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Climb Bio Strengthens Leadership Team with Key Executive Appointments to Advance Immune-Mediated Disease Pipeline

Monoclonal Antibody
  • Climb Bio appointed Edgar D. Charles, M.D., MSc as Chief Medical Officer, bringing over 20 years of immunology-focused pharmaceutical development experience from Bristol Myers Squibb and Merck & Co.
  • The company also hired Cindy J. Driscoll, MBA as Senior Vice President, Finance, a seasoned executive with over two decades of biotechnology industry experience.
  • Dr. Charles will lead clinical development of budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for immune-mediated diseases.
  • The appointments come at a pivotal time as Climb Bio prepares to execute clinical studies for both therapeutic programs targeting B-cell mediated diseases.

Fareva Opens New GMP Sterile Pilot Unit in France to Support Biotech Drug Manufacturing

Monoclonal Antibody
  • Fareva has launched a new GMP sterile pilot unit at its Pau site in France, designed to produce liquid and lyophilized injectable forms for biotechnology-derived medicines.
  • The facility features advanced isolator technology compliant with revised Annex 1 requirements and can handle products ranging from small molecules to highly potent substances up to OEB 5 classification.
  • The unit supports flexible batch production from 200 to 8,000 vials and enables manufacturing of monoclonal antibodies, mRNA in LNP form, proteins, peptides, and ADCs for clinical trials and small commercial batches.
  • The new capability strengthens Fareva's position in sterile Fill & Finish services and supports pharmaceutical development from Phase 1 studies through commercialization via the company's network of five sterile production sites.

Scholar Rock's Apitegromab Preserves Lean Muscle Mass During Weight Loss with Tirzepatide in Phase 2 Trial

Monoclonal Antibody
  • Scholar Rock's Phase 2 EMBRAZE trial demonstrated that apitegromab preserved 54.9% more lean mass compared to tirzepatide alone, adding 4.2 pounds of lean muscle during weight loss treatment.
  • Patients receiving the combination therapy achieved higher quality weight loss with 85% fat mass reduction versus 70% fat mass reduction with tirzepatide alone over 24 weeks.
  • The myostatin inhibitor apitegromab was well tolerated with no serious adverse events related to treatment, addressing concerns about muscle loss associated with GLP-1 obesity medications.
  • The positive results validate Scholar Rock's platform for developing selective myostatin inhibitors while the company remains focused on apitegromab's potential approval for spinal muscular atrophy.

Tislelizumab Shows Promise as Adjuvant Therapy for High-Risk Hepatocellular Carcinoma Patients

Monoclonal Antibody
  • A multicenter retrospective study of 108 patients demonstrated that tislelizumab, with or without tyrosine kinase inhibitors, significantly extended recurrence-free survival in high-risk hepatocellular carcinoma patients after curative resection.
  • Patients receiving adjuvant therapy for at least 6 months showed significantly longer recurrence-free survival compared to those treated for less than 6 months, with RFS rates of 89.8%, 71.3%, and 59.3% at 6, 12, and 24 months respectively.
  • Combination therapy with TKIs did not provide additional survival benefit over tislelizumab monotherapy but resulted in significantly higher rates of grade 3 or higher treatment-related adverse events (38.5% vs 18.6%).
  • The findings suggest tislelizumab monotherapy may be the optimal adjuvant approach for preventing HCC recurrence, balancing efficacy with acceptable toxicity profiles.

Adjuvant Immune Checkpoint Inhibitors in Postoperative Hepatocellular Carcinoma

NCT05221398Completed
Guangxi Medical University
Posted 3/3/2019

Aragen to Launch GMP Biologics Manufacturing in India with Advanced Fed-Batch Platform

Monoclonal Antibody
  • Aragen will commence GMP manufacturing at its Bangalore biologics facility in July 2025, utilizing an intensified fed-batch platform that delivers titers greater than 25 g/L.
  • The facility features flexible single-use 2-KL bioreactors capable of producing one batch every four to five days at full capacity, supporting both multi-client projects and rapid commercial scale-up.
  • Combined with Aragen's California site, the integrated facilities will offer end-to-end biologics services from cell line development to commercial manufacturing of monoclonal antibodies and biosimilars.
  • The expansion aligns with projections that India's CRDMO sector could grow to $22-25 billion by 2035, driven by increasing global pharma outsourcing and biologics demand.

