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.

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).