Tillman Gerngross, Adagio Therapeutics CEO

GV steps up to back Till­man Gern­gross’ new an­ti­body play against Covid-19 — and he’s al­ready think­ing about the IPO

Till­man Gern­gross had two good rea­sons to cel­e­brate on Mon­day.

First, he felt that Pfiz­er’s up­beat as­sess­ment of its piv­otal Covid-19 vac­cine da­ta marked an un­prece­dent­ed break­through in the speed of vac­cine de­vel­op­ment and a “big day” for sci­ence as a whole.

Sec­ond, he was ready to of­fer me a pre­view of an $80 mil­lion round de­signed to pro­pel his new biotech start­up — Ada­gio Ther­a­peu­tics — to­ward an IPO next year as it ramps up what he be­lieves can be a con­tender for the most pow­er­ful an­ti­body avail­able to com­bat a virus that has re­peat­ed­ly rat­tled the globe with waves of ris­ing in­fec­tion and death rates.

Gern­gross may not be the first an­ti­body de­vel­op­er to jump in­to the fray, or the sec­ond, but he still has char­ac­ter­is­ti­cal­ly large am­bi­tions for his first mol­e­cule, which is be­ing prepped for the clin­ic in Jan­u­ary as his team read­ies tri­als both as a pro­phy­lax­is to pre­vent in­fec­tion as well as a ther­a­py.

This time, he not on­ly brought to­geth­er his ex­ist­ing team of ven­ture back­ers — Po­laris Part­ners, Mithril Cap­i­tal, Fi­deli­ty Man­age­ment  & Re­search Com­pa­ny, and Or­biMed — he added Kr­ish­na Yesh­want at Google’s GV as the lead in­vestor along with Pop­u­la­tion Health Part­ners and Omega Funds.

The plan now, he tells me, is to move on from this fi­nanc­ing round to an­oth­er quick-step raise ear­ly next year “and then prob­a­bly take the com­pa­ny pub­lic.”

There’s a longterm plan, he says, but right now the fo­cus is all on Covid-19 and the pan­dem­ic up­on us. The IND is on sched­ule to ar­rive in De­cem­ber. The Phase I can run in Jan­u­ary, with Phase II ini­ti­a­tion in Feb­ru­ary and piv­otal da­ta be­fore the end of 2021.

“I think this is a big day for sci­ence,” the sci­en­tist told me hours af­ter the Pfiz­er pro­nounce­ment hit. “With­in less than a year we have some ef­fi­ca­cy da­ta in hu­mans; this is un­prece­dent­ed.” It took longer than that to fig­ure out what caused AIDS.

But while Mon­day’s piv­otal re­lease ahead of safe­ty da­ta marked a ma­jor ad­vance, Till­man — like most oth­ers in the now crowd­ed field of pan­dem­ic R&D — sees op­por­tu­ni­ties for more and bet­ter.

“The ques­tion marks that I have, and we’ve seen it from Pfiz­er’s own da­ta, is that the neu­tral­iz­ing an­ti­body titers wane very quick­ly,” he adds. “How that plays out in terms of du­ra­tion of re­sponse, we just don’t know.”

On the an­ti­body side, mean­while, two of the lead­ers — Eli Lil­ly and Re­gen­eron — have both had to deal with de­flat­ed ex­pec­ta­tions af­ter run­ning in­to weak re­spons­es, par­tic­u­lar­ly among the most se­vere pa­tients. That didn’t sur­prise Gern­gross, who al­ready de­cid­ed to forego that test.

Look­ing past the pan­dem­ic, Gern­gross’s back­ers are in­trigued by Ada­gio’s work re­lat­ed to “a high­ly con­served epi­tope on the spike pro­tein of be­ta-coro­n­avirus­es that tar­get hu­man ACE2,” a tar­get they be­lieve can play a role in fight­ing new virus­es as they mu­tate and emerge — a hot top­ic in the new­ly re­vived field of pan­dem­ic pre­pared­ness.

“There’s a lot more work to be done,” says Gern­gross, who’s hired a team ap­proach­ing the 40 mark with plans for lots more re­cruit­ing to come. “We’re go­ing to see some re­al trac­tion over the next year.”

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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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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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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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.

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.