Samantha Du, Zai Lab CEO

Chi­na's Zai Lab spins 2 more li­cens­ing deals, in­clud­ing a sud­den dive in­to neu­ro­science

Chi­na can­cer spe­cial­ist Zai Lab has made its name in-li­cens­ing West­ern drugs and us­ing its deep knowl­edge of the East Asian mar­ket to churn out re­sults. The biotech has now signed two more li­cens­ing deals for a trio of drugs, in­clud­ing a very sud­den jump in­to the neu­ro­science space.

First, Zai Lab inked a deal Tues­day with Karuna Ther­a­peu­tics for rights in main­land Chi­na, Hong Kong, Macau and Tai­wan to KarXT, an in­ves­ti­ga­tion­al M1/M4-pre­fer­ring mus­carinic ag­o­nist be­ing test­ed to treat a va­ri­ety of psy­chi­atric con­di­tions.

Zai Lab will shell out $35 mil­lion up­front in this one with the po­ten­tial for an ad­di­tion­al $80 mil­lion in de­vel­op­ment and reg­u­la­to­ry mile­stones and $72 mil­lion in sales mile­stones on top of roy­al­ties.

Karuna is eval­u­at­ing KarXT in a slate of late-stage tri­als to treat schiz­o­phre­nia and psy­chosis in Alzheimer’s pa­tients with two Phase III stud­ies for the schiz­o­phre­nia pro­gram ex­pect­ed to read­out in 2022. Mean­while, the com­pa­ny is set to be­gin an ad­di­tion­al Phase III tri­al look­ing at KarXT as an ad­junct ther­a­py for pre­vi­ous­ly treat­ed adults by the end of the year.

Mean­while, an up­com­ing Phase III study for KarXT in psy­chosis in Alzheimer’s is set to kick off by mid-2022.

The deal is sig­nif­i­cant in that it rep­re­sents Zai Lab’s first for­ay in­to neu­ro­science, an­oth­er branch­ing out for the can­cer spe­cial­ist. In a state­ment, CEO Saman­tha Du had this to say about why her team de­cid­ed to make the leap:

Our col­lab­o­ra­tion with Karuna is a sig­nif­i­cant mile­stone for Zai Lab, mark­ing the ex­pan­sion and di­ver­si­fi­ca­tion of our de­vel­op­ment and com­mer­cial port­fo­lio in­to neu­ro­science, our fourth ther­a­peu­tic area. KarXT is well po­si­tioned to serve as the an­chor as­set in our new neu­ro­science fran­chise. Zai Lab’s mis­sion is to de­liv­er in­no­v­a­tive med­i­cines to ad­dress un­met med­ical needs of pa­tients, and we look for­ward to work­ing with Karuna to bring KarXT to pa­tients in need in Greater Chi­na as soon as pos­si­ble.

In a sec­ond pact signed Tues­day, Zai Lab will pay $25 mil­lion up­front and a po­ten­tial ad­di­tion­al $590 mil­lion in down­stream mile­stones for rights to Blue­print Med­i­cines’ in­ves­ti­ga­tion­al EGFR TKI in­hibitors BLU-945 and BLU-701 in Chi­na, Hong Kong, Macau and Tai­wan, the com­pa­nies said Tues­day.

Both drugs are be­ing de­vel­oped specif­i­cal­ly to tar­get drug re­sis­tant mu­ta­tions in EGFR-pos­i­tive lung can­cer pa­tients who do not re­spond to oth­er EGFR in­hibitors. BLU-945 specif­i­cal­ly tar­gets the T790M and C797S and mu­ta­tions while BLU-701 tar­gets C797S with pre­clin­i­cal mod­els show­ing a high de­gree of CNS pen­e­tra­tion, po­ten­tial­ly mak­ing it a good op­tion for pa­tients with brain metas­tases.

Zai Lab sees these drugs as po­ten­tial first-in-class op­tions in Chi­na for EGFR-pos­i­tive NSCLC pa­tients whose dis­ease pro­gress­es with oth­er EGFR in­hibitors, and Blue­print is us­ing the deal as part of a glob­al clin­i­cal ef­fort to see both drugs reach ap­proval in Chi­na and else­where.

If ei­ther drug does get ap­proved in Chi­na, Blue­print will be due tiered roy­al­ties in the “low teens to mid-teens.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.