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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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