Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
Immunitas Therapeutics Inc., a company leveraging single cell analysis to identify and validate new drug targets, has closed $58 million in series B financing led by Agent Capital. The funds will be used to advance its lead program, the CD161 inhibitor IMT-009, into the clinic for testing against both solid tumors and hematological malignancies, pending approval of a forthcoming IND filing next year.
Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with an earlier-than-anticipated FDA approval of the drug for cancers associated with von Hippel-Lindau disease. The therapy will be marketed as Welireg.
Shares of Cohbar Inc. (NASDAQ:CWBR) hit a 52-week high on Aug. 11 following news that a mitochondrial peptide analogue it is testing for the potential treatment of nonalcoholic steatohepatitis (NASH) and obesity, CB-4211, delivered "robust" improvements in key biomarkers of liver damage and glucose levels vs. placebo during a small phase Ia/Ib study.
Shares of Axsome Therapeutics Inc. (NASDAQ:AXSM) hit a 52-week low on Aug. 9, falling 46.5% to close at $24.37, after the FDA said deficiencies in an NDA in major depressive disorder for its drug, AXS-05 (dextromethorphan + bupropion), would "preclude labeling discussions" for now.
Eqrx Inc., a startup co-founded by serial biotech entrepreneur and investor Alexis Borisy to deliver new medicines for cancer and other conditions at "radically lower prices," is poised to raise up to $1.8 billion via a merger with the special purpose acquisition company (SPAC) CM Life Sciences III Inc. The transaction, which would bring Eqrx to Nasdaq, includes a fully committed and upsized PIPE of $1.2 billion led by Softbank Group's SB Management Ltd. as well as SPAC sponsors Casdin Capital LLC and Corvex Management LP, plus $550 million of cash and trust held by the SPAC itself.
Pepgen Inc., a company developing new therapies for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) from its Enhanced Delivery Oligonucleotide platform, has closed an oversubscribed $112.5 million crossover financing. Funds from the round will be used to advance the DMD and DM1 candidates to the clinic in 2022 and 2023, respectively, as well as to expand its Boston-based team. The latest round follows Pepgen’s $45 million series A, led by RA Capital and announced in December 2020.
New top-line results from the phase IIb/III Allegro trial of Pfizer Inc.'s once-daily oral JAK3 inhibitor, ritlecitinib, have met the trial's primary efficacy endpoint of improving scalp hair regrowth in patients with alopecia areata vs. placebo. The new data, to be paired with long-term trial results from Pfizer's long-term Allegro-LT study, move the program one step closer to an expected early 2022 NDA filing.
Eli Lilly and Co. has established a multiyear collaboration with Kumquat Biosciences Inc. for the discovery, development and commercialization of new small molecules for stimulating tumor-specific immune responses. Kumquat will receive $70 million up front, including an equity investment, and is eligible for more than $2 billion in potential milestone payments plus royalties on any marketed products.
Peptidream Inc., fresh off expanding a multibillion-dollar research and license agreement with Takeda Pharmaceutical Co. Ltd. earlier this week, has inked a brand new deal with Alnylam Pharmaceuticals Inc. Valued at up to $2.2 billion, including milestones, the new deal is aimed at the discovery and development of peptide-siRNA conjugates for the delivery of therapies to a wide range of cell types and tissues beyond the liver, the central target of Alnylam's marketed products to date.
