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Clinical Trial News

DX&VX Secures $220 Million mRNA Cancer Vaccine Licensing Deal with U.S. Biotech Partner

Oncology
  • DX&VX has signed its first global out-licensing agreement worth approximately $220 million with a U.S. biotech company for its proprietary mRNA-based cancer vaccine technology.
  • The agreement includes development milestones totaling $220 million plus sales-based milestone payments exceeding 10% of cumulative sales over 15+ years, with projected post-commercialization revenues potentially exceeding $940 million.
  • DX&VX will retain responsibility for leading R&D activities including preclinical studies and Phase 1-3 clinical trials, while the partner handles global regulatory approvals and commercialization.
  • The licensed mRNA cancer vaccine has demonstrated superior anticancer efficacy in preclinical animal studies compared to global competitors currently in Phase 2b trials.

BriaCell Secures New Zealand Patent for HLA-Matched Whole-Cell Cancer Immunotherapy Technology

Precision Medicine
  • BriaCell Therapeutics has been granted New Zealand Patent No. 785587 for its whole-cell cancer vaccine technology, providing exclusivity through February 27, 2037.
  • The patent covers methods for selecting whole-cell cancer immunotherapy based on HLA allele profile matching to personalize treatment for cancer patients.
  • This patent award supports BriaCell's precision medicine approach and is part of the company's broader strategy to establish a strong international patent portfolio.
  • The technology aims to transform cancer care by personalizing immunotherapy for improved patient outcomes across multiple cancer indications.

Anika's Hyalofast Cartilage Repair Treatment Shows Mixed Results in Phase III Trial

  • Anika Therapeutics' Hyalofast cartilage repair scaffold failed to meet its co-primary endpoints in the pivotal FastTRACK Phase III study, missing statistical significance for KOOS Pain and IKDC function improvements over microfracture.
  • The treatment demonstrated statistically significant improvements in key secondary endpoints including KOOS Sports and Recreation Function and Quality of Life, measures that have supported prior FDA approvals for cartilage repair products.
  • Despite the mixed results, Anika plans to file the final PMA module in the second half of 2025, leveraging data from over 35,000 patients treated globally since 2009.
  • The study was impacted by higher dropout rates in the control arm and COVID-related missed visits, which reduced the evaluable sample size and complicated statistical analysis.

Viridian Therapeutics Secures $385 Million Deal with Kissei for Thyroid Eye Disease Therapies in Japan

Monoclonal AntibodyRare Disease
  • Viridian Therapeutics has entered into an exclusive licensing agreement with Kissei Pharmaceutical for veligrotug and VRDN-003 in Japan, receiving $70 million upfront with potential milestone payments up to $315 million.
  • Both drug candidates are anti-IGF-1R antibodies targeting thyroid eye disease, with veligrotug having demonstrated positive results in phase 3 THRIVE trials and VRDN-003 being a subcutaneous, half-life extended formulation.
  • The collaboration leverages Kissei's expertise in rare disease development and commercialization in Japan to address significant unmet medical needs for TED patients.
  • Viridian will also receive tiered royalties ranging from the 20s to mid-30s percent on net sales in Japan, while Kissei assumes all development and commercialization responsibilities.

Evotec Sells Toulouse Biologics Facility to Sandoz for $300M in Strategic Asset-Light Transition

  • Evotec SE and Sandoz AG signed a non-binding agreement for the potential $300 million sale of the Just-Evotec Biologics facility in Toulouse, France.
  • The transaction includes Evotec's proprietary continuous manufacturing technology for biosimilars, with additional revenue streams from technology licensing, development milestones, and product royalties.
  • This deal represents a key milestone in Evotec's strategic shift toward an asset-lighter, capital-efficient business model while maintaining economic upside through ongoing partnerships.
  • The facility has been dedicated entirely to Sandoz since July 2024, making this transaction a natural progression of their existing strategic collaboration.

