On the heels of an Eli Lil­ly deal, NextCure’s hot hand in I/O at­tracts a $93M trans-Pa­cif­ic ven­ture round

Last week Eli Lil­ly showed their faith in NextCure by fronting an im­muno-on­col­o­gy col­lab­o­ra­tion with $40 mil­lion in up­front and eq­ui­ty cash. This week the biotech is com­ing out with a $93 mil­lion raise to help il­lus­trate how trendy I/O re­mains in ven­ture cir­cles — es­pe­cial­ly if you promise to break some new ground in the field.

Michael Rich­man

Ex­perts in ex­plor­ing the sur­face of cells in the de­vel­op­ment of new can­cer ther­a­pies, their lead drug is in pre­clin­i­cal de­vel­op­ment. NC318 tar­gets S15, which the com­pa­ny be­lieves helps myeloid cells sur­vive and thrive, while tap­ping down on the T cell re­spons­es that are now be­ing dri­ven by a host of drugs in the clin­ic.

“Things have changed,” says CEO Michael Rich­man. “There’s a lit­tle I/O fa­tigue.”

NextCure, though, isn’t an­oth­er PD-1/L1 play. They plan to go in­to nov­el ar­eas, which NextCure sees as the true next-gen ap­proach to im­muno-on­col­o­gy.

“Our goal from the be­gin­ning: What about the non re­spon­ders?” he adds.

Lieping Chen

Their sci­en­tif­ic founder is Lieping Chen, a can­cer re­search pro­fes­sor at Yale. The pro­fes­sor was al­so a sci­en­tif­ic founder at Am­plim­mune, which Rich­man and some of his col­leagues ran be­fore sell­ing the com­pa­ny to As­traZeneca 5 years ago.

An ex­pert in im­munol­o­gy, Chen brings some broad tal­ents in the field, giv­ing Beltsville, MD-based NextCure a shot at de­vel­op­ing a much broad­er pipeline that ex­tends in­to au­toim­mune dis­eases and an­ti-in­flam­ma­to­ry con­di­tions — with im­pli­ca­tions for CNS ail­ments.

An­oth­er el­e­ment that sets the com­pa­ny apart, says the CEO, is that NextCure has its own GMP man­u­fac­tur­ing fa­cil­i­ty for the drugs it is test­ing. And that gives them con­trol of the en­tire pre-IND pack­age.

That’s the kind of pro­file that can dri­ve plen­ty of sup­port, es­pe­cial­ly as new Chi­nese in­vestors go deep­er and deep­er in­to the US scene.

Michael Yi

Hill­house Cap­i­tal Man­age­ment and Quan Cap­i­tal led the round, which in­clud­ed Bay City Cap­i­tal, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Ping An Ven­tures, Tai­ho Ven­tures, Ar­row­Mark Part­ners and NS In­vest­ment. All ex­ist­ing in­vestors al­so par­tic­i­pat­ed in this fi­nanc­ing, in­clud­ing Canaan Part­ners, Lil­ly Asia Ven­tures, Or­biMed Ad­vi­sors, Pfiz­er, Sofinno­va Ven­tures and Alexan­dria Ven­ture In­vest­ments. The raise al­so in­cludes $15 mil­lion Eli Lil­ly com­mit­ted when it signed up for the part­ner­ship last week.

Stel­la Xu

Michael Yi from Hill­house Cap­i­tal Man­age­ment and Stel­la Xu out of Quan Cap­i­tal will join the board of di­rec­tors.

Added all to­geth­er, NextCure has raised more than $180 mil­lion in 2 years.

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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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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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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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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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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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 14. 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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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).

Charlie Silver (Mission Bio)

'We want to be every­where.' Mis­sion Bio rais­es $70M be­hind re­sis­tance-hunt­ing se­quenc­ing plat­form

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silver’s startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detect early response or resistance to new cancer therapies.

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.