRAS mutant colon cancer, with first patient dosing expected in Q1 2026.
  • The drug has received FDA Orphan Drug and Rare Pediatric Disease designations for Ewing sarcoma, addressing a rare pediatric malignancy with no new approved therapies in over 30 years.
  • SEED's addressable patient population for RBM39-dependent cancers exceeds one million worldwide, including Ewing sarcoma, neuroblastoma, and KRAS-driven solid tumors.

Syntara Receives FDA Guidance for Amsulostat Phase 2 Trial in Myelofibrosis

Oncology
  • Syntara Limited received FDA guidance recommending a Phase 2 controlled trial for amsulostat in myelofibrosis to gather additional safety and efficacy data.
  • The FDA reviewed data from the ongoing MF-101 trial combining amsulostat with ruxolitinib and a proposal for a pivotal registrational study during a Type C meeting.
  • The Phase 2 trial will focus on symptom improvements and spleen volume reductions to optimize the design of a subsequent Phase 3 trial.
  • Syntara expects to report top-line Phase 1c/2 data for amsulostat in myelofibrosis in Q3 2025, with strong financial runway extending into 2027.

India's First Indigenous CAR-T Therapy Achieves Two-Year Remission Milestone in Aggressive Blood Cancer

CAR-TOncology
  • Seven patients with relapsed or refractory CD19-positive B-cell Non-Hodgkin Lymphoma treated with India's first indigenous CAR-T therapy have achieved over two years of progression-free survival.
  • Immuneel Therapeutics' Varnimcabtagene autoleucel (IMN-003A) demonstrated an 83% overall response rate at Day 90 and 83% complete response rate in the IMAGINE Phase 2 trial.
  • More than 50 patients across leading Indian hospitals have been treated with consistent outcomes and favorable safety profiles, marking a breakthrough in accessible cancer immunotherapy.
  • The therapy represents a significant advancement in making world-class CAR-T treatments available domestically, supported by government backing through BIRAC grants.

Iovance Biotherapeutics Implements Major Restructuring Amid Regulatory Setbacks and Commercial Challenges

Oncology
  • Iovance Biotherapeutics reduced its workforce by 19% in Q3 2025 and targets $100 million in annual savings to extend cash runway to late 2026.
  • The company withdrew its EU Marketing Authorization Application for Amtagvi after EMA feedback revealed clinical data misalignment, delaying European approval.
  • Amtagvi generated $54.1 million in Q2 2025 revenue, but the company revised 2025 revenue guidance downward by 40% to $250-300 million.
  • Clinical trials for Amtagvi in non-small cell lung cancer and endometrial cancer are progressing, with data expected in H2 2025.

Kura Oncology's Ziftomenib Receives FDA Priority Review for NPM1-Mutant AML, PDUFA Date Set for November 2025

OncologyPrecision Medicine
  • Kura Oncology's lead asset ziftomenib has advanced to FDA Priority Review for relapsed/refractory NPM1-mutant acute myeloid leukemia, with a PDUFA date of November 30, 2025.
  • The KOMET-001 pivotal trial demonstrated a 23% complete remission rate in heavily pretreated, high-risk patients, with manageable safety profile and no significant cardiac safety issues.
  • Ziftomenib is the only menin inhibitor to receive both Priority Review and Breakthrough Therapy Designation for this indication, positioning it as a potential first-in-class treatment.
  • The company reported Q2 2025 collaboration revenue of $15.3 million, missing analyst expectations of $39.1 million, while maintaining $630.7 million in cash reserves extending runway into 2027.

Relay Therapeutics Advances RLY-2608 to Phase 3 Trial with Promising Breast Cancer Data

Oncology
  • Relay Therapeutics initiated the Phase 3 ReDiscover-2 trial for RLY-2608, a pan-mutant selective PI3Kα inhibitor targeting breast cancer patients with high unmet medical needs.
  • Updated ASCO 2025 data showed RLY-2608 achieved a median progression-free survival of 10.3 months and 39% objective response rate in PI3Kα-mutated, HR+/HER2- metastatic breast cancer patients.
  • The company reduced R&D expenses by 30.5% year-over-year while maintaining $656.8 million in cash reserves, projected to fund operations into 2029.

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