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.”

The top career staff at the FDA has vowed not to let politics overrule 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 the FDA and other health agencies under his purview of their rule making 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.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.