HIV Vaccine Breakthrough: Clinical Trials Show Promise for Broadly Neutralizing Antibody Development
• Two phase 1 clinical trials demonstrate successful activation of rare immune cells needed to develop broadly neutralizing antibodies against HIV, marking significant progress in vaccine development.
• The innovative stepwise vaccination strategy using mRNA technology showed 100% success rate in generating VRC01-class antibody responses in participants who received both prime and boost doses.
• Results from trials conducted in North America and Africa showed similar immune responses, supporting the potential for a globally effective HIV vaccine targeting regions most affected by the pandemic.
HHS and NIH Launch "Generation Gold Standard" Universal Vaccine Platform to Combat Pandemic Threats
• The U.S. Department of Health and Human Services and NIH have announced "Generation Gold Standard," a next-generation universal vaccine platform using beta-propiolactone-inactivated whole-virus technology.
• The government-owned platform aims to develop universal vaccines against multiple strains of influenza and coronaviruses, with clinical trials for universal influenza vaccines scheduled to begin in 2026.
• The BPL-1357 intranasal flu vaccine is currently in advanced trials and designed to block virus transmission—a capability absent in current vaccines—with FDA approval targeted for 2029.
INSPIRE Trials: Computerized Alerts Improve Antibiotic Selection in Hospitalized Patients by Up to 35%
• NIH-funded clinical trials involving over 316,000 patients across 92 hospitals demonstrate that computerized alerts can improve appropriate antibiotic selection by 35% for abdominal infections and 28% for skin and soft tissue infections.
• The INSPIRE trials used patient-specific data to identify individuals at low risk for antibiotic-resistant infections, prompting physicians to switch from broad-spectrum to standard antibiotics when appropriate.
• Researchers from UC Irvine, Harvard Pilgrim Health Care Institute, and HCA Healthcare collaborated on the studies, which could significantly reduce antibiotic resistance and improve patient outcomes nationwide.
Daré Bioscience Fast-Tracks Sildenafil Cream Launch with Dual-Market Strategy for Women's Health
• Daré Bioscience has unveiled a dual-path approach to make its proprietary Sildenafil Cream formulation available via prescription by Q4 2025, responding to healthcare community urging and women's demand.
• The company is exploring a 503B compounding pathway to accelerate market access for its female sexual arousal disorder (FSAD) treatment, potentially creating the first FDA-approved therapy for this condition.
• CEO Sabrina Martucci Johnson will present the expanded business strategy at the Jones Healthcare and Technology Innovation Conference, with plans to evaluate similar approaches for other proprietary formulations in their portfolio.
GSK Launches Landmark Study to Investigate Shingles Vaccine's Potential to Reduce Dementia Risk
• British pharmaceutical company GSK is initiating a groundbreaking four-year study using data from up to 1.4 million NHS patients to determine if its Shingrix vaccine reduces dementia risk.
• Previous research suggests the shingles vaccine may lower dementia risk by up to 27%, with a Stanford Medicine study finding vaccinated Welsh adults were 20% less likely to develop dementia over seven years.
• If confirmed, this could represent a significant breakthrough in dementia prevention using an existing vaccine already administered through the NHS to adults aged 65 and older.
NIH Study: Single Dose of MEDI8852 Antibody Shows Complete Protection Against H5N1 Avian Flu in Primates
• A groundbreaking NIH study demonstrates that a single dose of MEDI8852, a broadly neutralizing antibody developed by MedImmune/AstraZeneca, provides complete protection against H5N1 avian influenza in macaques.
• The antibody targets a stable portion of the influenza virus protein, offering extended protection that could last weeks after administration, making it a promising preventive tool for potential H5N1 outbreaks.
• All macaques pre-treated with MEDI8852 survived H5N1 exposure with minimal or no symptoms, while untreated control subjects developed severe or fatal illness.
NIH-Funded Trial Evaluates AV-1, a Novel Therapeutic for Dengue
• A Phase 2 clinical trial is underway to assess AV-1, an investigational monoclonal antibody, for its ability to mitigate dengue symptoms.
• The trial involves exposing adult volunteers to a weakened dengue virus strain and administering AV-1 at varying doses to evaluate safety and efficacy.
• The study aims to determine how AV-1 impacts the immune response, viral clearance, and symptom reduction compared to placebo over a 155-day follow-up.
• With no FDA-approved treatments currently available, successful results could pave the way for further clinical evaluations of AV-1 against dengue virus.
BIO 300 Shows Promise in Improving Pulmonary Function in Post-COVID-19 Patients
• Humanetics Corporation's BIO 300 demonstrated statistically significant improvement in pulmonary function (FEV1) at 12 weeks, maintained at 12 months in post-COVID-19 patients.
• The Phase 2 trial also showed trends toward improved pulmonary function (DLCO, FVC) and enhanced quality of life in BIO 300-treated participants.
• BIO 300 was well-tolerated, with adverse events consistent with the patient population, and no new safety concerns were identified during the trial.
