A pro­tein en­gi­neer­ing plat­form spawns a new IL-2 play­er out of Basel, with hu­man tri­als loom­ing next sum­mer

Ver­sant Ven­tures is de­but­ing an­oth­er biotech up­start this morn­ing that its part­ners be­lieve has big po­ten­tial for de­vel­op­ing pipelines in prod­ucts cre­at­ed by its own unique plat­form tech. And they have their sights set first on one of the hottest tar­gets in im­muno-on­col­o­gy.

The com­pa­ny is Bright Peak Ther­a­peu­tics, launched out of Ver­sant’s Ridge­line Ther­a­peu­tics Dis­cov­ery En­gine in Basel, which is grow­ing clin­i­cal de­vel­op­ment roots in San Diego. And they have $35 mil­lion of Ver­sant A round cash to fund their dri­ve to the clin­ic.

Jef­frey Bode

The com­pa­ny founders have been us­ing tech out of Jef­frey Bode’s lab at ETH Zürich to cre­ate “de­sign­er cy­tokines” by chem­i­cal­ly as­sem­bling pro­teins in a way that al­lows them to op­ti­mize func­tion while adding con­ju­gate han­dles to pur­sue com­bi­na­tion prod­ucts. And they have de­vel­oped a keen eye to do­ing some­thing that works among pa­tients who are re­sis­tant to the first gen­er­a­tion of check­points on the mar­ket.

Bode calls this a “true med­i­c­i­nal chem­istry ap­proach to op­ti­miz­ing the mol­e­c­u­lar struc­ture of pro­teins…”

And they be­lieve it’s ide­al for IL-2, one of the Holy Grails in can­cer R&D.

Alex May­weg

Pro­leukin helped es­tab­lish the po­ten­cy of IL-2, but al­so comes with a tox­ic pro­file that se­vere­ly lim­its its use. Ver­sant man­ag­ing di­rec­tor Alex May­weg and CEO Sef Kurst­jens, the for­mer CMO at Astel­las, be­lieve Bode’s ap­proach gives them the tools to make it work right — in ways that Nek­tar’s con­tro­ver­sial shot at the ti­tle fails at.

“I thought this was re­al­ly dis­rup­tive,” en­thus­es May­weg. “Chemists have be­come in­creas­ing­ly bi­o­log­ic, en­gi­neers more mol­e­c­u­lar.”

Sef Kurst­jens

Over the past 2 years the team at Bright Peak has been work­ing their way through an ad­vanced pre­clin­i­cal pro­gram, Kurst­jens tells me, that will be capped in a cou­ple of weeks with non-hu­man pri­mate da­ta. And he ex­pects to be in the clin­ic next sum­mer to start a rapid fire de­vel­op­ment pro­gram aimed at demon­strat­ing its use both as a monother­a­py as well as in com­bi­na­tions.

Sig­nif­i­cant­ly, he says, “IL-2 ex­pands pa­tient re­spon­sive­ness for PD-L1 neg­a­tive” tu­mors, open­ing up a ma­jor mar­ket op­por­tu­ni­ty — if it all works in hu­mans.

This is how the com­pa­ny de­tails its work.

Bright Peak made three mod­i­fi­ca­tions to its IL-2 mol­e­cule. The first was to com­plete­ly block the cy­tokine’s abil­i­ty to en­gage the CD25 re­cep­tor on reg­u­la­to­ry T cells, which dra­mat­i­cal­ly shift­ed the bal­ance of ac­tiv­i­ty to­wards ef­fec­tor T cells and elim­i­nat­ed vas­cu­lar tox­i­c­i­ties. The sec­ond was to en­hance po­ten­cy on the be­ta/gam­ma re­cep­tors, which aug­ment­ed the de­sired ef­fects on CD8 T cell and NK pro­lif­er­a­tion. Fi­nal­ly, the mol­e­cule’s half-life was sig­nif­i­cant­ly ex­tend­ed through site-spe­cif­ic mod­i­fi­ca­tions.

And they have their sights set on two oth­er pro­grams for IL-18 and IL-7.

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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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.

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.

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.

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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Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Corbus Pharmaceuticals’ plans to position lenabasum as a pipeline-in-a-product aren’t going so well.

After shelving a program in scleroderma, the Norwood, MA-based biotech has revealed that its lead candidate failed both the primary and secondary endpoints in another Phase III trial.

Lenabasum failed to show a statistically significant difference in total improvement compared with placebo in treating dermatomyositis, a rare disease that causes muscle inflammation and skin rash, the company said Thursday. The news sent Corbus’ $CRBP stock spiraling around 30% early Thursday morning.

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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