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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.

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.

FDA Approves CSL's ANDEMBRY for Hereditary Angioedema Prevention with Novel Factor XIIa Targeting

Drug ApprovalMonoclonal AntibodyRare Disease
  • The FDA approved ANDEMBRY (garadacimab-gxii), the first and only prophylactic HAE treatment targeting factor XIIa, offering once-monthly dosing for patients 12 years and older.
  • Phase 3 VANGUARD trial data showed ANDEMBRY reduced HAE attacks by a median of more than 99% and a least squares mean of 89.2% compared to placebo, with 62% of patients remaining attack-free.
  • ANDEMBRY represents a breakthrough approach by inhibiting the top of the HAE cascade through factor XIIa targeting, providing sustained protection with convenient subcutaneous self-injection in 15 seconds or less.
  • CSL will launch ANDEMBRY commercially immediately with availability before the end of June, expanding treatment options for the approximately 1 in 50,000 people affected by this rare genetic disorder.

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

NCT04656418CompletedPhase 3
CSL Behring
Posted 1/27/2021

Clarametyx's CMTX-101 Shows Promise in Cystic Fibrosis Infection Trial, Advances to Next Phase

Monoclonal Antibody
  • Clarametyx Biosciences announced positive interim results from its Phase 1b/2a trial of CMTX-101, an immune-enabling antibody therapy for cystic fibrosis-associated pulmonary infections.
  • The interim analysis of 21 participants demonstrated a reduction in Pseudomonas aeruginosa burden with both 5 and 30 mg/kg doses, while maintaining a favorable safety profile.
  • The Independent Data Monitoring Committee approved continuation of the trial without modifications, with full enrollment of approximately 41 participants expected by end of 2025.
  • CMTX-101 targets bacterial biofilms to enhance antibiotic effectiveness and immune response, representing a novel approach to treating chronic respiratory infections.

A Study to Evaluate the Safety of CMTX-101 in People with Cystic Fibrosis

NCT06159725RecruitingPhase 1
Clarametyx Biosciences, Inc.
Posted 6/24/2024

Solu Therapeutics Appoints Enda Moran as COO to Scale CyTAC Platform Operations

Monoclonal Antibody
  • Solu Therapeutics has appointed Enda Moran, PhD, MBA as Chief Operating Officer to lead operational functions as the company advances its Phase 1 clinical trial of STX-0712.
  • Dr. Moran brings over three decades of biomanufacturing experience from Pfizer, GSK, and other major pharmaceutical companies to support Solu's CyTAC and TicTAC platforms.
  • The appointment comes as Solu progresses STX-0712 through Phase 1 development for resistant/refractory chronic myelomonocytic leukemia and other hematologic malignancies.
  • Dr. Moran will oversee chemistry manufacturing and controls, quality, program management, and infrastructure development to support multiple clinical and regulatory milestones.

Debiopharm Initiates First-in-Human Trial of CD37-Targeted ADC Debio 1562M for Relapsed/Refractory AML

Monoclonal AntibodyOncologyTargeted Therapy
  • Debiopharm has dosed the first patient in a Phase 1/2 trial of Debio 1562M, a first-in-class CD37-targeted antibody-drug conjugate for relapsed/refractory acute myeloid leukemia patients.
  • The compound utilizes Debiopharm's proprietary Trifecta approach, combining naratuximab antibody, MultiLink™ linker technology, and a microtubule inhibitor payload to target CD37 antigens on leukemic cells.
  • AML represents a significant unmet medical need with only 32% five-year overall survival and median survival as low as 7 months in certain populations.
  • Preclinical studies demonstrated Debio 1562M showed anti-leukemic activity across all AML subtypes and superior activity compared to current standard-of-care therapies.

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430RecruitingPhase 1
Debiopharm International SA
Posted 5/30/2025
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