BioNTech

Recursion's AI-driven drug REC-3964, an oral, non-antibiotic small molecule, has dosed its first patient in Phase II ALDER trial for recurrent Clostridioides difficile infection. REC-3964 targets toxin B's glucosyltransferase activity, differing from antibiotics by preserving gut microbiome. The trial aims to assess safety, tolerability, and efficacy, with results expected in Q4 2025. RecursionOS, the AI platform, accelerates drug development, reducing time and cost.

Pfizer's earnings beat expectations amid Starboard criticism; Novartis delays submission for MorphoSys drug; Biogen appoints new chief medical officer; VCs use U.S. startups to hedge bets on Chinese drugs; GSK acquires autoimmune drug candidate; key figures in cancer vaccine development; Medicare's drug price negotiations explained.

Ottimo Pharma, backed by Medicxi and led by David Epstein, develops a bi-functional antibody targeting PD-1 and VEGFR2 to enhance cancer immunotherapy, aiming for clinical trials in 2025.

Digital transformation in pharma is revolutionizing drug development, clinical trials, and patient interactions through AI, machine learning, and big data analytics, enhancing efficiency and personalization. About 55% of firms use digital technologies, optimizing processes and improving global healthcare. Key benefits include increased patient engagement, accelerated drug discovery, patient-driven research, gamification in health management, smart packaging solutions, crowdsourced clinical trials, ethical AI, integrated biometric monitoring, sustainability, and AI-powered decision support systems. Implementation steps involve establishing clear objectives, assessing current capabilities, formulating a strategic plan, investing in technologies, executing pilot projects, scaling successful initiatives, monitoring progress, and conducting regular evaluations. Real-life examples include Pfizer's AI-driven vaccine development, Novo Nordisk's AR in manufacturing, AstraZeneca's AI in cardiovascular trials, GSK's digital twin optimization, and Sanofi's digital quality assessment. Challenges such as legacy system integration, data security, cultural resistance, and fragmented data sources are addressed with phased modernization, robust cybersecurity, change management, and integrated data platforms.

FDA expands Pfizer's RSV vaccine Abrysvo indication to include adults 18-59 with chronic conditions at risk for lower respiratory tract disease. Abrysvo sales reached $515m in Q4 last year, positioning it as a key revenue driver amid declining Covid-19 product demand. Competitor GSK's Arexvy, approved for adults over 50, generated $1.2bn in sales last year. GlobalData forecasts Arexvy sales to reach $3.3bn by 2030, compared to $2.2bn for Abrysvo.

Self-amplifying mRNA (samRNA) vaccines face scientific and regulatory challenges, but experts believe they will eventually enter the market, especially for infectious diseases and cancer. Despite initial setbacks, Gennova Biopharmaceuticals' Gemcovac and Arcturus Therapeutics' Kostaive have gained approvals in India and Japan, respectively. The success of Kostaive is attributed to strategic timing and unique trial conditions. While samRNA therapeutics offer potential benefits over standard mRNA vaccines, technical hurdles and safety concerns remain, affecting their widespread adoption.

Doctors are trialling the world's first mRNA vaccine against norovirus, aiming to reduce health and economic burdens. The phase 3 trial, called Nova 301, will enroll 25,000 adults, focusing on those over 60, across several countries. The vaccine, based on mRNA technology, is expected to generate a strong immune response. If successful, a marketing application could be submitted in 2026, with further trials planned for teenagers and younger children.

Starboard Value urges Pfizer’s board to hold executives accountable for underperformance, citing misjudgments in acquisitions and R&D. Despite COVID-19 vaccine success, Pfizer faces criticism for pipeline failures and mismanaged deals, including the withdrawal of a sickle cell drug.

The ADC market, driven by technological advancements and personalized medicine, is expected to reach ~USD 26 billion by 2030 with a CAGR of ~14%. North America leads due to high cancer incidence and strong biopharmaceutical sector. Key players include F. Hoffmann-La Roche Ltd, DAIICHI SANKYO COMPANY, LIMITED, and Pfizer Inc. The market is dynamic, influenced by regulatory frameworks and innovation in linker technologies and payloads.

FDA imposes partial clinical hold on BioNTech's partner OncoC4's Phase 3 PRESERVE-003 trial evaluating BNT316/ONC-392 for metastatic NSCLC, due to varying outcomes between squamous and non-squamous patients. Current patients continue treatment, while other trials remain unaffected.