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.

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.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.