NOVARTIS

Novartis presented NVP-IWY357, a novel antimalarial with no cross-resistance to current drugs and potential for single-dose cure, at ACS Fall 2024 conference in Denver.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Google DeepMind releases AlphaFold 3 for academic use, predicting protein structures 50% more accurately. Linked to Isomorphic Labs aiming to revolutionize drug discovery, it has formed partnerships with Eli Lilly & Co. and Novartis AG. Google DeepMind, in collaboration with Isomorphic Labs, has predicted over 200 million protein structures using AlphaFold and introduced AlphaProteo for novel protein generation.

FDA approves Autolus Therapeutics' Aucatzyl, a CAR-T therapy for relapsed/refractory B-cell acute lymphoblastic leukemia, priced at $525,000, 11% higher than Gilead's Tecartus. Aucatzyl aims to reduce side effects and is the first CAR-T approved without a risk mitigation plan, with 63% complete remission rate in clinical trial.

Liposarcoma, a common subtype of soft tissue sarcoma, includes dedifferentiated liposarcoma (DDLPS) with high MDM2 amplification. Brigimadlin, an MDM2-p53 antagonist, showed stable disease in 75% of patients in a phase 1a/1b study. A phase 2/3 Brightline-1 trial compares brigimadlin to doxorubicin in advanced DDLPS, aiming to identify optimal dosing and assess progression-free survival.

The global biotechnology market is projected to reach $550.83 billion in 2024 and $2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR, and genomic sequencing. North America is expected to lead, with a revenue of $231.68 billion in 2024, due to established agricultural biotechnology and a robust GMO framework. Key players include Johnson & Johnson, Roche, Pfizer, and Novartis.

J.P.-G. consults for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead, MSD; receives travel compensation from Roche; employed by MEDSIR. G.A. receives honoraria from MEDSIR. M.G. receives travel support and honoraria from AstraZeneca, Gilead Sciences, Roche, Pfizer. A.L.-C. receives research support, consults, speaks, and travels for Roche, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, Daiichi Sankyo; owns MEDSIR, Initia-Research. J.C. consults, receives honoraria, research funding, stock, travel expenses, and patents for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies; holds patents for pharmaceutical combinations.

Autolus secures FDA approval for Aucatzyl, a CD19-targeting CAR-T therapy for relapsed or refractory B-cell precursor ALL, with no REMS requirement. Aucatzyl achieved 42% complete remission in the FELIX trial, with low rates of CRS and neurotoxicity. Competing with Novartis' Kymriah and Gilead/Kite's Tecartus, Aucatzyl aims to capture market share in the US, targeting around 3,000 patients.

Adlai Nortye (ANL) is developing Buparlisib, a PI3K inhibitor for recurrent/metastatic HNSCC post-anti-PD(L)1 treatment, with a phase III trial (BURAN) underway. Expected OS data in Q1 2025. ANL also has two other clinical drugs, AN4005 and AN0025, and a cash position of $98M as of June 2024.

The article discusses the challenges sponsors face with outsourced monitoring in clinical trials, emphasizing the need for stricter oversight and potential solutions, including reclaiming in-house monitoring to ensure patient safety and data integrity.