Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As sev­er­al Big Phar­ma play­ers se­cure biotech part­ners in the on­colyt­ic virus space for new im­muno-on­col­o­gy com­bos, Cowen and Per­cep­tive Ad­vi­sors have come out with their own bet on a start­up that promis­es to shine.

The mar­quee in­vestors are join­ing MPM, Deer­field, Cel­gene, Astel­las, Arkin Bio Ven­tures and UBS On­col­o­gy Im­pact Fund in back­ing the drug de­vel­op­er, On­corus, which will now de­ploy the $79.5 mil­lion in Se­ries B cash to­ward clin­i­cal de­vel­op­ment of its lead pro­gram. Oth­er new in­vestors in­clude Sur­vey­or Cap­i­tal, Sphera Funds, IMM In­vest­ment, QUAD In­vest­ment Man­age­ment, UTC In­vest­ment, SV In­vest­ment Corp and Shin­han In­vest­ment-Pri­vate Eq­ui­ty, the last five of which are Ko­re­an-based funds.

“Not all on­colyt­ic virus­es are the same and I think the in­vestors that came in­to this round clear­ly saw that we were much dif­fer­ent than oth­ers that are out there,” CEO Ted Ash­burn said.

It’s a good time to be work­ing on on­colyt­ic virus, he adds, as the in­dus­try has come to ap­pre­ci­ate its mul­ti­fold mech­a­nism of ac­tion. Not on­ly does an on­colyt­ic vi­ral in­fec­tion cause the tu­mor cell to dis­in­te­grate, the break­down it­self al­so re­leas­es anti­gens — and neoanti­gens — that in­duce an im­mune at­tack on can­cer.

Mitchell Fin­er

On­corus is de­vel­op­ing two tech plat­forms, each ad­dress­ing dif­fer­ent short­com­ings of cur­rent ap­proach­es: The first is an “armed” her­pes sim­plex virus that car­ries five trans­genes, in­clud­ing IL-12, CCL4, FLT3L and the well-known check­points CT­LA-4 and PD-L1, aimed at stim­u­lat­ing an im­mune re­sponse. The sec­ond is a syn­thet­ic virus com­posed of polynu­cleotides that en­code for on­colyt­ic virus­es en­cap­su­lat­ed with­in lipid nanopar­ti­cles.

Bris­tol-My­ers Squibb has shown in­ter­est in the “armed” ap­proach, dish­ing out $50 mil­lion up­front and promis­ing $886 mil­lion in mile­stones for PsiOxus to ex­plore the ap­proach, where the ther­a­py es­sen­tial­ly changes the phe­no­type of the tu­mor cell.

That was in 2016, just a few months af­ter On­corus got start­ed. In ad­di­tion to an “un­par­al­leled pay­load ca­pac­i­ty,” its HSV-based ON­CR-177 is al­so su­pe­ri­or in bal­anc­ing safe­ty and po­ten­cy, ac­cord­ing to Ash­burn.

Most of their com­peti­tors, he ex­plained, at­ten­u­ate their virus­es in or­der to pre­vent in­fect­ing nor­mal tis­sues. But with a mi­croR­NA tech­nique li­censed from the Uni­ver­si­ty of Pitts­burgh, On­corus are able to se­lec­tive­ly tune down the vi­ral ac­tiv­i­ty in healthy cells while al­low­ing the virus to repli­cate in full force with­in tu­mor cells.

“This is re­al­ly meant to be the de­fin­i­tive in­tra­tu­moral agent,” said Ash­burn, who jumped from Mod­er­na’s on­col­o­gy pro­gram to take the top job at On­corus.

Along with a team of 35, he’s look­ing to steer the pro­gram in­to the clin­ic ear­ly next year, start­ing with car­ci­no­ma of the head and neck, skin can­cer, liv­er metas­tases and breast can­cer. These ini­tial in­di­ca­tions are most sus­cep­ti­ble to HSV, read­i­ly in­jectable and cap­ture the largest mar­ket op­por­tu­ni­ties, he not­ed.

Af­ter that, On­corus al­so plans to nom­i­nate a can­di­date from its syn­thet­ic virus plat­form, which will be ad­min­is­tered in­tra­venous­ly — an at­trac­tive op­tion for lung can­cer where in­tra­tu­moral ad­min­is­tra­tion can be dan­ger­ous, or in cas­es where tu­mors are spread out. While pre­vi­ous at­tempts at dos­ing on­colyt­ic virus­es re­peat­ed­ly have been thwart­ed by neu­tral­iz­ing an­ti­bod­ies, Ash­burn said their syn­thet­ic virus, which car­ries polynu­cleotides and not pro­teins, ap­pears to suc­ceed in caus­ing an in­fec­tion in an­i­mal mod­els.

While they are fo­cused on ad­vanc­ing the in-house pro­grams with the avail­able funds, Ash­burn added the usu­al open­ness ap­plies to part­ner­ships or an IPO.

The new round is al­so bring­ing new di­rec­tors to the com­pa­ny. Robert Kirk­man, ex-CEO of On­cothyre­on, and Spencer Nam of KSV Glob­al are join­ing the board, which is chaired by co-founder and MPM part­ner Mitchell Fin­er.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.