Seagen and Zai Lab ink part­ner­ship on Tiv­dak ex­pan­sion in­to Chi­na and sur­round­ing ar­eas; NC biotech snaps up seed fund­ing

Zai Lab has signed on to com­mer­cial­ize Seagen and Gen­mab’s Tiv­dak — an ADC for re­cur­rent or metasta­t­ic cer­vi­cal can­cer in pa­tients in which chemother­a­py isn’t work­ing — in main­land Chi­na, Hong Kong, Macau and Tai­wan.

Seagen will get $30 mil­lion up­front, along with down­stream mile­stone pay­ments and tiered roy­al­ties. But the com­pa­ny will be split­ting all earn­ings from the Zai Lab agree­ment 50:50 with Gen­mab.

Tiv­dak got ac­cel­er­at­ed ap­proval in the US last year.

In a state­ment, Lingy­ing Wu, the di­rec­tor of gy­ne­co­log­ic on­col­o­gy at Chi­na’s Na­tion­al Can­cer Cen­ter said:

Fol­low­ing pro­gres­sion on first-line stan­dard of care ther­a­py, there are lim­it­ed treat­ment op­tions, and chemother­a­py has low ob­jec­tive re­sponse rates with poor out­comes. This rep­re­sents one of the biggest chal­lenges faced by gy­ne­co­log­ic on­col­o­gists with sig­nif­i­cant un­met needs for new ther­a­pies. We be­lieve Tiv­dak could be­come an im­por­tant treat­ment op­tion for pa­tients with cer­vi­cal can­cer in Chi­na, as it demon­strat­ed clin­i­cal­ly mean­ing­ful, durable re­spons­es with a tol­er­a­ble safe­ty pro­file.

— Lei Lei Wu

Tavros Ther­a­peu­tics rais­es a sec­ond seed round with $7.5 mil­lion go­ing in­to its cof­fers

Durham, NC-based biotech Tavros Ther­a­peu­tics is look­ing to march ahead with six fig­ures in its pock­et.

The Duke Uni­ver­si­ty spin­out has raised a Seed II round that was “over­sub­scribed” to the tune of $7.5 mil­lion. The cash will be go­ing to­ward drug dis­cov­ery and find­ing tar­gets in the on­col­o­gy space.

“This fi­nanc­ing strength­ens Tavros’ fi­nan­cial foun­da­tion as we con­tin­ue ex­pand­ing the util­i­ty of our plat­form and grow our team,” said Tavros CEO Eoin Mc­Don­nell in a state­ment.

The com­pa­ny got off the ground in 2020 with $3 mil­lion in seed fi­nanc­ing, along with a strate­gic col­lab­o­ra­tion with Zen­tal­is Phar­ma­ceu­ti­cals for the dis­cov­ery of small mol­e­cule drug can­di­dates.

The cur­rent raise was co-led by Pied­mont Cap­i­tal In­vest­ments and KdT Ven­tures, with par­tic­i­pa­tion from Alexan­dria Ven­ture In­vest­ments. — Tyler Patchen

X4 Phar­ma­ceu­ti­cals re­veals Phase Ib da­ta, now push­ing to ex­pand study

Three months af­ter slash­ing one-fifth of its staff af­ter se­cur­ing $55 mil­lion in a PIPE fi­nanc­ing, X4 Phar­ma­ceu­ti­cals re­vealed some Phase Ib da­ta. The biotech has been work­ing on de­vel­op­ing lead can­di­date ma­vorix­afor in a va­ri­ety of in­di­ca­tions, such as WHIM syn­drome (warts, hy­pogam­ma­glob­u­line­mia, in­fec­tions and myelokathex­is) and per the Phase Ib da­ta, in dif­fer­ent types of chron­ic neu­trope­nia.

The Phase Ib tri­al eval­u­at­ed the drug’s abil­i­ty to work as a monother­a­py to in­crease the num­ber of ab­solute neu­trophils in peo­ple with one of three types of chron­ic neu­trope­nia: id­io­path­ic, cyclic or con­gen­i­tal. The study al­so looked at ma­vorix­afor as a con­cur­rent ther­a­py with in­jectable gran­u­lo­cyte colony-stim­u­lat­ing fac­tor, al­so known as G-CSF.

The da­ta showed that all 14 neu­tropenic pa­tients en­rolled in the study reached nor­mal­ized ANC (ab­solute neu­trophil count), de­scribed as at least 1,500 cells/mi­cro­liter. When the drug was giv­en to six pa­tients with se­vere chron­ic neu­trope­nia as a monother­a­py, a sin­gle dose of ma­vorix­afor led to nor­mal­ized ANC lev­els in all par­tic­i­pants with­in two hours, with a mean ANC in­crease at peak of ~2,500 cells/mi­cro­liter.

X4 CMO Diego Ca­david praised the re­sults, adding that the tri­al is be­ing amend­ed and ex­pand­ed to a larg­er pa­tient pop­u­la­tion — hop­ing to start get­ting ad­di­tion­al da­ta in the first half of next year. — Paul Schloess­er

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.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Evotec inks li­cense agree­ment with J&J; On­colyt­ic virus biotech prices $15M IPO

Drug discovery and development player Evotec entered another licensing deal with Big Pharma — this time with J&J’s Janssen.

The companies put out word that they entered into a strategic collaboration and license agreement with each other that focuses on targeted immune-based cancer therapies, to be commercialized by Janssen.

According to a statement, the collaboration will hinge on Evotec’s integrated drug discovery and manufacturing capabilities. During the pre-clinical R&D phase, the companies will collaborate closely — and then Janssen will take on full responsibility for both clinical development and commercialization.