Burt Adelman. Novo Ventures

Here's a $25M seed fund aimed at back­ing some brash new drug ideas out of the Broad

As a for­mer aca­d­e­m­ic and a sea­soned drug de­vel­op­er, Burt Adel­man knew when he was re­cruit­ed as a se­nior ad­vi­sor to No­vo Ven­tures in 2017 that one of his key pri­or­i­ties needs to be in­tro­duc­ing the fund to the net­work he was so deeply em­bed­ded in.

“I was think­ing long and hard on how can I, as a Boston in­sid­er, help No­vo re­al­ly get in­side the ecosys­tem of Boston biotech?” he re­called in an in­ter­view with End­points News.

Is­si Rozen

No­vo Ven­tures, whose head­quar­ters is lo­cat­ed in a Dan­ish cam­pus that al­so hous­es No­vo Nordisk Foun­da­tion, had just re­cent­ly put its foot down in the city. De­spite its broad in­vest­ment man­date in life sci­ences and steady cash flow — it can in­vest any­where be­tween $400 mil­lion to $500 mil­lion per year — it didn’t have the con­nec­tions that oth­er, per­haps small­er, VCs in the area en­joyed. The per­ceived as­so­ci­a­tion with the di­a­betes drug­mak­er per­haps didn’t help, even though the two en­ti­ties are sep­a­rate­ly held by No­vo Hold­ings.

Adel­man found the an­swer while found­ing an­oth­er start­up, Verve Ther­a­peu­tics, with gene edit­ing tech out-li­censed from the Broad In­sti­tute. Catch­ing up with Broad chief busi­ness of­fi­cer Is­si Rozen, he re­al­ized that there was a press­ing need for fund­ing aca­d­e­m­ic projects that were too ad­vanced for NIH grants but not yet ma­ture enough for bio­phar­ma com­pa­nies to bet on.

The ex­plo­sion of new bi­o­log­i­cal con­cepts worth ex­plor­ing and new tar­gets worth val­i­dat­ing, Rozen said, al­so meant an op­por­tu­ni­ty for new part­ners — in ad­di­tion to its ex­ist­ing pacts with phar­ma and VCs like Deer­field — to step up.

“If you asked peo­ple 8 to 10 years ago what is an ide­al can­di­date to start talk­ing about ei­ther a ther­a­peu­tic dis­cov­ery to out-li­cense or start a com­pa­ny around, they would say 12 to 18 months from the clin­ic,” Rozen told End­points News. “Here we’re talk­ing about years be­fore the clin­ic. We’re re­al­ly shift­ing back.”

Scott Beard­s­ley

No­vo is chip­ping in $25 mil­lion to be­come a part­ner on that front over the next five years. All 4,000 of the in­ves­ti­ga­tors af­fil­i­at­ed with the Broad can ap­ply to the ac­cel­er­a­tor, dubbed No­vo Broad Green­house, for around $500,000 to test their ideas with­in a year and a half. If they pass the seed stage, No­vo will fund the projects fur­ther through a sprout stage un­til they are ready to bloom — ei­ther through a biotech spin­off or phar­ma out-li­cens­ing.

“The Broad Green­house was re­al­ly a way to help us start at that ear­li­est point in that cy­cle,” said Scott Beard­s­ley, man­ag­ing part­ner at No­vo Ven­tures about their vi­sion to be the “cra­dle of great life sci­ences.”

Beard­s­ley, Adel­man and Karen Hong, a part­ner in the Boston of­fice, are No­vo’s three per­ma­nent rep­re­sen­ta­tives on the Green­house’s joint steer­ing com­mit­tee, meet­ing every quar­ter with their coun­ter­parts from the Broad’s Cen­ter for the De­vel­op­ment of Ther­a­peu­tics (CDoT). When they are not con­ven­ing, the com­mit­tee al­so coach­es in­ves­ti­ga­tors on putting their ideas in the con­text of drug dis­cov­ery.

Hav­ing earned her PhD in Er­ic Lan­der’s lab be­fore he be­came the Broad’s di­rec­tor, Hong has first­hand knowl­edge of the in­sti­tute’s hu­man ge­net­ic ori­en­ta­tion.

Karen Hong

One ex­am­ple would be the work be­ing done by Dana-Far­ber re­searchers Kent Mouw and Eli Van Allen, one of five projects al­ready en­rolled in the Green­house. In their study of “ex­cep­tion­al re­spon­ders,” on­col­o­gists iden­ti­fied a cer­tain ge­net­ic mu­ta­tion that ap­peared to break a pro­tein and in­ter­fered with DNA re­pair. Pa­tients with that mu­ta­tion were al­so hy­per-re­cep­tive to plat­inum-based chemother­a­py. But they weren’t quite sure why — and they didn’t have the mon­ey to find out.

“Try­ing to come up with a sen­si­tiz­er to an old-fash­ioned chemother­a­py isn’t the most tra­di­tion­al­ly ob­vi­ous thing to do. And it’s pret­ty high-risk,” said Van Allen in a blog post.

With mon­ey from No­vo and sup­port from CDoT, their team will now screen small mol­e­cules in hopes of find­ing one that mim­ics the ef­fects of the bro­ken gene.

The Broad’s es­tab­lished re­la­tion­ship co­or­di­na­tion has saved every­one lots of pa­per­work, Adel­man said. And terms are al­ready in place for when No­vo wants to take an idea to the com­pa­ny cre­ation stage.

“We are not rip­ping the ba­by from the ma­ma,” he said. “We are ac­tu­al­ly cre­at­ing an en­vi­ron­ment where the sci­en­tists who have dis­cov­ered these ideas are in­ti­mate­ly in­volved go­ing for­ward in the process of ad­vanc­ing the idea to the ex­tent that even some of the fund­ing goes di­rect­ly back in their labs.”

That could mean a lot for the sci­en­tif­ic com­mu­ni­ty at large, Rozen added.

“Here we have very much in­creased ca­pac­i­ty to pros­e­cute ini­tial projects at a very large scale,” he said. “This is sig­nif­i­cant for fac­ul­ty to have this op­por­tu­ni­ty to ad­vance this sci­ence.”

Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

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Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

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On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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