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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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