• Humanetics is further evaluating BIO 300 for COVID-19 and other conditions involving lung inflammation, as well as medical countermeasure and oncology applications.
mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy
• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment.
• BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab.
• Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers.
• The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.
Ocugen's OCU410 ArMaDa Trial Proceeds to Phase 2 for Geographic Atrophy
• The Data and Safety Monitoring Board (DSMB) has approved the continuation of Phase 2 in Ocugen's OCU410 ArMaDa clinical trial for geographic atrophy (GA).
• Initial Phase 2 data indicates OCU410 is safe and well-tolerated, with no serious adverse events reported among the 15 subjects assessed.
• OCU410, a novel modifier gene therapy, is administered via a single subretinal injection, potentially reducing the treatment burden compared to current therapies.
• The ArMaDa trial is ongoing across 13 U.S. centers, with dosing expected to complete in early 2025 and further efficacy updates to be provided.
Capricor Therapeutics Completes FDA Submission for Deramiocel in DMD Cardiomyopathy
• Capricor Therapeutics has completed its Biologics License Application (BLA) submission to the FDA for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy.
• The BLA is supported by data from Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials, showing attenuation of cardiac implications of DMD.
• The FDA has been requested to grant priority review, potentially reducing the review period to six months from the standard ten months.
• The BLA submission triggers a $10 million milestone payment to Capricor from its distribution partner, Nippon Shinyaku.
Vaxart Advances Oral Vaccine Programs for COVID-19, Norovirus, and Influenza
• Vaxart's Phase 2b COVID-19 oral vaccine trial is set to expand to 10,000 participants, pending FDA review of safety data and BARDA approval.
• A Phase 1 trial for Vaxart's second-generation oral norovirus vaccine constructs is planned for the first half of 2025, with initial data expected by mid-2025.
• Preclinical studies are underway for a new avian influenza vaccine candidate, designed to address the latest clade 2.3.4.4b strains.
• Vaxart's existing funding, including a Project NextGen award, is expected to sustain operations into 2026, supporting key clinical and regulatory milestones.
Tecovirimat Fails to Improve Mpox Outcomes in NIH-Sponsored STOMP Trial
• The STOMP trial found that tecovirimat did not significantly reduce lesion resolution time or pain in adults with mild to moderate mpox.
• The Data Safety and Monitoring Board recommended halting further enrollment due to the lack of efficacy, leading NIAID to close the study.
• Tecovirimat remains available through the CDC's expanded access program for eligible patients with severe mpox or immunocompromised conditions.
• Researchers emphasize the importance of randomized clinical trials during outbreaks, despite the disappointing results for tecovirimat.
Corvus Pharmaceuticals' Soquelitinib Shows Promise in Phase 1 Atopic Dermatitis Trial
• Corvus Pharmaceuticals' Phase 1 trial of soquelitinib for atopic dermatitis shows a favorable safety and efficacy profile.
• Interim data from Cohort 2 indicates improvements in IGA 0 or 1 and EASI 75 scores compared to placebo.
• Soquelitinib, an oral ITK inhibitor, could offer a convenient and novel treatment option for immune diseases.
• The company plans to report full trial results in Q2 2025 and is advancing a Phase 3 trial in PTCL.
Soligenix's HyBryte Enrolls First Patients in Phase 3 CTCL Trial
• Soligenix initiates patient enrollment for the confirmatory Phase 3 FLASH2 trial of HyBryte for cutaneous T-cell lymphoma (CTCL).
• The FLASH2 trial builds upon previous positive Phase 3 results, aiming to demonstrate HyBryte's efficacy with an extended 18-week treatment period.
• HyBryte, a novel photodynamic therapy, has shown a promising safety profile and efficacy in early-stage CTCL, offering a new treatment option.
• Interim analysis of the FLASH2 study is anticipated in early 2026, with periodic updates on the trial's progress expected in 2025.
Soligenix Initiates Phase 2 Trial of Dusquetide (SGX945) for Behçet's Disease
• Soligenix has commenced patient enrollment in a Phase 2 clinical trial evaluating SGX945 (dusquetide) for the treatment of Behçet's Disease.
• The open-label study will enroll approximately 25 patients with mild to moderate Behçet's Disease, assessing lesion clearance and quality of life.
• Dusquetide, an innate defense regulator, aims to modulate the body's inflammatory response and promote tissue healing in Behçet's Disease ulcers.
• Topline results from the Phase 2 trial are expected in the first half of 2025, offering hope for an underserved patient population.
NIH Launches Trial of Rectal Microbicide for On-Demand HIV Prevention
• The NIH is sponsoring a clinical trial to assess a novel rectal HIV microbicide douche containing tenofovir for on-demand use.
• The trial will enroll 150 adults assigned male at birth who regularly use rectal douches before receptive anal intercourse.
• Participants will compare the rectal microbicide to oral PrEP, focusing on safety, acceptability, adherence, and preference.
• The study aims to expand HIV prevention options, particularly for gay, bisexual, and other men who have sex with men.
© Copyright 2025. All Rights Reserved by MedPath