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Clinical Trial News

Percheron Therapeutics Acquires Phase II-Ready Anti-VISTA Cancer Immunotherapy HMBD-002 in $290M Deal

Monoclonal Antibody
  • Percheron Therapeutics has licensed HMBD-002, a first-in-class monoclonal antibody targeting the VISTA immune checkpoint, from Hummingbird Bioscience in a deal worth up to $290 million.
  • The drug has successfully completed Phase I trials showing it is pharmacologically active, safe and well-tolerated, with Percheron planning to initiate Phase II trials in 2026.
  • HMBD-002 targets VISTA, a novel checkpoint protein that could reinvigorate immune responses in cancers resistant to existing checkpoint inhibitors like PD-1 or CTLA-4.
  • The licensing agreement marks a strategic shift for Percheron from rare diseases to immuno-oncology, following disappointing results with its previous asset avicursen.

BioCity's SC0062 Receives Second Breakthrough Therapy Designation for Diabetic Kidney Disease Treatment

  • BioCity Biopharma's highly selective ETA antagonist SC0062 has received its second Breakthrough Therapy Designation from China's NMPA, this time for treating diabetic kidney disease with albuminuria.
  • The Phase 2 2-SUCCEED study demonstrated statistically significant albuminuria reduction at the 20 mg dose with a favorable safety profile and no increased fluid retention risk.
  • SC0062 showed good safety both as monotherapy and in combination with standard-of-care therapies including SGLT2 inhibitors, RAAS inhibitors, and GLP-1 receptor agonists.
  • The dual BTD recognition validates SC0062's potential as a next-generation broad-spectrum renal therapy across multiple chronic kidney disease indications.

Vor Bio Secures Global Rights to Telitacicept in $4+ Billion Deal with RemeGen

  • Vor Bio acquired exclusive global rights (excluding Greater China) to develop and commercialize telitacicept, a dual-target fusion protein approved in China for multiple autoimmune diseases including generalized myasthenia gravis.
  • The licensing agreement includes $125 million in initial payments to RemeGen, with potential regulatory and commercial milestones exceeding $4 billion plus tiered royalties.
  • Telitacicept demonstrated a 4.8-point improvement in MG-ADL scale versus placebo at 24 weeks in a Phase 3 trial in China, with global Phase 3 results expected in the first half of 2027.
  • Jean-Paul Kress, MD, was appointed as Vor Bio's new CEO and Chairman, bringing extensive pharmaceutical leadership experience from MorphoSys and other major companies.

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis

2024-512126-29-00RecruitingPhase 3
Remegen Co. Ltd.
Posted 7/17/2024

New Zealand Launches World's First Clinical Trial Testing THC-CBD Combination for Canine Osteoarthritis

  • Hale Animal Health is conducting the first regulated clinical trial testing a THC-CBD liquid formulation for osteoarthritis pain management in over 100 dogs across New Zealand.
  • The six-week study aims to provide pain relief comparable to current anti-inflammatory medications but without the common side effects of digestive upset and liver or kidney damage.
  • Trial data will support regulatory applications to New Zealand's ACVM and eventually the FDA, with plans to register the product as a veterinary medicine in New Zealand, Australia, and the United States.
  • Eligible dogs receive free veterinary care including physical exams, X-rays, and blood screening, with the liquid treatment administered daily based on body weight.

Advanced Mycosis Fungoides Treatment Requires Strategic Sequencing of HDAC Inhibitors and Targeted Therapies

Targeted Therapy
  • Advanced mycosis fungoides with nodal involvement requires systemic approaches adapted from peripheral T-cell lymphoma management, as standard skin-directed therapies provide limited benefit in this setting.
  • CTCL patients typically require 50% dose reductions compared to systemic T-cell lymphoma protocols due to enhanced treatment sensitivity and altered tumor cell metabolism.
  • HDAC inhibitors including romidapsin and vorinostat demonstrate efficacy in patients with both peripheral blood and nodal involvement, while mogamalizumab shows particular effectiveness in circulating disease.
  • Chronic use of single-agent chemotherapy introduces unique toxicity considerations, with gemcitabine carrying risks of hemolytic uremic syndrome after continuous use for over a year.

