Jason Springs, Endpoint Health CEO

Pre­ci­sion drug + di­ag­nos­tics biotech scores mod­est Se­ries A, retro­fitting ex­ist­ing drug for new in­di­ca­tion

A small biotech is go­ing af­ter sep­sis — and it has raised some more mon­ey to ad­vance that goal and get its new­ly-ac­quired drug in­to the clin­ic.

With $52 mil­lion in debt and eq­ui­ty funds via a Se­ries A, pre­ci­sion ther­a­peu­tics out­fit End­point Health (no re­la­tion to End­points News) now has the cap­i­tal to al­so con­sid­er ex­pand­ing in­to au­toim­mune in­di­ca­tions, CEO Ja­son Springs tells End­points News.

The funds will push the biotech’s plat­form and pipeline for­ward, plus move the start­up’s in-li­censed drug to Phase II clin­i­cal tri­als and sub­mit an IND and IDE (In­ves­ti­ga­tion­al De­vice Ex­emp­tion) to the FDA lat­er in 2022, the com­pa­ny said Thurs­day.

In terms of re­cent de­vel­op­ments for the biotech, the Se­ries A comes just a few months af­ter End­point an­nounced a col­lab­o­ra­tion and li­cens­ing deal with Span­ish phar­ma and man­u­fac­tur­er Gri­fols for An­tithrom­bin III, a drug orig­i­nal­ly ap­proved in pa­tients with hered­i­tary an­tithrom­bin de­fi­cien­cy, an in­her­it­ed blood clot­ting dis­or­der. The planned in­di­ca­tion is sep­sis, a life-threat­en­ing con­di­tion where the body’s re­sponse to in­fec­tion goes over­board and can lead to or­gan fail­ure.

That deal in­clud­ed $25 mil­lion from Gri­fols for clin­i­cal de­vel­op­ment, and End­point gets ex­clu­sive rights to the drug in sep­sis in all coun­tries ex­cept for Chi­na. End­point al­so takes on fu­ture clin­i­cal de­vel­op­ment re­spon­si­bil­i­ties, plus split­ting the costs for man­u­fac­tur­ing and pay­ing Gri­fols roy­al­ties.

And while sep­sis is the biotech’s first em­pha­sis, Springs said it’s not the on­ly one the biotech has on its radar. Part of the plan is look­ing at au­toim­mune in­di­ca­tions, such as pos­si­bly rheuma­toid arthri­tis and IBD.

Even though au­toim­mune in­di­ca­tions are a much more com­pet­i­tive space in re­cent years thanks to the suc­cess of megablock­buster drugs such as Hu­mi­ra ($20 bil­lion+ in an­nu­al sales is noth­ing to laugh at), Springs not­ed that there is room to find a niche. The CEO added:

It’s im­por­tant to know that there are I think, more than 60 rec­og­nized au­toim­mune in­di­ca­tions. So I men­tioned ar­eas like rheuma­toid arthri­tis and in­flam­ma­to­ry bow­el dis­ease, be­cause they’re very well-known. That’s al­so where we have some da­ta. But there are many, many in­di­ca­tions where, de­spite ad­vances in the more well-known au­toim­mune in­di­ca­tions, like RA or IBD, there’s pa­tients suf­fer­ing from ill­ness­es where they re­al­ly have no next gen­er­a­tion, or nov­el ther­a­pies that can re­solve their dis­ease. They’re stuck with steroids, which have a num­ber of com­pli­cat­ed prob­lems if you take them sys­tem­i­cal­ly for too long. So we think that im­prov­ing pa­tients who are cur­rent­ly not be­ing well-served by ex­ist­ing ther­a­pies is an im­por­tant area.

End­point’s in­vestors in­clude May­field, Hum­boldt Fund, AME Cloud Ven­tures, Boom Cap­i­tal, Al­ix Ven­tures, Yaya Cap­i­tal, Wire­frame Ven­tures, The Ven­ture Col­lec­tive, HCX Ven­tures and Glob­al Health In­vest­ment Cor­po­ra­tion (GHIC).

In short, the biotech has been pri­mar­i­ly fo­cused on its da­ta plat­form af­ter be­ing found­ed in 2019. So far, the da­ta plat­form is sort of the ba­sis of the biotech, which has been work­ing on de­vel­op­ing drug can­di­dates that tar­get spe­cif­ic pa­tient pop­u­la­tion groups. How those groups are iden­ti­fied is by the use of “com­pan­ion di­ag­nos­tics,” a blood test that End­point de­vel­oped.

Springs told End­points that the re­sults from the blood test feed in­to the biotech’s main da­ta plat­form, most­ly gene ex­pres­sion da­ta and the mea­sure of RNA, and goes out and looks for un­der­ly­ing pat­terns in pa­tient bi­ol­o­gy. The CEO then elab­o­rat­ed about sep­sis — and how the biotech found three sub­groups of pa­tients when tak­ing a look at gene ex­pres­sion da­ta. Springs called these groups A, B and C for sim­plic­i­ty’s sake.

“What we no­ticed is that, for ex­am­ple, there’s a group of pa­tients that are hav­ing a ro­bust but ap­pro­pri­ate im­mune re­sponse,” Springs said. He added that “we call them type A pa­tients. And these are pa­tients that ac­tu­al­ly seem to have pret­ty good out­comes. They have an adap­tive im­mune re­sponse, they’re fight­ing off their in­fec­tion. Sep­a­rate from those pa­tients, we could see a group that we would call type B, and these are pa­tients that are hav­ing a stronger in­flam­ma­to­ry re­sponse, one that may lead to dam­age to the pa­tient’s own body.”

Springs then dis­cussed the third group of pa­tients — type C — which End­point saw could ex­pe­ri­ence com­pli­ca­tions in sep­sis from co­ag­u­lopa­thy, a con­di­tion that can re­sult in ex­ces­sive clot­ting. Springs fur­ther added that as these pa­tients could form sub­stan­tial num­bers of blood clots and ex­pe­ri­ence or­gan dam­age and high mor­tal­i­ty rates, End­point hy­poth­e­sized that the drug from Gri­fols could work — which is what they’re plan­ning to test.

In terms of size, the biotech is cur­rent­ly about 25 strong, but with the new in­fu­sion of cash, Springs said the biotech is look­ing at hir­ing an­oth­er 10-20 with­in the next 12-18 months.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.