Robert LaCaze, incoming CEO of Mnemo Therapeutics

Bay­er on­col­o­gy vet Robert La­Caze has his eyes on next steps — land­ing his first gig as CEO of Sade­lain co-found­ed biotech

Three weeks af­ter Bay­er put out word that Robert La­Caze, its head of their on­col­o­gy strate­gic busi­ness unit, was jump­ing ship, we now know where he’s head­ed: the transat­lantic T-cell biotech Mnemo Ther­a­peu­tics, where La­Caze will be tak­ing up the helm and mov­ing for­ward as CEO on May 1.

Alain Maiore

Found­ing CEO Alain Maiore is stay­ing with the com­pa­ny, but is piv­ot­ing his role from CEO to COO.

Michel Sade­lain, the CAR-T re­searcher and Juno co-founder at Memo­r­i­al Sloan Ket­ter­ing, had put his name and cell en­gi­neer­ing tech­nol­o­gy be­hind the start­up when it of­fi­cial­ly launched back in June — and he’s list­ed as a sci­en­tif­ic co-founder. Maiore said at the time that they as a com­pa­ny were ready to bring on the next gen­er­a­tion of cell ther­a­pies in what­ev­er fla­vor they come.

About this time last year, the French biotech, which set a record last year for the high­est Se­ries A out of a French biotech at $90 mil­lion, had on­ly 7 em­ploy­ees. As of this week, they are now at 45 em­ploy­ees — with of­fices and labs in Paris, New York and now Prince­ton, where La­Caze and some re­searchers will be work­ing out of.

La­Caze told End­points News this morn­ing that he had helped pick Chris­tine Roth as his re­place­ment at Bay­er, where he had been work­ing for the last six years. La­Caze and Roth are for­mer col­leagues — they did their front­line man­ag­er train­ing to­geth­er while they both worked at Bris­tol My­ers Squibb back in the 1990s. So when Roth takes over his role on March 1, he will be­gin his tran­si­tion out of Bay­er and bring her up to speed on his now-for­mer job while en­gag­ing more with Mnemo.

“But at some point in time, when I was look­ing at my ca­reer and what I want­ed to do, you know… It’s a nat­ur­al tran­si­tion for me to tran­si­tion to a CEO type of role. But I want­ed to be very care­ful which type of com­pa­ny I went to,” La­Caze said.

And one night, La­Caze got a call, where he and Mnemo got con­nect­ed.

In bring­ing La­Caze aboard the biotech, Maiore told End­points:

What I re­al­ly want­ed to avoid as a founder is a pit­fall of many Eu­ro­pean biotech com­pa­nies where the founders are glued to their chairs and they don’t know when to bring the right tal­ent to pro­pel the com­pa­ny for­ward. I re­al­ly want­ed to avoid that mis­take. And you know, it’s been re­al­ly a pleas­ant jour­ney. The more we spoke with and talked with Robert, the more we felt that we could work well to­geth­er. And so the board and in­vestors share that per­spec­tive that Robert can make a huge con­tri­bu­tion in putting this com­pa­ny on the map.

What’s next for the com­pa­ny? Ac­cord­ing to Maiore, one of the big goals is to raise a Se­ries B — which he and La­Caze will do to­geth­er. When the biotech raised the Se­ries A last year, Mnemo ex­pect­ed it would last the biotech three years, through 2024. How­ev­er, Maiore says that they are ahead of sched­ule in terms of re­search, and spar­ing some of the de­tails, they are look­ing at rais­ing the Se­ries B be­fore the three years are up.

And on the re­search and pipeline side, the com­pa­ny has a few pre­clin­i­cal as­sets in play, Maiore told End­points — and the biotech hopes to have com­plet­ed INDs by the end of 2023.

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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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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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.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

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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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.