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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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