US sells Wu-Tang Clan al­bum to cov­er Shkre­li debt; Or­biMed backs GSK vet­s' Chi­nese start­up

Mar­tin Shkre­li be­came a top tar­get for ridicule and anger in the mid-2010s when he and his biotech Tur­ing Phar­ma­ceu­ti­cals raised the price of a life-sav­ing med­i­cine from $13.50 to $750 per pill. But he al­so gained no­to­ri­ety around that time for pur­chas­ing a one-of-a-kind al­bum from rap group the Wu-Tang Clan at auc­tion for about $2 mil­lion.

Now, the al­bum is on the move again.

The De­part­ment of Jus­tice an­nounced Tues­day it has sold the al­bum, “Once Up­on a Time in Shaolin,” to an undis­closed buy­er to help cov­er Shkre­li’s $7.36 mil­lion debt when he was con­vict­ed for de­fraud­ing in­vestors in 2017. The sale of the al­bum ac­count­ed for the re­main­der of Shkre­li’s bal­ance, the de­part­ment said in a news re­lease.

Pros­e­cu­tors had seized the al­bum back in 2018 and the new buy­er is a group of peo­ple, rather than an in­di­vid­ual, per a New York Times re­port. The iden­ti­ties of the pur­chasers re­main undis­closed, as does the sale price.

The al­bum was per­ceived as akin to a fine art piece as the pur­chas­ing agree­ment from the orig­i­nal auc­tion con­tained sev­er­al re­stric­tions, in­clud­ing bar­ring the own­er from re­leas­ing any of the songs com­mer­cial­ly for 88 years. On­ly one copy of the al­bum was made, and the new own­ers are bound to the same re­stric­tions.

A lawyer for the group, Pe­ter Scoolidge, lis­tened to the al­bum as part of the sale arrange­ment, per the NYT, say­ing, “It’s a banger, man. It’s a banger.”

The move to sell the al­bum came the same day that DoJ seized a tablet bear­ing part of the epic of Gil­gamesh, one of the world’s old­est sur­viv­ing pieces of lit­er­a­ture. Known as the Gil­gamesh Dream Tablet, it was for­feit­ed by the own­ers of re­tail chain Hob­by Lob­by, who were ac­cused of smug­gling more than 5,500 ar­ti­facts out of Iraq to dis­play at their Mu­se­um of the Bible. Hob­by Lob­by paid a $3 mil­lion fine in 2018 in the scan­dal. — Max Gel­man

Or­biMed backs GSK vets’ take on brain-pen­e­trant breast can­cer drugs

Three years af­ter launch­ing Zion Phar­ma with a unique take on small mol­e­cule can­cer drugs, a pair of Glax­o­SmithK­line vets have bagged their sec­ond round.

Jack Cheng and Ding Zhou, who had both worked at GSK’s Shang­hai hub, had cen­tered the pitch around their deep grasp of drug me­tab­o­lism and phar­ma­co­ki­net­ics, or DMPK. Where­as Zhou spent close to two decades as a chem­istry lead at the British phar­ma, Cheng held a stint as head of DMPK at As­traZeneca be­fore re­unit­ing with his for­mer col­league.

Or­biMed led the $40 mil­lion Se­ries B, which is de­signed to fu­el a hir­ing dri­ve on top of R&D.

Stay­ing on a straight and nar­row path, Zion’s lead can­di­date is a breast can­cer drug that can get in­to the brain, in hopes of treat­ing the metas­tases that af­fect be­tween 30% to 50% of new­ly di­ag­nosed pa­tients. Cur­rent treat­ments like surgery or ra­di­a­tion have too many side ef­fects and don’t help pa­tients live too much longer, ac­cord­ing to the com­pa­ny.

“De­sign­ing chem­i­cal en­ti­ties that can pass through the blood-brain bar­ri­er and the abil­i­ty to pre­dict and as­sess the en­ti­ties’ DMPK at­trib­ut­es are core to the Zion team’s com­pet­i­tive­ness,” Or­biMed part­ner Da­song Wang said in a state­ment. “Zion’s breast can­cer pro­gram for brain metas­tases showed PK, tox­i­col­o­gy and ef­fi­ca­cy re­sults in Phase I that aligned very well with pre­clin­i­cal pre­dic­tions.”

