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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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