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-6. 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, parain­fluen­za virus 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.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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