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Starpharma Advances Dendrimer Drug Delivery Platform with Genentech Partnership and Clinical Progress

Oncology
  • Starpharma's DEP platform has treated over 350 patients in clinical trials, with DEP SN38 receiving positive FDA feedback for potential Fast Track designation in platinum-resistant ovarian cancer.
  • The company secured an $8.3 million upfront payment from Genentech in a collaboration worth up to $855 million in milestone payments for developing dendrimer drug conjugates.
  • Commercial products VivaGel BV and Viraleze continue expanding globally, with VivaGel now registered in over 40 countries and Viraleze achieving 40% online sales growth.
  • Despite revenue declining to $5.9 million from $9.8 million year-over-year, the company maintains $15.4 million in cash reserves while advancing radiotheranostics programs toward 2026 clinical trials.

Er-Kim Secures Exclusive Distribution Rights for CNX Therapeutics' Oncology Portfolio in Central & Eastern Europe and Turkey

Oncology
  • Er-Kim, an international pharmaceutical company with 40+ years of experience in emerging EMEA markets, has signed an exclusive distribution agreement with CNX Therapeutics for oncology products across Central & Eastern Europe and Turkey.
  • The partnership will expand access to CNX's established oncology portfolio, including Cardioxane (dexrazoxane) and Savene (dexrazoxane), across all CEE markets through Er-Kim's extensive regional distribution network.
  • This strategic collaboration leverages Er-Kim's proven track record of distributing 68+ products to 50+ countries with revenues exceeding EUR 305M, positioning both companies to enhance cancer patient access in underserved regions.

Charles River Laboratories Joins EU-Backed EASYGEN Consortium to Accelerate Bedside CAR-T Manufacturing

CAR-TOncology
  • Charles River Laboratories has joined the EASYGEN Consortium, a European Union-backed initiative aimed at developing fully automated, hospital-based CAR-T cell therapy manufacturing within 24 hours.
  • The company will leverage its 3D screening technologies and patient-derived xenograft bank to create an ex vivo platform for rapid safety and efficacy screening of CAR-T cell candidates.
  • Currently, fewer than 20 percent of eligible patients receive CAR-T therapy due to complex, time-intensive manufacturing processes and limited capacity at specialized facilities.
  • The five-year research project involves 18 academic, research, industry and clinical partners across eight countries, targeting reduced costs and expanded patient access to personalized cell therapies.

EMA Grants First-Ever Orphan Drug Designation for Radiation Maculopathy Treatment

Rare DiseaseOncology
  • The European Medicines Agency has granted orphan drug designation to Roca Therapeutics' RCT002, marking the first formal recognition of radiation maculopathy as a distinct medical indication.
  • RCT002 is a first-in-class eye drop therapy designed to address resistant neovascularization, inflammation, fibrosis, and oxidative stress in patients experiencing vision loss after radiotherapy.
  • The designation opens pathways for accelerated regulatory support and targeted therapeutic development for a condition that currently has no approved treatment options.
  • Roca Therapeutics plans to initiate first-in-human clinical trials for RCT002 in 2026 while currently fundraising to support the program.

Zephyr AI Names Watson Pharmaceuticals Founder Dr. Allen Chao as CEO, Acquires Aster Insights to Accelerate Cancer Drug Development

AIPrecision MedicineReal World EvidenceOncology
  • Zephyr AI has appointed Dr. Allen Chao, founder of Watson Pharmaceuticals, as Chief Executive Officer, bringing over 40 years of biopharmaceutical leadership experience.
  • The company simultaneously acquired Aster Insights, gaining access to the world's largest observational cancer study dataset with over 400,000 lifetime-consented patients.
  • The combined entity creates a formidable real-world evidence platform that integrates AI-driven precision medicine with comprehensive genomic, clinical, and transcriptome data.
  • Integration efforts are already underway focusing on biomarker discovery, clinical trial optimization, and AI-enabled companion diagnostics development.

