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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

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.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

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.