Marc Lajoie (L) and Scott Boyken (Outpace Bio)

A pair of Lyell founders look to shift the cell ther­a­py par­a­digm — and they've got $30M to get their plan off the ground

Rick Klaus­ner’s Lyell has tak­en the cell ther­a­py field by storm, re­cruit­ing an All-Star team with the goal of cre­at­ing the first CAR-Ts for sol­id tu­mors. But the com­pa­ny may have been too pro­duc­tive — too good at its job — the­o­riz­ing more po­ten­tial ther­a­pies than it could han­dle alone.

As a re­sult, some of that re­search has been spun out in­to a new biotech called Out­pace Bio, with Lyell founders and for­mer co-di­rec­tors of cell and pro­tein en­gi­neer­ing Marc La­joie and Scott Boyken, get­ting things start­ed with a $30 mil­lion Se­ries A on Wednes­day. Lyell it­self is one of the lead in­vestors in the round and is al­so team­ing up with Out­pace in a col­lab­o­ra­tion for T cell ther­a­pies against sol­id tu­mors.

La­joie is tak­ing the reins as CEO with Boyken fill­ing the CSO role. The duo said they first start­ed think­ing about spin­ning out back in June, got the ini­tial op­er­a­tion up and run­ning last No­vem­ber and closed the fi­nanc­ing last month.

The quick ad­vances point to­ward an ear­ly val­i­da­tion of their ap­proach and a hefty in­vestor ap­petite for their part­ner-fo­cused busi­ness mod­el, La­joie told End­points News.

“It’s not a fa­mil­iar pat­tern to a lot of in­vestors, and we’re su­per hap­py with our syn­di­cate,” La­joie said. “They all see the broad­er vi­sion here that re­al­ly, in or­der for cell ther­a­pies to be suc­cess­ful, we’re go­ing to need to make step change in how we can pro­gram cells to be more ef­fi­ca­cious.”

Out­pace’s big idea is to pi­o­neer the next gen­er­a­tion of cell ther­a­pies through many dif­fer­ent ap­proach­es. One promi­nent area is in de no­vo pro­teins. Where­as pro­teins evolved over mil­lions of years to per­form spe­cif­ic func­tions, de no­vo pro­teins can be pro­grammed to ex­e­cute dif­fer­ent tasks, al­low­ing Out­pace to con­trol bi­ol­o­gy in a way that can’t be done nat­u­ral­ly, Boyken said.

Some of the founders’ ear­ly re­search here grabbed head­lines, earn­ing a fea­ture in the Wash­ing­ton Post two years ago — the work came from La­joie and Boyken’s time in David Bak­er’s lab at the Uni­ver­si­ty of Wash­ing­ton.

But de no­vo pro­tein de­sign is just one of the many tools in Out­pace’s tool­box. With the in­ter­dis­ci­pli­nary team they’ve as­sem­bled, La­joie and Boyken hope to shift the line of thought in the cell ther­a­py field in­to one that fo­cus­es more on how cells make de­ci­sions and how they re­spond in the right way at the right time.

“Cells are the unit of co­or­di­nat­ing all func­tions, and when you have these dis­eases like can­cer and au­toim­mu­ni­ty, those are re­al­ly caused by cells mak­ing the wrong de­ci­sions,” La­joie said. “What we want to be able to do is har­ness that com­plex­i­ty of cells in or­der to be able to ad­dress those prob­lems, which are re­al­ly just cells telling oth­er cells the wrong thing.”

The part­ner­ship with Lyell will keep things close to the orig­i­nal fam­i­ly, but al­so gives Out­pace a promi­nent col­league as it looks to make a name on its own. By lock­ing down this col­lab­o­ra­tion and al­so fo­cus­ing on fu­ture team ups, it lets the biotech “cov­er a lot of ground sci­en­tif­i­cal­ly,” La­joie not­ed.

Here, they’ll be hon­ing in on the bi­ol­o­gy of cy­tokines, shoot­ing for im­proved ef­fi­ca­cy in can­cer while try­ing to avoid the tox­i­c­i­ty that comes with it. Out­pace is still work­ing on in­ter­nal pipeline de­vel­op­ment, which La­joie says will pro­vide the foun­da­tion of its part­ner­ship mod­el.

And it’s that mod­el where Out­pace sees the field go­ing in the fu­ture.

“We re­al­ly think that this tech­nol­o­gy and this mod­el is re­al­ly need­ed for the cell ther­a­py space right now,” Boyken said. “In ad­di­tion to the Lyell part­ner­ships, all the con­ver­sa­tions we’ve been hav­ing as well as our ini­tial Se­ries A has re­al­ly proved that that is the case. And we feel re­al­ly val­i­dat­ed that this is a mod­el that’s go­ing to work.”

In ad­di­tion to Lyell, Wednes­day’s round was al­so led by AR­TIS Ven­tures. Ad­di­tion­al par­tic­i­pa­tion came from Ab­stract Ven­tures, Civ­i­liza­tion Ven­tures, Mubadala Cap­i­tal, Play­ground Glob­al, Sah­sen Ven­tures, and WRF Cap­i­tal.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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