News brief­ing: Dew­point scores an­oth­er Big Phar­ma deal, this time with Pfiz­er; Kite joins forces with Ox­ford Bio­Ther­a­peu­tics

Over the last 13 months, Dew­point Ther­a­peu­tics has scored big part­ner­ships with Bay­er and Mer­ck, aim­ing to pi­o­neer a new field of bi­ol­o­gy called bio­mol­e­c­u­lar con­den­sates. On Wednes­day, the biotech reeled in an­oth­er big phar­ma deal.

Dew­point agreed to a re­search col­lab­o­ra­tion with Pfiz­er on Wednes­day for the de­vel­op­ment of ther­a­pies for my­oton­ic dy­s­tro­phy type 1, a rare ge­net­ic dis­or­der. The deal can be worth up to $239 mil­lion when ac­count­ing for all mile­stones.

Among the three deals, Dew­point has the op­por­tu­ni­ty to earn up to $644 mil­lion from the three phar­ma gi­ants.

Bio­mol­e­c­u­lar con­den­sates are droplet-like struc­tures that form dy­nam­i­cal­ly with­in cells when di­verse “com­mu­ni­ties” of pro­teins, RNAs and oth­er bio­mol­e­cules come to­geth­er through phase sep­a­ra­tion. Dew­point had tak­en ad­van­tage of be­ing the on­ly play­er in the space with its first two deals, but a new biotech called Nereid jumped in­to the are­na in No­vem­ber.

DM1 is an in­her­it­ed ge­net­ic dis­or­der linked with the DMPK gene. Those with the dis­or­der ex­pe­ri­ence mus­cle loss and weak­ness, dif­fi­cul­ty breath­ing, cataracts, heart con­di­tions, in­tel­lec­tu­al dis­abil­i­ty, and ear­ly death. — Max Gel­man

Kite joins forced with Ox­ford Bio­Ther­a­peu­tics for five tar­gets

Gilead’s Kite has a brand new part­ner.

The out­fit is team­ing up with Ox­ford Bio­Ther­a­peu­tics on a re­search col­lab­o­ra­tion to eval­u­ate five tar­gets in hema­tol­ogy and sol­id tu­mors. Fi­nan­cial terms of the deal were not dis­closed, but in­clud­ed an up­front pay­ment and mile­stone promis­es.

OBT will val­i­date the five tar­gets, which pre­vi­ous­ly iden­ti­fied us­ing its pro­pri­etary plat­form, and aim to gen­er­ate an­ti­bod­ies against them. Kite and Gilead will then de­vel­op and com­mer­cial­ize ther­a­pies based on these tar­gets or an­ti­bod­ies.

“Se­lect­ing the right tar­get is fun­da­men­tal for the suc­cess­ful de­vel­op­ment of first-in-class cell ther­a­pies,” OBT CEO Chris­t­ian Rohlff said in a state­ment. “We are de­light­ed that Kite, the glob­al leader in cell ther­a­py, has rec­og­nized the po­ten­tial of OBT’s OGAP dis­cov­ery plat­form and an­ti­body ca­pa­bil­i­ties through this part­ner­ship.” — Max Gel­man

Ra­dius Health snags rights to cannabid­i­ol oral so­lu­tion for $12.5 mil­lion

Ra­dius Health is shov­el­ing out $12.5 mil­lion — and po­ten­tial­ly an­oth­er $15 mil­lion in mile­stones — to de­vel­op Be­nu­via Ther­a­peu­tics’ syn­thet­ic cannabid­i­ol oral so­lu­tion RAD011 for Prad­er-Willi syn­drome (PWS).

Kel­ly Mar­tin

The Boston-based biotech an­nounced on Wednes­day that it inked a deal for glob­al de­vel­op­ment and com­mer­cial­iza­tion rights to the can­di­date, and plans on launch­ing a piv­otal Phase II/III tri­al in the sec­ond half of 2021. CEO Kel­ly Mar­tin said PWS will be used as an “an­chor in­di­ca­tion,” and plans on in­ves­ti­gat­ing oth­er or­phan dis­ease in­di­ca­tions “in due course.”

“For the next three in­di­ca­tions, any or all of which can be pur­sued at Ra­dius’ dis­cre­tion, the Com­pa­ny may pay up to $45 mil­lion in de­vel­op­ment mile­stones. In ad­di­tion, Ra­dius may pay sales-based mile­stone pay­ments and a tiered, high sin­gle-dig­it ef­fec­tive roy­al­ty,” Ra­dius said in a state­ment.

Mar­tin was brought in last April to re­place for­mer CEO Jes­per Høi­land, who re­turned home to Den­mark. Ra­dius has seen its stock price slide steadi­ly since win­ning the race with Am­gen on os­teo­poro­sis and jump­ing in­to the mar­ket with Tym­los, which brought in $173 mil­lion in net sales in 2019. — Nicole De­Feud­is

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

Presentations at the European Hematology Association began Friday, with Autolus Therapeutics revealing data they say continue to show the benefit of their CAR-T program.

The Autolus program, known as 0be-cel, achieved a 100% complete remission rate in a cohort of indolent B Cell Non-Hodgkin lymphoma patients, with all nine treated patients hitting the mark as of the May 17 cutoff. Another three patients are still awaiting treatment, while a fourth enrolled individual died due to a Covid-19 infection.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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Verona signs Chi­na deal for PhI­II COPD drug; Te­va con­tin­ues le­gal bat­tle with Eli Lil­ly, al­leg­ing new patent in­fringe­ments on mi­graine drug

After a February Phase II win put Verona’s bad memories of a 2019 flop behind them, the company is now engaging in partnerships to ship out the experimental drug should it continue to produce positive results in Phase III.

Verona is teaming up with Nuance Pharma on a $219 million collaboration to commercialize ensifentrine in China, Macau Hong Kong and Taiwan, the companies announced Thursday. The deal includes $25 million in upfront cash and a $15 million equity stake in Nuance Biotech, the parent company of Nuance Pharma. Verona is eligible for up to $179 million in milestones.