Steve Potts, OncoMyx CEO

Biotech up­start gets $50M to test new virus-based ther­a­pies against sol­id tu­mors

The team at On­coMyx is try­ing to lever­age one ther­a­peu­tic to treat sev­er­al forms of can­cer, us­ing the Myx­o­ma virus. Wednes­day, it an­nounced the clos­ing of a $50 mil­lion Se­ries B fi­nanc­ing to take it a step clos­er to that goal.

Beni Rovin­s­ki

The round was co-led by Lu­mi­ra Ven­tures and B Cap­i­tal Group with par­tic­i­pa­tion from LYZZ Cap­i­tal and its Se­ries A in­vestors Boehringer In­gel­heim Ven­ture Fund, De­los Cap­i­tal, Xer­aya Cap­i­tal, Ko­rea In­vest­ment Part­ners, City Hill Ven­tures, and Madi­son Part­ners. Beni Rovin­s­ki, the man­ag­ing di­rec­tor at Lu­mi­ra Ven­tures, and Widya Mulyasas­mi­ta, the se­nior prin­ci­pal of health­care at B Cap­i­tal Group, will join the com­pa­nies board of di­rec­tors.

“We’re pret­ty ex­cit­ed about it, we’re re­al­ly kind of right on track for get­ting this par­tic­u­lar pro­gram in­to peo­ple,” CEO Steve Potts said.

Widya Mulyasas­mi­ta

Potts has worked in on­col­o­gy for two decades, get­ting his PhD from the Uni­ver­si­ty of Cal­i­for­nia-Davis and work­ing for Sur­roMed, Biovia and Quest Di­ag­nos­tics in his ear­ly ca­reer. Most re­cent­ly, he was with Igny­ta, which he called a clas­sic pre­ci­sion med­i­cine sto­ry in which he had an amaz­ing in­hibitor, and they test­ed 30,000 pa­tients in 16 coun­tries, just to get 50 peo­ple for tri­als. With On­coMyx, the goal is to lever­age myx­o­ma’s unique qual­i­ties to build a one-ther­a­peu­tic im­munother­a­py plat­form to de­liv­er mul­ti­ple can­cer-killing pay­loads.

There are three things that are tru­ly need­ed: a pro­gram­ma­ble mul­ti-arm­ing con­cept; sys­temic, IV de­liv­ery; and a non­hu­man pathogen to get around any pre-ex­ist­ing hu­man im­mu­ni­ty. The mul­ti-armed myx­o­ma virus de­liv­ers dif­fer­ent an­ti-tu­mor im­munomod­u­la­to­ry pro­teins that hit crit­i­cal points in the can­cer’s im­mu­ni­ty cy­cle and stim­u­late an an­ti-tu­mor re­sponse. Since it’s not a hu­man pathogen, there’s no pre-ex­ist­ing im­mu­ni­ty to over­come.

“If you look at im­munother­a­py cur­rent­ly, about 1 of every 7 pa­tients are cur­rent­ly ben­e­fit­ing from im­munother­a­py..and that’s kind of across the board, across all tu­mors types,” Potts said in a call with End­points News. “Of course we all know that every­body’s try­ing a lot of dif­fer­ent things, but what we see here is that we can pro­gram a virus with mul­ti­ple ad­di­tion­al trans­genes in it and de­liv­ery it sys­tem­i­cal­ly to re­al­ly move that nee­dle so that 6 out of 7 pa­tients that cur­rent­ly aren’t ben­e­fit­ing from im­munother­a­py, we can get that num­ber down.”

Pre­clin­i­cal da­ta show that On­coMyx has shown safe­ty and ef­fi­ca­cy in a range of can­cers, from hema­to­log­i­cal ma­lig­nan­cies to sol­id tu­mor, the com­pa­ny said. The fund­ing will help them ad­vance the pro­gram in GI tu­mors. It will al­so go to­ward im­prov­ing the man­u­fac­tur­ing op­er­a­tions.

Cur­rent­ly, On­coMyx is part­nered with one US-based man­u­fac­tur­er. The man­u­fac­tur­ing process for the myx­o­ma virus is sim­i­lar to the man­u­fac­tur­ing process for the small­pox vac­cine, and the com­pa­ny is us­ing that al­ready-ex­ist­ing know-how to ap­ply that to its newest process.

“Some of that vac­cine knowl­edge we can cer­tain­ly ap­ply, and we have been as we build this out,” he said. “The nice thing about this par­tic­u­lar virus is that it’s very sta­ble, and so once it’s en­gi­neered, it lends it­self to man­u­fac­tur­ing. You can put six dif­fer­ent an­ti-can­cer agents in­to it, and still have the virus be­have as it be­haves in na­ture. It’s very ex­cit­ing.”

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.