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

→ 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.

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

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

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

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

Credit: AP Images

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

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

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)

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

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

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

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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Mark Genovese (Stanford via Twitter)

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

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

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.