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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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News brief­ing: Eli Lil­ly com­pletes $1B+ Pre­vail buy­out; El­zon­ris ap­proved in Eu­rope for adults

Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.

The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.