Here are the latest stories being discussed in biopharma today:
1. BrainStorm Cell Therapeutics is proceeding with a Phase 3b study, in consonance with the FDA’s Special Protocol Assessment (SPA), for their ALS cell treatment called NurOwn. This study could be BrainStorm’s last-ditch effort to have the therapy approved and is projected to launch during the course of this year.
2. Nvelop Therapeutics has launched with an impressive $100 million in seed funding, aiming to address significant challenges in the gene editing field. The startup intends to improve the precision delivery of gene-modifying tools such as CRISPR/Cas9, base editing, and prime editing, that have previously been hindered by delivery issues.
3. In brief: Acrivon has successfully raised a $130 million Private Investment in Public Equity (PIPE) with investors including RA Capital and Perceptive Advisors. Meanwhile, Vincerx Pharma released disappointing Phase 1 data on metastatic tumor trials, which sent its stock tumbling 75% in morning trading.
4. Define Ventures has enlisted Evolent Health CEO, Frank Williams, as a venture partner, further strengthening its strong focus on early-stage digital health startups. Williams’ experience includes co-founding Evolent Health and leading it through to its IPO.
5. After the $14 billion Bristol Myers Squibb acquisition of Karuna Therapeutics, Karuna executives and founding team are back with SeaPort Therapeutics. This new startup has already entered the clinical phase and attracted $100 million in investment, aiming to create better versions of active drugs.
6. FDA officials have expressed concerns regarding the overuse of immunotherapies for early-stage cancer patients. With Keytruda (Merck) and Opdivo (Bristol Myers Squibb), the onus is on pharmaceutical companies to prove that immune checkpoint therapy is more beneficial than surgical procedures in early-stage cancer patients.
7. Despite competition from biosimilars, AbbVie still controls 96% of the Humira market a year after competitors entered the space.
8. Pfizer asserts that it wants to be the ‘first and only’ Respiratory Syncytial Virus (RSV) vaccine to cover adults as young as 18 years old, backed by Phase 3 data.
9. AstraZeneca is observing promising results from its safe PARP inhibitor, with nearly 50% of responses in advanced breast cancer patients.
