Zaiqi Wang, InxMed CEO

Chi­na biotech In­xMed bags $19M Se­ries A+ to de­vel­op PhI FAK in­hibitor

Near­ly a year af­ter Nan­jing, Chi­na-based In­xMed bagged its first-ever IND ap­proval, the com­pa­ny has raked in ¥130 mil­lion (about $19 mil­lion) in a Se­ries A+ to de­vel­op its fo­cal ad­he­sion ki­nase (FAK) small mol­e­cule in­hibitor pro­gram.

The fi­nanc­ing round — led by En­no­va­tion Ven­tures and Chi­na Growth Cap­i­tal and joined by In­noMed Cap­i­tal and Grand Yangtze Cap­i­tal — will al­low the com­pa­ny to push its lead drug, IN10018, through the clin­ic for mul­ti­ple can­cer in­di­ca­tions. The com­pa­ny said it pre­vi­ous­ly raised “tens of mil­lions” in US dol­lars in Se­ries A fi­nanc­ing.

“The suc­cess­ful com­ple­tion of A+ round fi­nanc­ing would al­low us to ad­vance our clin­i­cal pro­gram and strength­en the com­pa­ny’s R&D ca­pa­bil­i­ty and ca­pac­i­ty,” In­xMed chair­man and CEO Za­iqi Wang said in a state­ment.

IN10018 is cur­rent­ly in Phase I test­ing for uveal melanoma and NRAS mu­tant metasta­t­ic melanoma; ovar­i­an and gas­tric can­cer; and pan­cre­at­ic can­cer and non-small cell lung can­cer. The com­pa­ny is fo­cused on com­bi­na­tion ther­a­pies, and in June read out ear­ly re­search da­ta that showed IN10018 can over­come drug re­sis­tance in can­cer pa­tients when ad­min­is­tered with KRAS G12C in­hibitors.

In March, In­xMed dosed the first pa­tients in a Phase Ib tri­al study­ing IN10018 both as monother­a­py and in com­bi­na­tion with Roche’s MEK in­hibitor co­bime­tinib, in pa­tients with metasta­t­ic uveal melanoma or NRAS mu­tant metasta­t­ic melanoma. That tri­al will in­clude 6 US sites and 3 in Aus­tralia.

Cur­rent­ly, no stan­dard-of-care treat­ment ex­ists for metas­ta­sized uveal melanoma. And chemother­a­pies or liv­er-di­rect­ed treat­ments don’t keep tu­mors un­der con­trol long-term. The biotech be­lieves that FAK in­hibitors could over­come the fi­brot­ic bar­ri­er and im­mune tol­er­ance, boost­ing tar­get­ed ther­a­py, chemother­a­py, im­muno-ther­a­py and ra­di­a­tion ther­a­py.

In­xMed al­so got the OK from the Chi­na Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) in De­cem­ber to launch Phase I test­ing of IN10018 in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic gas­tric can­cer.

“We be­lieve IN10018 has broad po­ten­tial for the treat­ment of can­cer pa­tients and are very ex­cit­ed to re­ceive ap­proval from NM­PA to ini­ti­ate clin­i­cal tri­als of IN10018 in Chi­na. This is an­oth­er im­por­tant mile­stone for In­xMed, demon­strat­ing our abil­i­ty to con­duct clin­i­cal tri­als in both the U.S. and Chi­na and lever­age ad­van­tages of both coun­tries to cre­ate glob­al val­ue,” Wang an­nounced in De­cem­ber.

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.

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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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.

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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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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