Left to right: AbCellera head of BD Kevin Heyries, CEO Carl Hansen, COO Véronique Lecault, head of corporate development Murray McCutcheon

Ab­Cellera rais­es $105M in first ma­jor ven­ture round as Covid-19 an­ti­body nears clin­ic

Over its first decade of ex­is­tence, Ab­Cellera had many things: A new tech­nol­o­gy with sci-fi vibes, fund­ing from the Bill & Melin­da Gates Foun­da­tion, gov­ern­ment con­tracts, part­ner­ships with large phar­ma com­pa­nies and biotechs, a re­search fa­cil­i­ty in Van­cou­ver with dozens and then even­tu­al­ly over a hun­dred em­ploy­ees. Even, most re­cent­ly, a lead­ing ex­per­i­men­tal Covid-19 treat­ment.

They just didn’t have what al­most every biotech did: streams of ven­ture cash.

That’s chang­ing to­day. Ab­Cellera has an­nounced a $105 mil­lion Se­ries B round, led by Or­biMed and DCVC. The in­flux is more than 10 times the com­pa­ny’s 2018 Se­ries A: a $10 mil­lion round that came af­ter years of self-fund­ing through part­ner­ships. It will go to­ward adding more than 100 em­ploy­ees to the cur­rent 140-per­son staff, the com­ple­tion of a sprawl­ing new R&D fa­cil­i­ty next year and, even­tu­al­ly, its own man­u­fac­tur­ing fa­cil­i­ty.

“It’s been quite a re­mark­able path to get here,” CEO Carl Hansen told End­points News. It “is quite a shift in strat­e­gy now in think­ing of a large fi­nanc­ing, which is re­flec­tive of our be­lief that there’s a huge op­por­tu­ni­ty and that cap­i­tal be­ing de­ployed in build­ing and in­te­grat­ing tech­nolo­gies, in build­ing ca­pac­i­ty, should be com­men­su­rate with that op­por­tu­ni­ty.

“We’re sort of chang­ing our pos­ture,” he added. “It’s now a pos­ture of ag­gres­sive growth.”

The fi­nanc­ing round comes af­ter Ab­Cellera has emerged from rel­a­tive anonymi­ty to be­come one of the most-watched de­vel­op­ers of Covid-19 treat­ments, writ­ten up in Busi­ness­week and MIT Tech­nol­o­gy Re­view. Their lab-on-a-chip de­vice, based on work Hansen had done at the Uni­ver­si­ty of British Co­lum­bia, iso­lates an­ti­body-pro­duc­ing cells from blood sam­ples and us­es ma­chine learn­ing to iso­late the best ones. They ob­tained a blood sam­ple from a Covid-19 sur­vivor in Feb­ru­ary, be­gan a part­ner­ship with Eli Lil­ly the next month, and the phar­ma gi­ant is plan­ning to file an IND for their lead an­ti­body by the end of the month — one of three com­pa­nies, along­side Vir and Re­gen­eron, on sim­i­lar clin­i­cal paths. Al­though not a vac­cine, an­ti­bod­ies have been used to ef­fec­tive­ly treat or, for a short pe­ri­od, pre­vent oth­er in­fec­tious dis­eases such as Ebo­la and RSV.

Ab­Cellera, though, had al­ready pro­vid­ed that “lab-on-a-chip” tech­nol­o­gy to nu­mer­ous oth­er com­pa­nies who had sci­en­tif­i­cal­ly de­fined tar­gets but want­ed Ab­Cellera’s ex­per­tise in se­lect­ing an­ti­bod­ies — they cite 55 dif­fer­ent “com­plet­ed pro­grams,” and have worked with Gilead, Pfiz­er, Glax­o­SmithK­line, Mer­ck, No­var­tis and the US De­part­ment of De­fense — and Hansen said the fi­nanc­ing had been un­der dis­cus­sions since the fall. Covid-19 changed lit­tle, ex­cept to pro­vide the same head­winds that have buf­fet­ed biotech: They’ve shuf­fled shifts and hours, even as they de­vot­ed much of their staff to an all-out ef­fort to de­vel­op a treat­ment.

“If any­thing Covid-19 is a time-com­pressed ex­am­ple of what we’ve built the com­pa­ny to do,” Hansen said. “To look at a sit­u­a­tion where there’s an ur­gent need for a ther­a­peu­tic and bring a tech­nol­o­gy to ac­cel­er­ate that.”

The Se­ries B (which al­so fea­tured Viking Glob­al In­vestors, Pe­ter Thiel, Founders Fund, Eli Lil­ly, Uni­ver­si­ty of Min­neso­ta, and Pre­sight Cap­i­tal) will ex­pand their re­search ca­pac­i­ty to reach what Hansen said has been a long-run­ning rise in in­ter­est from oth­er com­pa­nies who want to part­ner with them. On top of tack­ling more pre­clin­i­cal projects, they’ll even­tu­al­ly be able to man­u­fac­ture an­ti­bod­ies through Phase II.

There are no plans, though, to bring their own drugs to mar­ket. Hansen is stick­ing with his bread and but­ter.

“The whole the­sis of the com­pa­ny is that we’re a tech­nol­o­gy and not a biotech,” he said. “We are not go­ing to change.”

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.