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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.

Leonard Schleifer (AP Images)

Re­gen­eron adds more pos­i­tive PhI­II da­ta for its NGF pro­gram — but safe­ty is still a big con­cern

Two years after fasinumab hit its first late-stage bar, Regeneron is standing by its “high-risk, high reward” bet on the NGF antibody. But while new Phase III data solidified the potential reward, the risk is still threatening to blow it all up.

Regeneron execs and analysts alike now have their eyes set on a rival drug from Pfizer and Eli Lilly, whose fate at the FDA will likely set the scene for the class.