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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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