NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

Wockhardt's antibiotic WCK 6777 granted fast-track designation by USFDA for cUTI and cIAI, following promising Phase 1 safety data, positioning it for OPAT in ambulatory settings.

Wockhardt's WCK 6777, a once-a-day β-lactam enhancer antibiotic, successfully completed Phase I study by NIH's DMID, showing promising safety profile. FDA granted Fast Track designation for cUTI and cIAI treatment. WCK 6777 is designed for outpatient-parenteral antimicrobial therapy, active against meropenem-resistant Gram negative pathogens, potentially reducing hospital admissions and costs.

UC Irvine's Wen School of Population & Public Health received $1.6 million for a 5-year renewal of its BigCARE program, focusing on training researchers in big data analysis for cancer research. The program, led by Min Zhang and Dabao Zhang, aims to equip researchers with advanced skills to manage and analyze complex datasets, advancing precision cancer medicine. The funding will support an annual summer workshop for researchers, oncologists, and students.

Soligenix partners with Sterling Pharma Solutions to optimize synthetic hypericin production for HyBryte™ and SGX302, targeting CTCL and psoriasis. The collaboration aims to scale up manufacturing for clinical trials and commercialization, with a focus on reducing costs and advancing clinical programs.

NIH's NIAID selects Emergex's T cell-priming vaccine candidate for Betacoronaviruses for clinical trials under Project NextGen, aiming to induce variant-agnostic, durable cell-mediated immunity and reduce the need for frequent booster vaccinations.

NIAID selects Emergex for Project NextGen to develop next-gen COVID-19 vaccines, focusing on T cell-priming candidates like CoronaTcP, aiming for variant-agnostic, long-lasting protection with reduced need for boosters.

Tonix Pharmaceuticals CEO, Dr. Seth Lederman, participated in the 'RECOVER Treating Long COVID (TLC) - Navigating the Pathway Forward' workshop, discussing clinical trial endpoints for Long COVID therapeutics. Lederman highlighted the potential of Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID, drawing parallels to Progression-Free Survival (PFS) in cancer drug development.

New U.S. patent issued for a novel coronavirus pneumonia biomarker (≤60% FiO₂) prognostic for opaganib's potential efficacy in treating COVID-19. Post-hoc data from opaganib's Phase 2/3 study showed better outcomes in patients with ≤60% FiO₂ levels, including reduced need for supplemental oxygen, intubation/mechanical ventilation, and mortality.

No approved therapies exist for Long COVID. RECOVER-TLC, an FNIH initiative led by NIAID, aims to unite the scientific and patient community to find new approaches. The program builds on lessons from the 2021 NIH's RECOVER initiative. The community is invited to suggest promising therapeutic approaches for Long COVID symptoms.

Tonix Pharmaceuticals CEO Seth Lederman participated in the 'Endpoints' panel at the RECOVER Treating Long COVID workshop, discussing clinical trial endpoints for potential Long COVID therapeutics. Lederman recommended validating Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID trials, drawing parallels to the regulatory pathway for cancer drugs.