Christian Leisner, CDR-Life CEO

RA, Jeito and Omega back a small Swiss biotech to en­ter an I/O field paved by Adap­ti­m­mune

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.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

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.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

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

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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