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.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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