Akiram's Targeted Radiotherapy AKIR001 Advances to Next Phase After Completing First Patient Cohort Without Safety Concerns

Targeted TherapyOncologyOrphan Drug
  • Swedish biotech Akiram Therapeutics completed the first patient cohort of its Phase I trial for AKIR001, a targeted radiopharmaceutical combining an anti-CD44v6 antibody with lutetium-177 for aggressive solid tumors.
  • No dose-limiting toxicities or safety concerns were observed in the initial cohort, allowing the trial to proceed to the next stage as planned at Karolinska University Hospital.
  • The study targets patients with difficult-to-treat cancers including anaplastic thyroid, head and neck, gynecological, and non-small cell lung cancers.
  • AKIR001 delivers radiation directly to tumor cells while minimizing damage to surrounding healthy tissue through its selective targeting of the CD44v6 cancer marker.

[177Lu]Lu-AKIR001 First-in-human Study

NCT06639191Not Yet RecruitingEarly Phase 1
Karolinska University Hospital
Posted 11/1/2024

Royalty Pharma Acquires $950 Million IMDELLTRA Royalty Rights from BeOne Medicines

Drug ApprovalOncology
  • Royalty Pharma acquired BeOne Medicines' royalty rights to IMDELLTRA (tarlatamab-dlle) for up to $950 million, with $885 million paid upfront and an option for additional $65 million within 12 months.
  • IMDELLTRA is a first-in-class DLL3-targeting bispecific T-cell engager approved for extensive-stage small cell lung cancer patients who progressed after platinum-based chemotherapy.
  • The drug generated $215 million in sales during the first half of 2025 and is projected to exceed $2.8 billion by 2035 according to analyst consensus.
  • BeOne retains China commercial rights and will share in royalties on annual sales above $1.5 billion, while maintaining rights to other collaboration assets including xaluritamig.

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

GSK Launches First PD-1 Immunotherapy and PARP Inhibitor for Gynecological Cancers in India

OncologyDrug Approval
  • GlaxoSmithKline has introduced Jemperli and Zejula therapies in India, marking the company's entry into the oncology segment with treatments for gynecological cancers.
  • Jemperli becomes the first and only approved PD-1 immunotherapy for second-line treatment of mismatch repair-deficient/microsatellite instability-high advanced or recurrent endometrial cancer in India.
  • Zejula is positioned as the only PARP inhibitor approved as first-line monotherapy maintenance for all biomarker types in advanced ovarian cancer in India.
  • Both therapies are already trusted and approved in over 40 countries globally, addressing critical unmet medical needs in women's cancer care.

Harbour BioMed Appoints Yajie Li as Chief Medical Officer to Advance Antibody Therapeutics Pipeline

Monoclonal AntibodyOncology
  • Harbour BioMed has appointed Yajie Li as Chief Medical Officer to lead clinical development and regulatory strategy for the company's immunology and oncology programs.
  • Li brings over a decade of pharmaceutical experience from multinational corporations including Merck and Johnson & Johnson, plus nine years at China's National Medical Products Administration.
  • The appointment strengthens Harbour BioMed's capabilities as it advances its pipeline using proprietary antibody technologies including Harbour Mice, HBICE, and HBICA platforms.
  • Li will evaluate early-stage assets based on unmet medical needs and scientific differentiation while reporting directly to CEO Dr. Jingsong Wang.

Defence Therapeutics Raises Up to $1.2M Through Convertible Debenture Financing to Advance ADC Platform

Oncology
  • Defence Therapeutics announced a non-brokered private placement of debenture units for up to $1.2 million in gross proceeds to fund its ADC development programs.
  • Each $1,000 unit includes an 8.0% convertible debenture and 1,666 warrants, with conversion at $0.60 per share and warrant exercise at $0.75 per share.
  • The company specializes in developing next-generation antibody-drug conjugates using its proprietary ACCUM® technology platform for precision cancer therapy delivery.
  • The financing structure provides Defence with flexible capital while offering investors potential equity upside through conversion and warrant features over a two-year term.

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