CEO Shawn Leland (Elevation)

El­e­va­tion On­col­o­gy bags $65M to push failed Mer­ri­mack drug through PhII

Shawn Le­land hadn’t even heard of NRG1 as an on­col­o­gy tar­get un­til he was sit­ting in a pre­sen­ta­tion at ES­MO 2018 in Mu­nich. Alex Drilon, an on­col­o­gist at the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter in New York, was pre­sent­ing on tar­get­ed ther­a­pies for lung can­cer — and Le­land was en­thralled.

“He put up one slide with­in that pre­sen­ta­tion that de­scribed the tar­get of NRG1 gene fu­sion and the fact that they were po­ten­tial­ly drug­gable with a HER3 mon­o­clon­al an­ti­body ap­proach,” Le­land said.

The wheels be­gan turn­ing. Af­ter the pre­sen­ta­tion, he pulled a bunch of lit­er­a­ture on NRG1 fu­sion and be­gan re­search­ing.

In Ju­ly, Le­land un­veiled a start­up, El­e­va­tion On­col­o­gy, with a $32.5 mil­lion Se­ries A round and a clin­i­cal can­di­date for sol­id tu­mors with NRG1 ge­nom­ic fu­sion. And on Wednes­day, he land­ed a $65 mil­lion Se­ries B to com­plete en­roll­ment in the can­di­date’s Phase II tri­al, and a pro­mo­tion. Le­land’s tak­ing over from in­ter­im CEO Steve Elms, who will re­main chair of El­e­va­tion’s board of di­rec­tors. And Drilon, who in­spired Le­land at ES­MO, is on the biotech’s sci­en­tif­ic ad­vi­so­ry board.

“There is this unique abil­i­ty to go out and get a li­cense or ac­quire a HER3 mon­o­clon­al an­ti­body and re­pur­pose it for this ge­net­i­cal­ly de­fined pa­tient pop­u­la­tion, where a HER3 mon­o­clon­al an­ti­body ap­proach was very much tai­lored to the dis­ease bi­ol­o­gy,” Le­land said.

The biotech ac­quired its lead can­di­date, Mer­ri­mack’s high-pro­file serib­an­tum­ab, last year for up to $58 mil­lion. The drug pre­vi­ous­ly flunked a Phase II tri­al eval­u­at­ing its ef­fi­ca­cy in non-small cell lung can­cer in com­bi­na­tion with do­c­etax­el — but un­like Mer­ri­mack, El­e­va­tion isn’t fo­cused on HER3 am­pli­fi­ca­tions and over­ex­pres­sion. It’s tar­get­ing that NRG1 fu­sion, which Le­land says is more ac­tive in dri­ving tu­mor growth.

“If you’re able to iden­ti­fy … these NRG1 gene fu­sions, it’s high­ly un­like­ly that they have an­oth­er ge­nom­ic aber­ra­tion that may be lead­ing to the growth of their can­cer,” Le­land said.

Mer­ri­mack’s serib­an­tum­ab flop was one of sev­er­al for the com­pa­ny. Af­ter the can­di­date and do­c­etax­el failed to show im­prove­ments in the pro­gres­sion-free sur­vival of NSCLC pa­tients com­pared to do­c­etax­el treat­ments alone, the biotech added it to the scrap heap and slashed 60% of its staff. Last Ju­ly, the com­pa­ny’s ex­ec­u­tives fled the scene.

Le­land is now hop­ing to turn around an ac­cel­er­at­ed ap­proval for serib­an­tum­ab with re­sults from the biotech’s open-la­bel Phase II CRE­STONE study. The Se­ries B will be used to fin­ish en­rolling a to­tal of 75 pa­tients across three co­horts.

The round was led by Cor­morant As­set Man­age­ment, ven­Bio Part­ners, with help from a slate of new and old in­vestors in­clud­ing: Box­er Cap­i­tal of Tavi­s­tock Group, Janus Hen­der­son, Sam­sara Bio­cap­i­tal, and Vi­vo Cap­i­tal, Ais­ling Cap­i­tal, Ver­tex Ven­tures, Qim­ing Ven­ture Part­ners USA, Driehaus Cap­i­tal Man­age­ment, and BVF Part­ners. Back-to-back rais­es and in­volve­ment from Cor­morant, which is known as a crossover play­er, would typ­i­cal­ly in­di­cate an IPO is on the way. But El­e­va­tion re­spond­ed:

A fu­ture IPO is a pos­si­bil­i­ty, al­though the Com­pa­ny has no im­me­di­ate plans to file. The Se­ries B po­si­tions the Com­pa­ny with a strong base of crossover in­vestors to sup­port a pub­lic list­ing if that is the most fa­vor­able route for ad­di­tion­al fund­ing, based on mar­ket con­di­tions at the time.

“There’s lim­it­ed to no op­tions for these pa­tients, and the abil­i­ty for them to get a ther­a­py on a clin­i­cal tri­al, with an agent like serib­an­tum­ab that’s unique­ly tai­lored to this dis­ease bi­ol­o­gy as­so­ci­at­ed with the NRG1 fu­sion, we be­lieve is key,” Le­land said. “I think it’s one of those tar­gets that, you know, caught a lot of at­ten­tion as of late, but up un­til prob­a­bly the past 12 to 24 months pri­or to that, there was very lit­tle known about NRG1.”

El­e­va­tion faces com­pe­ti­tion from Rain Ther­a­peu­tics’ tar­lox­o­tinib and Merus’ MCLA-128, both of which are al­so in Phase II. The race is tight, but Le­land ex­pects to read out in­ter­im da­ta by mid-2021.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

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