Greg Verdine, FogPharma CEO

With the clin­ic in sight, Greg Verdine's start­up bags $178M for new class of tar­get­ed ther­a­pies

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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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