Bill Haney, Skyhawk

Fat­ten­ing the bankroll, Bill Haney adds can­cer R&D pow­er­house Mer­ck to Sky­hawk's ros­ter of part­ners out to drug RNA

What­ev­er Bio­gen learned about Sky­hawk in the 6 months since it an­ted up $74 mil­lion to get a col­lab­o­ra­tion go­ing with their R&D team on drug­ging RNA for neu­rode­gen­er­a­tion, it must have been a pos­i­tive ex­pe­ri­ence.

Dean Li Linkedin

The big biotech has al­ready come back to the bar­gain­ing ta­ble and signed up to ex­pand the range of tar­gets on their dis­cov­ery list. And this morn­ing Sky­hawk is al­so an­nounc­ing that phar­ma gi­ant Mer­ck has stepped up with its own ini­tia­tive on neu­rode­gen­er­a­tion while adding can­cer to the RNA menu of col­lab­o­ra­tive spe­cial­ties at the up­start drug dis­cov­ery unit for the first time.

Sky­hawk chief Bill Haney wasn’t be­ing ex­plic­it about the terms — Mer­ck, in par­tic­u­lar, is tra­di­tion­al­ly loathe to dis­cuss the fi­nan­cial de­tails in­volved in their dis­cov­ery pacts — but fac­tor in the $149 mil­lion in hard up­fronts al­ready an­nounced with Bio­gen, Cel­gene and Take­da (al­so on neu­rode­gen­er­a­tion), and Haney tells me lit­tle Sky­hawk has round­ed up “quite a bit of mon­ey” with its deals in just 18 months. With the eq­ui­ty Haney has at­tract­ed or put in, the bankroll push­es well past the $200 mil­lion mark. 

The mile­stones? They stretch up in­to the bil­lions. Mer­ck alone at­tached a $600 mil­lion deal to­tal on every pro­gram they opt­ed for.

Tyler Jacks Jacks Lab

Dean Li, the head of dis­cov­ery at Mer­ck Re­search Labs, says the phar­ma gi­ant sees this deal as an op­por­tu­ni­ty to do some­thing brand new in RNA splic­ing, with a plan to go af­ter some cur­rent­ly un­drug­gable goals. (And no, he didn’t say which ones.)

Haney, a doc­u­men­tary film­mak­er and busy biotech en­tre­pre­neur, placed a heavy em­pha­sis on grow­ing the com­pa­ny with deal cash since he and the in­sid­ers at the com­pa­ny put up $8 mil­lion in seed mon­ey at the be­gin­ning of 2018. And while Sky­hawk wasn’t the first of the group of star­tups to un­veil plans to dis­cov­er small mol­e­cules that could be used to drug RNA, they’ve come up with the most im­pres­sive ros­ter of al­liances in the field.

Tai Wong Linkedin

Haney al­so runs Drag­on­fly, which in­cludes Tyler Jacks at MIT — a mar­quee sci­en­tist in the on­col­o­gy world — as one of the co-founders. Af­ter serv­ing as an un­of­fi­cial ad­vis­er at Sky­hawk for some time now, Jacks has now for­mal­ly ac­cept­ed the role of head of the sci­en­tif­ic ad­vi­so­ry board at the com­pa­ny, which has built up a staff of 40 in Cam­bridge with a full-time equiv­a­len­cy group of 120. 

Sky­hawk has been grow­ing fast, but Haney says it’s al­so been run­ning at a de­lib­er­ate speed. The team pur­pose­ful­ly held back on open­ing up talks on the on­col­o­gy front un­til last Jan­u­ary’s JP Mor­gan con­fab. Can­cer is where the in-house pro­gram is fo­cused, with 2 pro­grams set to en­ter the clin­ic near-term. And now that they are div­ing deep­er in­to can­cer with some plans to ex­plore vir­gin ter­ri­to­ry in R&D, he’s brought in Bris­tol-My­ers vet Tai Wong as VP of on­col­o­gy bi­ol­o­gy. Wong spent 19 years at Bris­tol run­ning the on­col­o­gy drug dis­cov­ery unit. Then he jumped to Pelo­ton, which was ac­quired by Mer­ck for $2.2 bil­lion.

It’s a small world.

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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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.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

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.

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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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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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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