AstraZeneca

M.J.D. has consulted, advised, and spoken for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Pfizer, AstraZeneca, Zealand Pharma, Carmot/Roche, and Amgen. She has also received grants from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Janssen, Sanofi-Aventis, and Eli Lilly. J.G. has no competing interests.

A Phase II trial showed AstraZeneca's Lynparza (olaparib) effective in treating recurrent prostate cancer without hormone therapy, prompting larger follow-up studies in biomarker-selected subgroups. Lynparza, a PARP inhibitor, demonstrated efficacy in patients with homologous recombination repair gene mutations, particularly BRCA2, with higher response rates than seen with hormonal suppression. The study suggests that not all prostate cancer patients need hormone therapy and highlights the need for biomarker-selected trials to identify responders.

Animal models and traditional in vitro assays have limitations in drug development, leading to the adoption of Organ-on-a-chip (OOC) technology. Two case studies illustrate how human OOC models resolved conflicting animal data, guiding safer drug development and reducing animal use. Early integration of human and animal OOC systems can refine preclinical study design and de-risk first-in-human studies.

The Global Biotechnology Market, valued at USD 1,094.6 Billion in 2024, is projected to reach USD 2772.7 Billion by 2032, with a CAGR of 14.2%. The market report includes detailed analysis, key players, and segments such as applications and technologies, with regional assessments covering North America, Europe, Asia Pacific, Latin America, and Middle East and Africa.

Veeva Systems announces Veeva Site Connect, enhancing sponsor-site collaboration with new capabilities and a streamlined experience, reducing trial time and cost. Seven top 20 biopharmas have adopted the platform for simplified trial execution.

The article presents various studies on antibody drug conjugates, including datopotamab deruxtecan (Dato-DXd) and trastuzumab deruxtecan (T-DXd), in different cancer types such as endometrial, ovarian, breast, lung, and gastric cancers. It also covers studies on immuno-oncology treatments like durvalumab and neoadjuvant strategies, as well as initial results from first-in-human studies of new antibody-drug conjugates like AZD8205 and AZD5335. Additionally, it discusses the role of circulating tumor DNA (ctDNA) dynamics in treatment responses and long-term survival outcomes in various cancer settings.

Deepak Bhatt, a prominent cardiologist, discussed common pitfalls in interpreting clinical trial data at the ESC Congress 2024. His work, cited over 275,000 times, focuses on pivotal trials like REDUCE-IT and SCORED. Bhatt highlighted the 17-year lag between scientific discovery and its adoption into clinical practice.

Nurix Therapeutics' NX-1607, an oral CBL-B inhibitor, is in clinical trials to enhance T cell activation, addressing limitations of immune checkpoint inhibitors. Initial results presented at ACS Spring 2024.

Imfinzi approved in the US for treating resectable non-small cell lung cancer before and after surgery, based on the AEGEAN trial showing a 32% reduction in risk of recurrence.

July's Molecules of the Month feature Novartis' molecular glue degrader for sickle cell disease, Pfizer's tinlorafenib for melanoma with brain metastasis, AstraZeneca's AZ-PRMT5i-1 for MTAP-deficient cancers, MTX-531 for dual EGFR/PI3K inhibition, and LifeMine Therapeutics' XC219 discovered via top-down approach. Paxalisib shows promising data in glioblastoma, and Takeda's OX2R-selective agonist offers potential in Alzheimer's disease.