Bharat Biotech's Oral Cholera Vaccine 'Hillchol' Successfully Completes Phase III Trials
• Bharat Biotech's oral cholera vaccine Hillchol has demonstrated non-inferiority against both Ogawa and Inaba serotypes in Phase III clinical trials involving 1,800 participants across India.
• The successful trial results position Hillchol as a potential solution to the global oral cholera vaccine shortage, with Bharat Biotech's facilities capable of producing up to 200 million doses annually.
• Cholera affects approximately 2.86 million people and causes 95,000 deaths annually worldwide, highlighting the significant public health impact of this vaccine development.
Valneva and LimmaTech Advance Pioneering Shigella Vaccine into Phase 2 Trials
• Valneva and LimmaTech have initiated two Phase 2 clinical trials for S4V2, the world's most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis, a major global health threat.
• Shigellosis causes approximately 165 million infections annually, resulting in 600,000 deaths worldwide, with children under five in low- and middle-income countries being particularly vulnerable.
• The FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious condition with no currently approved vaccine, despite increasing antibiotic resistance complicating treatment.
UK Invests £600 Million in Health Data Research Service to Accelerate Clinical Trials
• The UK government has announced a £600 million ($764m) investment to create a Health Data Research Service, providing researchers with a single, secure access point to national health datasets.
• The initiative aims to reduce clinical trial setup times from over 250 days to 150 days by March 2026 through streamlining bureaucracy and standardizing contracts.
• Pharmaceutical industry leaders, including GSK CEO Emma Walmsley, have welcomed the investment, highlighting the UK's unique potential to leverage NHS data to accelerate medical innovation.
Afuresertib Plus Paclitaxel Fails to Improve Survival in Platinum-Resistant Ovarian Cancer Trial
• Phase 2 PROFECTA-II/GOG-3044 trial shows afuresertib plus paclitaxel did not significantly improve progression-free or overall survival compared to paclitaxel alone in platinum-resistant ovarian cancer patients.
• Biomarker analysis suggests patients with higher pAKT expression (>1) may benefit more from the combination therapy, with median PFS of 5.4 months versus 2.9 months with paclitaxel alone.
• The combination therapy demonstrated a manageable safety profile but had higher rates of diarrhea (64.6% vs 19.1%) and more frequent treatment discontinuations (20.2% vs 6.4%) compared to paclitaxel monotherapy.
Regeneron Leads $60 Million Consortium to Accelerate UK Biobank Genome Sequencing for Alzheimer's and Parkinson's Drug Discovery
• Regeneron has formed a consortium with AbbVie, Alnylam, AstraZeneca, Biogen, and Pfizer, with each company committing $10 million to accelerate sequencing of 500,000 UK Biobank genomes by end of 2019.
• The project aims to identify new biological targets for drug development, particularly for neurological diseases like Alzheimer's and Parkinson's, where current failure rates exceed 90%.
• Regeneron's automated sequencing capabilities through its Genetics Center have dramatically reduced processing time, potentially revolutionizing drug discovery by linking genetic data with health records from 500,000 volunteers.
• After an exclusive access period for consortium members, all sequencing data and research findings will be made publicly available to the broader scientific community.
MTBVAC TB Vaccine Enters Landmark Phase 2b Trial Across Three African Countries
• The IMAGINE trial has commenced with first vaccinations of MTBVAC, a novel tuberculosis vaccine candidate, administered in South Africa on February 19, 2025, marking a significant step in combating the world's deadliest infectious disease.
• The large-scale safety and efficacy trial will enroll approximately 4,300 participants with latent TB infection across 15 sites in South Africa, Kenya, and Tanzania, evaluating MTBVAC's effectiveness in preventing active TB lung disease.
• MTBVAC, developed by Spanish researchers and Biofabri/Zendal, is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current trials, offering potential advantages over the century-old BCG vaccine.
RH5.1/Matrix-M Malaria Vaccine Shows Promise as Blood-Stage Defense
• A Phase IIb trial of the RH5.1/Matrix-M vaccine shows 55% efficacy in preventing clinical malaria over six months in young children.
• The vaccine also demonstrated over 80% efficacy against high levels of malaria parasites, suggesting potential in preventing severe cases.
