AlloVir rides IPO boom on first mar­ket day, soars af­ter bag­ging $276 mil­lion

Mass­a­chu­setts-based AlloVir hit Wall Street Thurs­day, join­ing the ranks of drug mak­ers to strike big in the 2020 IPO boom.

The biotech’s 16.3 mil­lion shares priced at $17 each — the mid­point of a $16 to $18 range — earn­ing $276 mil­lion. AlloVir, which sur­vived on most­ly grant mon­ey and was known as Vira­Cyte un­til last year, ini­tial­ly reg­is­tered for a $100 mil­lion IPO on Ju­ly 6. But in the foot­steps of oth­er phar­mas go­ing pub­lic for the first time this year, it up­sized by 1.5 mil­lion shares.

Shares $ALVR kept ris­ing through­out the day, clos­ing up 49.35% at $25.39.

Many have ben­e­fit­ed from the “his­toric” boom, in­clud­ing a col­lec­tive $772 mil­lion-plus haul last week by iTeos, Nurix, An­nex­on and In­ozyme, all of which priced at the high end or above their ex­pect­ed ranges.

The first signs of a boom ap­peared in Jan­u­ary, then gave way to a slow­er pe­ri­od as a re­sult of the Covid-19 pan­dem­ic. But a resur­gence is un­der­way — by June, all 23 new­ly pub­lic com­pa­nies priced above their mid­point or up­sized their of­fer­ing. SPACs (spe­cial pur­pose ac­qui­si­tion com­pa­nies) al­so played a part; they now rep­re­sent near­ly 35% of list­ings, as op­posed to 3% in 2014, the Nas­daq’s Jay Heller told End­points ear­li­er this month.

AlloVir launched from the Bay­lor Col­lege of Med­i­cine’s Cen­ter for Cell and Gene Ther­a­py in 2013, and was tapped by David Hal­lal last year to be El­e­vate­Bio’s first port­fo­lio com­pa­ny. The deal meant a $120 mil­lion round of fund­ing for AlloVir’s late-stage drug de­vel­op­ment.

Hal­lal owned 28.39%  of shares af­ter the of­fer­ing, ac­cord­ing to AlloVir’s S-1/A fil­ing. Vikas Sin­ha, Ans­bert Gadicke and Morana Jo­van-Em­biri­cos, all on El­e­vate­Bio’s board of di­rec­tors, owned 23.26%, 21.99%  and 25.36% re­spec­tive­ly.

The com­pa­ny will use its IPO funds to ad­vance its al­lo­gene­ic T cell ther­a­pies for treat­ing vi­ral dis­eases. Its cur­rent pro­grams span 12 dif­fer­ent virus­es, but the lead can­di­date, Vi­ra­lym-M, tar­gets BK virus, cy­tomegalovirus, ade­n­ovirus, Ep­stein-Barr virus, and hu­man her­pesvirus. The com­pa­ny has three Phase III piv­otal tri­als and three Phase II proof-of-con­cept tri­als for use of Vi­ra­lym-M in pe­di­atric and adult pa­tients planned for 2020 and 2021.

In a Phase II proof-of-con­cept tri­al of Vi­ra­lym-M in­clud­ing 58 par­tic­i­pants, 93% of stem cell trans­plant pa­tients who were in­fect­ed with tar­get virus­es showed a “clin­i­cal re­sponse,” ac­cord­ing to the S-1. The drug earned pri­or­i­ty med­i­cines (PRIME) des­ig­na­tion by the EMA to treat in­fec­tions caused by tar­get­ed virus­es in HSCT pa­tients, and re­gen­er­a­tive med­i­cine ad­vanced ther­a­py (RMAT) des­ig­na­tion by the FDA to treat he­m­or­rhag­ic cys­ti­tis caused by BKV in adults and chil­dren.

“While these des­ig­na­tions may not lead to a faster de­vel­op­ment process and do not in­crease the like­li­hood that a prod­uct can­di­date will re­ceive ap­proval from the FDA or EMA, we ex­pect that PRIME and RMAT des­ig­na­tions will re­sult in in­creased EMA and FDA in­ter­ac­tions to sup­port our de­vel­op­ment ef­forts and may en­able an ex­pe­dit­ed reg­u­la­to­ry re­view process,” AlloVir’s S-1 fil­ing states.

Oth­er drugs in the pipeline in­clude ALVR106 to treat res­pi­ra­to­ry syn­cy­tial virus, in­fluen­za, pelvic in­flam­ma­to­ry dis­ease and hu­man metap­neu­movirus; ALVR107 to treat he­pati­tis B; ALVR108 to treat hu­man her­pesvirus-8; and ALVR109 to treat SARS-CoV-2. AlloVir’s mech­a­nisms in­clude what CSO Ann Leen has called “an im­mune sys­tem in a dish”: virus-spe­cif­ic T cells from blood donors that are used to re­store im­mu­ni­ty in those with T cell de­fi­cien­cies.

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.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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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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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

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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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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