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Clinical Trial News

Purdue Pharma Supreme Court Petition Could Reshape Patent Obviousness Standards for Pharmaceutical Industry

  • Purdue Pharma has filed a petition for certiorari to the U.S. Supreme Court that could significantly alter how courts evaluate secondary considerations in patent obviousness analyses.
  • The case specifically challenges the nexus standard developed by the U.S. Court of Appeals for the Federal Circuit, potentially transforming patent law precedent.
  • Legal experts suggest the outcome could have far-reaching implications for pharmaceutical patent protection strategies and obviousness determinations across the industry.
  • The petition represents a critical juncture for patent practitioners and pharmaceutical companies navigating the evolving legal landscape of intellectual property protection.

Epitopea Strengthens Leadership Team as RNA-Based Cancer Immunotherapy Platform Advances Toward Clinical Trials

  • Epitopea has appointed key executives including Siri Brinchmann-Hansen Torhaug as Head of Oncology Development and Gertrud Koefoed Rasmussen as Head of Development Operations to accelerate clinical development of its CryptiVax™ RNA-based immunotherapies.
  • The company expanded its research capabilities with the addition of Dr. Theres Oakes as Director of Translational Sciences and Dr. Lisa Smith as Director of Research to support the transition from preclinical to clinical stages.
  • Epitopea's proprietary CryptoMap™ platform identifies novel Cryptigen™ tumor-specific antigens hidden within cancer's "junk" DNA, targeting a new class of broadly shared antigens across multiple patients with the same tumor type.
  • The leadership expansion represents a significant milestone in advancing the company's off-the-shelf RNA-based immunotherapies for hard-to-treat cancers into clinical trials.

CRISPR Gene Editing Enables Mice to Produce Diabetes Drug Exenatide for Sustained Weight Control

Gene Editing
  • Japanese researchers at the University of Osaka used CRISPR gene editing to engineer mouse liver cells to produce exenatide, a diabetes and obesity medication, eliminating the need for regular injections.
  • The genome-edited mice maintained therapeutic drug levels in their blood for over six months, showing sustained weight control and improved glucose metabolism after a single treatment.
  • The study demonstrates potential for transforming chronic disease management by turning the liver into a continuous drug production factory, though only 1% of liver cells successfully incorporated the gene.
  • This approach could address the challenge of frequent dosing required for GLP-1 receptor agonists like exenatide, which typically need weekly or daily injections to maintain therapeutic levels.

Varda Space Industries Secures $187 Million Series C to Advance Microgravity Drug Manufacturing

  • Varda Space Industries raised $187 million in Series C funding led by Natural Capital and Shrug Capital, bringing total capital raised to $329 million for microgravity-enabled pharmaceutical manufacturing.
  • The company has completed three successful orbital missions and demonstrated breakthrough crystallization of ritonavir Form III, a previously unstable drug formulation that could not be produced on Earth.
  • Varda opened a new 10,000 square foot laboratory in El Segundo to develop processes for crystallizing biologics, targeting the $210 billion monoclonal antibody market.
  • The company's reusable orbital capsules reach Mach 25 during reentry and serve dual purposes as pharmaceutical laboratories and hypersonic testbeds for government partners.

Sanofi Advances Long-Term Amlitelimab Study for Moderate to Severe Atopic Dermatitis

  • Sanofi is conducting a Phase 2/Phase 3 long-term extension study to evaluate the safety, tolerability, and efficacy of subcutaneous amlitelimab in patients with moderate to severe atopic dermatitis.
  • The open-label study began on August 22, 2022, and follows participants from previous amlitelimab trials, with treatment administered every four weeks via subcutaneous injection.
  • The study includes both responder and non-responder participants from previous trials, with protocols for drug withdrawal and treatment restoration to monitor treatment durability.
  • Positive results from this ongoing research could strengthen Sanofi's competitive position in the dermatological treatment market and potentially impact investor confidence in the company's pipeline.

Medidata Expands Partnership with University of Sydney to Accelerate Clinical Trial Innovation

  • Medidata has expanded its six-year partnership with the NHMRC Clinical Trials Centre at the University of Sydney, now supporting 30 concurrent studies through its unified platform.
  • The collaboration enables streamlined clinical trial operations by consolidating multiple data systems, improving data management capabilities and research efficiency.
  • The CTC utilizes Medidata solutions particularly for studies that may contribute to regulatory submissions, with emphasis on adaptive and platform trial development.
  • The partnership demonstrates Medidata's proactive approach to global data privacy and security compliance while supporting complex and evolving trial settings.

TandemAI and Perpetual Medicines Merge to Advance AI-Driven Small Molecule and Peptide Drug Discovery

AIDrug Discovery
  • TandemAI and Perpetual Medicines have completed a strategic merger to create an expanded AI and physics-based drug discovery platform covering both small molecules and peptides.
  • The combined company will leverage TandemAI's proven track record with over 150 pharmaceutical partners and Perpetual's computational peptide discovery platform to accelerate therapeutic development.
  • More than ten client programs from TandemAI are expected to reach clinical trials within the next 12 months, demonstrating the commercial viability of their AI-driven approach.
  • The merger positions the combined entity to capitalize on the growing commercial opportunity in peptide therapeutics, particularly following the success of GLP-1, IL-23, and PCSK9 drug classes.

Renasant Bio Raises $54.5M to Develop Novel Ion Channel Therapies for ADPKD

  • Renasant Bio secured $54.5 million in seed funding from investors including 5AM Ventures, Atlas Venture, OrbiMed and Qiming Venture Partners USA to develop treatments for autosomal dominant polycystic kidney disease (ADPKD).
  • The company is developing corrector and potentiator therapies inspired by cystic fibrosis treatments, targeting malformed ion channels that cause ADPKD in approximately 12 million people worldwide.
  • Renasant's lead small molecule corrector candidate is currently in preclinical testing and designed to work across the wide range of mutations that cause ADPKD, with clinical trials planned for the next few years.

Renovaro Biosciences Converts $9.7M Debt to Equity, Strengthens AI-Driven Drug Discovery Platform

AIPrecision MedicineDrug Discovery
  • Renovaro Inc. (NASDAQ:RENB) announced that senior debt holders agreed to convert approximately $9.7 million of outstanding debt into equity through the issuance of 53.6 million shares at $0.30 per share.
  • The debt conversion significantly enhances the company's balance sheet by eliminating debt obligations and interest payments, providing greater financial flexibility for growth initiatives.
  • The biotechnology company focuses on AI-driven precision medicine, developing innovative therapies and diagnostics in oncology, infectious disease, and autoimmune disorders using machine learning integrated with biomedical research.

Neurizon Receives FDA Approval for Strategy to Lift Clinical Hold on ALS Drug NUZ-001

FDA Approval
  • Neurizon Therapeutics received written FDA confirmation accepting its strategy to lift the clinical hold on NUZ-001, an investigational treatment for amyotrophic lateral sclerosis (ALS).
  • The company has completed two required preclinical pharmacokinetic studies ahead of schedule to address FDA concerns about systemic exposure data.
  • Neurizon anticipates submitting its complete response to the FDA in the coming weeks and expects the clinical hold to be lifted by August 2025.
  • The regulatory progress positions NUZ-001 for entry into the HEALEY ALS Platform Trial in the second half of 2025.

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