Less than a year af­ter bank­ing $74.5 mil­lion in a Se­ries B, San Diego-based Kin­nate Bio­phar­ma is fol­low­ing up with a Se­ries C to bring its pipeline of pre­ci­sion on­col­o­gy drugs to the clin­ic.

The two-year-old com­pa­ny just raised $98 mil­lion in a round led by RA Cap­i­tal Man­age­ment, and is eye­ing INDs for its two lead pro­grams — ki­nase in­hibitors that tar­get BRAF, FGFR2 and FGFR3 mu­ta­tions. If all goes well in pre­clin­i­cal stud­ies, CEO Ni­ma Farzan ex­pects its BRAF pro­gram to en­ter Phase I in the first half of next year, with its FGFR pro­gram not far be­hind.

“A very small per­cent­age of pa­tients can re­spond over a long pe­ri­od of time … to a tar­get­ed ther­a­py,” Farzan told End­points News. “So we’re re­al­ly fo­cused on bring­ing drugs that ei­ther are go­ing af­ter known onco­genic dri­vers that cur­rent­ly aren’t tar­get­ed by drugs, or help­ing over­come those re­sis­tance mu­ta­tions.”

While there are cur­rent­ly FDA-ap­proved op­tions for pa­tients with Class I BRAF mu­ta­tions, Kin­nate saw an op­por­tu­ni­ty to de­vel­op in­hibitors tar­get­ing Class II and III mu­ta­tions. Kin­nate’s in­hibitors are de­signed to block BRAF pro­tein dimers. Right now, the com­pa­ny is fo­cus­ing on pa­tients with melanoma and non-small cell lung can­cer.

Kin­nate’s FGFR can­di­dates are de­signed to ad­dress mu­ta­tions in FGFR2 fu­sion gene-pos­i­tive in­tra­hep­at­ic cholan­gio­car­ci­no­ma and FGFR3-al­tered urothe­lial car­ci­no­ma. The com­pa­ny aims to over­come re­sis­tance to cur­rent FGFR drugs on the mar­ket.

“Over time, pa­tients de­vel­op re­sis­tance to these drugs through cer­tain mu­ta­tions in FGFR that makes the cur­rent drugs not ef­fec­tive,” Farzan said.

Kin­nate has set out to de­vel­op a drug that’s ef­fec­tive against the FGFR al­ter­ation, as well as the most com­mon re­sis­tant mu­ta­tions. Farzan sees the drug ini­tial­ly as a sec­ond-line treat­ment for those who have be­come re­sis­tant to cur­rent drugs, and even­tu­al­ly as a first-line treat­ment.

The com­pa­ny will al­so use Se­ries C funds to de­vel­op its CDK12 in­hibitor, though Farzan said it is “more dif­fi­cult to say” when that pro­gram will be ready for an IND.

The Se­ries C in­clud­ed new in­vestors Viking Glob­al In­vestors, Ven­rock Health­care Cap­i­tal Part­ners, Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, LLC, Janus Hen­der­son In­vestors, Sur­vey­or Cap­i­tal, Box­er Cap­i­tal of Tavi­s­tock Group, Lo­gos Cap­i­tal, and an in­vest­ment fund as­so­ci­at­ed with SVB Leerink. Re­turn­ing in­vestors Fore­site Cap­i­tal, Or­biMed, Nex­tech In­vest, and Vi­da Ven­tures al­so backed the round.

“I re­al­ly do see this not as an as­set or two we are de­vel­op­ing, but as a com­pa­ny we are build­ing,” Farzan said.

The Pax­Vax vet spent sev­en years as pres­i­dent and CEO be­fore the com­pa­ny was bought by Emer­gent BioSo­lu­tions in 2018. In March, he took over for Kin­nate co-founder and for­mer CEO Stephen Kaldor.

Ap­proval of Kin­nate’s lead pro­grams “would con­tin­ue to demon­strate that tar­get­ed ther­a­pies are a sub­stan­tial ad­di­tion to the ar­ma­men­tar­i­um that physi­cians have to bat­tle can­cer. Can­cer is a … it’s kind of a nev­er-end­ing strug­gle,” Farzan said. “… It’s al­ways go­ing to try to de­vel­op mu­ta­tions and de­vel­op re­sis­tance, and so you have to con­stant­ly keep in­no­vat­ing.”

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.