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.

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.