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Clinical Trial News

UK Regulator Reports 111 Deaths Potentially Linked to GLP-1 Weight Loss Medications

  • The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has recorded 111 deaths potentially associated with GLP-1 receptor agonist weight loss medications through May 29, 2024.
  • Saxenda (liraglutide) was linked to the highest number of fatal reports with 37 deaths, followed by Mounjaro (tirzepatide) with 33 and semaglutide-based drugs with 30 deaths.
  • While no direct causal relationship has been established, the MHRA acknowledges these reports raise "a suspicion" of a possible link between the medications and fatalities.
  • The only confirmed death directly linked to these medications in the UK was Susan McGowan, a 58-year-old Scottish nurse who died after taking Mounjaro.

Avata Biosciences Secures $95M Partnership with Oceanus Bio for Novel CBD Therapies in Asian Markets

  • Avata Biosciences has signed a co-development and licensing agreement with Oceanus Bio worth $95 million in milestones and contributions for exclusive rights to AVAT-021 and AVAT-022 in Japan and Asia.
  • AVAT-021 represents a technological breakthrough as a solid dose cannabidiol therapy that can pack more than 200mg of CBD into size 0 capsules for treatment-resistant epilepsy and schizophrenia.
  • The company has achieved positive Phase 1 data demonstrating tolerability and bioavailability of AVAT-021 compared to Epidiolex, meeting all pharmacokinetic objectives.
  • Avata plans to file an Investigational New Drug application in the second half of 2025 using the FDA's 505(b)(2) expedited regulatory pathway for faster market access.

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.

Llusern Scientific Achieves ISO 13485 Certification for Rapid UTI Diagnostic System

  • Llusern Scientific has received ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform that delivers lab-accurate UTI results in approximately 30 minutes.
  • The portable device addresses the global burden of over 400 million annual UTI cases by enabling precise bacterial identification and reducing antibiotic overprescription by up to two times.
  • The certification represents a crucial regulatory milestone for global market expansion, with commercial launches planned for India and MENA region in 2025 and the US in 2026.

SunRock Biopharma and Escugen Partner to Develop First-in-Class CCR9-Targeted ADC for Solid Tumors

  • SunRock Biopharma and Escugen have formed a strategic partnership to co-develop SRB123, a first-in-class antibody-drug conjugate targeting CCR9 for multiple solid tumors including pancreatic, ovarian, and lung cancers.
  • The collaboration combines SunRock's proprietary SRB1 antibody with Escugen's EZWi-Fit™ linker-payload platform to create a precision oncology candidate designed for tumors with high CCR9 expression.
  • CCR9 represents an underexploited but clinically validated target associated with metastatic potential and chemoresistance, particularly in pancreatic and ovarian cancers.
  • Both companies will share development responsibilities and file joint patents, with the primary goal of generating preclinical proof-of-concept data to support early clinical entry.

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.

HanchorBio's HCB101 Checkpoint Inhibitor Shows Promising Safety and Efficacy Balance in Phase 1b Trial

Oncology
  • HanchorBio presented interim Phase 1b data for HCB101, a CD47-targeting checkpoint inhibitor, at the 2025 ASCO Annual Meeting showing favorable safety and tolerability across escalating doses.
  • The treatment demonstrated early anti-tumor activity with confirmed partial responses in head and neck cancer and non-Hodgkin's lymphoma patients, while achieving high-level CD47 receptor occupancy.
  • HCB101 achieved a 26.7% disease control rate in Phase 1a data with 100% safety across all dose levels, addressing the traditional trade-off between safety and efficacy in checkpoint inhibitor treatments.
  • The company has launched a multi-region Phase 2 trial spanning Taiwan, the United States, and China, enrolling patients with multiple cancer types including lung, head and neck, stomach, and breast cancers.

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

NCT05892718RecruitingPhase 1
FBD Biologics Limited
Posted 10/2/2023

Processa Pharmaceuticals Secures $452.5M Licensing Deal for Gastroparesis Drug PCS12852

  • Processa Pharmaceuticals has entered into a binding term sheet with Intact Therapeutics for the exclusive licensing of PCS12852, a 5-HT4 receptor agonist targeting gastroparesis and gastrointestinal motility disorders.
  • The deal structure includes $452.5 million in total milestone payments, with $2.5 million in near-term payments, double-digit royalties on future sales, and a 3.5% equity stake in Intact Therapeutics.
  • PCS12852 completed a Phase 2a trial demonstrating strong safety, tolerability, and efficacy signals in patients with diabetic gastroparesis, addressing a condition with limited treatment options.
  • The agreement allows Processa to unlock value from its non-oncology assets while maintaining focus on cancer therapy development, with Intact's GI-focused strategy positioned to advance the drug toward commercialization.

FDA Grants Orphan Drug Designation to Medicovestor's First-in-Class ADC for Pancreatic Cancer

Oncology
  • The FDA has granted Orphan Drug Designation to ADoBind MC001, Medicovestor's lead antibody-drug conjugate candidate for treating pancreatic cancer, one of the most aggressive malignancies with a five-year survival rate under 10%.
  • ADoBind MC001 represents a new class of chemoimmunotherapy ADCs that combines enhanced antibody-dependent cellular cytotoxicity with improved payload delivery and prolonged tumor engagement through proprietary platform innovations.
  • The designation provides seven years of market exclusivity upon approval, tax credits, and fee waivers, while Medicovestor progresses through IND-enabling studies with Phase 1 trials expected to begin in early 2026.

Astrocyte Pharmaceuticals Initiates Phase 2 Trial for First-in-Class Concussion Drug AST-004

  • Astrocyte Pharmaceuticals has dosed the first patient in its Phase 2 STARFAST trial testing AST-004, the first drug to demonstrate neuroprotective effects against concussion in preclinical studies.
  • The company received a $3 million NIH grant to develop an oral formulation of AST-004, making the treatment more accessible for field deployment.
  • AST-004 is a selective adenosine A1 and A3 receptor agonist designed to enhance mitochondrial energy metabolism in glial cells following brain injury.
  • The Phase 2 trial in Australian football players will evaluate whether intravenous AST-004 administered within 6 hours of concussion can reduce brain damage and accelerate recovery.

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