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.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.