• RH5.1/Matrix-M targets the blood-stage of malaria, complementing existing vaccines that target the liver-stage of the parasite.
• The RH5.1/Matrix-M vaccine was well-tolerated, with mild adverse events, positioning it as a potential second line of defense against malaria.
Singapore Launches Asia's First mRNA BioFoundry to Advance Nucleic Acid Therapeutics
• Singapore has officially launched the non-GMP NATi mRNA BioFoundry, Asia's first dedicated mRNA manufacturing facility, marking a significant advancement in the country's nucleic acid therapeutics capabilities.
• The $97 million facility, developed through collaboration between NATi, A*STAR, and Wellcome Leap, features automated manufacturing processes that enhance productivity and reduce production costs for mRNA-based products.
• While currently focused on research and preclinical production, the BioFoundry is designed to rapidly scale up during health emergencies, potentially producing up to 20 billion doses of RNA-based vaccines monthly during outbreaks.
KarXT (Cobenfy) Approved for Schizophrenia: A Novel, Nondopaminergic Approach
• The FDA approved KarXT (Cobenfy) on September 26, 2024, marking the first new mechanism of action for schizophrenia treatment since 1954.
• KarXT combines xanomeline and trospium to modulate brain circuits via muscarinic cholinergic receptors, offering a nondopaminergic approach to managing schizophrenia symptoms.
• Clinical trials (EMERGENT-1, -2, -3, -4, -5) demonstrated significant improvements in PANSS scores and supported the long-term safety and efficacy of KarXT.
• Cobenfy's unique mechanism and adverse event profile necessitate prescriber education to optimize its use as a novel treatment option for schizophrenia.
Glaucoma Drug Methazolamide Shows Promise in Reducing Tau Protein Toxicity Linked to Dementia
• Researchers found that carbonic anhydrase (CA) inhibitors, particularly methazolamide, significantly reduced tau protein levels in animal models.
• The study used zebrafish and mouse models genetically engineered to express human tau protein, showing improved neuronal health and cognitive performance with methazolamide.
• The findings suggest CA inhibitors could slow neurodegeneration by accelerating tau clearance, potentially benefiting diseases like Alzheimer’s.
• Further studies are needed to assess long-term effects and optimal dosage in humans, despite the promising results in animal models.
BioVersys' BV100 Shows Promise in Phase 2 Trial for Ventilator-Associated Pneumonia
• BioVersys AG announced positive preliminary results from its Phase 2 trial of BV100 for ventilator-associated bacterial pneumonia (VABP), showing strong signs of efficacy.
• The trial met its primary endpoint, with BV100 demonstrating a favorable safety profile and achieving expected pharmacokinetic targets in VABP patients.
• BioVersys plans to initiate a global Phase 3 registration trial for BV100 in the second half of 2025, aiming to address the unmet need for CRAB infections.
• Alpibectir, BioVersys' second clinical asset for tuberculosis, completed a Phase 2a trial showing human proof of concept and will continue development with GSK.
Safety and Efficacy of the Blood-Stage Malaria Vaccine RH5
A recent clinical trial, registered under ClinicalTrials.gov ID: NCT05790889, has been conducted to evaluate the safety and efficacy of the RH5 malaria vaccine. The study received ethical approvals from the National Ethical Committee of the Ministry of Health in Burkina Faso and the Oxford Tropical Research Ethics Committee in the UK. Funding for this research was provided by several organizations, including the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust.
Novel Drug Combinations Show Promise in Lung Cancer Treatment
• Researchers have identified new drug combinations that enhance immunotherapy effectiveness in lung cancer, particularly in tumors resistant to standard treatments.
• A study shows that combining ATR inhibitors with topotecan improves outcomes for relapsed small cell lung cancer by activating the immune system.
• Combining KRAS G12C and SHP2 inhibitors with immunotherapy significantly reduced tumor size and recurrence in mice with lung cancer.
• Dual checkpoint inhibitors may benefit non-small cell lung cancer patients with STK11 and KEAP1 mutations, improving response rates and survival.
Triptans Outperform Newer Migraine Drugs in Efficacy, Meta-Analysis Shows
• A comprehensive meta-analysis reveals that older triptan medications, like eletriptan, are more effective for acute migraine treatment than newer gepants.
