The Pharma Navigator

Pharma multinational, Sanofi, and pioneers in targeted alpha therapies in oncology, Orano Med, have entered a partnership to develop next-generation radioligand therapies (RLTs) using lead-212 alpha-emitting isotopes, which follows a recent announcement between Orano Med, RadioMedia and Sanofi to advance RLTs in rare cancers, focusing on one late-stage project, AlphaMedix™. Targeted alpha therapy relies on combining the ability of biological vectors to target cancer cells with the short-range and highly energetic cell-killing capabilities of alpha-emitting radioisotopes. The vector directs the radioisotope to the target cancer cells expressing the specific marker. This unique mechanism of action aims to damage or destroy target cancer cells, while limiting impact on nearby healthy cells. Read more here👇

Catalent Pharma Solutions has completed a series of upgrades to its large-scale spray drying unit (GEA PSD-4) at its Boston, Massachusetts, facility. By adding capacity and multi-solvent capabilities, Catalent can now provide enhanced spray-drying services at the site for amorphous solid dispersion (ASD) formulations across late-stage to commercialization projects. Lorenzo Carletti, president of clinical development and supply at Catalent, noted the importance of ASDs in overcoming the aqueous solubility issues that plague the oral development pipeline, suggesting that between 75-80% of molecules in pre-clinical and clinical development are affected, and require bioavailability enhancing technologies. He added that by adding to the company’s spray drying capabilities, “Catalent becomes the CDMO with the widest commercial-scale bioavailability enhancing technologies.” Read more here👇

Chinese clinical-stage biotech company, LaNova Medicines, has raised $42 mn in a Series C1 funding round as it pursues innovations focusing on tumor microenvironment and developing innovative drugs for tumor specificity targeted ADCs and immunoregulatory large molecules. The company plans to use the funding to speed up clinical progress of its products at clinical phase - including LM-302 and LM-108 - and develop an antibody platform, next-generation ADC technology platform, and dual-antibody technology platform. Following promising preclinical results, the company has initiated its first-in-human clinical trial for LM-299, an anti-PD-1/VEGF BsAb targeting advanced solid tumors.

TuHURA Biosciences, Inc. Biosciences, a phase 3 immuno-oncology firm, has merged with Kintara Therapeutics, Inc. NASDAQ: KTRA, a developer of novel cancer therapies. The newly combined entity - continuing to trade as TuHURA Biosciences - will focus on advancing innovative cancer therapies, including their immune response agonist IFx-2.0 and tumor microenvironment modulators as the company seeks to overcome resistance to current immunotherapies. Read more here👇

BioDuro-Sundia, the U.S. headquartered contract research, development and manufacturing organization (CRDMO), has opened a new kilo laboratory at its R&D campus, located in the Free-Trade Zone of Shanghai, China. Kilo labs provide pilot-scale production and enable scale-up synthesis for drug substance. The company said the investment will further enhance its ability to accelerate more drug candidates from discovery through to preclinical and clinical phases to meet the growing demands of its global partners. The opening follows closely behind that of a new compound management center at the same site, which enabled the site to store and handle clients’ compounds at the drug discovery phase. Read more here👇

Several U.S. consumer groups and labor unions have asked the FTC to block Novo Holdings planned $16.5 bn acquisition of Catalent Pharma Solutions, amidst concerns that the potential deal could stifle competition in the market for GLP-1 receptor agonist drugs. The groups argue that the acquisition would further solidify Novo Nordisk's leading position - dominated by Ozempic and Wegovy – and that this could potentially lead to higher prices and reduced access to these critical medications. They also contend that the deal could give Novo Nordisk control over Catalent's production facilities, and thus limit its rivals' ability to manufacture competing drugs. The move comes amid growing scrutiny from lawmakers - including the U.S. Senator Elizabeth Warren - who has also raised concerns about the merger’s potential to reduce competition. Senator Warren has asked the FTC to closely investigate the deal. 

As the 2024 U.S. election between Donald Trump and Kamala Harris approaches, the biopharma industry is keenly watching how each candidate's policies could shape the future of the sector. Although the Inflation Reduction Act (IRA) has already set the stage for significant changes in drug regulations, neither candidate is expected to completely overhaul the current regulatory framework due to the IRA and a divided Congress, but their differing approaches could lead to important shifts in the industry. Read more here👇

The 2024 Nobel Prize in Physiology or Medicine has been awarded to Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (miRNA) - a class of small RNA molecules that play a crucial role in gene regulation. Their research revealed a new mechanism that controls gene expression, which is essential for cellular function and development, which has significantly expanded the understanding of gene regulation and its impact on diseases like cancer and diabetes. miRNAs could revolutionize the future of precision medicine and novel therapeutic strategies, making them promising therapeutic targets and diagnostic biomarkers for various diseases, including cancer, neurological disorders, and cardiovascular conditions. Read more here👇

An AI proof-of-concept study from Dandelion Health has identified an additional 44 million lower-risk cardiovascular patients who could benefit from a GLP-1 treatment. Using inclusion criteria similar to the Novo Nordisk-sponsored trial that helped convince the FDA that Wegovy had heart benefits, Dandelion examined whether GLP-1 use might reduce the risk of major adverse cardiac events such as heart attack or stroke in overweight and obese patients in lower-risk patients that didn’t have severe pre-existing cardiovascular disease. The results expanded on the findings of Novo’s trial, which found Wegovy reduced the risk of major cardiac events in the study group by as much as 20%, and providing treatment for these additional patients could head off 17,300 heart attacks and 16,700 strokes a year, according to study authors.

Clinical-stage biopharmaceutical - OnKure Therapeutics - has finalized its merger with Reneo Pharmaceuticals and raised $65 mn through a private investment as the company looks to accelerate the development of their mutant-specific PI3Kα inhibitor portfolio. PI3Kα is the most frequently mutated oncogene in cancers, with the most common - PI3KαH1047R - found in 15% of breast cancer and 4% of cancers overall. OnKure’s lead product candidate, OKI-219, is an orally bioavailable, highly selective inhibitor of PI3KαH1047R, which the company suggests should significantly improve the activity and safety relative to currently approved PI3Kα inhibitors. Read more here👇