ATAI adds MD­MA biotech to grow­ing list of psy­che­del­ic mak­ers; Aca­dia adds $52.5M up­front pain buy­out

For years, the biggest push in psy­che­del­ic drug de­vel­op­ment has been around MD­MA, a par­ty drug long thought to have po­ten­tial ben­e­fits for pa­tients with PTSD. Rick Doblin, for years psy­che­del­ic ther­a­py’s most promi­nent ad­vo­cate and fundrais­er, and his non-prof­it, MAPS, have raised mil­lions to ad­vance clin­i­cal tri­als, most re­cent­ly rais­ing $30 mil­lion to com­plete a Phase III study in vet­er­ans.

But ATAI, the Ger­man-born biotech that has quick­ly be­come the most promi­nent pri­vate pro­mot­er and dri­ver of psy­che­del­ic ther­a­py, still thinks they have some­thing to of­fer. Yes­ter­day, the port­fo­lio an­nounced their lat­est sub­sidiary: Em­path­Bio.

Srini­vas Rao

The idea be­hind Em­path­Bio is that Doblin’s ap­proach, while promis­ing, will on­ly rep­re­sent MD­MA 1.0. In a a re­cent MAPS analy­sis of pooled Phase II stud­ies – not a per­fect­ly sound mea­sure but good enough to sup­port more stud­ies – about half of the 100 pa­tients who re­ceived the drug didn’t have the di­ag­nos­tic symp­toms for PTSD two months af­ter their last dos­ing. The prob­lem, said ATAI CSO Srini­vas Rao, is that the drug has to be ad­min­is­tered over mul­ti­ple days in fa­cil­i­ties where pa­tients are su­per­vised by trained pro­fes­sion­als for hours.

“The chal­lenge with MD­MA as it’s en­vi­sioned by MAPS is that it’s dif­fi­cult to de­ploy and to scale up,” Rao told End­points News. “What we want to do is tran­si­tion this more to an out­pa­tient, or day-ther­a­py type of ap­proach, so we’re look­ing at com­pounds that are po­ten­tial­ly safer.”

The com­pa­ny re­mains far from the clin­ic, but they will work on MD­MA-like com­pounds that they say have a bet­ter pro­file. With at least one oth­er com­pa­ny, no­tably Kures, ATAI and its sub­sidiaries have tweaked gener­ic, plant or oth­er non-patentable mol­e­cules in large part to make them patentable, en­sur­ing there’s a vi­able com­mer­cial path­way.

But Em­path­Bio CEO Glenn Short point­ed to the po­ten­tial for some of these tweaks to re­duce hy­per­ten­sion of MD­MA, al­low­ing it to be giv­en pa­tients with co-mor­bidi­ties, as well as al­low­ing it to be giv­en over short­er pe­ri­ods of time and in less con­trolled set­tings, al­low­ing pa­tients to re­ceive the drug in rur­al and oth­er ar­eas.

Aca­dia adds to pain pipeline 

Aca­dia has been adding to its pipeline of late, most re­cent­ly pick­ing up new Alzheimer’s and de­men­tia can­di­dates in a mile­stone-heavy deal with Van­der­bilt Uni­ver­si­ty. Now, in a larg­er deal, they’ve added a new pre­clin­i­cal and ear­ly-stage clin­i­cal pipeline of pain drugs, buy­ing out Cer­Sci Ther­a­peu­tics for $52.5 mil­lion up­front and $887 mil­lion in mile­stones.

The com­pa­ny had been de­vel­op­ing for mul­ti­ple neu­ro­log­i­cal in­di­ca­tions but had been fo­cused on non-opi­oid painkillers for acute and chron­ic pain. A lead com­pound, ACP-044, was shown tol­er­a­ble in Phase I stud­ies. Aca­dia said a Phase II study is planned for next year.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.