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IsoBio Secures $5 Million Series Seed Funding to Advance Antibody-Isotope Conjugates for Cancer Treatment

Monoclonal AntibodyOncologyTargeted Therapy
  • IsoBio, Inc. has closed a $5 million Series Seed financing round led by ASP Isotopes Inc. to develop antibody-isotope conjugates (AICs) targeting both validated and novel tumor antigens for cancer treatment.
  • The strategic partnership with ASP Isotopes and its subsidiary PET Labs aims to address critical isotope supply chain challenges that have historically constrained radiotherapy development and commercialization.
  • IsoBio is developing radiotherapeutics containing Lutetium-177, Actinium-225, Terbium-161, and other novel radioisotopes using proprietary linker and conjugation technology.
  • The company is led by radiation oncologist Bruce Turner, M.D., Ph.D., who previously co-led the merger creating Immunome and has extensive experience in targeted oncology therapeutics.

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.

PTAB Director Denies Amgen's IPR Challenges Against Bristol Myers Squibb's Opdivo Patents Based on Settled Expectations

Monoclonal Antibody
  • The USPTO Acting Director discretionarily denied two of Amgen's inter partes review petitions challenging Bristol Myers Squibb's Opdivo and Yervoy patents, citing "strong settled expectations" due to the patents being in force for six and seven years respectively.
  • The decision marks a significant shift in PTAB policy, as settled expectations had not previously been cited as grounds for discretionary denial in biosimilar-related IPRs, potentially making it more difficult for biosimilar manufacturers to challenge older patents.
  • Amgen is developing ABP 206, a biosimilar version of Opdivo, which generated $5.35 billion in U.S. sales for Bristol Myers Squibb in 2024.
  • A third IPR petition challenging a newer 2022 patent was referred to the Board for merit review, suggesting that patent age may be a critical factor in future discretionary denial decisions.

Delhi High Court Rejects Roche's Bid to Force Zydus to Disclose Sigrima Manufacturing Process

Monoclonal Antibody
  • The Delhi High Court declined to order Zydus Lifesciences to disclose the manufacturing process of its breast cancer drug Sigrima after F. Hoffmann-La Roche failed to meet mandatory requirements under Section 104A of the Patents Act.
  • Roche alleged that Zydus' Sigrima infringes its patent rights over monoclonal antibody biologic Pertuzumab (Perjeta), but the court ruled that mere similarity between end products does not establish identical manufacturing processes.
  • Justice Amit Bansal noted that Roche had not conducted analytical characterization or reverse engineering of Zydus' product to substantiate its claims, which is a statutory requirement under Section 104A.
  • The ruling represents a significant legal victory for Zydus, which launched Sigrima in the market in June 2024, protecting its proprietary manufacturing information from disclosure.

European Regulators Recommend Expanding Novo Nordisk's Alhemo for Hemophilia A and B Without Inhibitors

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending label expansion of Alhemo (concizumab) to treat severe hemophilia A and moderate/severe hemophilia B without inhibitors.
  • Phase 3 explorer8 trial results showed Alhemo prophylaxis reduced bleeding episodes by 86% in hemophilia A patients and 79% in hemophilia B patients compared to no prophylaxis treatment.
  • The label expansion would make Alhemo available to approximately 12,000 EU patients with hemophilia A and B without inhibitors, representing 79.2% of the market segment.
  • Patient-reported outcomes demonstrated 70.9% of participants preferred Alhemo over their previous hemophilia treatment, with improvements in quality of life and reduced treatment burden.

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

NCT04082429Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 11/13/2019

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

NCT04083781Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 10/21/2019

NextCure's Anti-Siglec-15 Antibody NC605 Shows Promise for Osteogenesis Imperfecta Treatment in Preclinical Study

Monoclonal AntibodyRare Disease
  • NextCure's NC605, a novel anti-Siglec-15 antibody, demonstrated improved bone microarchitecture and reduced fracture incidence in preclinical studies of osteogenesis imperfecta mice.
  • The treatment showed superior bone quality outcomes compared to current anti-resorptive therapies by both inhibiting bone loss and producing new bone with increased quality and density.
  • NC605 represents a potential breakthrough for osteogenesis imperfecta patients, as there is currently no FDA-approved standard of care for this rare brittle bone disease.
  • NextCure is seeking financial support to advance NC605 toward an Investigational New Drug submission within 12 to 18 months.

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.

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

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

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

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

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

Kling Bio Partners with Sanofi to Develop Next-Generation Antiviral Antibodies Using Proprietary B Cell Platform

Monoclonal Antibody
  • Kling Bio has entered into a collaboration and license option agreement with Sanofi to discover neutralizing antibodies against a clinically relevant human viral pathogen using its Kling-Select platform.
  • The Kling-Select platform leverages patient-derived B cells to rapidly identify novel antibodies and conserved viral epitopes, with validated candidates already developed against RSV, COVID-19, and influenza.
  • The partnership aims to develop next-generation antiviral therapeutics and inform more efficacious vaccine design by combining Kling Bio's antibody discovery expertise with Sanofi's vaccine development leadership.
  • The collaboration highlights the potential of B cell immortalization technology to address global health challenges through the discovery of first-in-class, human-derived antibodies.

Long-Acting Anti-TSLP Antibody HBM9378/WIN378 Enters Global Phase 2 Trial for Asthma Treatment

Monoclonal Antibody
  • Windward Bio has initiated the global Phase 2 POLARIS trial evaluating HBM9378/WIN378, a long-acting anti-TSLP monoclonal antibody for asthma treatment, with initial data expected in mid-2026.
  • The fully human antibody targets thymic stromal lymphopoietin (TSLP) and has been engineered for extended half-life with potential twice-yearly dosing, addressing the need for more effective long-acting treatments.
  • HBM9378/WIN378 demonstrated extended half-life, low antidrug antibody incidence, and good safety profile in Phase 1 trials, with additional COPD clinical programs planned for 2026.
  • The therapy represents a collaborative effort between Harbour BioMed and Kelun-Biotech, with Windward Bio holding exclusive global licensing rights outside Greater China and select Asian countries.

Former Poseida CEO Kristin Yarema Named to Lead Ikena-Inmagene Merger as Companies Advance Anti-OX40 Therapy

Monoclonal Antibody
  • Ikena Oncology and Inmagene Biopharmaceuticals have appointed former Poseida Therapeutics CEO Kristin Yarema to lead the merged company ImageneBio following their anticipated July 2025 closing.
  • The merger includes a concurrent $75 million private placement and will focus on advancing IMG-007, an anti-OX40 monoclonal antibody that recently completed Phase 2a trials in atopic dermatitis and alopecia areata.
  • IMG-007 demonstrated sustained clinical activity with a 34.7-day half-life in subcutaneous formulation, supporting potential for infrequent dosing in immunological and inflammatory diseases.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT07037901RecruitingPhase 2
Inmagene LLC
Posted 6/17/2025

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