Since com­ing in­to a mas­sive wind­fall with its Covid-19 vac­cines, Mod­er­na has been look­ing for ways to ex­pand its mR­NA tech­nolo­gies in­to oth­er promis­ing ar­eas. On Mon­day, the biotech took its next step to­ward that goal.

Mod­er­na is part­ner­ing with Caris­ma Ther­a­peu­tics on a huge slate of “CAR-M” pro­grams to treat can­cer, the com­pa­nies an­nounced Mon­day morn­ing, promis­ing $45 mil­lion up­front and $35 mil­lion in eq­ui­ty. Though the amount of mile­stones was not spec­i­fied, the biotechs not­ed Mod­er­na has the op­tion to nom­i­nate up to 12 tar­gets for de­vel­op­ment.

Caris­ma will lead pre­clin­i­cal and dis­cov­ery ef­forts while Mod­er­na will take charge for clin­i­cal stud­ies and po­ten­tial com­mer­cial­iza­tion.

“It’s a clear tech­nol­o­gy fit for our mR­NA LNP plat­form,” Rose Lough­lin, Mod­er­na SVP of re­search and ear­ly de­vel­op­ment, told End­points News of the deal. “By part­ner­ship, it re­al­ly lets us quick­ly ex­pand the reach of that plat­form … It’s ide­al for this type of ap­pli­ca­tion, giv­en what they can do. They re­al­ly com­ple­ment our cur­rent on­col­o­gy port­fo­lio.”

Stéphane Ban­cel

The Covid-19 vac­cine has turned Mod­er­na from a biotech with no ap­proved prod­ucts in­to a com­pa­ny worth more than $87 bil­lion as of Mon­day morn­ing — and its CEO, Stéphane Ban­cel, in­to a multi­bil­lion­aire. Pri­or to Mon­day, Mod­er­na al­ready had a few on­col­o­gy pro­grams un­der its belt, in­clud­ing can­cer vac­cines and ex­per­i­men­tal ther­a­peu­tics in­ject­ed di­rect­ly in­to tu­mors.

But Mon­day’s deal marks a new step in that port­fo­lio ex­pan­sion, push­ing Mod­er­na in­to in vi­vo cell ther­a­py tech­nol­o­gy. When the plat­forms are used to­geth­er, Lough­lin said, the mR­NA and LNPs will be used to de­liv­er the CAR-M ther­a­pies, where ‘M’ stands for mono­cytes, a class of in­nate im­mune cells.

“As we think about this ap­pli­ca­tion, in im­muno-on­col­o­gy, it is very much di­rect­ing the im­mune im­pact of these cells to the tu­mor, chang­ing that tu­mor mi­croen­vi­ron­ment and then uti­liz­ing the rest of the im­mune sys­tem, re­al­ly train­ing it to fight the tu­mor,” Lough­lin said. “They’re al­so pre­sent­ing anti­gens from that can­cer cell.”

For Caris­ma, the part­ner­ship marks the next step in the com­pa­ny’s growth, CEO Steve Kel­ly told End­points. The biotech, launched back in 2017 to de­vel­op sol­id tu­mor cell ther­a­pies us­ing CARs and macrophages, put its first pro­gram in­to the clin­ic last year for an au­tol­o­gous CAR-M tar­get­ing HER2-ex­press­ing tu­mors.

Mono­cytes, though, are the pre­cur­sor to macrophages, Kel­ly not­ed, es­sen­tial­ly a pro­drug for the white blood cells. The com­pa­nies will fo­cus on de­liv­er­ing mR­NA ex­pres­sion for CARs to mono­cytes in cir­cu­la­tion, which will then “traf­fic to the tu­mor and dif­fer­en­ti­ate in­to macrophages at that point,” Kel­ly said.

The way the two plat­forms fit to­geth­er “comes down to the speci­fici­ties of the lipid nanopar­ti­cle,” Kel­ly added.

It re­mains to be seen whether Mod­er­na’s suc­cess­es in Covid-19 can be repli­cat­ed in oth­er fields, but ear­ly re­turns have not al­ways im­pressed in­vestors. Last month, Mod­er­na re­leased da­ta for its mR­NA flu shots tout­ing sig­nif­i­cant boost­ing of an­ti­bod­ies, but they didn’t ap­pear to of­fer any clear ad­van­tages over al­ready ap­proved jabs.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.