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.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,300+ biopharma pros reading Endpoints daily — and it's free.