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.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.