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Clinical Trial News

Real-World Analysis Reveals Unexpected Safety Signals for Temozolomide in Glioma Treatment

Real World EvidenceOncology
  • A comprehensive analysis of 13,608 temozolomide-related adverse events from the FDA's FAERS database identified both expected hematologic toxicities and unexpected safety signals including pulmonary embolism and opportunistic infections.
  • The study found that blood and lymphatic system disorders showed the strongest safety signal with a relative odds ratio of 5.94, confirming temozolomide's known myelosuppressive effects in real-world settings.
  • Unexpected adverse events such as pulmonary embolism (ROR 4.96) and Pneumocystis jirovecii pneumonia (ROR 7.09) emerged as significant safety concerns, suggesting the need for updated clinical monitoring guidelines.
  • The findings support lowering thresholds for thromboprophylaxis and Pneumocystis prophylaxis in temozolomide-treated patients compared to current clinical guidelines.

GSK Advances Dostarlimab in Phase 3 Colon Cancer Trial and Phase 2 Endometrial Cancer Study

Oncology
  • GSK is conducting a Phase 3 randomized trial evaluating perioperative dostarlimab monotherapy versus standard of care in patients with untreated T4N0 or Stage III dMMR/MSI-H resectable colon cancer.
  • The colon cancer study, which began in August 2023, compares dostarlimab administered pre and post-surgery against standard treatments FOLFOX or CAPEOX.
  • A separate Phase 2 trial is testing dostarlimab combined with carboplatin-paclitaxel in Japanese patients with primary advanced or recurrent endometrial cancer.
  • Both studies represent significant opportunities for GSK to expand dostarlimab's therapeutic applications in oncology beyond its current indications.

Champions Oncology Appoints Rob Brainin as New CEO to Drive Data Platform Expansion

Leadership ChangeDrug Discovery
  • Champions Oncology has appointed Rob Brainin as Chief Executive Officer effective August 25, 2025, succeeding Dr. Ronnie Morris who will transition to Executive Chair.
  • Brainin brings over 25 years of life sciences experience, most recently serving as Chief Business Officer at Veracyte and previously as CEO of Genuity Science.
  • The leadership change positions Champions to expand beyond core CRO services into robust data offerings and advance its discovery therapeutics subsidiary, Corellia AI.
  • Dr. Morris, who led the company since 2017, will remain actively involved in strategic initiatives while supporting the leadership transition.

Amphastar Pharmaceuticals Plans to Quadruple US Manufacturing Capacity in Major Domestic Expansion

  • Amphastar Pharmaceuticals announced a multi-year expansion to quadruple production capacity at its Rancho Cucamonga headquarters over the next three to five years.
  • The strategic initiative represents the company's largest domestic infrastructure investment, featuring a new state-of-the-art production plant with expanded automation and advanced technologies.
  • The expansion will support development and manufacture of critical medications including new pipeline candidates, while creating jobs in R&D, engineering, manufacturing, and quality operations.
  • All of Amphastar's finished pharmaceutical products are manufactured in the United States, reinforcing the company's commitment to domestic production and supply chain resilience.

Nuwellis Terminates REVERSE-HF Clinical Trial to Refocus on Outpatient Heart Failure Market

  • Nuwellis announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for hospitalized heart failure patients.
  • The company will redirect resources toward outpatient heart failure programs, pediatric, and critical care markets where it sees greater scalable impact and business growth potential.
  • The decision will save approximately $4.0 million over the next 2.5 years and was not related to device performance or safety concerns.
  • The terminated trial had enrolled 167 patients since beginning enrollment in 2022, and the company plans to analyze existing data for potential clinical publications.

Australian Researchers Develop Pan-Coronavirus Vaccine Candidate with 99.9% Protection Against Multiple Variants

  • Researchers at the Centenary Institute and University of Sydney have developed CoVEXS5, a novel COVID-19 vaccine candidate that reduced viral levels in infected mice by 99.9% compared to unvaccinated controls.
  • The vaccine uses a fusion-based spike protein design incorporating elements from multiple coronaviruses to provide broad protection against current variants including Omicron XBB.1.5 and SARS-CoV-1.
  • CoVEXS5 incorporates Sepivac SWE, an open-access adjuvant that eliminates licensing restrictions and reduces production costs, potentially improving global vaccine equity.
  • The development addresses ongoing COVID-19 circulation in Australia, where over 115,000 cases have been reported to the National Notifiable Diseases Surveillance System in 2025.

FDA Approves EXZOLT, First Oral Treatment for Northern Fowl Mites in Poultry

Drug Approval
  • The FDA has approved EXZOLT (fluralaner oral solution), the first systemic oral treatment for northern fowl mites in chickens, offering a novel alternative to traditional topical sprays.
  • Penn State researchers conducted pivotal efficacy studies showing over 90% reduction in mite populations, demonstrating the treatment's effectiveness in both broiler breeders and layer chickens.
  • The innovative water-administered treatment targets the parasite's nervous system while maintaining a zero-day egg withdrawal period and 11-day meat withdrawal period.
  • EXZOLT addresses significant economic losses in poultry operations caused by northern fowl mites, which reduce weight gain, egg quality, and production in affected birds.

BioNTech Chief Strategy Officer Ryan Richardson to Step Down After Seven-Year Tenure

OncologyCAR-T
  • Ryan Richardson will step down as Chief Strategy Officer from BioNTech's Management Board on September 30, 2025, after serving since January 2020.
  • Richardson played a pivotal role in BioNTech's transformation from a private clinical-stage biotech to a publicly listed company, contributing to over $1 billion in capital raising through IPO and subsequent financings.
  • The departure comes as BioNTech positions itself to become a multi-product company focused on cancer therapeutics, with the transition of Richardson's responsibilities already underway.
  • BioNTech's stock has shown resilience with a 13.9% quarterly increase and 30.09% annual return, outperforming the broader biotechnology sector despite ongoing challenges.

University of Guelph Develops Canada's First mRNA Bird Flu Vaccine for Commercial Poultry

  • Researchers at the University of Guelph are developing Canada's first bird flu vaccine using mRNA technology, targeting low pathogenic avian influenza in commercial poultry.
  • The mRNA platform offers high adaptability for rapidly mutating viruses, allowing researchers to make adjustments for new strains without starting from scratch.
  • The vaccine is being optimized for nasal administration to facilitate mass vaccination of poultry flocks, with preliminary results showing positive outcomes.
  • The earliest version of the vaccine could become available within a few months, with the ultimate goal of controlling virus spread within chicken populations and preventing transmission to humans.

Telomir-1 Outperforms Standard Chemotherapy in Reversing Cancer Gene Silencing

Oncology
  • Telomir Pharmaceuticals' Telomir-1 fully reversed STAT1 gene silencing in aggressive prostate cancer cells, while Paclitaxel showed no effect and Rapamycin achieved only partial reduction.
  • The drug demonstrated unique ability to simultaneously reactivate both STAT1 and TMS1 tumor suppressor genes, potentially overcoming immune evasion and apoptosis resistance in cancer.
  • Telomir-1 did not elongate telomeres in cancer cells, reinforcing its safety profile and selective action in targeting appropriate cellular mechanisms.
  • Previous studies showed Telomir-1 reduced tumor volume by approximately 50% and eliminated chemotherapy-induced mortality when combined with Paclitaxel.

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