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.

Brian Kaspar. AveXis via Twitter

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Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

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Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

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Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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