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Zymeworks Receives FDA Clearance for ZW251, Novel Glypican-3 Targeted ADC for Hepatocellular Carcinoma

Oncology
  • The FDA has cleared Zymeworks' investigational new drug application for ZW251, a first-in-class antibody-drug conjugate targeting glypican-3 for hepatocellular carcinoma treatment.
  • ZW251 incorporates Zymeworks' proprietary topoisomerase 1 inhibitor payload and demonstrated strong anti-tumor activity in preclinical studies with favorable tolerability up to 120 mg/kg in non-human primates.
  • The Phase 1 clinical trial is expected to begin in 2025, marking the second ADC from Zymeworks' pipeline to advance to clinical development using their proprietary payload technology.
  • Glypican-3 is expressed in over 75% of hepatocellular carcinoma cases, representing a significant target for this most common form of primary liver cancer.

Delhi High Court Rules Against Roche in Pertuzumab Patent Disclosure Case, Clarifies Section 104A Requirements for Biologics

Monoclonal AntibodyOncology
  • The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • The court established that Section 104A can be invoked at interim stages of patent litigation and prevails over general discovery provisions under the Commercial Courts Act.
  • The ruling clarifies that "identical product" requirements under Section 104A cannot be diluted for biological drugs, even though absolute replication is scientifically difficult.
  • The decision impacts ongoing patent disputes in India's biosimilar market, particularly for cancer treatments where regulatory reference to branded biologics does not automatically imply process infringement.

CytoDyn Files $100M Mixed Shelf Offering to Advance Leronlimab Through Phase III Trials

Oncology
  • CytoDyn Inc. filed a $100 million mixed securities shelf offering under SEC Form S-3 to provide capital flexibility for advancing its lead drug candidate leronlimab through Phase III trials.
  • Leronlimab, a CCR5 antagonist, is progressing through Phase II trials for oncology indications including triple-negative breast cancer and non-alcoholic steatohepatitis, with results expected at the 2025 ESMO meeting.
  • The strategic filing allows the company to issue various securities without repeated regulatory approvals, potentially minimizing dilution while funding critical clinical milestones.
  • The drug targets combined HIV and oncology markets estimated at over $150 billion, positioning CytoDyn for potential partnerships or licensing deals with larger pharmaceutical companies.

Comprehensive Pipeline Analysis Reveals 200+ Investigational Drugs for Metastatic Hormone Refractory Prostate Cancer

OncologyTargeted Therapy
  • A new comprehensive report analyzes over 200 pipeline drugs from 180+ companies targeting metastatic hormone refractory prostate cancer, highlighting the extensive research efforts in this challenging therapeutic area.
  • Key late-stage candidates include PNT2002 by Lantheus targeting PSMA in Phase III trials, and Opevesostat by Merck, an oral CYP11A1 inhibitor also in Phase III development.
  • The pipeline spans multiple development stages from discovery to Phase III, with promising mid-stage candidates like XL092 by Exelixis exploring receptor tyrosine kinase inhibition in Phase II trials.
  • Current treatment approaches involve next-generation androgen receptor inhibitors and chemotherapy agents, but significant unmet needs remain for patients experiencing disease progression despite anti-androgen treatments.

Bristol Myers Squibb Appoints AstraZeneca's Cristian Massacesi as New Chief Medical Officer

Oncology
  • Bristol Myers Squibb has appointed Cristian Massacesi, M.D., former AstraZeneca Chief Medical Officer, as Executive Vice President, Chief Medical Officer, and Head of Development, effective August 1, 2025.
  • Massacesi replaces Samit Hirawat, who led Bristol Myers' development efforts for six years and oversaw the launch of blockbuster drugs including Reblozyl, which generated nearly $1.8 billion in revenue in 2024.
  • The leadership change comes as Bristol Myers faces significant challenges from generic competition for Revlimid and looming patent expirations for key drugs Opdivo and Eliquis.
  • Massacesi brings over 20 years of biopharmaceutical experience and previously led AstraZeneca's global organization of more than 3,000 employees, advancing over 150 clinical studies and securing multiple regulatory approvals.

