News brief­ing: ADC gets a speedy FDA re­view for their DL­B­CL ther­a­py; Qi­a­gen teams with the world's new fa­vorite biotech

The transat­lantic biotech ADC Ther­a­peu­tics is get­ting a speedy re­view for its an­ti-body drug con­ju­gate lon­cas­tux­imab tesirine (Lon­ca), de­vel­oped for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma.

Chris Mar­tin ADC

ADC $AD­CT said Fri­day morn­ing that the FDA put their drug on the fast lane, pro­vid­ing a pri­or­i­ty re­view for the drug with a May 21 PDU­FA date. The biotech won over reg­u­la­tors with Phase II da­ta that re­flect­ed an over­all re­sponse rate of 48.3% (70/145 pa­tients) and a com­plete re­sponse rate of 24.1%.

“The FDA’s ac­cep­tance of our BLA and grant­i­ng of pri­or­i­ty re­view for Lon­ca is a tremen­dous ac­com­plish­ment that brings ADC Ther­a­peu­tics one step clos­er to be­ing able to of­fer pa­tients with re­lapsed or re­frac­to­ry DL­B­CL a great­ly need­ed new treat­ment op­tion in 2021,” said ADC chief Chris Mar­tin. — John Car­roll

Qi­a­gen gets to work on a new di­ag­nos­tic for BioN­Tech

Qi­a­gen has signed up to work with mR­NA pi­o­neer BioN­Tech on a new di­ag­nos­tic that can be used to flag pa­tients with squa­mous cell car­ci­no­ma of the head and neck caused by in­fec­tions with hu­man pa­pil­lo­mavirus.

Their as­say will be de­signed to de­tect the pres­ence of HPV geno­types as­so­ci­at­ed with the biotech’s can­cer treat­ment BNT113. And then Qi­a­gen plans to ex­pand that to be­come a uni­ver­sal HPV com­pan­ion di­ag­nos­tic.

Ac­cord­ing to Qi­a­gen, head and neck squa­mous cell car­ci­no­ma is the sixth most com­mon can­cer, trig­ger­ing more than 650,000 cas­es and lead­ing to 330,000 deaths. Those num­bers are ex­pect­ed to dou­ble by 2035. — John Car­roll

An­ten­gene goes pub­lic in Hong Kong

An­ten­gene, the Hong Kong-based on­col­o­gy com­pa­ny long backed by Cel­gene, has gone pub­lic in an over­sub­scribed of­fer­ing worth rough­ly $340 mil­lion.

The com­pa­ny launched in 2017 with $21 mil­lion and a li­cens­ing deal with Cel­gene. They’ve since added oth­er as­sets from Karyopharm and As­traZeneca and raised an ad­di­tion­al $217 mil­lion in pri­vate fi­nanc­ing, in­clud­ing a $97 mil­lion Se­ries C ear­li­er this year.

The biotech now has dozens of pro­grams, but their fur­thest along as­set is the Karyopharm drug Se­linex­or. Ap­proved in the US, An­ten­gene is now test­ing it in Phase II for two blood can­cers and non-small cell lung can­cer. — Ja­son Mast

Ob­sid­i­an teams with MD An­der­son

MD An­der­son has been ratch­et­ing up its biotech part­ner­ships in re­cent months, par­tic­u­lar­ly around im­muno-on­col­o­gy.  Now they’re team­ing up with Ob­sid­i­an Ther­a­peu­tics.

The Michael Gilman-found­ed start­up has been qui­et since their $50 mil­lion launch back in 2017, but the com­pa­ny just added a new CSO as they work on their new spin to cell ther­a­py.

The idea is to be able to con­trol cell ther­a­pies such as CAR-T with oral drugs that will in­crease or de­crease the num­ber of ac­tive T cells in a pa­tient. The two en­ti­ties will team up on a tu­mor-in­fil­trat­ing lym­pho­cyte ther­a­py (TIL) that can be con­trolled with IL-15, with the goal of treat­ing sol­id tu­mors.

“TIL ther­a­py has emerged as a promis­ing op­tion for treat­ing pa­tients with sol­id tu­mors, though its wide­spread use to­day is lim­it­ed by safe­ty and ef­fi­ca­cy chal­lenges,” Rod­abe Amaria, as­so­ciate pro­fes­sor of Melanoma Med­ical On­col­o­gy at MD An­der­son, said in a state­ment. “We are pleased to work with Ob­sid­i­an to ad­vance their nov­el cy­toTIL pro­gram, which has the po­ten­tial to dri­ve more durable treat­ment re­spons­es and ex­pand TIL ther­a­py to a broad­er group of our pa­tients.”  — Ja­son Mast

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.