The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies.
Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.
Takeda Pharmaceutical Co. Ltd. has stress-tested Engitix Ltd.’s extracellular matrix (ECM) drug discovery platform and is coming back for more, expanding the existing collaboration from liver fibrosis to inflammatory bowel disease (IBD).
One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent.
Microbiotica Ltd. of Cambridge, U.K., has raised £50 million ($67 million) in series B funding as the company aims to test its microbiome-based technology in early cancer and ulcerative colitis trials. The funding was co-led by new investors Tencent and Flerie Invest, with British Patient Capital on board along with existing investors Cambridge Innovation Capital, IP Group and Seventure. With response rates to checkpoint inhibitors still very low, Microbiotica’s scientists think that the way to improve the immune system’s response to these drugs is by modifying the bacteria present in the gut.
It’s no mystery why Scipher Medicine Corp. successfully raised $110 million in a series D financing round to further develop the company’s precision medicine platform. The company aims to address one of most modern medicine’s most challenging enigmas: how to eliminate the cost and adverse effects associated with the prescription of expensive medications that provide life-changing outcomes for some and no benefit for others. The new funds boost Scipher’s total funding to $227 million, of which $192 million has come into the Waltham, Mass.-based company’s coffers in the last 12 months.
Pfizer Inc. is to buy Arena Pharmaceuticals Inc. for $6.7 billion, adding a potential follow-up to inflammatory diseases pill Xeljanz (tofacitinib) to its pipeline plus several other potential medicines targeting gastroenterology, dermatology and cardiology.
Theravance Biopharma Inc.’s phase IIb fizzle with izencitinib in ulcerative colitis (UC) put a dent in shares, as Wall Street mulled the ongoing phase II study in Crohn’s disease (CD) as well as prospects regarding the deal with Johnson & Johnson.
Differences between Seres Therapeutics Inc.’s next-generation microbiome therapy and SER-287 were highlighted in the wake of the phase IIb failure with the latter in the study called Eco-Reset, which missed its primary endpoint of improving clinical remission rates in ulcerative colitis (UC) compared to placebo.
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC.
