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

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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