FDA grants full approval to Keytruda in tumor-agnostic setting; Candel pauses trial enrollment

30 Mar 2023
endpts.com
Clinical ResultPhase 2Immunotherapy
In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test. Merck pooled data — mainly overall response rates — from three open-label trials to support this filing. The first enrolled 124 patients with advanced MSI-H/dMMR colorectal cancer that progressed after chemo; the second enrolled 373 patients with advanced MSI-H/dMMR non-colorectal cancers who progressed following prior therapy; and the third comprised seven pediatric patients with MSI-H/dMMR cancers. By Merck’s analysis, Keytruda showed an ORR of 33.3% across these three trials, including a complete response rate of 10.3%, at a median follow-up time of 20.1 months. — Amber Tong Candel Therapeutics is pausing enrollment in a Phase II trial of its lead viral immunotherapy candidate, a decision it attributes to “cost management and dynamic portfolio management initiatives.” The trial was testing CAN-2409, which consists of a construct encoding the thymidine kinase carried in an adenovirus vector, in borderline resectable pancreatic adenocarcinoma. But additional funding would be required to keep pushing that trial forward, Candel suggested. Despite the pause, the biotech expects to present initial data from the trial by the end of the year. — Amber Tong Akero revealed Wednesday that it had a positive meeting with the FDA at the end of Phase II of its NASH program — and divulged some details about the Phase III portion. There will be two parallel, randomized and placebo-controlled trials that plan on starting enrollment sometime later this year, Akero said in a statement. The first trial, called Synchrony Histology, will examine two different doses of Akero’s NASH candidate EFX in patients that have pre-cirrhotic NASH confirmed via biopsy, and have either stage 2 or 3 fibrosis. The primary endpoint for the efficacy study is both resolution of NASH and fibrosis improvement of at least one stage. The other trial, Synchrony Real-World, will take a look at the drug’s safety and tolerability in patients who have a non-invasive diagnosis of NASH or NAFLD, nonalcoholic fatty liver disease. One of the secondary endpoints will be change in fibrosis biomarkers. Akero noted that it plans to finalize the trial design of a third Phase III clinical trial, an outcomes trial testing efficacy and safety in cirrhotic patients, after a Phase IIb readout in Q4. Overall, Akero plans to enroll at least 1,500 patients. Akero touted positive Phase IIb data last fall, showing that its NASH candidate and ex-Amgen drug efruxifermin, or EFX, met the primary and multiple secondary endpoints in 128 patients with biopsy-confirmed, pre-cirrhotic NASH. Akero immediately followed that up with a $175 million public offering. — Paul Schloesser After seeing its stock rise more than 65% in one day on the back of Phase I data for an investigational obesity drug, Viking Therapeutics is now following the data-to-public offering train. The San Diego biotech said Wednesday it will offer up more than 17 million shares of its common stock at a price of $14.50 a pop. Viking expects to nab $250 million from the offering, slated for a Monday close, and more could come via a 30-day option to buy another 2.586 million shares. Viking said its GLP-1/GIP dual agonistGLP-1/GIP dual agonist led to 6% more weight loss at the highest dose, but the data come from a small, early-stage study and will need to be further fleshed out in a larger, longer Phase II, which the biotech expects to start in the middle of this year. Viking hopes to follow the suit of other weight-loss drugmakers already on the market or in the clinic: Novo Nordisk, Eli Lilly, Amgen and others. — Kyle LaHucik After saying it would go for a $125 million stock sale , Biomea Fusion is now angling for $150 million. That would more than double the Redwood City, CA biotech’s reserves after it disclosed early data this week on an ongoing Phase I/II study for treating type 2 diabetes. The trial sampling was small but investors liked what they saw, sending Biomea’s shares on a quick ride up the skyscraper elevator. The offering will include 5 million shares of common stock at a price of $30 apiece. A 30-day option allows underwriters to buy another 750,000 shares. The offering is slated to wrap up on Monday. — Kyle LaHucik Antibody biotech ImmunoPrecise put out word Thursday that it reached a deal with Astellas, but giving no info on the financial specifics of the deal. According to a statement from ImmunoPrecise, the AI-focused company made an agreement with Astellas subsidiary Xyphos Biosciences to jointly research and optimize in silico generated antibodies — going after an undisclosed tumor microenvironment target. ImmunoPrecise said that the molecule has a potential to enhance anti-tumor immunity, and that Astellas has an exclusive option to in-license any development candidates that are generated. This new deal is only two days after Astellas inked a similar deal with MIMETAS — in exchange for an undisclosed amount of upfront and milestone payments, Astellas got its hands on MIMETAS’s immuno-oncology disease assays. — Paul Schloesser
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