Noam Solomon and Luis Voloch set out, when they launched Im­mu­nai in 2018, to map out the im­mune sys­tem cell by cell.

The two en­gi­neers — who had met at MIT and like to il­lus­trate their com­pa­ny’s stature by point­ing out the num­ber of em­ploy­ees who had been trained at Palan­tir, Google or Face­book — saw the po­ten­tial in col­lat­ing all the in­for­ma­tion churned out by a sin­gle cell-se­quenc­ing mul­ti-omics plat­form. You can tell drug­mak­ers what ex­act­ly is in their cell ther­a­py prod­ucts, pro­file for aca­d­e­mics the im­mune re­sponse to their ex­per­i­men­tal treat­ments, or even sug­gest new bio­mark­ers that seem to be rel­e­vant in a dis­ease.

“Every sam­ple that we se­quence is more than a ter­abyte of in­for­ma­tion,” Solomon, the CEO, told End­points News. “So if we are talk­ing about the data­base on the or­der of thou­sands and even tens of thou­sands of sam­ples, we’re talk­ing about mas­sive data­bas­es, and run­ning com­pu­ta­tions on such a large data­base re­quires dif­fer­en­ti­at­ed ca­pa­bil­i­ties.”

But as Im­mu­nai signed more deals, they re­al­ized that some­thing else was miss­ing. Part­ners of­ten didn’t have a “da­ta-dri­ven” way to val­i­date the tar­gets, Solomon said, and they be­lieve they could help by of­fer­ing one more step be­yond min­ing in­sights from their big data­base.

So hav­ing raised $20 mil­lion in seed fund­ing last May, the duo have bagged a $60 mil­lion Se­ries A to move in­to what they call func­tion­al ge­nomics.

“It moves us from the cor­rel­a­tive analy­sis — which can still be very pow­er­ful — in­to things that are like causal val­i­da­tion,” CTO Voloch said. “We’re build­ing our whole in­fra­struc­ture to be able to do this at a scale and so­phis­ti­ca­tion that no one has right now.”

The set­up will be com­plete with a wet lab equipped to con­duct both in vi­vo and in vit­ro test­ing. Af­ter its al­go­rithms iden­ti­fy a ge­net­ic sig­na­ture po­ten­tial­ly tied to tu­mor re­sponse, for ex­am­ple, sci­en­tists at the com­pa­ny could then de­sign ex­per­i­ments to tease out the tar­get’s val­ue.

That’s the promise, at least, for the col­lab­o­ra­tors at Bay­lor Col­lege of Med­i­cine and the phar­ma cus­tomers who gained ac­cess to the AI plat­form through a deal with 10x Ge­nomics.

Im­mu­nai has so far ac­crued sam­ples “in the thou­sands” with a 70-strong team spread across 15 coun­tries, and there are plans to dou­ble or even triple the group as they push to se­quence more.

But Voloch em­pha­sized that it’s the abil­i­ty to look at in­di­vid­ual cells — some­times lon­gi­tu­di­nal­ly, track­ing T cell clon­al ex­pan­sion over the course of treat­ment — that mat­ters most.

“We have a data­base of cells so peo­ple can query for cells of spe­cif­ic fea­tures,” he said. “And that’s how we’ve been think­ing about it and so all of our ma­chine learn­ing and AI is large­ly at that cell unit.”

Schus­ter­man Fam­i­ly In­vest­ments, Duquesne Fam­i­ly Of­fice, Catalio Cap­i­tal Man­age­ment and Dex­cel Phar­ma led the round, while ex­ist­ing in­vestors Vi­o­la Ven­tures and TLV Part­ners par­tic­i­pat­ed.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.