Ex­ist­ing in­vestors at Qim­ing, Sher­pa Ven­ture Cap­i­tal, Ming Bioven­tures and Med-Fine Cap­i­tal al­so joined the fi­nanc­ing. — Am­ber Tong

My­covia wins pri­or­i­ty re­view in quest to shake up yeast in­fec­tion mar­ket

Pulling up be­hind Scynex­is in the race to de­vel­op oral an­ti­fun­gals against yeast in­fec­tions, My­covia is speed­ing to­ward a pri­or­i­ty re­view.

The Durham, NC-based biotech an­nounced Wednes­day the FDA has ac­cept­ed its NDA for otesec­ona­zole and grant­ed the com­pound a speedy look-see. Reg­u­la­tors have set the PDU­FA date for Jan. 27, 2022.

My­covia is aim­ing to win an OK in an area that Scynex­is hasn’t won ap­proval yet: re­cur­rent vul­vo­vagi­nal can­didi­a­sis, or chron­ic yeast in­fec­tion de­fined as at least three episodes per year. Scynex­is gained ap­proval in vul­vo­vagi­nal can­didi­a­sis for its Brex­afemme pill last month.

My­covia says da­ta from three Phase III stud­ies are back­ing the NDA, in­clud­ing two glob­al tri­als and one US-based tri­al. The drug­mak­er says otesec­ona­zole showed su­pe­ri­or ef­fi­ca­cy to Pfiz­er’s flu­cona­zole, cur­rent­ly the mar­ket’s stan­dard-bear­er.

“RVVC is a dif­fer­ent con­di­tion from yeast in­fec­tions, sim­ply known as VVC, so it re­quires a dif­fer­ent treat­ment. Re­search shows that flu­cona­zole, the stan­dard of care for VVC, is more than 90% ef­fec­tive in treat­ing an ini­tial episode of VVC, but in stud­ies of pa­tients with RVVC, greater than 50% of women ex­pe­ri­ence a re­cur­rence fol­low­ing main­te­nance ther­a­py dis­con­tin­u­a­tion,” My­covia CEO Patrick Jor­dan said in a state­ment. — Max Gel­man

On the heels of a $363M Parkin­son’s deal, Ipsen places a big bet on a new can­cer tar­get

It’s been a cou­ple of weeks since Ipsen bet $363 mil­lion on IR­LAB’s lev­odopa-in­duced dysk­i­ne­sia (LID) can­di­date — but the Paris-based com­pa­ny isn’t quite done mak­ing deals.

Ipsen has promised up to $852 mil­lion to col­lab­o­rate on BAKX Ther­a­peu­tics’ pre­clin­i­cal BAX ac­ti­va­tor in leukemia, lym­phoma and sol­id tu­mors, the com­pa­nies said on Tues­day.  Ipsen will shell out $14.5 mil­lion of that up­on clos­ing, and the part­ners will split the costs and prof­its.

“This part­ner­ship brings to­geth­er Ipsen’s ex­cel­lent clin­i­cal de­vel­op­ment and com­mer­cial ca­pa­bil­i­ties with our in­dus­try-lead­ing knowl­edge of the BAX pro­tein and our unique com­pu­ta­tion­al plat­form,” BAKX CEO Sree Kant said in a state­ment.

The pro­gram, dubbed BKX-001, is the re­sult of pi­o­neer­ing work around apop­to­sis by BAKX’s sci­en­tif­ic co-founders Loren Walen­sky and Evri­pidis Ga­vathi­o­tis. When dereg­u­lat­ed, apop­to­sis — the nat­u­ral­ly oc­cur­ring process of pro­grammed cell death — can lead to un­con­trolled cell di­vi­sion and tu­mor de­vel­op­ment. BAX is a new tar­get in the apop­to­sis cell-sig­nal­ing path­way, down­stream of oth­er an­ti-apop­tot­ic pro­teins like  BCL-2, BCL-XL, and MCL-1, the com­pa­ny said.

BAKX has an­oth­er two undis­closed can­di­dates in the dis­cov­ery stage, ac­cord­ing to its web­site. — Nicole De­Feud­is 

A pre­vi­ous ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed that BAKX’s can­di­date is a BAX in­hibitor. A cor­rec­tion has been made.

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

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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.