Northwest Bio still hanging on; Five Prime’s latest round of layoffs claims 70

October 11, 2019 11:02 AM EDT

Northwest Bio still hanging on; Five Prime's latest round of layoffs claims 70

Endpoints Staff

→ Penny stock Northwest Biotherapeutics is still hanging on. The company, which is developing DCVax for solid tumor cancers, has announced that they’ve reached a settlement with the SEC. The company has agreed to pay a fine of $250,000 “in connection with past weaknesses in its internal controls” and the company will neither admit nor deny any violations under the settlement.

→ Long-sliding biotech Five Prime Therapeutics will layoff 70 employees as part of a corporate restructuring as it struggles to find its footing. The oncology-focused company has been in free-fall since late 2017, when its Bristol-Myers Squibb-partnered drug cabiralizumab showed weak efficacy and a troubling safety profile in early-stage pancreatic cancer. In January, they cut 41 jobs, about a fifth of its workforce at the time, and in September they tapped William Ringo as interim CEO after Aron Knickerbocker resigned. On Thursday, Ringo announced the layoffs. “The company will retain a small research group focused on advancing three wholly-owned, late-stage research assets and will increasingly rely on outsourcing and contracted capabilities,” the company wrote.

→ Israeli biotech Therapix Biosciences — a company that is investigating the use of cannabinoid-based drugs in the reduction of symptoms in adults suffering from Tourette’s syndrome — has revealed updates on its planned merger with Destiny Biosciences. According to the letter of intent, “the parties agreed to allow until October 31, 2019, to complete the definitive agreement before abandoning the transaction.” Therapix’s board of directors said that it is willing to give Destiny additional time to reach a decision. Destiny is currently carrying out a valuation analysis of the merger.

AUTHOR

Endpoints Staff

editor@endpointsnews.com

June 3, 2020 08:57 AM EDT

R&D

Is a powerhouse Merck team preparing to leap past Roche — and leave Gilead and Bristol Myers behind — in the race to TIGIT domination?

John Carroll

Editor & Founder

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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June 2, 2020 06:00 AM EDTUpdated 07:18 AM

Venture

Pfizer’s Doug Giordano has $500M — and some advice — to offer a certain breed of 'breakthrough' biotech

John Carroll

Editor & Founder

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Platform and the Evolution Toward Off-The-Shelf Immuno-Oncology Approaches

Peter Kufer

Vice President & Innovator of BiTE® Technology, Amgen

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

ENDPOINTS CAREERS

Process Development Scientist, Compound Management

Recursion Pharmaceuticals

Salt Lake City, UT

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Credit: AP Images

June 3, 2020 07:39 AM EDT

Coronavirus

Covid-19 roundup: BARDA supports Operation Warp Speed with big $628M contract to service America's vaccine production needs

Natalie Grover

Reporter

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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June 3, 2020 07:34 AM EDT

R&D

Regulatory

FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review

Jason Mast

Associate Editor

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Adam Keeney (NodThera)

June 3, 2020 07:36 AM EDTUpdated 08:32 AM

Venture

As NLRP3 players head for first clinical face-off, Novo, Sanofi fuel trans-Atlantic contender with $55M

Amber Tong

Editor

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Ken Frazier, AP Images

June 2, 2020 11:17 AM EDTUpdated 6 hours ago

People

R&D

In Focus

Why Merck waited, and what they now bring to the Covid-19 fight

Jason Mast

Associate Editor

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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ENDPOINTS CAREERS

Senior Drug Discovery Scientist

New York, NY

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Mark Genovese (Stanford via Twitter)

June 2, 2020 10:31 AM EDTUpdated 10:45 AM

People

Gilead woos filgotinib clinical investigator from Stanford to lead the charge on NASH, inflammatory diseases

Amber Tong

Editor

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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June 2, 2020 10:19 AM EDT

Protocols

Novartis chips in $10M for IPO-bound partner Pliant; Tenax shares soar on heart drug data

Endpoints Staff

→ Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.