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.

The US Solicitor General is calling on the Supreme Court to take up a fiercely debated case that could have a chilling effect on generic drug companies’ willingness to bring their copycats to market under so-called “skinny” labels, meaning the generic can only be approved for some of the reference product’s indications.

The case in question relates to GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg (carvedilol). At the time in 2007, Teva’s generic label first included two of the three Coreg indications, but Teva did not initially win approval for the third indication for congestive heart failure.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors Archimed and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sarissa Capital gained another foothold in its takeover of Amarin with the departure of the Irish drugmaker’s CEO.

Amarin revealed Friday in an SEC filing that Karim Mikhail resigned as president and CEO earlier this week. However, there’s still an ongoing dispute between Mikhail and Amarin, with the now ex-CEO insisting that he has a claim to severance as a result of his resignation. However, Amarin says it disagrees and plans to dispute that claim.

The NIH provided billions of dollars over a decade to foreign companies for research projects that use animals — and the US Government Accountability Office thinks the NIH needs to strengthen its oversight of those sites to ensure the animals’ welfare.

In a report released Thursday based on an investigation requested by Congress, the GAO recommended that the NIH conduct site visits and require third-party verification of the annual reports submitted by the companies in order to “provide reasonable assurance that award recipients’ annual self-reported project information is reliable and adequate to ensure the humane care and use of laboratory animals.”