Nikolai Kley, Orionis Biosciences CEO

No­var­tis-part­nered Ori­o­n­is se­cures $55M to push cy­tokine pro­gram in­to clin­ic

In sev­en years, a small com­pa­ny has built two pro­grams in im­muno-on­col­o­gy and mol­e­c­u­lar glues and got it­self in­to a part­ner­ship with one of the world’s biggest phar­ma com­pa­nies. Now the transat­lantic biotech has re­filled its cof­fers.

Ori­o­n­is Bio­sciences an­nounced Wednes­day morn­ing that it fin­ished a Se­ries C round and se­cured $55 mil­lion. That in­fu­sion gives Ori­o­n­is flex­i­bil­i­ty to ex­pand its R&D op­er­a­tions, in­crease its pipeline and bring as­sets in­to hu­man tri­als. The biotech plans to in­tro­duce its lead can­di­date, a con­di­tion­al­ly ac­tive cy­tokine ther­a­py, in­to the clin­ic some­time next year.

Robert Pe­tit

Founder and CEO Niko­lai Kley tells End­points News that the Ghent, Bel­gium, and Waltham, MA biotech was found­ed back in 2015, and has de­vel­oped two plat­forms — one for I/O-fo­cused cy­tokines and one for mol­e­c­u­lar glues and oth­er de­graders.

On top of the fi­nanc­ing, Ori­o­n­is al­so an­nounced that it hired Robert Pe­tit as its head of ear­ly clin­i­cal de­vel­op­ment in re­cent months. A Bris­tol My­ers Squibb vet and part of the pi­o­neer­ing team that helped es­tab­lish the first check­point in­hibitor ther­a­py ip­il­i­mum­ab (FDA-ap­proved in 2011 and mar­ket­ed as Yer­voy), Pe­tit joined the biotech in March af­ter re­cent stints as CSO at Caris­ma Ther­a­peu­tics, Ad­vax­is and Saros Ther­a­peu­tics.

Kley said that af­ter the biotech was found­ed, it stayed in se­mi-stealth for a few years, build­ing out its tech­nol­o­gy plat­forms un­til it an­nounced a part­ner­ship with No­var­tis in 2020:

And the mis­sion there was to cre­ate plat­forms that are first of all, unique and can ad­dress sort of some of the big chal­lenges in drug dis­cov­ery, reach­ing in­tractable tar­gets, and so forth — cre­ate this in a very mod­u­lar fash­ion so that we can scale it.

The start­up got con­nect­ed with No­var­tis through Kley’s pre­vi­ous back­ground as co-founder of For­ma Ther­a­peu­tics (just ac­quired last month by No­vo Nordisk for $1.1 bil­lion). He knew peo­ple at No­var­tis and knew that it had an in­ter­est in mol­e­c­u­lar glues. The two signed a drug dis­cov­ery part­ner­ship back in 2020.

As for what dis­tin­guish­es Ori­o­n­is from oth­er biotechs in the space, Kley tout­ed that its plat­forms al­low for op­tion­al­i­ty and for risk-tak­ing, go­ing much broad­er in terms of drug dis­cov­ery. Its more ad­vanced plat­form, called A-Kine, has been work­ing on what Kley called “fine­ly tuned cy­tokine ef­fec­tor mol­e­cules” that could har­ness the im­mune sys­tem against can­cer — in­clud­ing even cold tu­mors, an­oth­er name for can­cer tu­mors that ren­der check­point in­hibitors in­ef­fec­tive.

Ori­o­n­is’ oth­er plat­form, called Al­lo-Glue, is less ad­vanced than A-Kine — but that fo­cus­es on cel­lu­lar in­ter­ac­tions, study­ing them at scale and then find­ing mul­ti­ple ap­proach­es to use: ei­ther E3 lig­as­es to bind to a pro­tein and then de­grade, or in­volv­ing a “tar­get-cen­tric” ap­proach. Here’s how Kley ex­plained it:

If you have a tar­get of ther­a­peu­tic in­ter­est, and you want to iden­ti­fy or dis­cov­er a glue that pro­motes its degra­da­tion, now you match it up with an E3 lig­ase and you do a large-scale di­ver­si­ty screen­ing ap­proach to iden­ti­fy glues that en­hance or pro­mote these in­ter­ac­tions.

Next steps for the biotech in­clude in­tro­duc­ing at least one lead can­di­date in can­cer, with a fo­cus on sol­id tu­mors, in­to the clin­ic, as well as grow­ing the pipeline and hir­ing more peo­ple. The biotech cur­rent­ly has 45 em­ploy­ees and plans to con­tin­ue to grow, but Kley de­clined to share specifics on how long the fi­nanc­ing would last the com­pa­ny.

Ex­ist­ing and new in­vestors par­tic­i­pat­ed in the round, in­clud­ing Cor­morant As­set Man­age­ment, No­var­tis and a se­ries of undis­closed “high-cal­iber in­vest­ment funds,” Ori­o­n­is said.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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