Be­fore the ad­vent of CAR-T, the term cell ther­a­py con­jured up very dif­fer­ent im­ages. Sure, there were can­cer im­munother­a­pies like Den­dreon’s Provenge, but more com­mon were the var­i­ous fla­vors of stem cell ther­a­pies and cell trans­plan­ta­tion.

None of that has gone away, even if they’ve been nudged out of the spot­light — and a lit­tle biotech has gar­nered $54 mil­lion (£40 mil­lion) to show that both the old and new ideas of cell (and gene) ther­a­py can mesh to­geth­er to form a spe­cial breed of plat­form com­pa­ny.

Joe Dupere

Ix­a­ka is launch­ing with quite a bit of his­to­ry. For­mer­ly Rex­gen­ero, it had li­censed a tech­nol­o­gy known as con­cen­trat­ed mul­ti-cell ther­a­pies from the An­dalu­sian Re­gion­al Min­istry of Health in Seville, Spain to get start­ed in 2015 and last June ex­pand­ed its fo­cus by bag­ging France’s aratin­ga.bio and its tar­get­ed nanopar­ti­cles — which puts a twist to off-the-shelf CAR-T ther­a­pies. Through it all, the com­pa­ny’s head­quar­ters had re­mained in Lon­don.

While the two ini­tial pro­grams — a Phase III mul­ti-cell ther­a­py de­signed to treat the se­ri­ous car­dio­vas­cu­lar con­di­tion chron­ic limb-threat­en­ing is­chemia, and a pre­clin­i­cal CD19 can­cer drug — may seem un­re­lat­ed to each oth­er, CEO Joe Dupere be­lieves that they re­quire the same un­der­ly­ing ex­per­tise to de­liv­er. That spans leg­isla­tive knowl­edge, man­u­fac­tur­ing knowhow, reg­u­la­to­ry deft­ness, lo­gis­ti­cal ex­pe­ri­ence and more.

“So there are a num­ber of fac­tors which are very, very com­mon be­tween cell and gene ther­a­pies, to­geth­er with some spe­cif­ic fac­tors around in­di­vid­ual in­di­ca­tions,” he told End­points News. “So we have ca­pa­bil­i­ties and a good net­work in the car­dio­vas­cu­lar area, in the on­col­o­gy area, but we very much view that the ca­pa­bil­i­ties we have from a sci­en­tif­ic, med­ical, clin­i­cal per­spec­tive en­able us to de­sign so­lu­tions that we can ap­ply to a whole range of dif­fer­ent in­di­ca­tions but uti­liz­ing our fun­da­men­tal un­der­stand­ing of the bi­ol­o­gy, med­i­cine, and how do you bring these prod­ucts to mar­ket.”

The new fund­ing, which comes from ex­ist­ing share­hold­ers, will see Ix­a­ka to the end of its on­go­ing Phase III for REX-001, the car­dio­vas­cu­lar prod­uct.

To date, more than 150 peo­ple had been treat­ed with the au­tol­o­gous ther­a­py, Dupere not­ed. Clin­i­cians first ex­tract bone mar­row from pa­tients, then trans­port­ed to a fa­cil­i­ty where the most ac­tive cells (stem cells, T cells, mono­cytes, gran­u­lo­cytes, and so on) are picked out and pack­aged in­to a sy­ringe that then gets in­fused back, tar­get­ing the ves­sels in the low­er leg.

The idea is that the cells would then re­store the im­bal­ance of cells at those ves­sels and, ac­cord­ing to Ix­a­ka, it had looked promis­ing in Phase II tri­als. Up to 80% of those small­er groups had re­spond­ed as hoped, with blood flow re­stored, “ul­cers healed, pain re­lieved.”

With an in­ter­im analy­sis slat­ed for lat­er this year, Dupere said Ix­a­ka will al­so plan for a sec­ond Phase III — this time not just in Eu­rope but al­so in the US — as well as scal­ing up man­u­fac­tur­ing and get­ting ready for com­mer­cial­iza­tion and mar­ket ac­cess, even though ap­proval isn’t ex­pect­ed un­til 2024 or 2025.

For the sec­ond lead pro­gram, dubbed Celtic, the Se­ries A should be suf­fi­cient to fu­el an­i­mal proof of con­cept. Some­what like Umo­ja, a fel­low up­start based out of Seat­tle, Ix­a­ka is aim­ing to pro­duce a bi­o­log­ic that lets can­cer pa­tients make their own CAR-T in vi­vo.

The tools they’re us­ing are poly­mer-based nanopar­ti­cles that con­tain a mod­i­fied, in­ert lentivirus and a cell-spe­cif­ic pro­mot­er as the ge­net­ic car­go. Ix­a­ka will start by lever­ag­ing the well-known CD19 tar­get to see if it can prove faster, cheap­er and even more ef­fec­tive than the first (and, by the time it gets fur­ther, like­ly sec­ond) wave of CAR-T prod­ucts. In both pro­grams, Dupere added, the cost of goods is a frac­tion of what peo­ple cur­rent­ly as­so­ciate with CAR-T cell ther­a­pies.

“That gives you much more scope to go for dif­fer­ent in­di­ca­tions which wouldn’t po­ten­tial­ly sup­port such high lev­els,” he said — in­di­ca­tions that Ix­a­ka is now in the process of “triag­ing.”

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.