There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
CDR-Life Inc. has closed a $76 million series A round to advance development of a new generation of cancer immunotherapies designed to treat solid tumors by targeting intracellular antigens that occur only in tumors, with the aim of increasing effectiveness while reducing off-target effects.
After a difficult start, there’s been more progress in PIK3 drug class, with FDA approval of Novartis AG’s Vijoice (alpelisib) for the rare condition PIK3CA-related overgrowth spectrum (PROS).
In a first of its kind phase I trial, Rejuvenate Biomed NV has secured ethical clearance to induce acute sarcopenia in 42 healthy subjects, aged 65 to 75 years old. That will be achieved by placing a cast on one leg to induce sarcopenia through muscle disuse. The volunteers in the double-blind trial will then receive either RJx-01, an oral small molecule for treating sarcopenia, or placebo.
The challenging financial environment of 2022 will lead to an increase in partnerships, according to representatives of the two big Swiss biopharma companies, Roche Holding AG and Novartis AG.
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Targeted radiopharmaceutical specialist Precirix NV has closed an €80 million (US$87.8 million) series B financing, enabling it to complete phase II development of CAM-H2, a potential treatment for HER2-positive metastatic breast cancer and gastric cancer. The round follows initial data showing there were no dose limiting toxicities in the first cohort of patients in the phase I/II trial, and a positive review from the safety committee.
