Back in 2016, up­on grad­u­at­ing with his PhD from Uni­ver­si­ty Col­lege Lon­don, Giuseppe Maz­za and his pro­fes­sor Mas­si­mo Pin­zani spun out En­gi­tix to un­der­stand dis­ease from a slight­ly dif­fer­ent an­gle. Now they’re ready to build out a pipeline — and they’ve piqued the in­ter­est of British bil­lion­aire hedge fund man­ag­er Mike Platt.

Mike Platt

En­gi­tix un­veiled a $54 mil­lion Se­ries A round ear­ly Wednes­day morn­ing, on top of a new col­lab­o­ra­tion deal with Ital­ian bio­phar­ma com­pa­ny Dom­pé. The fo­cus is on the hu­man ex­tra­cel­lu­lar ma­trix (ECM) — the net­works of pro­teins and car­bo­hy­drates that pass be­tween cells, com­mu­ni­cat­ing and as­sur­ing the whole sys­tem func­tions.

If cells are like the bricks of a build­ing, the ECM is the scaf­fold­ing that sup­ports them, Maz­za ex­plained. The En­gi­tix CEO be­lieves un­der­stand­ing the ECM is im­por­tant to fig­ur­ing out how dis­eases progress — and new ways of tack­ling them. To do so, they’ve built ECM mod­els by tak­ing re­sect­ed tis­sues, “de­cel­lu­lar­iz­ing” them (re­mov­ing the cells) and then lat­er grow­ing cell lines in what’s left over. They source the hu­man tis­sue from an es­tab­lished net­work of biobanks.

“If you think that we live in a 3D en­vi­ron­ment, cells, in or­der to grow and de­vel­op tis­sue and de­vel­op or­gans, they need a frame­work, they need the in­fra­struc­ture,” Maz­za told End­points News. 

En­gi­tix has sev­er­al in-house pro­grams in the works, for pri­ma­ry scle­ros­ing cholan­gi­tis (PSC), ade­no­car­ci­no­ma (PDAC) and liv­er metas­ta­sis, and he­pa­to­cel­lu­lar car­ci­no­ma (HCC), as well as part­nered dis­cov­ery pro­grams in fi­bro­sis and sol­id tu­mors. Back in 2020, Take­da plumped down an up­front plus up to $500 mil­lion in biobucks for a dis­cov­ery and de­vel­op­ment pact in fi­brot­ic liv­er dis­eases, in­clud­ing non-al­co­holic steato­hep­ati­tis (NASH).

“We start­ed as a plat­form busi­ness. We have an ex­cel­lent part­ner­ship with Take­da and of course, this is ob­vi­ous­ly a top pri­or­i­ty in the busi­ness to ex­pand ob­vi­ous­ly oth­er po­ten­tial part­ner­ships, but the pri­or­i­ty is to move the in­ter­nal pipeline from val­i­dat­ed tar­gets to pre-IND stage,” Maz­za said.

That’s where the Se­ries A fund­ing comes in. The lat­est round was co-led by Nether­ton In­vest­ments, a fund in­vest­ing on be­half of Platt, who’s join­ing the team’s board of di­rec­tors. It’ll be used to push to­ward the clin­ic and ex­pand the team from 38 to 80 by year’s end. If all goes well, they’ll be in the clin­ic in 2025, Mas­sa said.

“I am pre­pared to take a risk and in­vest in in­no­v­a­tive tech­nol­o­gy ear­ly, back­ing high­ly pas­sion­ate teams with strong lead­er­ship,” Platt said in a state­ment. “Hav­ing in­vest­ed from the start, En­gi­tix’s progress and achieve­ments with­in less than two years from its seed fi­nanc­ing have been im­pres­sive.”

Un­der the new deal with Dom­pé, En­gi­tix will get di­rect ac­cess to the Ital­ian bio­phar­ma’s fa­cil­i­ties and re­sources, in­clud­ing its struc­ture-based drug de­sign plat­form that lever­ages the Ital­ian su­per­com­put­er cen­ter CINECA. En­gi­tix will re­tain full con­trol over its pro­grams — and though the com­pa­nies aren’t shar­ing the fi­nan­cial terms of the deal, Dom­pé will be el­i­gi­ble for cer­tain mile­stones and roy­al­ties.

“I think that strate­gi­cal­ly we need to ad­dress un­met med­ical needs. At the end of the day, biotech is re­al­ly chal­leng­ing, so at least you need to try to ad­dress big chal­lenges. That’s my ap­proach,” Maz­za said, adding that the team has dis­cussed go­ing af­ter oth­er con­di­tions like lung fi­bro­sis, cer­tain neu­rode­gen­er­a­tive dis­or­ders, or col­orec­tal can­cer.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.