Play­ing the long game in I/O, J&J inks $1.04B deal to buy on­colyt­ic virus plat­form biotech BeneVir

J&J $JNJ is bring­ing a low-pro­file biotech — and some ear­ly-stage on­colyt­ic virus­es — in­to its fold, ce­ment­ing its im­muno-on­col­o­gy pipeline with some nascent tech­nolo­gies that it be­lieves will be trans­for­ma­tion­al.

Matt Mul­vey

Janssen, J&J’s biotech arm, is pay­ing $140 mil­lion up­front to ac­quire BeneVir in a deal that car­ries a string of ad­di­tion­al mile­stone pay­ments up to $900 mil­lion. Though the on­colyt­ic virus­es it just bagged are still pre­clin­i­cal can­di­dates, look­ing down the road, Janssen be­lieves they can treat sol­id tu­mor can­cers both as stand­alone ther­a­pies and in com­bos.

At the core of BeneVir is the T-Stealth plat­form, which it says makes virus­es that can at once in­fect and kill can­cer cells, evade de­tec­tion by im­mune T cells (so they have more time to spread), and help ac­ti­vate T cells against anti­gen-pre­sent­ing can­cer cells. The goal, ac­cord­ing to CEO Matt Mul­vey, is to reach pa­tients who do not re­spond to check­point in­hibitors.

Pe­ter Lebowitz

“On­colyt­ic vi­ral im­munother­a­py holds ex­cit­ing po­ten­tial in the treat­ment of sol­id tu­mors through the prim­ing and aug­ment­ing of an an­ti-tu­mor im­mune re­sponse,” said Pe­ter Lebowitz, Janssen’s head of on­col­o­gy, in a state­ment. “BeneVir’s unique tech­nol­o­gy plat­form com­ple­ments our im­muno-on­col­o­gy re­search, which is fo­cused on bring­ing for­ward an ar­ray of nov­el im­munother­a­pies and com­bi­na­tions that may im­prove treat­ment out­comes for pa­tients.”

Ian Mohr

Set to be­come a part of the Janssen On­col­o­gy Ther­a­peu­tic Area, BeneVir will main­tain a re­search pres­ence in Rockville, MD, where it has been based since found­ed in 2011. The team will stay on its orig­i­nal track to op­ti­mize the next gen­er­a­tion of T-Stealth on­colyt­ic virus­es and ex­e­cute oth­er pre­clin­i­cal ac­tiv­i­ties.

Found­ed on re­search com­ing out of NYU re­searcher Ian Mohr’s lab, BeneVir first got go­ing with a non­tra­di­tion­al fund­ing source: Pansend, a HC2 Hold­ings sub­sidiary that had fo­cused on med­ical de­vice in­vest­ments.

The deal marks the lat­est in a sud­den flur­ry of ac­tiv­i­ty for Lebowitz, who re­cent­ly arranged a $350 mil­lion cash pact to part­ner with Leg­end Biotech to de­vel­op its BC­MA-tar­get­ing CAR-T LCAR-B38M for mul­ti­ple myelo­ma. J&J has had some no­table suc­cess­es in the can­cer R&D field, but it’s been an al­so-ran in the I/O cat­e­go­ry. Go­ing af­ter these deals now in­di­cates that the phar­ma gi­ant ex­pects it can still make a splash in a field with a mul­ti­tude of ri­vals. That won’t be easy, but J&J is hard to ig­nore when the com­pa­ny pur­sues a strat­e­gy.

The deal is sched­uled to close this quar­ter.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.