Boehringer In­gel­heim joins the crowd and goes all-in on on­colyt­ic virus­es, buy­ing Vi­raTher­a­peu­tics in $244M deal

Boehringer In­gel­heim de­cid­ed 3 years ago it that would take an ac­tive role in fos­ter­ing the on­colyt­ics virus biotech Vi­raTher­a­peu­tics. 

The Ger­man com­pa­ny’s ven­ture arm in­vest­ed in the fledg­ling’s biotech’s tiny $4 mil­lion A round in the sum­mer of 2015. BI ex­ecs came back with a $230 mil­lion dis­cov­ery deal — build­ing in a buy­out op­tion — and then added a sec­ond pro­gram. And this morn­ing they’re go­ing all in, buy­ing the com­pa­ny in a deal val­ued at $244 mil­lion.

BI is keep­ing the com­pa­ny — a spin­out of Aus­tria’s Med­ical Uni­ver­si­ty of Inns­bruck — right where it is, adding the group and the re­gion­al con­nec­tions they have on cam­pus as a sub­sidiary as they look to jump in­to the clin­ic with a lead pro­gram.

Heinz Schw­er

Boehringer first tied up with Vi­raTher­a­peu­tics just months ahead of Am­gen’s land­mark ap­proval of T-Vec, the world’s first mar­ket­ed on­colyt­ic virus. And since then the field has ex­plod­ed with new re­search projects as dozens of new play­ers brewed up to beat the pi­o­neer.

Ear­li­er this year J&J ex­e­cut­ed one of its clas­sic bil­lion-dol­lar deals to buy BeneVir. Mer­ck’s R&D chief Roger Perl­mut­ter — who steered the T-Vec deal at Am­gen — bagged Vi­r­a­lyt­ics for $394 mil­lion. A re­cent study from the Can­cer Re­search In­sti­tute found 69 OVs in clin­i­cal de­vel­op­ment and an­oth­er 95 in a pre­clin­i­cal pro­gram.

What’s the big deal?

On­colyt­ic virus­es are the Tro­jan horse of im­muno-on­col­o­gy. The virus­es are de­signed to in­fect can­cer cells, in­vad­ing the dis­ease, and then ex­plod­ing them, which sub­se­quent­ly sig­nals the im­mune sys­tem to mount an at­tack on the sur­vivors. There’s a clear clin­i­cal track record show­ing how they work. And now a host of ri­vals like PsiOxus and many, many oth­ers be­lieve that sys­temic ad­min­is­tra­tion will do a bet­ter job. 

Vi­raTher­a­peu­tics ex­ecs — led by Mor­phoSys vet Heinz Schw­er — have al­so been busy en­gi­neer­ing an OV ther­a­py that they be­lieve can do a bet­ter job of ini­tial­ly evad­ing de­tec­tion by the im­mune sys­tem, avoid­ing trig­ger­ing any an­ti­bod­ies and the­o­ret­i­cal­ly mak­ing it pos­si­ble to do re­peat ad­min­is­tra­tions.

Not sur­pris­ing­ly, BI al­so plans to whip up a pipeline of com­bi­na­tion ap­proach­es, arm­ing their OV with can­cer drugs that can both amp up the im­mune sys­tem at­tack and charge di­rect­ly at can­cer cells.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.