A li­cens­ing deal worth up to $520 mil­lion has been fu­el­ing lit­tle-known Swiss biotech CDR-Life since May 2020, but the five-year-old start­up is ready to haul in tra­di­tion­al ven­ture cap­i­tal fi­nanc­ing.

Rafaèle Tord­j­man

Af­ter Boe­hinger In­gel­heim ful­ly took con­trol of the duo’s col­lab­o­ra­tion on a pre­clin­i­cal an­ti­body for ge­o­graph­ic at­ro­phy — one of the lead­ing caus­es of blind­ness — last sum­mer, CDR-Life went to work find­ing in­vestors to take its plat­form for­ward in sol­id tu­mors. Fill­ing that fund­ing role are RA Cap­i­tal Man­age­ment and Rafaèle Tord­j­man’s Jeito Cap­i­tal, who are co-lead­ing CDR-Life’s $76 mil­lion Se­ries A with help from Otel­lo Stam­pac­chia’s Omega Funds.

“We didn’t need the Se­ries A as ear­ly as you might oth­er­wise per­haps need. The tim­ing is per­fect now. We are a lit­tle over a year from the clin­ic with our pri­ma­ry project and we want­ed to raise the funds to move that project to clin­i­cal proof of con­cept,” CEO Chris­t­ian Leis­ner told End­points News.

Otel­lo Stam­pac­chia

The biotech will en­ter the clin­ic some­time next year to gear up its first hu­man study for clin­i­cal proof of con­cept in can­cer around 2025, Leis­ner said. Pri­or to co-found­ing CDR-Life in 2017, Leis­ner was a unit leader for ear­ly de­vel­op­ment pro­grams in oph­thal­mol­o­gy at ES­BAT­e­ch, a No­var­tis com­pa­ny, and be­fore that held var­i­ous roles at NI­BR and else­where across the Big Phar­ma.

CDR-Life’s lead can­di­date, CDR404, is a dual MAGE-A4 T cell en­gager that is go­ing af­ter lung, blad­der and esophageal can­cers. MAGE-A4 is an “in­cred­i­bly at­trac­tive” tar­get be­cause of its unique­ness to tu­mor tis­sues, Leis­ner said. “You won’t find them much in healthy cells con­trary to many oth­er can­cer tar­gets,” he added.

Adap­ti­m­mune has been a lead­ing biotech in the MAGE-A4 field and plans to ask the FDA to ap­prove its drug afa­mi-cel for the treat­ment of ad­vanced/metasta­t­ic syn­ovial sar­co­ma in the fourth quar­ter of this year, the com­pa­ny said last month. Leis­ner called Adap­ti­m­mune’s MAGE-A4 pro­gram “re­al­ly en­cour­ag­ing, show­ing us that the tar­get is like­ly to re­al­ly work in pa­tients with these types of ther­a­pies.”

Be­hind CDR404 are three dis­cov­ery-stage as­sets — named 505, 106 and 304.

Be­yond those, CDR-Life wants to link arms with an­oth­er part­ner, in a sim­i­lar deal to the BI one, for CDR101, which tar­gets mul­ti­ple myelo­ma.

The Swiss up­start has “pre­clin­i­cal da­ta show­ing that this mol­e­cule is su­pe­ri­or to BC­MA ther­a­pies that are cur­rent­ly in clin­i­cal de­vel­op­ment from a num­ber of com­pa­nies,” Leis­ner said. “We think we have a good li­cens­ing da­ta pack­age, and we would like to fo­cus our own ef­forts on the sol­id tu­mor pro­grams.”

Along­side Leis­ner, the found­ing team in­cludes chair­man Do­minik Es­ch­er, CFO Kon­stan­tin von Schulthess, CSO Leonar­do Bor­ras and tech­ni­cal de­vel­op­ment chief Rou­ven Bin­gel-Er­len­mey­er. The group has worked on new an­ti­body drugs be­fore, in­clud­ing the FDA-ap­proved Beovu, a No­var­tis treat­ment for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.