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.”

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.