• The study suggests eletriptan, rizatriptan, sumatriptan, and zolmitriptan offer superior pain relief and sustained pain freedom compared to lasmiditan, rimegepant and ubrogepant.
• Researchers recommend triptans as a first-line treatment for migraines, given their efficacy and lower cost, but note contraindications for patients with cardiovascular issues.
• The analysis highlights the underutilization of triptans in migraine management, urging healthcare professionals to consider them as a preferred option.
Hydroxychloroquine Shows Moderate COVID-19 Prevention in Large Clinical Trial
• A large, double-blind, placebo-controlled trial (COPCOV) found a 15% reduction in symptomatic COVID-19 with hydroxychloroquine compared to placebo.
• The study also demonstrated a significant reduction in all-cause respiratory illness and fewer workdays lost due to illness among those taking hydroxychloroquine.
• Hydroxychloroquine was well-tolerated and safe in the study, which included over 4,600 participants across 11 countries from 2020 to 2022.
• Researchers emphasize that current immunity from vaccines and natural infections has reduced COVID-19 severity, making hydroxychloroquine unnecessary for prevention today.
Cancer Clinical Trials Inappropriately Exclude Patients with Duffy-Null Phenotype
• A recent study reveals that many cancer clinical trials exclude individuals with the Duffy-null phenotype, a trait common in people of African and Middle Eastern descent.
• The exclusion is due to lower neutrophil counts in Duffy-null individuals, which are misinterpreted as a sign of increased infection risk during cancer treatment.
• Researchers recommend that clinical trials adjust neutrophil count criteria to include Duffy-null individuals and avoid inappropriate dose reductions.
• Addressing this inequity could improve clinical trial representation and treatment outcomes for diverse populations.
Phase 2 Trial Assesses 99mTc-maraciclatide for ILD Prognosis
• A Phase 2 study, PREDICT-ILD, has commenced to evaluate 99mTc-maraciclatide, a novel molecular imaging agent, for predicting interstitial lung disease (ILD) progression.
• The study will compare 99mTc-maraciclatide uptake in patients with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrosing-ILD, against healthy controls to assess its efficacy as a prognostic marker.
• Researchers aim to determine if 99mTc-maraciclatide can identify αvβ3 activity and predict disease progression in patients with fibrosing ILD, potentially improving treatment strategies.
• The PREDICT-ILD study, involving multiple NHS sites, seeks to address the urgent need for better diagnostic tools in managing unpredictable ILD progression.
Bharat Biotech and Hilleman Laboratories Launch Oral Cholera Vaccine, Hillchol, in India
• Bharat Biotech has launched Hillchol, an oral cholera vaccine developed in partnership with Hilleman Laboratories, after successful Phase III trials.
• Hillchol utilizes a single, genetically engineered inactivated Hikojima bacteria strain and is manufactured in Hyderabad, India.
• The vaccine aims to address the growing global shortage of cholera vaccines, with Bharat Biotech having capacity to produce 200 million doses.
• Hilleman Laboratories, a joint venture between MSD and Wellcome Trust, facilitated the vaccine's development from Phase II through technology transfer.
Bill Gates Optimistic About Progress in M72 Tuberculosis Vaccine Clinical Trial
• Bill Gates expressed optimism about the M72 tuberculosis vaccine clinical trial, anticipating a 70% efficacy in reducing the disease.
• The ongoing Phase 3 trial, costing $500 million, is a collaboration between GSK, the Wellcome Trust, and the Gates MRI.
• The M72/AS01E vaccine aims to prevent pulmonary TB in adolescents and adults, potentially marking the first new TB vaccine in over a century.
• Current TB treatments require a nine-month regimen, and multidrug-resistant TB remains a significant public health challenge, spurring the need for new drugs and vaccines.
UK Life Sciences Council Lacks Transparency Despite Critical Industry Role
• The UK Life Sciences Council (LSC), a key government-industry forum chaired by Prime Minister Rishi Sunak, operates with minimal public transparency despite its significant influence on healthcare and pharmaceutical policy.
• The 24-member council includes leaders from major pharmaceutical companies, government officials, and healthcare organizations, but lacks publicly available terms of reference and meeting minutes.
• Recent LSC discussions have focused on critical issues including Brexit, pandemic response, and £113 million in new funding for health research missions across cancer, mental health, obesity, and addiction.
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