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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.