Major Pharma Companies Establish Innovation Hubs in Hyderabad to Accelerate Drug Development

AI
  • Agilent Technologies opened a new Biopharma Experience Center in Hyderabad, offering end-to-end solutions across chromatography, mass spectrometry, cell analysis, and lab informatics to accelerate drug development.
  • Eli Lilly inaugurated a 2.20 lakh square foot technology and innovation hub in Hyderabad, planning to expand from 100 to 1,500 professionals focused on AI, automation, and software engineering.
  • Both investments reinforce Hyderabad's position as a global hub for life sciences innovation, with the city hosting eight of the top ten global pharma companies and over 230 US FDA-approved manufacturing facilities.
  • The facilities are designed to leverage India's talent pool in artificial intelligence and data sciences while supporting global drug development pipelines for major health challenges including diabetes, obesity, Alzheimer's disease, and cancer.

Nuoyuan Medical's Pemefolacianine Completes Phase I Trial, Advances Precision Tumor Surgery

Targeted Therapy
  • Nuoyuan Medical's Pemefolacianine, a folate receptor alpha-targeted fluorescent imaging agent, successfully completed Phase I clinical trials in China with no drug-related adverse events reported among 32 healthy participants.
  • The novel contrast agent demonstrated favorable pharmacokinetics with dose-dependent increases in plasma concentration and fluorescence intensity, positioning it as the first FR-α targeted agent from China to receive FDA IND approval.
  • Pemefolacianine offers enhanced targeting specificity with eight times higher affinity for FR-α compared to FR-β, potentially reducing false-positive rates in intraoperative tumor imaging.
  • The company has initiated Phase II trials in China and is preparing U.S. clinical trials as part of its dual-track global development strategy, with patents secured across major markets.

Sanofi's SAR446523 Receives FDA Orphan Drug Designation for Relapsed/Refractory Multiple Myeloma

Monoclonal Antibody
  • The FDA has granted orphan drug designation to SAR446523, Sanofi's investigational GPRC5D-targeting monoclonal antibody for treating relapsed or refractory multiple myeloma.
  • SAR446523 is an IgG1-based antibody with enhanced ADCC activity that targets GPRC5D, a receptor highly expressed on plasma cells in multiple myeloma patients.
  • The drug is currently being evaluated in a phase 1 first-in-human study as a subcutaneous treatment for patients with relapsed or refractory multiple myeloma.
  • Multiple myeloma affects more than 180,000 people globally each year and remains incurable with a 62% five-year survival rate for newly diagnosed patients.

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

NCT06630806RecruitingPhase 1
Sanofi
Posted 10/30/2024

ESC Congress 2025 to Showcase Pivotal Cardiovascular Trials with Global Health Impact

  • ESC Congress 2025 will present over 40 pivotal cardiovascular studies in 10 Hot Line sessions from August 29 to September 1 in Madrid, focusing on global health priorities.
  • Key trials will examine whether long-term beta-blockers remain necessary after myocardial infarction and test earlier withdrawal of antiplatelet and anticoagulation therapies to reduce bleeding risks.
  • The PARACHUTE-HF trial will provide the first mortality-based evidence for treating chronic Chagas cardiomyopathy affecting 6-7 million patients, primarily in Latin America.
  • Novartis will present 19 abstracts showcasing cardiovascular portfolio advances, including pelacarsen for elevated lipoprotein(a) and abelacimab for atrial fibrillation safety.

Harbour BioMed to Present Phase II Data on Novel Anti-CTLA-4 Antibody Combination for Treatment-Resistant Colorectal Cancer at ESMO 2025

Monoclonal Antibody
  • Harbour BioMed will present Phase II clinical data on porustobart (HBM4003), a next-generation anti-CTLA-4 antibody, combined with tislelizumab for microsatellite stable metastatic colorectal cancer at ESMO Congress 2025.
  • The multicenter study enrolled heavily pretreated patients with non-liver metastatic MSS colorectal cancer, a population with limited response to current immune checkpoint inhibitors.
  • Porustobart represents the first fully human heavy-chain-only antibody in clinical development globally, featuring enhanced Treg cell depletion and improved safety profile compared to conventional CTLA-4 antibodies.
  • The combination therapy addresses a significant therapeutic challenge, as MSS metastatic colorectal cancer remains resistant to standard immunotherapy approaches.

HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

NCT05167071Active, Not RecruitingPhase 1
Harbour BioMed (Guangzhou) Co. Ltd.
Posted 12/28/2021

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