Four years af­ter it im­plod­ed at Sanofi, John Hood is res­ur­rect­ing the myelofi­bro­sis drug fe­dra­tinib

Fe­dra­tinib was one of the biggest clin­i­cal drug dis­as­ters that oc­curred at Sanofi un­der the tu­mul­tuous reign of CEO Chris Viehbach­er. But af­ter im­plod­ing with spec­tac­u­lar ef­fect right at the thresh­old of a new drug ap­pli­ca­tion four years ago, one of the drug’s co-in­ven­tors — a sci­en­tist named John Hood — has pa­tient­ly picked up all the shat­tered pieces and put it to­geth­er in­to a new com­pa­ny that just scored a $22.5 mil­lion ven­ture round.

Now Hood’s lit­tle biotech is go­ing af­ter that FDA/EMA ap­proval that elud­ed the phar­ma gi­ant.

If he’s right, Hood has scored one of the biggest biotech coups of the year. But let’s start this sto­ry with a lit­tle back­ground.

Sev­en years ago, Sanofi scooped up a biotech called Targe­Gen in a $635 mil­lion deal, bag­ging a mid-stage JAK2 myelofi­bro­sis drug — then dubbed TG 101348 — that had gath­ered promis­ing ear­ly-stage hu­man da­ta. Hood, the for­mer re­search chief at Targe­Gen and a co-in­ven­tor of the drug, moved on to co-found a biotech uni­corn com­pa­ny called Sa­mumed, fo­cused on re­gen­er­a­tive med­i­cine with Hood tak­ing the CSO job.

In 2013, the FDA dropped a clin­i­cal hold on fe­dra­tinib af­ter a few pa­tients be­gan to de­vel­op Wer­nicke’s en­cephalopa­thy — a dan­ger­ous neu­ro­log­i­cal con­di­tion tied to vi­t­a­min B de­fi­cien­cy. And Sanofi’s top team quick­ly put a bul­let in it, scrap­ping a pro­gram that in­clud­ed sev­en on­go­ing clin­i­cal tri­als. The phar­ma gi­ant shoved the mor­tal­ly wound­ed pro­gram on the shelf, and that’s where it sat un­til ear­ly 2016, when Hood de­cid­ed to start his own com­pa­ny, get the rights back and pur­sue transat­lantic ap­provals.

To hear Hood tell it, af­ter the clin­i­cal tri­als end­ed, the pa­tients in­volved were shift­ed to stan­dard of care and be­gan to re­lapse.

“That’s when physi­cians and pa­tients be­gan to reach out to me,” Hood says, look­ing for some way to get the drug un­der com­pas­sion­ate use rules. That in­spired him to go for it.

I hap­pened to pick up word of what was hap­pen­ing at the time, and Hood and I start­ed ex­chang­ing oc­ca­sion­al mes­sages around his progress. Wait for it, he would write, it was grad­u­al­ly com­ing to­geth­er.

Sanofi gave up the drug for eq­ui­ty in Hood’s com­pa­ny, Im­pact Bio­med­i­cines in San Diego, which now has a lean-and-mean team of six. The pack­age in­cludes pos­i­tive Phase III re­sults (with a p-val­ue of 0.0001 says a proud Hood) da­ta from 877 pa­tients in 18 stud­ies.

“There was no out-of-pock­et,” Hood tells me. Sanofi took an eq­ui­ty stake in the biotech for its share.

The FDA came through in Au­gust, drop­ping the clin­i­cal hold af­ter Hood made the case that the side ef­fects that so alarmed in­ves­ti­ga­tors and reg­u­la­tors in 2013 could be at­trib­uted to a small num­ber of cas­es of thi­amine de­ple­tion linked to the high meta­bol­ic rate of can­cer pa­tients and mal­nour­ish­ment.

Says Hood: “It was easy enough to mit­i­gate.”

Kevin John­son

Hood’s backed by a globe-trot­ting team at Medicxi, where Kevin John­son — a buoy­ant Cam­bridge grad and sci­en­tist who had been head of re­search at the leg­endary Cam­bridge An­ti­body Tech­nol­o­gy — put to­geth­er the fi­nanc­ing round to fund what comes next.

That next part still has to be worked out, the CEO tells me. I sug­gest­ed that if any­thing, reg­u­la­tors have em­braced speed­ed up de­vel­op­ment pro­grams in on­col­o­gy, which could put him right back at the FDA’s door, knock­ing for mar­ket en­try.

Af­ter spend­ing more than 18 months putting this all to­geth­er, though, Hood is still tak­ing it one step at a time. He’ll know more about how fast he can move af­ter meet­ing with reg­u­la­tors to test their ap­petite for speed.

I asked John­son what his first thoughts were when he and Hood talked it over.

My ini­tial re­ac­tion to the sto­ry was that I couldn’t grasp the thought process that led to it be­ing put on clin­i­cal hold and there­fore not reach­ing the mar­ket. We pieced that all to­geth­er at a lat­er stage, and while it looks like a strange de­ci­sion in ret­ro­spect, at the time, with those spe­cif­ic mar­ket con­di­tions, it would have been a brave de­ci­sion to keep go­ing. Of course it’s all dif­fer­ent now.
On John him­self, he re­al­ly does think like that and I love it! It’s my ex­pe­ri­ence that the top biotech and phar­ma en­tre­pre­neurs are dri­ven by a need to do good, rather than just make mon­ey. In the end I guess it’s a be­lief sys­tem- do the right things for the right rea­sons and the mon­ey will fol­low as a con­se­quence. It does tend to work out that way. He’s al­so what I call a hand­shake guy; you shake hands on some­thing and that’s it. He could have played us but he didn’t. That too is con­sis­tent with his phe­no­type.

In most cas­es like this, Hood and his tiny band of staffers would be set­ting him­self up to do a deal on the drug. But Hood isn’t jump­ing that far ahead ei­ther. Right now, he says, he’s work­ing on the kind of fi­nan­cial pack­age that would “al­low us to take it the whole way.”

That may sound a bit far-fetched, but the whole sto­ry up to this point was im­prob­a­ble.

Hood’s just get­ting start­ed again.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”