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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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