Alafair Biosciences Initiates Multi-Center Study of VersaWrap Hydrogel Device for Achilles Tendon Repair

  • Alafair Biosciences has enrolled the first patient in the B.R.A.A.D study, a multi-center controlled case series evaluating VersaWrap for Achilles tendon repair at UC Davis Foot and Ankle Orthopaedics Clinic.
  • The study aims to assess VersaWrap's ability to reduce postoperative complications such as tendon tethering, addressing limitations of traditional surgical repair techniques including long healing times and scar tissue formation.
  • VersaWrap is an FDA-cleared bioresorbable device comprising hyaluronic acid and alginate that provides tissue protection and can be delivered as either a sheet or flowable gel.

CDC's Reconstituted Vaccine Advisory Panel Votes to Eliminate Thimerosal from All Flu Vaccines

Monoclonal Antibody
  • The newly appointed Advisory Committee on Immunization Practices (ACIP) voted 5-1 to recommend thimerosal-free influenza vaccines for all age groups, despite the preservative being present in only 6% of U.S. flu vaccines.
  • Committee members expressed concerns that restricting thimerosal-containing vaccines could reduce vaccine access, particularly in global markets where multi-dose vials are more cost-effective.
  • The panel also approved RSV prevention recommendations, voting 5-2 to recommend clesrovimab for infants under 8 months during their first RSV season.
  • Public health experts criticized the committee's focus on thimerosal as scientifically unfounded, noting the preservative was already removed from pediatric vaccines over 20 years ago.

DBV Technologies Initiates COMFORT Toddlers Phase 3 Study for Viaskin Peanut Patch in Young Children

  • DBV Technologies has begun screening the first subject in its COMFORT Toddlers Phase 3 supplemental safety study, evaluating the Viaskin Peanut patch 250 μg in peanut-allergic children ages 1-3 years old.
  • The double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 centers in the U.S., Canada, Australia, UK and Europe over six months with an optional 18-month extension.
  • Data from COMFORT Toddlers is designed to supplement the completed Phase 3 EPITOPE study and support a Biologics License Application submission to the FDA anticipated in the second half of 2026 under the Accelerated Approval Pathway.

TME Pharma Appoints Diede van den Ouden as New CEO to Advance Glioblastoma Drug Development

Oncology
  • TME Pharma shareholders unanimously approved the appointment of Diede van den Ouden as new CEO, succeeding Aram Mangasarian at the company's 2025 annual general meeting.
  • The leadership transition comes as TME Pharma has achieved significant clinical progress with NOX-A12 in glioblastoma, earning FDA fast track designation for the challenging brain cancer indication.
  • Van den Ouden, who is also a major shareholder, will focus on accelerating strategic initiatives for both NOX-A12 and NOX-E36 while securing funding and partnerships.
  • The company has strengthened its financial position with reduced cash burn and a secured 12-month runway as it advances multiple clinical programs targeting the tumor microenvironment.

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

NCT04121455Active, Not RecruitingPhase 1
TME Pharma AG
Posted 9/12/2019

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741Not Yet RecruitingPhase 2
TME Pharma AG
Posted 1/1/2026

Cellugy Secures €8.1 Million EU Funding to Scale Microplastic Alternative for Cosmetics Industry

  • Danish biotechnology company Cellugy has secured €8.1 million in EU LIFE Programme funding to accelerate commercialization of EcoFLEXY, a biofabricated cellulose-based rheology modifier designed to replace fossil-derived microplastics in cosmetics.
  • The BIOCARE4LIFE project aims to prevent the release of 259 tonnes of microplastics annually by project completion, with projections rising to 1,289 tonnes per year by 2034.
  • EcoFLEXY targets the €2.8 billion global rheology modifier market, where approximately 70% of products are still based on fossil, non-degradable ingredients that face increasing regulatory scrutiny under EU REACH regulations.
  • The four-year funding will support process optimization, commercial validation, and industrial scaling, with Cellugy planning to achieve significant sales within three to five years.

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