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Clinical Trial News

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.

Tharimmune Appoints New CEO and Board Members to Advance Opioid Antagonist TH104 Development

  • Tharimmune announced key leadership changes with Sireesh Appajosyula becoming CEO and Vincent LoPriore appointed Executive Chairman in June 2025.
  • The company added James Gordon Liddy, a retired Navy SEAL Commander with national security expertise, to its board of directors to support TH104 development.
  • TH104 is a buccal film formulation designed to deliver opioid antagonist therapy for military personnel and first responders exposed to weaponized fentanyl and high-potency opioids.
  • The leadership appointments strengthen Tharimmune's strategic position as it advances its lead candidate through the 505(b)2 regulatory pathway for respiratory and nervous system depression prevention.

Lipella Pharmaceuticals Secures Patent for MRI-Based Diagnostic Technology to Detect Interstitial Cystitis

  • Lipella Pharmaceuticals received U.S. Patent No. 12,326,492 for an MRI-based method to detect lesions in body cavities, specifically targeting interstitial cystitis diagnosis.
  • The patent provides protection through at least 2045 and covers technology that could enhance outcome assessments for mucosal disorders across Lipella's pipeline.
  • The diagnostic method utilizes a novel MRI contrast agent to non-invasively monitor lesion progression or regression in body cavities.
  • The technology could support Lipella's existing clinical programs including LP-310 for oral lichen planus, LP-10 for hemorrhagic cystitis, and LP-50 for bladder cancer.

Health Canada Proposes Elimination of Phase III Clinical Trials for Biosimilar Approvals

Drug Approval
  • Health Canada has released draft guidance that would eliminate the requirement for comparative Phase III clinical trials in biosimilar drug approvals, marking a significant policy reversal.
  • The proposed changes would limit clinical requirements to comparative pharmacokinetic studies and optional pharmacodynamic evaluations, focusing instead on extensive analytical similarity data.
  • This regulatory shift aligns with similar moves by the European Medicines Agency and FDA discussions that have led some companies to terminate or minimize Phase III biosimilar trials.
  • The consultation period for the draft guidance runs until September 8, 2025, with potential implementation representing a pivotal change in Canada's biosimilar regulatory landscape.

PHOENIX Study Launches World's Largest Pharmacogenomics Trial to Personalize Drug Prescribing in Scotland

Precision Medicine
  • The PHOENIX Study, one of the largest pharmacogenomics trials globally, will recruit up to 4,000 patients over two years to investigate how genetic profiles affect responses to 60 commonly prescribed NHS medications.
  • Around 15% of patients are expected to carry genetic variants that may reduce medication effectiveness or increase side effects, which currently go unnoticed without genetic testing.
  • Led by Professor Sandosh Padmanabhan at the University of Glasgow, the trial aims to provide real-world evidence for implementing precision medicine across Scotland's healthcare system.
  • Participants undergo simple genetic testing with results returned within days to help doctors determine optimal drug selection and dosing based on individual genetic makeup.

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