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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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