A biotech fledg­ling cross-bred in France and Switzer­land launch­es to take on liv­er prob­lems of glob­al di­men­sions

Drug de­vel­op­ment is a glob­al busi­ness, but when it comes to rais­ing ven­ture cash, star­tups in Eu­rope and the US are of­ten op­er­at­ing on com­plete­ly dif­fer­ent scales.

Con­sid­er Alen­tis Ther­a­peu­tics, a biotech in­cu­bat­ed in Basel, Switzer­land that says it has found the “mas­ter switch” for a num­ber of ad­vanced liv­er dis­eases, from fi­bro­sis due to NASH to he­pa­to­cel­lu­lar car­ci­no­ma. The Se­ries A grant to­tal: $13.2 mil­lion (CHF 13.5 mil­lion).

Thomas Baumert

Founder Thomas Baumert was in Boston a few days be­fore the an­nounce­ment. With this kind of pro­file, he re­calls peo­ple telling him, “we prob­a­bly could eas­i­ly get 50 mil­lion in the Unit­ed States.”

But Baumert, whose decade-long re­search at the Uni­ver­si­ty of Stras­bourg formed the foun­da­tion of Alen­tis, is hap­py where he is. Be­tween his sci­en­tif­ic base in the French city and Basel, his small team of 4 have “the best of both worlds,” with ac­cess to both cut­ting edge trans­la­tion­al sci­ence and “fan­tas­tic in­fra­struc­ture” for run­ning a biotech busi­ness. Not to men­tion the cal­iber of the sci­en­tif­ic ad­vis­ers and ser­vice providers they reg­u­lar­ly work with, many of whom are No­var­tis or Roche alums.

Markus Ew­ert

CEO Markus Ew­ert — ex-No­var­tis staffer and for­mer CBO of Abl­ynx — adds that the cur­rent funds should last a cou­ple of years, tak­ing Alen­tis’s lead mon­o­clon­al an­ti­body through CMC de­vel­op­ment and some tox stud­ies.

Af­ter that, though, they will like­ly need $30 mil­lion to $35 mil­lion more in or­der to car­ry out sol­id clin­i­cal stud­ies. Part­ners with deep­er pock­ets are wel­come to pick up the tab af­ter proof-of-con­cept.

All the while, Alen­tis will con­tin­ue op­ti­miz­ing some oth­er com­pounds dis­cov­ered on its plat­form — a spe­cial cell cul­ture mod­el that cap­tures the cell cir­cuits and gene ex­pres­sion of pa­tients with late-stage liv­er dis­ease in a way that oth­ers haven’t been able to, ac­cord­ing to Bau­rmert — to beef up the pipeline. They are al­so in talks with big­ger play­ers who are in­ter­est­ed in uti­liz­ing the plat­form tech on their own projects, Ew­ert says.

He plans to dou­ble the head­count at the com­pa­ny, but in­tends to keep the full-time team rel­a­tive­ly small.

Bio­Med­Part­ners and BB Pure­os Bioven­tures — both Swiss VC funds — co-led the round and each sends a rep­re­sen­ta­tive to the board. They were joined by BPI France (al­so join­ing the board), Schroder Ad­veq and the Ger­man High-Tech Grün­der­fonds.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

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New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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