Pfiz­er spins off drug or­phans in­to a PhI­II-ready start­up backed by Bain to the tune of $103M

Like a lot of Big Phar­ma com­pa­nies with a big pipeline, Pfiz­er can’t de­vel­op all the drugs it has. So what do you do with the good drugs that still can’t make the cut?

In Pfiz­er’s case, you spin a line­up of your best, fur­thest ad­vanced ex­per­i­men­tal meds in­to a new com­pa­ny, while look­ing to add more when the time is ripe.

Lara Sul­li­van, an R&D strat­e­gy ex­ec, has gained the com­pa­ny’s sup­port to split off from the phar­ma gi­ant with four of its clin­i­cal-stage or­phans, cre­at­ing a new com­pa­ny called Spring­Works Ther­a­peu­tics. And with con­sid­er­able help from two big Bain funds, they’re start­ing out with a mega-round of $103 mil­lion for the Se­ries A.

Lara Sul­li­van

Sul­li­van, the new­ly un­veiled pres­i­dent of Spring­Works, says she gained con­sid­er­able sup­port for this new ven­ture from Pfiz­er’s chief med­ical of­fi­cer Fre­da Lewis-Hall, who is tak­ing a board spot on Spring­Works to help over­see the fu­ture of these drugs, with Pfiz­er lend­ing its fi­nan­cial sup­port along­side Bain Cap­i­tal Life Sci­ences, Bain Cap­i­tal Dou­ble Im­pact, Or­bimed and LifeArc.

It’s no easy task grab­bing four drugs out of the pipeline at a glob­al op­er­a­tion like Pfiz­er, even if they haven’t made the cut on R&D fund­ing.

“I’ve got a cou­ple of more gray hairs than I did a few years ago,” Sul­li­van tells me, when she got start­ed pur­su­ing this project. Lewis-Hall helped cham­pi­on the ef­fort, and then they built sup­port among the com­pa­ny’s lawyers, ac­coun­tants and sci­en­tists, who are on­ly too aware that even in a top 10 R&D out­fit like Pfiz­er  there are far more de­vel­op­ment projects than mon­ey to fund the work.

Sul­li­van tells me they’re still grow­ing the staff, but the top po­si­tions are oc­cu­pied by some high-pro­file fig­ures in the in­dus­try — from Chair­man Dan Lynch, to Bain Cap­i­tal Dou­ble Im­pact’s De­val Patrick, the for­mer gov­er­nor of Mass­a­chu­setts, on the board. Stephen Squin­to, a co-founder and for­mer R&D chief of Alex­ion — now a ven­ture part­ner at Or­biMed — is step­ping in as act­ing head of re­search at the up­start. Jeff Schwartz, a gen­er­al part­ner at Bain’s re­cent­ly cre­at­ed life sci­ences group along­side Adam Kop­pel, is al­so tak­ing a spot on the board.

Spring­Works is a di­rect out­growth of an in­creas­ing­ly com­mon strat­e­gy that is find­ing an abun­dance of deep-pock­et play­ers — in­clud­ing some ma­jor out­fits that are new to the game — who are ready to gam­ble hun­dreds of mil­lions of dol­lars on drug R&D.

Just like Vivek Ra­maswamy, who’s built a grow­ing biotech en­ter­prise with mul­ti­ple ten­ta­cles around Roivant Sci­ences with the castoffs to be found in Big Phar­ma, Whar­ton grad Sul­li­van found a way to jump­start a ma­ture biotech with a pipeline of ad­vanced as­sets with hu­man da­ta. And with a slate of new CEOs tak­ing over ma­jor R&D shops, shift­ing fo­cus and re­al­lo­cat­ing funds, this is one trend that seems to be gain­ing mo­men­tum.

It doesn’t stop here, ei­ther, for Spring­Works. Sul­li­van and her team are work­ing with Pfiz­er and oth­ers in the in­dus­try and acad­e­mia to find more clin­i­cal-stage drugs they can add to the pipeline to grow the com­pa­ny even fur­ther.

Spring­Works has plen­ty on its plate to get start­ed. Pfiz­er, like most of the ma­jor phar­ma com­pa­nies, tends to stick to its late-stage pipeline when they talk up R&D, so these drugs have been fly­ing large­ly un­der the radar.

  • The lead drug is nirogace­s­tat (PF-03084014), a gam­ma-sec­re­tase in­hibitor which will be moved in­to Phase III now for rare cas­es of desmoid tu­mors, a slow-grow­ing non-metasta­t­ic tu­mor of con­nec­tive tis­sue cells, which can cause se­vere mor­bid­i­ty, pain and loss of func­tion.
  • There’s a MEK 1/2 in­hibitor, PF-0325901, for the ge­net­ic dis­or­der NF1, one of three ge­net­ic con­di­tions known as neu­rofi­bro­mato­sis. It’s been through Phase I/II and will now head in­to a piv­otal tri­al.
  • An­oth­er rare con­di­tion, hered­i­tary xe­ro­cy­to­sis — char­ac­ter­ized by de­hy­drat­ed red blood cells — will be tar­get­ed by sen­i­capoc (PF-05416266).
  • An FAAH in­hibitor (PF-0445784) is be­ing de­vel­oped for post-trau­mat­ic stress dis­or­der.

To get in­to the Spring­Works pipeline, the drugs had to pass two fa­mil­iar chal­lenges in the biotech world: Was it tar­get­ing a dis­ease where there are no good drugs to choose from? And was there enough hard sci­ence to back up their po­ten­tial in mak­ing the grade with piv­otal da­ta?

Based on their work at Pfiz­er so far, there are plen­ty more like this out there.

“We an­tic­i­pate there will be plen­ty of more com­pounds,” says Sul­li­van.

At this stage, there’s no telling ex­act­ly how long the $103 mil­lion will last, though they ex­pect at a min­i­mum to get through the late-stage work on mid-stage proof-of-con­cept stud­ies on the 4. The com­pa­ny has a set of big names be­hind it, but the staff is still un­der 10, though grow­ing fast.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.