Fol­low­ing the ex­o­dus at Im­muno­core, Eliot Forster takes the reins at F-star — how long be­fore the crossover and an IPO?

LON­DON — Over the past 12 years, F-star has built up a rep for an­ti­body de­sign work that’s gar­nered the avid at­ten­tion of a line­up of both big and re­mark­able de­vel­op­ment part­ners. But aside from the deals it’s done, and the mile­stones it’s been rack­ing up, the Cam­bridge biotech nev­er raised much cash for its op­er­a­tions from in­vestors.

Em­ploy­ee #99, though, may just do some­thing about that.

This morn­ing Eliot Forster, the high-pro­file biotech ex­ec who re­cent­ly left the helm at Im­muno­core, will step up to the CEO’s job at F-star. He’s tak­ing the top job at a time the biotech is ad­vanc­ing to­ward its first clin­i­cal de­vel­op­ment work on an in-house pipeline — putting the com­pa­ny at the cross­roads.

In an in­ter­view in Lon­don on Sun­day, I point­ed out that with the re­cent ap­point­ment of At­las part­ner Nes­san Berming­ham to the ex­ec­u­tive chair­man’s job at F-star and his own move, it seemed like the game plan would like­ly call for a siz­able crossover round and IPO. That’s a fi­nanc­ing piv­ot which he agreed seemed “ob­vi­ous and sen­si­ble” giv­en the com­pa­ny’s cash re­quire­ments to build the in-house pipeline, which is where the fo­cus is now.

“They need to go through that step that — if biotechs are lucky — they get to go through,” says Forster.

Just 5 months ago F-star be­gan an ear­ly-stage study of FS118, a bis­pe­cif­ic that tar­gets PD-L1 as well as LAG-3, un­der op­tion to Mer­ck KGaA. Forster now us­es it as an ex­am­ple of the kind of next-gen drug that can suc­ceed in the mar­ket­place, in­cor­po­rat­ing the PD-L1 check­point with an­oth­er tar­get, rather than work­ing on a com­bi­na­tion of two pricey drugs.

The plat­form tech re­volves around F-star’s abil­i­ty to add an anti­gen bind­ing site in the Fc re­gion of an an­ti­body, com­ing up with a bis­pe­cif­ic de­signed to re­main rel­a­tive­ly straight­for­ward to man­u­fac­ture. 

John Hau­ram

Un­der CEO John Hau­ram — who’ll be help­ing out now as a con­sul­tant as he ends a reg­u­lar com­mute from Copen­hagen to spend more time with the fam­i­ly — the biotech al­so signed deals with Ab­b­Vie and Bris­tol-My­ers Squibb, though Bris­tol-My­ers re­cent­ly de­cid­ed to drop their col­lab­o­ra­tion. De­nali, though, has been pumped about the neu­ro­science pact they struck with F-star, es­pe­cial­ly af­ter run­ning through some late pre­clin­i­cal work on their drugs.

Forster has raised some eye-open­ing sums, most no­tably the whop­ping $320 mil­lion record-set­ting — for Eu­rope — round in 2015.

This is around the time that a biotech could, in Forster’s words, “fart in a bag and get 10 mil­lion for it.” 

Forster, though, abrupt­ly left his top job at the com­pa­ny last Feb­ru­ary, not long af­ter he told me that he was look­ing for an­oth­er mon­ster round of cash. And in short or­der, his whole ex­ec­u­tive team at Im­muno­core was swept away and re­placed.

Forster won’t com­ment on what hap­pened. But in dis­cus­sions with sev­er­al peo­ple fa­mil­iar with the talks in­side Im­muno­core, it’s ap­par­ent the biotech was hav­ing a hard time stick­ing with its high-end uni­corn val­u­a­tion. The pres­sure point over val­u­a­tion led to his de­par­ture and the ex­o­dus that fol­lowed, with a new team in to pick up the pieces.

That’s all be­hind Forster, though. F-star has some valu­able ven­ture re­la­tion­ships, and we’re in a time when clin­i­cal-stage I/O com­pa­nies can ex­pect a warm wel­come on the Nas­daq, the go-to spot for UK drug de­vel­op­ers these days.

F-star will now get a chance to join a se­lect group of top play­ers in the Gold­en Tri­an­gle who can ben­e­fit from the cur­rent fundrais­ing en­vi­ron­ment, with in­vestors on both sides of the At­lantic in­ter­est­ed in step­ping up. At a time when Brex­it is push­ing the UK to a break with the EU, the coun­try’s top biotechs are spend­ing more time look­ing to the mas­sive US mar­ket to the west. And F-star is no ex­cep­tion.


Im­age: Eliot Forster. JOHN CAR­ROLL, END­POINTS NEWS

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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