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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,100+ biopharma pros reading Endpoints daily — and it's free.

Lon­za hits the ex­it on gel and liq­uid cap­sules, of­fload­ing 2 pro­duc­tion sites to NextPhar­ma

With the contract manufacturing market on a hot streak with the Covid-19 vaccine rollout, Lonza has opened its war chest in recent months for a suite of expansions. But now, with its focus elsewhere, the company is looking to contract its capsule offerings for pharma.

The CDMO giant will offload its lipid capsule production sites in Ploërmel, France, and Edinburgh, UK, as part of a plan to exit the pharmaceutical capsules space while maintaining its market foothold in consumer health and nutrition, the company said Tuesday.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,100+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,100+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.