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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.