Therapy delivery and the physicians who administer them are keys in CG Oncology Inc.’s drive to develop bladder cancer treatments. The company, which just closed an oversubscribed $120 million series E financing to continue on the development path, has its lead oncolytic immunotherapy, CG-0070, intravesically delivered via a catheter, in the clinic.
Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%.
A second death in the study of davoceticept (ALPN-202) has prompted Alpine Immune Sciences Inc. to stop enrolling participants in two phase I studies of the CD28 co-stimulator and dual checkpoint inhibitor, throwing the program’s future into doubt.
Over the next two weeks, the team at NGM Biopharmaceuticals Inc. will be digging through the data from its phase II trial of complement 3 inhibitor NGM-621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration, following reports of a top-line miss Oct. 17 and a severe reaction from investors, who sent shares (NASDAQ:NGM) plummeting 70.5% to close at $3.41.
It was a busy day at Moderna Inc. as Merck & Co. Inc. exercised its option to jointly develop and commercialize a personalized cancer vaccine with Moderna in a deal the two companies inked in 2016. Moderna also notched another emergency use authorization (EUA) for its COVID-19 vaccine, this one targeting the omicron variant, for use by those under age 18.
The closely watched pivotal phase III trial called Stellar by Merck & Co. Inc. with sotatercept delivered in a big way for the company, helping to validate the firm’s $11.5 billion buyout about a year ago of Acceleron Pharma Inc.
Photys Therapeutics Inc. raised a $75 million series A financing to develop phosphorylation-inducing chimeric small-molecule medicines to fix dysfunctional proteins. Photys, of Cambridge, Mass., was founded by the Longwood Fund and Amit Choudhary of Brigham and Women’s Hospital and the Broad Institute of MIT and Harvard University.
Data on the development of novel noncationic macrocyclic peptides for inhibiting GTPase KRAS signaling for the potential treatment of cancer were presented by investigators from Merck & Co. Inc.
Orna Therapeutics Inc., which is pioneering a novel circular RNA protein expression technology in several therapeutic areas, has achieved lift-off. The Cambridge, Mass.-based company has closed a broadly based alliance in infectious disease and oncology with Merck & Co. Inc., under which it is getting $150 million up front and up to $3.5 billion in development, regulatory and sales-based milestones. In addition, Merck, of Rahway, N.J., is investing another $100 million in Orna’s equity, as part of its $221 million series B round, which the company also disclosed on Aug. 16.
As expected, the U.S. House of Representatives passed, on a 220-207 party-line vote, a legislative package Aug. 12 that, for the first time, allows Medicare to directly negotiate some prescription drug prices, while imposing severe penalties and an excise tax on companies that refuse to negotiate or don’t comply with the government price.
