Bio Roundup: CRISPR Ruling, “America’s Nobels,” IPOs & More

Xconomy National — 

The long-running patent feud over CRISPR-Cas9 gene editing appears to be over, just as U.S. biotech companies gear up for the first human tests of the landmark technology.

This week, a federal appeals court upheld a previous ruling handing a CRISPR-Cas9 patent to the Broad Institute of MIT and Harvard. The decision by the three-judge panel essentially said that the Broad patent was different enough so as not to infringe on a patent awarded to a rival group at the University of California, Berkeley. Berkeley could appeal to the U.S. Supreme Court, but it’s not yet clear if it will do so.

In other life science news this week, Gilead Sciences (NASDAQ: GILD) bucked CRISPR in favor of a different type of gene editing technology; “America’s Nobels” were awarded; and the rolling biotech IPO train picked up new passengers. Let’s get to those stories and more in the roundup.


—Three of the nation’s largest private oncology practices teamed with Flatiron Health to start OneOncology, a healthcare company aiming to help cancer patients treated at community practices receive the same level of care as they would get at a major medical center. The company, formed by practices in Tennessee and New York, got a $200 million investment from private equity firm General Atlantic.

Gilead Sciences is partnering with Precision BioSciences, using the Durham, NC, company’s Arcus gene-editing technology to work on a potential cure for hepatitis B virus infection.

—OncoResponse, a cancer immunotherapy developer based in both Seattle and Houston, raised a $40M Series B round as it prepares to advance its lead drugs into clinical testing.

Atreca Therapeutics of Redwood City, CA, closed a $125 million Series C round, also to bring experimental immunotherapies into clinical trials.

—Coda Biotherapeutics reeled in a $19 million Series A round to pursue a gene therapy that alters a patient’s cells to produce a “switch,” which can then be modulated by the patient swallowing a pill. Coda, of South San Francisco, CA, will first try its approach to treat chronic pain.


—Acorda Therapeutics (NASDAQ: ACOR) got a one-two punch of bad news. A federal appeals court rejected its attempt to overturn a 2017 ruling invalidating patents on its lead drug, dalfampridine (Ampyra), and then the FDA delayed by three months an approval decision on its Parkinson’s disease drug Inbrija. The FDA could now approve both Inbrija and a rival drug from Sunovion Pharmaceuticals in January. Acorda shares fell more than 30 percent this week.

—The FDA rejected a plan from Amicus Therapeutics (NASDAQ: FOLD) to seek accelerated approval of a drug for Pompe disease and asked the company for more data. Amicus aims to try again, with more data in hand, next year.

—The agency is also reviewing whether to update the label for the cholesterol lowering drug alirocumab (Praluent), to include data showing it may reduce the risk of major cardiovascular events such as heart attacks or strokes. Regeneron Pharmaceuticals (NASDAQ: REGN), the drug’s developer, revealed that data in March along with a price cut.

—The Merck (NYSE: MRK) antibiotic ceftolozane/tazobactam (Zerbaxa), acquired in the 2014 buyout of Cubist Pharmaceuticals, succeeded in a Phase 3 study in adults with bacterial pneumonia. The antibiotic is already approved for complicated urinary tract and intra-abdominal infections.

—Bristol-Myers Squibb (NYSE: BMY) released promising Phase 2 data for a psoriasis drug that could compete with the current standard-of-care anti-inflammatory drugs.

—Gilead and partner Galapagos said their rheumatoid arthritis drug filgotinib met its main goals in a Phase 3 study.

—Amgen (NASDAQ: AMGN) of Thousand Oaks, CA, released positive but very early data (in five patients) for an experimental multiple myeloma treatment, knocking a few percentage points off the share prices of Bluebird Bio (NASDAQ: BLUE) and Celgene (NASDAQ: CELG), who are collaborating on a different—and potentially more complicated—type of myeloma treatment.


Kodiak Sciences filed plans for a $100 million IPO as the Palo Alto, CA-biotech prepares for studies testing … Next Page »

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