Im­muno­Gen maps new path to ac­cel­er­at­ed ap­proval; BioN­Tech scores €50M fund­ing from Eu­ro­pean bank

→ Ear­li­er this year, strug­gling Im­muno­Gen was shooed away by the FDA with their case for an ac­cel­er­at­ed ap­proval of their an­ti­body-drug con­ju­gate mirve­tux­imab so­rav­tan­sine, which had failed a Phase III study for ovar­i­an can­cer. But the com­pa­ny now has some hope­ful news to re­port as the FDA stat­ed that a “new sin­gle-arm study in plat­inum-re­sis­tant ovar­i­an can­cer could sup­port ac­cel­er­at­ed ap­proval” of the drug. The biotech will now ini­ti­ate that tri­al, SO­RAYA, to test the ef­fi­ca­cy of the monother­a­py in women with fo­late re­cep­tor al­pha (FRα)-high plat­inum-re­sis­tant ovar­i­an can­cer who have been pre­vi­ous­ly treat­ed with Avastin.

→ Wall Street new­bie BioN­Tech has ob­tained a €50 mil­lion (around $55 mil­lion) loan from the Eu­ro­pean In­vest­ment Bank to back an ex­pan­sion in the pro­duc­tion ca­pac­i­ties for its mR­NA-based prod­uct can­di­dates and fund R&D as well as mar­ket ac­cess work.

→ Switzer­land’s Celles­tia Biotech has brought its to­tal haul to $50 mil­lion by bring­ing in new Asian in­vestors to its $20 mil­lion Se­ries B. FC Cap­i­tal of Shang­hai, PPF Group and Part­ners In­vest­ment of Seoul, along­side a group of pri­vate in­vestors, are buy­ing in­to the po­ten­tial of a drug dis­cov­ery plat­form tar­get­ing the NOTCH tran­scrip­tion com­plex. The lead drug, a small mol­e­cule in­hibitor dubbed CB-103, is cur­rent­ly in Phase I.

→ Since de­but­ing six years ago with the sup­port of the late Hen­ri Ter­meer, Amy­lyx Phar­ma­ceu­ti­cals has laid rel­a­tive­ly low, but to­day the com­pa­ny is break­ing out some pos­i­tive da­ta from their CEN­TAUR study test­ing the ef­fi­ca­cy of their drug, AMX0035, for peo­ple with ALS. The study met the pri­ma­ry end­point, by show­ing a sta­tis­ti­cal­ly sig­nif­i­cant slow­ing of ALS with use of the drug com­pared to place­bo.

→ Bel­gium-based liv­er-fo­cused stem cell ther­a­py de­vel­op­er Promethera Bio­scienceswhich bagged €39.7 mil­lion (about $44.4 mil­lion) in May — has made an ad­di­tion of €7.5 mil­lion to that amount. The round was led by new in­vestors Sony In­no­va­tion Fund by IGV and Pe­ga­sus Tech Ven­tures, among oth­ers. The funds will be used to­ward the ad­vance­ment of the com­pa­ny’s clin­i­cal pro­grams in NASH and acute-on-chron­ic liv­er fail­ure (ACLF) — with planned launch­es dur­ing 2020 — as well as to ac­cel­er­ate Promethera’s growth in Asian mar­kets.

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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UP­DAT­ED: 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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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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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)

UP­DAT­ED: 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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