Jean-François Pariseau (left) and Dion Madsen (Amplitude)

Am­pli­tude rais­es $50M to fu­el ‘emerg­ing’ Cana­di­an biotech field

Nine months and an IPO since they spun out the Busi­ness De­vel­op­ment Bank of Cana­da’s health­care arm in­to its own VC, the in­vestors be­hind Am­pli­tude have raised an­oth­er $50 mil­lion to pour in­to Cana­da’s nascent biotech sec­tor.

The new round, part of the CAD $200 mil­lion the firm is try­ing to raise for its first fund, will go pri­mar­i­ly to­ward two ar­eas: what founders Jean-François Pariseau and Dion Mad­sen see as an “emerg­ing” tar­get­ed and cell ther­a­py field in Van­cou­ver and an emerg­ing ar­ti­fi­cial in­tel­li­gence field in Mon­tre­al. Sim­i­lar to some of the big­ger name VCs to their south, the part­ners will try to find promis­ing sci­ence out of aca­d­e­m­ic and in­no­va­tion cen­ters in the two metro ar­eas, pack­age them with some com­ple­men­tary and de-risk­ing in­tel­lec­tu­al prop­er­ty and some new tal­ent, and spin out biotechs.

”There are clus­ters emerg­ing in Cana­da around tar­get­ed and cel­lu­lar ther­a­py in Van­cou­ver and around AI in Toron­to or Mon­tre­al, and those would be ar­eas where we would” in­vest, Mad­sen told End­points News. “Typ­i­cal­ly, we’re look­ing for re­al­ly sig­nif­i­cant in­no­va­tions.”

Around 30% of the fund will al­so go to lat­er-stage medtech com­pa­nies.

As proof for the mod­el, Am­pli­tude is now tout­ing the suc­cess of the syn­thet­ic lethal­i­ty com­pa­ny Re­pare Ther­a­peu­tics, which in June raised $220 mil­lion in one of the largest IPOs in Cana­di­an biotech his­to­ry. It’s a bit of a bold claim, though, giv­en that Am­pli­tude — then still un­der the aus­pices of the BDAC — was just one of sev­er­al in­vestors in the Ver­sant-launched com­pa­ny’s Se­ries B last year, and that the biotech’s pub­lic of­fer­ing came as part of an un­prece­dent­ed biotech stock mar­ket boom.

Still, for Mad­sen and Pariseau, it’s val­i­da­tion that there is bil­lion-dol­lar sci­ence to be found in Cana­da for those who know how to build it.

Per­haps the most promi­nent ex­am­ple of that has come in the past few months in the form of a dif­fer­ent com­pa­ny, Ab­Cellera. Long a lit­tle-known play­er that helped gov­ern­ments, biotechs and Big Phar­ma build an­ti­bod­ies, the com­pa­ny emerged at the front of the Covid-19 treat­ment hunt af­ter they signed a part­ner­ship with Eli Lil­ly in March to de­vel­op neu­tral­iz­ing an­ti­bod­ies for the coro­n­avirus. They lat­er emerged as the first com­pa­ny to bring a neu­tral­iz­ing an­ti­body in­to the clin­ic, and they se­cured a $105 mil­lion Se­ries B from a hand­ful of big name in­vestors on the way.

Mad­sen said they had been watch­ing Ab­Cellera since 2013, short­ly af­ter its launch, en­cour­ag­ing them to de­vel­op their own com­pounds. They put in of­fers for both last year’s Se­ries A, but they were still in for­ma­tion at the time and Ab­Cellera took an of­fer from DCVC. They were one of many to put in an of­fer for the Se­ries B.

”We were out­bid,” he said.

When it comes to AI com­pa­nies, the firm will fo­cus on those that look a bit more like the biotechs that have their own wet labs and de­vel­op­ment pipelines, such as Daphne Koller’s In­sitro, than the ones that just use ad­vance al­go­rithms to search out mol­e­cules, such as Atom­wise. The first ex­am­ple of that, Mad­sen said, was Deep Ge­nomics. They joined a $40 mil­lion Se­ries B for the biotech in Jan­u­ary.

“I think AI is be­com­ing more and more gen­er­a­tive as a tech­nol­o­gy, and more wide­ly used. To me, it’s kind of the next evo­lu­tion,” Pariseau told End­points. “And it’s al­so cheap­er.”

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.