AstraZeneca

Promise Bio emerges from stealth with $8.3M seed investment to accelerate its computational platform using epiproteomics and AI for immune-mediated disease treatment. The platform, developed from foundational research by Dr. Assaf Kacen and Prof. Yifat Merbl, profiles post-translational modifications from mass-spectrometry data. The funding, led by Awz Ventures and AION Labs, aims to advance precision medicine and build the world’s largest PTM database.

Merck's clesrovimab, awaiting FDA approval by June 2025, aims to protect newborns from RSV, competing with Sanofi and AstraZeneca's Beyfortus. RSV vaccines for young children are on hold due to safety concerns. Merck's clesrovimab could be available for ordering by July if approved.

Jazz Pharmaceuticals' ZIIHERA® approved for HER2-positive biliary tract cancer; Merus's BIZENGRI® approved for NRG1+ pancreatic adenocarcinoma and NSCLC; AstraZeneca's IMFINZI® approved for limited-stage small cell lung cancer and under Priority Review for muscle-invasive bladder cancer.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.

Cizzle Biotechnology Holdings PLC expands its North American distribution agreement to include the Caribbean and Cayman Islands. The company's CIZ1B lung cancer blood biopsy test, set to launch next April, identifies a biomarker linked to early-stage lung cancer. Cizzle aims to diagnose other cancers post-2025. The company highlights the inaccuracies of low-dose CT scans and collaborates with Moffitt Cancer Center for test evaluation.

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

Adjusting for principal components in genome-wide association studies can induce collider bias, especially in admixed populations where PCs may capture local genomic features instead of global ancestry. LD pruning is more effective than excluding high LD regions, but optimal parameters vary. Model-based ancestry inference may offer a better alternative in some cases. Careful pre-processing and checking of PCs are crucial to avoid spurious associations.

The ZEST trial, aiming to evaluate niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed to accrue enough eligible patients. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Only 40 patients were enrolled, with insufficient data to assess niraparib efficacy.

Grace Liu from Sino Biological discusses Antibody-Drug Conjugates (ADCs), a cancer therapy combining precision targeting with potent cytotoxic drugs. ADCs consist of a monoclonal antibody, cytotoxic payload, and linker, balancing efficacy and safety. Sino Biological offers comprehensive ADC development solutions, aiding in the complex process from discovery to clinical studies.

The enzyme inhibitor market is projected to grow from US$2.8 Bn in 2023 to US$5.9 Bn by 2034, driven by applications in disease management, particularly cardiovascular diseases, oncology, and autoimmune disorders. Key drivers include advancements in monoclonal antibodies, RNA-based inhibitors, and oncology therapies. Major players like Merck & Co., Novartis AG, and Pfizer Inc. are investing in R&D and strategic partnerships to meet healthcare demands.