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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.