ARCH Ven­ture Part­ners is buy­ing in­to Greg Ver­dine’s vi­sion for a world where no tar­gets are off-lim­its — with the goal of fi­nal­ly push­ing the first drug in­to the clin­ic.

The size of the Se­ries D fi­nanc­ing — $178 mil­lion — match­es the grand am­bi­tions Fog­Phar­ma has sketched out with its He­li­con com­pounds, a new class of polypep­tide drugs it says com­bines the cell-pen­e­trat­ing ca­pac­i­ty of small mol­e­cules with the tar­get-en­gag­ing tenac­i­ty of bi­o­log­ics.

The biotech is hop­ing to file an IND for FOG-001, a TCF-block­ing β-catenin in­hibitor, by mid-2023, a few months be­hind a Q4 2022 pro­jec­tion that Ver­dine of­fered up at the time of Fog’s $107 mil­lion Se­ries C in spring 2021. It’s al­so lin­ing up a slate of pro­grams hit­ting can­cer tar­gets that have been out of reach by oth­er ap­proach­es: TEAD, NRAS, Pan-KRAS, ERG and Cy­clin E1.

Ver­dine, a chemist at Har­vard and se­r­i­al en­tre­pre­neur, launched Fog­Phar­ma in 2016 with the idea for a “brace” that would lock polypep­tide struc­tures in place so that they can bet­ter pen­e­trate cells, home in on spe­cif­ic tar­gets and stay in the body for longer.

He told End­points News Mon­day morn­ing that he had want­ed to drug β-catenin from the very be­gin­ning, giv­en that it’s a dri­ver of 20% to 30% of all can­cer. But the tar­get in­ter­acts with so many pro­teins that it took sev­er­al at­tempts to fig­ure out the ex­act pro­tein Fog­Phar­ma would need to go af­ter — and on­ly set­tled on TCF af­ter the Broad In­sti­tute came up with DepMap, a can­cer de­pen­den­cy map lay­ing out the in­ter­ac­tions that var­i­ous can­cer cells are most de­pen­dent on.

Fog­Phar­ma will first test FOG-001 in col­orec­tal can­cer, where Ver­dine not­ed that 80% to 90% of pa­tients see ac­ti­va­tion of β-catenin. Lat­er tri­als in oth­er can­cer types may re­quire bio­mark­er-based pa­tient screen­ing.

“In ad­di­tion to tak­ing the lead prod­uct in­to the clin­ic, we al­so have back­ups, we have sec­ond gen,” Ver­dine said. “There’s a lot go­ing on there.”

Rick Klaus­ner

In con­junc­tion with the round, he’s re­cruit­ed Rick Klaus­ner — the for­mer Na­tion­al Can­cer In­sti­tute chief of Juno, Lyell and now Al­tos Labs fame — to the board of di­rec­tors.

These He­li­con polypep­tides, Ver­dine said in a state­ment, “rep­re­sent the fu­ture of pre­ci­sion med­i­cine.”

The round fea­tured two oth­er new in­vestors, Milky Way In­vest­ments and Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, as well as a group of ex­ist­ing in­vestors. Oth­er back­ers in­clude Ven­Bio Part­ners, Deer­field Man­age­ment, GV, Cor­morant As­set Man­age­ment, funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, In­vus, Far­al­lon Cap­i­tal Man­age­ment, HBM Health­care In­vest­ments, Cas­din Cap­i­tal, and Pags­Group.

Hav­ing raised $107 mil­lion just a year and a half ago, Ver­dine said the lat­est cash in­fu­sion will keep Fog­Phar­ma fund­ed un­til the sec­ond half of 2025. Ini­tial da­ta from tri­als are ex­pect­ed in mid-2024.

“The (pa­tient-de­rived tu­mor xenografts) da­ta are re­al­ly phe­nom­e­nal,” he said. “So if we get any­thing close to that in pa­tients, I think we’ll have all kinds of op­tions avail­able to us.”

Ed­i­tor’s note: Sto­ry up­dat­ed to add com­ment from Greg Ver­dine.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.