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Clinical Trial News

NYU Engineers Develop First Immunocompetent Leukemia-on-a-Chip Device to Advance CAR-T Cell Therapy Testing

CAR-T
  • Researchers from NYU Tandon School of Engineering and University of Pennsylvania have created the first microscope slide-sized "leukemia-on-a-chip" device that combines bone marrow structure with a functioning human immune system.
  • The device enables real-time observation of CAR-T cell dynamics in an authentic microenvironment, revealing previously unseen interactions including a "bystander effect" where engineered cells stimulate non-targeted immune cells.
  • The platform can be assembled within half a day compared to months for animal models, opening possibilities for personalized medicine applications where patient-specific samples can be tested against multiple CAR-T cell designs.
  • Fourth-generation CAR-T cells demonstrated superior performance at lower dosages within the chip environment, suggesting potential for optimizing dose regimens while reducing toxic side effects.

Catalio Capital Closes $400M Fund IV to Back Healthcare and Biotech Companies Amid Market Downturn

Drug Discovery
  • Catalio Capital Management announced the closing of its more than $400 million Fund IV, continuing its focus on healthcare and biotechnology investments despite challenging market conditions.
  • The venture capital firm, founded in 2020, has already deployed Fund IV capital into 16 companies, including diagnostics company PinkDx and drug discovery company Superluminal Medicines.
  • The biotech venture market experienced a dramatic decline from $152.3 billion in 2023 to just $12 billion last year, reflecting broader challenges from higher interest rates and reduced IPO activity.

AstraZeneca CEO Reportedly Considers US Stock Listing Move Amid UK Regulatory Frustrations

  • AstraZeneca CEO Pascal Soriot has privately expressed preference to move the company's stock market listing from London to New York, according to multiple sources cited by The Times.
  • The potential move reflects Soriot's reported frustration with the UK's operating environment and concerns about declining European competitiveness against the US and China.
  • AstraZeneca's share price rose 2.8% following the news, highlighting investor support for a potential US listing that could provide higher valuations.
  • A listing shift would represent a major blow to the London Stock Exchange, which has already lost several FTSE 100 companies to US markets in recent years.

Outlook Therapeutics Approaches Critical FDA Decision for LYTENAVA as European Launch Validates Market Potential

Drug Approval
  • Outlook Therapeutics awaits FDA decision by August 27, 2025, for LYTENAVA (bevacizumab-vikg), which would be the first FDA-approved ophthalmic formulation of bevacizumab in the U.S. with 12 years of regulatory exclusivity.
  • The company has already secured regulatory approval in the European Union and UK, with successful commercial launches in Germany and UK, including endorsements from NICE and Scottish Medicines Consortium.
  • LYTENAVA targets the $4 billion+ anti-VEGF market for wet AMD, potentially capturing 20-30% market share by replacing 2.7 million annual off-label bevacizumab injections in the U.S.
  • New CEO Bob Jahr brings 20 years of commercial expertise to navigate the critical commercialization phase, though the company faces financial challenges with $8.9 million in cash reserves as of June 2025.

Simtra BioPharma Solutions Completes Major Facility Expansion in Germany to Meet Growing Injectable Therapeutics Demand

  • Simtra BioPharma Solutions has completed construction of a new 1,800 square meter production facility at its Halle, Germany campus, expanding total production area to nearly 12,000 square meters.
  • The expansion creates 150 new jobs and adds four freeze dryers, bringing the site's total to 15 units, while introducing prefilled syringe technology for the first time at the German facility.
  • The facility enhances Simtra's capacity for sterile fill/finish services including vial filling for liquid and lyophilized products, supporting development of targeted cancer treatments and other critical injectable therapeutics.
  • This expansion follows Simtra's strategic investments including a $250 million facility expansion in the US and a partnership with Merck KGaA to support antibody-drug conjugate manufacturing.

First Oral Drug MA-5 Shows Promise for Rare Barth Syndrome in Preclinical Studies

Rare Disease
  • Researchers at Tohoku University discovered that oral drug MA-5 can improve both heart and muscle problems in Barth syndrome, a rare genetic disorder affecting 1 in 300,000 births worldwide.
  • MA-5 boosted cellular energy production by up to 50% and protected cells from oxidative stress-induced death by enhancing interactions between mitochondrial proteins mitofilin and ATP synthase.
  • The drug dramatically improved climbing ability and normalized elevated heart rates in Drosophila models, while correcting abnormal mitochondrial structures in human muscle cells derived from patient iPS cells.
  • Phase I clinical trials in Japan have been completed successfully, with Phase II trials being prepared, making MA-5 the first oral medication for Barth syndrome to progress to clinical trial stage.

Lixte Biotechnology Secures $5 Million Private Placement to Advance Cancer Therapy Development

Oncology
  • Lixte Biotechnology Holdings completed a $5 million private placement on June 30, 2025, with proceeds designated for general corporate purposes and working capital to support ongoing cancer therapy development.
  • The company's lead compound LB-100, a first-in-class PP2A inhibitor, has demonstrated tolerability in cancer patients at doses associated with anti-cancer activity and represents a pioneering approach in activation lethality cancer biology.
  • Proof-of-concept clinical trials for LB-100 are currently underway for colon, small cell lung, and sarcoma cancers, with the compound showing potential to enhance both chemotherapies and immunotherapies.

Lixte Biotechnology Secures $5M Funding for Cancer Therapy Development, Stock Surges 55%

  • Lixte Biotechnology Holdings completed a $5 million private placement on July 2, 2025, to advance clinical trials for its lead cancer compound LB-100.
  • The company's stock price surged 55.94% following the funding announcement, rising from $0.905 to $3.15 per share within days.
  • LB-100 is being developed as a potential treatment for soft-tissue sarcomas and other cancers, with a Phase 2 trial in collaboration with Spain's Sarcoma Group combining the drug with doxorubicin.
  • Despite the funding success, Lixte faces financial challenges including a recent loss of $709,555 and negative return on assets of -118.02%.

House Republicans Subpoena Former Pfizer Executive Over Alleged COVID-19 Vaccine Trial Delays

  • House Judiciary Committee subpoenaed former Pfizer executive Dr. Philip Dormitzer over allegations that senior Pfizer executives deliberately slowed COVID-19 vaccine clinical testing before the 2020 election.
  • GSK reported that Dormitzer told colleagues the three most senior people in Pfizer R&D were involved in a decision to deliberately slow down clinical testing to avoid completion before election results.
  • Dormitzer has denied intentionally delaying vaccine rollout and stated his comments to GSK colleagues were misinterpreted, while Pfizer maintains the development process was driven by science.
  • The subpoena demands Dormitzer's deposition on July 22 after he failed to voluntarily comply with committee requests for testimony and documents.

ONWARD Medical Submits FDA 510(k) Application for Home Use of ARC-EX Spinal Cord Stimulation System

  • ONWARD Medical has submitted a 510(k) application to the FDA seeking clearance to expand the ARC-EX System indication for home use, potentially broadening access to this spinal cord injury therapy.
  • The company simultaneously filed a CE Mark application to enable commercialization of the ARC-EX System in the European Union and other countries recognizing CE marking.
  • The ARC-EX System is currently the first and only FDA-cleared technology indicated to improve hand sensation and strength after spinal cord injury.
  • Recent Pathfinder2 Study results demonstrated significant functional improvements in upper body strength, trunk control, and balance after one year of treatment with no plateau in therapeutic benefit.

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