Agenus Partners with Noetik to Develop AI-Powered Biomarkers for Precision Immunotherapy

AIPrecision MedicineMonoclonal Antibody
  • Agenus and Noetik announced a research collaboration to develop predictive biomarkers for the BOT/BAL immunotherapy combination using AI-powered virtual cell models.
  • The partnership leverages Noetik's OCTO foundation model, trained on data from nearly 200 million tumor and immune cells across thousands of patients with various cancer types.
  • The collaboration aims to identify which patients are most likely to respond to botensilimab and balstilimab treatment, potentially improving clinical trial outcomes and patient care.
  • Botensilimab has been evaluated in over 1,200 patients across nine tumor types and has shown responses even in immunotherapy-resistant "cold" tumors.

Prometheus Laboratories Expands Precision-Guided Dosing Platform with New Tests for IBD Biologics

Precision MedicineMonoclonal Antibody
  • Prometheus Laboratories launched PredictrPK VDZ and PredictrPK UST, precision-guided dosing tests for vedolizumab and ustekinumab in IBD patients, expanding their platform to cover four major biologics.
  • The tests incorporate drug clearance measurements alongside traditional therapeutic drug monitoring to provide personalized dosing recommendations and optimize biologic exposure.
  • Clinical studies demonstrate that higher vedolizumab clearance is associated with 9-fold and 2-fold lower likelihood of endoscopic and clinical remission respectively in Crohn's disease patients.
  • A separate study of 213 IBD patients showed that 81% of healthcare providers found PredictrPK ADA helpful for selecting optimal adalimumab dosing and patient discussions about dose escalation.

China Patent Office Upholds Harbour BioMed's Heavy Chain Antibody Patent in Legal Victory Over Biocytogen

Monoclonal Antibody
  • The China National Intellectual Property Administration affirmed the validity of Harbour BioMed's patent covering fully human heavy chain-only antibody production methods on June 5, 2025.
  • Harbour BioMed's patent infringement lawsuit against Biocytogen advances to trial after China's Supreme Court dismissed jurisdictional challenges and affirmed Shanghai court authority.
  • The legal victory strengthens Harbour BioMed's intellectual property position for its Harbour Mice® platform technology used in developing novel antibody therapeutics for immunology and oncology.

Orion and Glykos Extend ADC Partnership to Develop Six Next-Generation Cancer Therapies

OncologyMonoclonal Antibody
  • Orion Corporation and Glykos Finland have extended their research collaboration to develop up to six next-generation antibody-drug conjugates (ADCs) targeting solid tumors.
  • The expanded agreement doubles Orion's access to Glykos' proprietary hydrophilic payload and linker technology, which offers improved efficacy and tolerability compared to conventional ADCs.
  • Glykos will receive milestone payments and royalties from the development and commercialization of the ADC programs, maintaining the same financial terms as the original three-program agreement.
  • The collaboration leverages Orion's oncology expertise and clinical development capabilities with Glykos' advanced ADC technology platform to bring new cancer treatments to patients.

Thyroid Cancer Pipeline Shows Robust Growth with 50+ Companies Developing Novel Therapies

Monoclonal AntibodyCAR-T
  • DelveInsight's 2025 pipeline report reveals over 50 companies are actively developing 51+ therapies for thyroid cancer treatment, indicating a robust therapeutic landscape.
  • Novartis announced a Phase III study evaluating dabrafenib plus trametinib for BRAFV600E mutation-positive differentiated thyroid cancer patients refractory to radioactive iodine.
  • Children's Hospital of Philadelphia initiated a study combining larotrectinib with 131I therapy for NTRK fusion differentiated thyroid cancer patients.
  • Emerging therapies include CAR-T cell therapy AIC100 from AffyImmune Therapeutics and novel BRAF inhibitor RX208 from Suzhou NeuPharma.

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