David Hallal

AlloVir tests how much an an­tivi­ral biotech can reap in a pan­dem­ic stock mar­ket

The pan­dem­ic stock mar­ket has proven fruit­ful for vir­tu­al­ly any type of biotech. Now a 7-year-old cell ther­a­py start­up will see how much it can yield for a com­pa­ny that spe­cial­izes in fight­ing virus­es.

AlloVir, a com­pa­ny that un­til 2019 large­ly lived off grant mon­ey, has filed for a $100 mil­lion IPO to back its line of off-the-shelf, virus-fight­ing T cells. Al­though in nor­mal cir­cum­stances, $100 mil­lion could be a sol­id re­turn for a biotech that got its first ma­jor round of fund­ing on­ly last year, we’ll have to wait to see how much the com­pa­ny ul­ti­mate­ly earns. As Covid-19 has sent in­vestor mon­ey scur­ry­ing to al­most any­one in drug de­vel­op­ment, every sin­gle biotech to go pub­lic this year has prized above their mid­point or up­sized their of­fer­ing, ac­cord­ing to Re­nais­sance Cap­i­tal, some­times dra­mat­i­cal­ly so.

Found­ed in 2013 out of Bay­lor Col­lege of Med­i­cine’s Cen­ter for Cell and Gene Ther­a­py, AlloVir emerged with a splash last year af­ter ex-Alex­ion chief David Hal­lal made it the first port­fo­lio com­pa­ny for El­e­vate­Bio, his start­up fo­cused on ac­cel­er­at­ing in­no­v­a­tive cell and gene ther­a­pies. Hal­lal led a $120 mil­lion round for the biotech and be­came its CEO.

Ann Leen

The idea be­hind AlloVir is to cre­ate what CSO Ann Leen has called “an im­mune sys­tem in a dish.” T cells are ex­tract­ed from healthy vol­un­teers, ex­pand­ed in the lab, and then giv­en to im­muno-com­pro­mised pa­tients to help them fend off in­fec­tions they would oth­er­wise not be able to. Their pro­grams span 12 dif­fer­ent virus­es, and their lead can­di­date Vi­ra­lym-M is meant to pro­tect against BK virus, cy­tomegalovirus, ade­n­ovirus, Ep­stein-Barr virus, and hu­man her­pesvirus.

The com­pa­ny has al­ready test­ed Vi­ra­lym-M in one tri­al on pa­tients who were im­mune-com­pro­mised from a stem cell trans­plant, and re­port­ed a “93% clin­i­cal re­sponse rate.” The IPO pro­ceeds will help push that drug through Phase II and Phase III.

It will al­so help ad­vance four oth­er can­di­dates for oth­er virus­es, in­clud­ing — be­cause no biotech with an­tivi­ral tech­nol­o­gy would be com­plete with­out one now — a SARS-CoV-2 pro­gram that is sup­posed to en­ter a proof-of-con­cept study lat­er this year.

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.

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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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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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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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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Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

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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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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