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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.