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Clinical Trial News

Frazier Healthcare Partners Closes $1.3 Billion Fund for Early-Stage Biotech Investments

Oncology
  • Frazier Healthcare Partners has successfully closed a $1.3 billion venture capital fund specifically targeting early-stage biotechnology companies and startup creation.
  • The firm was one of the most active biotech investors in 2024, participating in 17 deals and leading nearly one-third of those transactions.
  • Recent successful exits include Scorpion Therapeutics' $2.5 billion drug sale to Eli Lilly and major acquisitions like Novartis' $3.5 billion purchase of Chinook Therapeutics.
  • The new fund launch comes amid declining biotech venture funding, which dropped from $7 billion to $4.8 billion in Q2 2025 according to HSBC Innovation Banking.

Altasciences Partners with VoxCell BioInnovation to Integrate 3D Bioprinting Technology into Preclinical Drug Development

  • Altasciences and VoxCell BioInnovation have formed a strategic collaboration to enhance preclinical research by integrating 3D bioprinted tissue platforms into early-phase drug development services.
  • The partnership combines Altasciences' comprehensive drug development capabilities with VoxCell's cutting-edge 3D tissue technology to create more predictive and human-relevant preclinical testing environments.
  • VoxCell's proprietary bioprinted tissues closely mimic human tumors and biological structures, offering advanced platforms for evaluating drug efficacy, safety, and toxicity before animal or human studies.
  • The collaboration will initially focus on drug screening for ocular indications, with plans to expand into additional therapeutic areas and applications.

Protopia AI Secures $1.25M Air Force Contract to Advance Privacy-Preserving AI Technology for Secure Code Development

AI
  • Protopia AI received a $1.25 million Direct-to-Phase II SBIR contract from the U.S. Air Force to demonstrate its Stained Glass Transform technology for secure AI-powered software development.
  • The technology enables Air Force teams to use coding large language models without exposing proprietary codebases in plain text, addressing critical security concerns in AI adoption.
  • This partnership with the Air Force Sustainment Center Software Directorate represents a significant milestone for privacy-preserving AI applications in mission-critical environments.
  • The contract highlights the growing need for dual-use technologies that enable secure generative AI adoption across both military and commercial applications.

University of Colorado Launches $29 Million EFFECT Trial to Evaluate Early Fibrinogen Replacement in Trauma Care

  • The University of Colorado Anschutz Medical Campus received a $29 million grant from Octapharma to lead the EFFECT Trial, evaluating early fibrinogen replacement in trauma patients with life-threatening bleeding.
  • The multicenter randomized trial will enroll 800 participants across 12 top-tier trauma centers, representing the first U.S. clinical trial to rigorously evaluate fibrinogen concentrate as a frontline trauma intervention.
  • The study aims to address hemorrhage, the primary cause of preventable death after traumatic injury, by targeting fibrinogen depletion which occurs first among coagulation factors.
  • Results could transform trauma resuscitation protocols for both civilian and military care, potentially influencing global trauma treatment guidelines.

ImmuneOnco's CD47xCD20 Bispecific IMM0306 Advances to Phase II with Promising Efficacy in B-Cell Lymphomas

Oncology
  • ImmuneOnco Biopharmaceuticals completed first patient enrollment in Phase II clinical trial of IMM0306, the world's first CD47xCD20 bispecific molecule to reach clinical stage.
  • Phase I data demonstrated encouraging efficacy with 81.8% overall response rate in follicular lymphoma/marginal zone lymphoma patients when combined with lenalidomide.
  • IMM0306 showed favorable safety profile with no dose-limiting toxicities or cytokine storm toxicity observed across eight dose groups up to 2.0 mg/kg.
  • The company is pursuing multiple clinical development pathways including monotherapy and combination studies across various B-cell lymphoma indications.

Marengo Therapeutics Strengthens Leadership with Pfizer Veteran Dolsten and Oncology Expert Tabernero

Precision MedicineOncology
  • Marengo Therapeutics appointed former Pfizer Chief Scientific Officer Mikael Dolsten to its Board of Directors and renowned oncologist Josep Tabernero to its Scientific Advisory Board in July 2025.
  • Dolsten brings over 16 years of R&D leadership experience at Pfizer, where he oversaw more than 36 drug approvals including breakthrough oncology therapies.
  • Tabernero, Director of the Vall d'Hebron Institute of Oncology and former ESMO President, will advise on clinical development of Marengo's immunotherapies across multiple tumor types.
  • The appointments come as Marengo advances invikafusp alfa, which has shown encouraging clinical signals in PD-1-resistant tumors with a 63% disease control rate in TMB-H gastrointestinal cancers.

Moderna Announces 10% Workforce Reduction as Part of $1.5 Billion Cost-Cutting Initiative

  • Moderna plans to cut approximately 10% of its global workforce by year-end, reducing employee count from roughly 5,800 to under 5,000 as part of broader cost reduction efforts.
  • The layoffs are part of a comprehensive $1.5 billion annual operating expense reduction plan by 2027, following declining COVID-19 vaccine sales and missed first-quarter expectations.
  • Despite workforce reductions, Moderna maintains a positive outlook with three approved products and potential for up to eight additional products in the next three years.
  • The company's stock has fallen more than 20% this year amid declining vaccine sales, adding pressure for cost-cutting measures beyond research and development reductions.

Chipscreen Biosciences Receives FDA IND Approval for Brain-Penetrant Aurora B Inhibitor CS231295

Oncology
  • Chipscreen Biosciences has received FDA IND approval for CS231295, a next-generation brain-penetrant Aurora B selective inhibitor for treating advanced solid tumors.
  • CS231295 represents the first compound of its design to enter clinical trials globally, targeting genetic vulnerabilities in hard-to-treat cancers including those with RB1 deletion.
  • The drug demonstrates strong blood-brain barrier permeability, offering significant therapeutic potential for both primary brain tumors and brain metastases.
  • CS231295 completed first patient enrollment in its Phase I trial in China in May 2025, with FDA approval now accelerating U.S. clinical development.

Vanda Pharmaceuticals Reports Strong Q2 2025 Results with Multiple Drug Applications Under FDA Review

Drug Approval
  • Vanda Pharmaceuticals reported a 27% increase in Fanapt net product sales to $29.3 million in Q2 2025, driven by expanded sales efforts and direct-to-consumer campaigns.
  • The company has three drug applications under FDA review: Bysanti for bipolar I disorder and schizophrenia (PDUFA date February 21, 2026), tradipitant for motion sickness (PDUFA date December 30, 2025), and plans to submit imsidolimab BLA for generalized pustular psoriasis in 2025.
  • Total net product sales across all three marketed drugs reached $52.6 million in Q2 2025, representing a 4% increase year-over-year, though the company reported a net loss of $27.2 million compared to $4.5 million in Q2 2024.

Symbiosis Pharmaceutical Services Achieves Manufacturing Milestone with 1,000th Sterile Injectable Batch

Monoclonal Antibody
  • Symbiosis Pharmaceutical Services, a global contract manufacturing organization, has successfully completed its 1,000th sterile drug product batch since its founding in 2011.
  • The Scottish-based company has manufactured complex injectable products including monoclonal antibodies, antibody-drug conjugates, viral vectors, and advanced therapy medicinal products across clinical and commercial stages.
  • Symbiosis played a crucial role in COVID-19 vaccine development by manufacturing nearly one million doses of the Oxford University/AstraZeneca vaccine at its Stirling facility to support clinical trials.
  • The milestone reflects the company's growth from a startup to an internationally recognized sterile manufacturer supporting global pharmaceutical development and commercial supply chains.

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