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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha raise $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.