Re­jig­ging Mer­ck KGaA part­ner­ship, Eliot Forster gains full con­trol of the al­pha in F-star's con­stel­la­tion

Eliot Forster walked in­to this year’s JP Mor­gan con­fer­ence — his first since as­sum­ing the CEO seat at F-star — with a clear goal in mind: Talk to Mer­ck KGaA about get­ting its lead bis­pe­cif­ic an­ti­body back.

Four months lat­er, the sea­soned biotech en­tre­pre­neur is pleased to find FS118 ful­ly un­der his team’s con­trol as he piv­ots F-star away from a part­ner­ship mod­el in­to a more ma­ture, in­de­pen­dent play­er mak­ing its own calls in the clin­ic.


Im­age: Eliot Forster. JOHN CAR­ROLL for END­POINTS NEWS

In ad­di­tion to un­lock­ing more po­ten­tial val­ue in the long term, the arrange­ment al­lows F-star to pur­sue a bio­mark­er-dri­ven de­vel­op­ment strat­e­gy — with the speed and agili­ty of a small biotech but the dis­cern­ment and cash re­serve of a 13-year-old out­fit. Hav­ing re­cent­ly ex­pand­ed to the US, F-star now boasts of over 100 staffers spread be­tween both Cam­bridges in the US and UK.

The strate­gic shift will mean chart­ing new av­enues for fund­ing as part­ner­ship mon­ey stops com­ing in. Forster, known among Eu­ro­pean cir­cles for a record-set­ting $320 mil­lion round at Im­muno­core, pre­vi­ous­ly told End­points News that a siz­able crossover round and IPO are all in the pic­ture.

What re­mains un­changed is the com­pa­ny’s pitch: a plat­form tech that can add an anti­gen bind­ing site in the Fc re­gion of an an­ti­body, churn­ing up bis­pecifics that re­main straight­for­ward (and thus cheap) to man­u­fac­ture.

In the case of FS118, the tech con­jures a next-gen drug that tar­gets both PD-​L1 and LAG-​3, a T cell sur­face mol­e­cule thought to hin­der pro­lif­er­a­tion of the im­mune cells. By in­cor­po­rat­ing a check­point with an­oth­er an­ti­body in one ther­a­py, Forster sees a win­ning en­try for the mar­ket­place that can re­place a com­bi­na­tion of two pricey drugs.

“The ju­ry’s ful­ly out” on the mer­its of PD-L1 ver­sus PD-1 as a tar­get, Forster tells me. And be­ing able to find PD-L1, which is over­ex­pressed on tu­mor cells, might make it eas­i­er for the T cells to see and un­leash an at­tack on them.

The com­pa­ny has start­ed an ear­ly-stage study of FS118, which is ex­pect­ed to gen­er­ate its first da­ta cut late this year.

F-star re­mains tied up with Mer­ck KGaA on four oth­er pre­clin­i­cal pro­grams, two of which the Ger­man phar­ma is li­cens­ing. Mean­while, the li­cense agree­ments with Ab­b­Vie and De­nali — both li­cens­ing agree­ments with no op­tions to ac­quire de­vel­op­ment rights back — will stand as F-star’s on­ly sig­nif­i­cant dis­cov­ery part­ner­ships for some time to come.

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.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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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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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Trevor Martin (Mammoth)

Eye­ing in-vi­vo edit­ing, Mam­moth li­cens­es Jen­nifer Doud­na’s new CRISPR en­zyme

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.

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.

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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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).