European Regulators Recommend Approval of Vorasidenib for IDH-Mutant Grade 2 Glioma

Drug ApprovalTargeted TherapyOncology
  • The European Medicines Agency's CHMP has issued a positive opinion recommending approval of vorasidenib (Voranigo) for treating grade 2 IDH-mutant glioma in patients aged 12 years and older following surgical resection.
  • The recommendation is based on the phase 3 INDIGO trial showing vorasidenib significantly improved progression-free survival to 27.7 months versus 11.1 months with placebo.
  • If approved by the European Commission, vorasidenib would become the first targeted therapy for grade 2 IDH-mutant diffuse glioma in the European Union.
  • The drug is already approved in the United States, Canada, Australia, Israel, UAE, Saudi Arabia, and Switzerland for this indication.

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

NCT04164901Active, Not RecruitingPhase 3
Institut de Recherches Internationales Servier
Posted 1/5/2020

Everest Medicines Raises HK$1.57 Billion to Accelerate AI+mRNA Platform and Pipeline Development

CAR-TOncology
  • Everest Medicines completed a significantly oversubscribed share placement raising approximately HK$1.57 billion to fund global R&D and commercialization efforts.
  • The company will allocate 50% of proceeds to advance its AI+mRNA platform, including EVM14 and EVM16 cancer vaccines that have achieved regulatory milestones.
  • EVM14 became Everest's first mRNA therapeutic vaccine to receive dual IND acceptance from both China's NMPA and the U.S. FDA.
  • The funding will also support commercialization of existing products including NEFECON for IgA nephropathy and the anticipated approval of VELSIPITY for ulcerative colitis.

Janux Therapeutics Advances Multi-Platform Pipeline with Novel ARM Technology for Autoimmune Diseases

Oncology
  • Janux Therapeutics showcased its expanded immunotherapy pipeline at R&D Day, highlighting three proprietary platforms: TRACTr, TRACIr, and the novel ARM platform targeting autoimmune diseases.
  • The company's CD19-ARM demonstrated rapid, deep B-cell depletion with prolonged memory B cell reset in non-human primates while maintaining a large safety window, positioning it for first-in-human trials in H1 2026.
  • Clinical programs JANX007 and JANX008 continue enrollment with data updates expected in H2 2025, while new TROP2-TRACTr and PSMA-TRACIr programs advance toward clinical development.
  • The company reported $996.0 million in cash and investments as of Q2 2025, providing substantial runway for its expanding development programs.

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

NCT05519449RecruitingPhase 1
Janux Therapeutics
Posted 9/15/2022

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

NCT05783622RecruitingPhase 1
Janux Therapeutics
Posted 4/19/2023

IDEAYA Biosciences to Present Phase 2 Darovasertib Data for Uveal Melanoma at ESMO 2025

Precision MedicineOncology
  • IDEAYA Biosciences will present Phase 2 clinical data on neoadjuvant darovasertib in primary uveal melanoma at the 2025 ESMO meeting in Berlin.
  • The presentation will include data from over 90 patients across both plaque brachytherapy and enucleation-eligible cohorts, focusing on enucleation prevention and vision preservation.
  • Darovasertib has received FDA Breakthrough Therapy Designation for neoadjuvant uveal melanoma in subjects requiring enucleation.
  • The company has initiated a multi-site, global randomized Phase 3 neoadjuvant registrational trial (OptimUM-10) in primary uveal melanoma in Q3 2025.

Neoadjuvant Darovasertib in Primary Uveal Melanoma

NCT07015190RecruitingPhase 3
IDEAYA Biosciences
Posted 10/1/2025

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

NCT05907954RecruitingPhase 2
IDEAYA Biosciences
Posted 7/3/2023

Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals

Drug ApprovalMonoclonal AntibodyOncology
  • Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.
  • The company achieved two significant regulatory milestones with FDA approvals of Zynyz for squamous cell anal carcinoma and Monjuvi for follicular lymphoma, expanding treatment options for cancer patients.
  • Niktimvo, launched in Q1 2025, demonstrated continued strong commercial uptake with $13.6 million in sales, while Opzelura revenues grew 35% to $164 million driven by increased patient demand in both atopic dermatitis and vitiligo.
  • The company raised its 2025 revenue guidance for Jakafi and other oncology products, reflecting strong first-half performance and successful product launches.

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

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