Dec. 3 Quick Takes: Moderna, NIH tout persisting neutralizing antibodies from COVID vaccine; plus Bayer, Galapagos, Braeburn, J&J and Equillium
Three-month immunity data for Moderna, NIH COVID vaccine
NIH reported in The New England Journal of Medicine that all 34 Phase I subjects who received two doses of 100 ug mRNA-1273 from Moderna Inc. (NASDAQ:MRNA) 28 days apart had detectable neutralizing antibodies 119 days after the first vaccination. Neutralizing geometric mean titers assessed in a plaque reduction assay were 430 in volunteers ages 18-55 at day 119 vs. 654 at day 43. In the ages 56-70 cohort, titers at day 119 were 269, down from 878 at day 43; and in participants ages ≥71, day 119 titers were 165 vs. 317 at the earlier time point.
The company, which on Monday applied for emergency use authorization, also reaffirmed that it expects to have 20 million vaccine doses available in the U.S. by year-end and 100-125 million doses globally available next quarter.
BLA submitted for first Genmab DuoBody based on Phase I data
The Janssen unit of Johnson & Johnson (NYSE:JNJ) submitted a BLA for amivantamab to treat patients with metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The BLA submission, which is based on data from the monotherapy arm of the Phase I CHRYSALIS study of the EGFR- and c-MET-targeting bispecific antibody, is the first for a product developed via the DuoBody platform from Genmab A/S (NASDAQ:GMAB; CSE:GMAB).
Bayer launches cell, gene therapy platform
Bayer AG (Xetra:BAYN) has launched a cell and gene therapy platform within its pharmaceuticals division to support internal R&D, collaborations, licensing and acquisitions relating to the modalities. It includes the integration of regenerative medicine company BlueRock Therapeutics L.P. and gene therapy company Asklepios BioPharmaceutical Inc. (informally AskBio), which operate autonomously. Bayer has 15 preclinical programs in the platform, including five advanced assets, and plans to submit three INDs annually; the pharma is focusing on stem cell therapies, gene augmentation, gene editing and allogeneic cell therapies across a range of indications.
Galapagos hits in IPF
GLPG1205 from Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) is heading for a Phase IIb dose finding study after the GPR84 antagonist met the primary endpoint of an improvement in forced vital capacity in the Phase II PINTA trial to treat idiopathic pulmonary fibrosis (IPF).
Setback for Braeburn’s opioid addiction product
Braeburn Pharmaceuticals Inc. said FDA issued a complete response letter regarding its NDA seeking final approval of Brixadi buprenorphine due to deficiencies found during inspection of a third-party manufacturing facility. Brixadi is a subcutaneous weekly and monthly extended release formulation of the opioid use disorder therapy buprenorphine; it received “tentative” approval by FDA in 2018.
COVID course correction for Phase III of Biocon mAb
Equillium Inc. (NASDAQ:EQ) is no longer planning to start its FDA-cleared Phase III EQUINOX trial of itolizumab to treat hospitalized COVID-19 patients. CEO Bruce Steel told BioCentury that the decision was largely driven by the efficacy of COVID-19 vaccines MRNA-1273 from Moderna Inc. (NASDAQ:MRNA) and BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), which are expected to gain emergency use authorization from FDA this month. Equillium has U.S. and Canadian rights to the anti-CD6 mAb from Biocon Ltd. (NSE:BIOCON; BSE:535523).
c-MET (MET; HGFR) - c-Met receptor tyrosine kinase
EGFR (ErbB1; HER1) – Epidermal growth factor receptor
GPR84 – G protein-coupled receptor 84