Wern­er Cautreels is leav­ing Se­lec­ta, hand­ing reins to Bay­er vet; No­var­tis lines up a man­u­fac­tur­ing part­ner for Chi­na CAR-T mar­ket­ing

Wern­er Cautreels

Wern­er Cautreels, the long­time CEO at Se­lec­ta Bio­sciences $SELB, is re­tir­ing from his post. The biotech re­port­ed this morn­ing that Bay­er vet Carsten Brunn has been named as the new CEO. Cautreels is stay­ing on as an ad­vis­er af­ter he leaves his job at the end of this year. Se­lec­ta is prep­ping a Phase III study for SEL-212, an ex­per­i­men­tal gout drug. Cautreels was named CEO in 2010, a cou­ple of years af­ter the launch of the com­pa­ny fo­cused on Syn­thet­ic Vac­cine Par­ti­cle tech from the lab of MIT’s Bob Langer.

No­var­tis $NVS has found a man­u­fac­tur­ing part­ner in Chi­na for its CAR-T drug Kym­ri­ah. No­var­tis is pay­ing $40 mil­lion for a chunk of stock in Cel­lu­lar Bio­med­i­cine Group $CB­MG, which will take the lead on man­u­fac­tur­ing the ther­a­py while No­var­tis steers ahead on dis­tri­b­u­tion, reg­u­la­to­ry and com­mer­cial­iza­tion ef­forts in Chi­na. “To­geth­er with No­var­tis, we hope to bring the first CAR-T cell ther­a­py to pa­tients in Chi­na,” says CB­MG CEO Tony Liu. “In ad­di­tion, we con­tin­ue to fo­cus on de­vel­op­ing CB­MG’s pipeline of im­muno-on­col­o­gy as­sets.”

The Dutch com­pa­ny A-Man­sia Biotech raised an €18 mil­lion Se­ries A fi­nanc­ing round to back its re­search in­to the mi­cro­bio­me. Its found­ing sci­en­tists are Pro­fes­sor Willem de Vos from Wa­genin­gen Uni­ver­si­ty and Pro­fes­sor Patrice D. Cani from the Uni­ver­si­ty of Lou­vain.

Mérieux Eq­ui­ty Part­ners has lined up the launch of its Mérieux Par­tic­i­pa­tions 3 fund, with an ini­tial $235 mil­lion to in­vest. Part­ners will be on the look­out for small- to mid-cap eq­ui­ty in­vest­ments in a range of com­pa­nies in health­care and nu­tri­tion.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capitol Hill heavyweight Jim Greenwood is taking his decades of experience in the intertwining worlds of biopharma and Congress to the law firm DLA Piper, where he’s opening up a new policy and regulatory practice alongside former Pfizer lawyer Geoffrey Levitt.

As Congress wrangles over how to bring down drug prices, the former BIO CEO told Endpoints News in an interview that his top three priorities will be, “Price controls, price controls and price controls.”

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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