Merck announced that the FDA has extended the action date for the supplemental biologics license application, or sBLA, for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, or NSCLC, in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations. The sBLA is based on results of the Phase 3 KEYNOTE-042 trial where Keytruda monotherapy demonstrated a significant improvement in overall survival compared with chemotherapy in this patient population. The company recently submitted additional data and analyses to the FDA, which constitutes a major amendment and extends the Prescription Drug User Fee Act, or target action date, by three months to April 11, 2019. Merck continues to work closely with the FDA during the review of this sBLA.
Thursday, December 20, 2018
Incyte announces first patient treated in ruxolitinib cream trial
Incyte announced that the first patient has been treated in the Phase 3 TRuE-AD clinical trial program evaluating the long-term safety and efficacy of ruxolitinib cream as monotherapy for adolescent and adult patients with atopic dermatitis, or AD, who are candidates for topical therapy. The TRuE-AD clinical trial program includes two Phase 3 studies evaluating the safety and efficacy of ruxolitinib cream in patients with atopic dermatitis. The primary endpoint of the TRuE-AD studies is the proportion of participants achieving an investigator’s global assessment treatment success, or IGA-TS, defined as an IGA score of 0 or 1 with at least a two-point improvement from baseline at week 8.
Akorn appoints Douglas Boothe CEO
Akorn announced that Douglas Boothe has been named president and CEO, effective January 1, 2019. Most recently, Boothe served as the president of the generics division of Impax Laboratories.
https://thefly.com/landingPageNews.php?id=2840377
Gritstone Gets FDA Fast Track for Colorectal Cancer Treatment
Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to GRANITE-001 for the treatment of colorectal cancer. GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone’s proprietary EDGETM artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.
“Colorectal cancer remains a major contributor to cancer deaths and has not yet proved very amenable to first generation immunotherapy,” said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. “We believe GRANITE-001 has the potential to be a valuable therapeutic option for these patients through its highly personalized design. The ability to leverage tumor markers, or neoantigens, specific to a patient’s own tumor cells in the development of a personalized immunotherapy is regarded as the next frontier of cancer therapy. We look forward to continuing our productive dialogue with the FDA under their Fast Track program as we seek to advance GRANITE-001 expeditiously for the potential benefit of patients.”
The FDA grants Fast Track designation to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives Fast Track designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more quickly.
Reuters: Indian regulator orders J&J to stop using raw material in Baby Powder
India’s drugs regulator has ordered Johnson & Johnson to stop manufacturing its Baby Powder using raw materials in two of its Indian factories until test results prove they are free of asbestos, a senior official said on Thursday.
The official at the Central Drugs Standard Control Organization (CDSCO), who declined to be named citing the sensitivity of the matter, said a written order had been sent to the U.S. company telling it to stop using the “huge quantities” of raw materials stocked in its plants in northern and western India.
The company said on Wednesday that Indian drug authorities visited some of its facilities and took “tests and samples” of its talcum powder. It also said that the safety of its cosmetic talc was based on a long history of safe use and decades of research and clinical evidence by independent researchers and scientific review boards across the world.
Google Ventures enlists machine learning pro Kapeller for new breed of biotech
Over the past few years GV — the venture fund formerly known as Google Ventures — has become one of those investors the computational players in particular love bringing in to their syndicate. Getting their cash endorsement is a coup in the machine learning crowd.
Now the folks at GV are taking one step further down the road to doing more of their own biotech creations. Rosana Kapeller, who co-founded and helped launch the computational discovery biotech Nimbus as its chief scientific officer, has signed on as GV’s first entrepreneur-in-residence for life sciences. Over the next year or so she’ll be exploring more about the world of machine learning in biotech, with an eye to selecting one of these newcos to run.
“I really want to start companies,” Kapeller tells me, with a special focus on the crossroads where high tech meets drug discovery — GV’s sweet spot.
There’s a considerable amount of new work going on here, she adds, citing the business that Daphne Koller is venturing into with insitro, an artificial intelligence player she’s been setting up since leaving Calico. And there are many others on the path to an A round.
There’s a considerable amount of new work going on here, she adds, citing the business that Daphne Koller is venturing into with insitro, an artificial intelligence player she’s been setting up since leaving Calico. And there are many others on the path to an A round.
“We see so many projects either strong on machine learning and weak on development, or vice versa,” says GV general partner Krishna Yeshwant. “Rosana has exposure across both cultures.”
“We are definitely going to be starting more companies,” he adds, and Kapeller will be key in that process.
That’s not all. GV has brought in David Reshef to help sharpen their presence with machine learning in life sciences. The computer science expert with a PhD from MIT and an academic track record that includes studying statistics at Oxford as a Marshall Scholar will also be involved in GV’s startup plans.
Money has been pouring into machine learning and platform companies in particular, which you can see at a string of companies that have been sucking up billions in capital this year. Is that a bubble?
Probably, says Yeshwant. But that actually can work in their favor.
“One thing we’re not short of is capital,” he says bluntly. And that won’t change even if the bubble pops.
“Think of it as a response to a bubble,” he says. “You need to finance a company all the way through.” And GV can do that through thick and thin.
I asked Kapeller what she thought about the bubble question. Her response:
“This is definitely a bubble.”
Kapeller was out raising money in 2009, so she knows what hard times look like when general investors shun high risk fields like biotech. But at the same time those hard times forced companies to be more disciplined about their work.
“I think things are going to change dramatically,” she says. But that’s not necessarily a bad thing.
There are plenty of macro reasons to spur a correction now, says Yeshwant. But some things are fundamental and enduring.
“Great biology, great people, will always be successful,” he says, “especially in this industry where it’s so hard to make things work.”
Being present at the creation of a whole new breed of biotech was never going to be easy. GV, though, plans to make it fun.
Judge dismisses lawsuit accusing Craig Venter of stealing trade secrets
A California judge has dismissed a suit in which genomics pioneer Craig Venter’s old company accused him of stealing trade secrets.
The decision on Tuesday brings to a close a messy breakup between Venter, the 72-year-old celebrity scientist who helped sequence the human genome, and Human Longevity, the struggling San Diego genomics company that Venter founded in 2013 and departed this past spring.
Human Longevity this past summer filed the now-dismissed suit in civil court against the J. Craig Venter Institute, Venter’s nonprofit research organization that employs several hundred scientists and staff near San Diego and Washington, D.C.
Human Longevity’s complaint had accused Venter of leaving the company with his company-issued laptop in tow so that he could take with him trade secrets — among them, the names and contact information of Human Longevity’s clients and would-be clients — to try to set up a competing business.
The complaint also alleged that Venter tried to steal away Human Longevity’s employees and investors, in violation of an agreement he had signed.
But in the ruling dismissing the suit, the judge concluded that Human Longevity hadn’t demonstrate that its case met the legal threshold required for a company or individual to sue when its trade secrets have been misappropriated.
Human Longevity soared to a valuation of around $1.6 billion in 2017 on the back of Venter’s bold ambition to build the world’s largest database of human genetic data and mine it for insights that could yield new drugs. The company’s best-known offering: an exhaustive medical workup “in a spa-like setting” marketed to people who are apparently healthy but might have silent diseases and vulnerabilities lurking in their genes. The price tag: $25,000, though discounted versions were also introduced.
But Human Longevity has struggled to find customers. Earlier this month, the company raised money at a valuation 80 percent lower than when it last raised money in 2017, the Wall Street Journal reported.
Erin Trenda, one of the attorneys representing JCVI in the case, said that “we are pleased the court agrees that HLI’s allegations are meritless and fail to state a trade secret claim.”
Subscribe to:
Posts (Atom)