Merck goes in deeper with Keytruda/Lynparza combo; PureTech unveils stem cell therapy startup
→ Merck is opening up a new wing of its Keytruda pipeline, devoting it to a slate of new Phase III combination studies with Lynparza in treating prostate cancer. Researchers spotted anti-tumor activity in 3 cohorts, sending them the signal they were looking for to pile on pivotal studies in search of a new market. “These promising data presented at ASCO GU coupled with the significant unmet medical need in patients with metastatic castration-resistant prostate cancer, propelled us to initiate three new Phase 3 trials to further evaluate these KEYTRUDA combination regimens,” noted Merck’s Roy Baynes.
→ PureTech Health is helping chart a path for Siddhartha Mukherjee to bring some of his research from Columbia University to the clinic with a new startup. Debuting with a $42 million round led by 5AM Ventures and RA Capital Management, Vor Biopharma is looking to treat hematological malignancies with hematopoietic stem cell therapies, starting with acute myeloid leukemia. 5AM managing partner Kush Parmar is taking the executive chairman role while Joshua Resnick of RA Capital also joins the board. Other investors include Johnson & Johnson Innovation – JJDC, Novartis Institutes for BioMedical Research and Osage University Partners.
→ Tesaro‘s PARP drug Zejula, which in 2017 saw its label expanded by the FDA, has shown early promise in a mid-stage study in certain metastatic castration-resistant prostate cancer patients. J&J $JNJ and Tesaro – which is now a part of GSK $GSK – agreed to collaborate on testing the drug, known chemically as niraparib, in 2016. Preliminary data from the 120-patient study showed 40% of patients with pathway defects – BRCA1 or BRCA2 – who received treatment with niraparib demonstrated an objective response rate as measured by a decreased tumor size in soft tissue.
→ It’s on. Sarepta $SRPT today said that the FDA has accepted its NDA for golodirsen (SRP-4053) as it hunts another accelerated approval for a new drug to treat Duchenne muscular dystrophy. The agency set the PDUFA date at August 19.
→ A generic version of Celgene’s best-selling cancer drug Revlimid will soon be available around the world. Alvogen announced that it has launched the generic in Romania, Croatia, Bulgaria and the Baltic states, with a global rollout to follow.
In regards to the generic Revlimid news today, per Credit Suisse and others $CELG licensed the drug to Alvogen for these countries so it's a non-event.
— Brad Loncar (@bradloncar) February 13, 2019
→ TCR2 Therapeutics has priced its IPO at $15 a share. The Cambridge, MA-based TCR biotech raised $75 million from the offering, pricing at the midpoint of the range it set for itself. The stock will begin trading today as $TCRR.
→ Vertex $VRTX says it came up with positive data from their Phase III study of tezacaftor in combination with ivacaftor, hitting the primary endpoint of absolute change in lung clearance index (LCI2.5) through 8 weeks of treatment. Researchers say that there was “a statistically significant improvement in LCI2.5 among patients treated” with the combo. An application is due in H2.
→ Caladrius Biosciences says its Phase IIa study using a Treg strategy for autoimmune diseases failed. Researchers tested CLBS03 in newly diagnosed Type 1 diabetes patients, hoping that the well-known effect that Tregs have in blunting an immune system attack would work for this disease. Its shares $CLBS were down 15% in mid-morning trading.