John Hood bags $90M for his quest to get fe­dra­tinib OK’d by FDA and cat­a­pult in­to the mar­ket

It took 18 months for John Hood to get the late-stage drug fe­dra­tinib back from Sanofi, as­sem­ble a small crew of ex­ecs for his start­up Im­pact Bio­med­i­cines and bring Medicxi in for a $22.5 mil­lion round to get this JAK2 ki­nase in­hibitor back on track. And in the last 14 days, he’s com­plet­ed a deal for up to $90 mil­lion in fi­nanc­ing need­ed to launch the drug — pro­vid­ed the FDA is will­ing.

“It takes a lot of mon­ey to launch a drug,” Hood tells me in an up­date. And now he has it.

None of this new mon­ey, by the way, is di­lut­ing his group’s eq­ui­ty stake.

John Hood

Hood left his job as a co-founder and CSO of re­gen­er­a­tive med biotech Sa­mumed to mount a sal­vage op­er­a­tion on fe­dra­tinib — a myelofi­bro­sis drug the FDA dropped a clin­i­cal hold on way back in 2013 af­ter some pa­tients be­gan to de­vel­op Wer­nicke’s en­cephalopa­thy.

Sanofi shelved the drug af­ter the safe­ty is­sue erupt­ed, but now Hood — the co-in­ven­tor of the drug when he ran R&D at Targe­Gen, ac­quired by Sanofi in a $635 mil­lion deal — has al­so con­vinced the FDA that the lethal side ef­fect re­searchers fret­ted about four years ago could be man­aged, get­ting that hold lift­ed.

The $90 mil­lion is com­ing from Ober­land Cap­i­tal in a se­ries of mile­stone pay­ments based on Hood’s suc­cess at mov­ing for­ward in this cam­paign. The first $20 mil­lion comes with the FDA’s clar­i­fi­ca­tion of the reg­u­la­to­ry path ahead. The next $20 mil­lion comes when the drug is filed. Then they can get up to $50 mil­lion to fund the launch, which Hood reck­ons will re­quire an or­phan drug sales force of about 40.

Ober­land’s bet­ting on the drug’s near-term suc­cess, with a deal to get paid back through drug roy­al­ties, a cre­ative way for Hood and his or­ga­ni­za­tion to hang on to eq­ui­ty.

Hood is op­ti­mistic that Sanofi, which took an eq­ui­ty stake in the biotech in ex­change for the rights, had done the hard clin­i­cal work to get fe­dra­tinib ready for an NDA. He feels he has the da­ta in hand to prove that the drug is the best sec­ond-line ther­a­py avail­able for myelofi­bro­sis pa­tients, the best hope for pa­tients who are no longer re­spond­ing to stan­dard of care.

If he pulls this off with a vir­tu­al crew and most­ly non-di­lu­tive cash where the gi­ant Sanofi had failed, it will be one of the come­back sto­ries of the decade.

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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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.

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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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.

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.”

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.