Reagan Jarvis, Anocca CEO

Af­ter slic­ing and dic­ing TCRs for 8 years, Swedish biotech re­loads to an­gle for a spot in crowd­ed cell ther­a­py space

Södertäl­je, Swe­den, the his­toric home to the As­tra half of As­traZeneca, may seem an un­like­ly place for cut­ting-edge R&D on T cell re­cep­tors and cell ther­a­pies. And Rea­gan Jarvis — a trans­plant from New Zealand who had spent his aca­d­e­m­ic years study­ing in­nate im­mune sig­nal­ing — read­i­ly ad­mits he doesn’t fit your usu­al mold for a biotech founder.

But that’s where Jarvis found him­self eight years ago af­ter meet­ing Mikael Blomqvist, a Swedish en­tre­pre­neur who asked him to pitch some ideas for a new com­pa­ny.

His pro­pos­al, in short, was about sys­tem­at­ic in­dus­tri­al­ized analy­sis of T cell bi­ol­o­gy — putting to­geth­er an au­to­mat­ed ma­trix of as­says to an­swer a long list of ques­tions about a long list of TCRs. While the break­out suc­cess of CAR-T in blood can­cers would soon sweep the biotech world, Jarvis saw at the time no em­pir­i­cal way to find and de­fine what good tu­mor tar­gets and TCRs look like.

Blomqvist, whom Jarvis de­scribes as an in­dus­tri­al­ist, liked the idea. They co-found­ed a com­pa­ny named Anoc­ca, and Blomqvist chipped in $30 mil­lion via his in­vest­ment group Michano to get things start­ed.

The un­usu­al­ly large seed fi­nanc­ing — topped up lat­er with a sim­i­lar­ly sized Se­ries A — has al­lowed Jarvis, the CEO, to “me­thod­i­cal­ly” scale out the plat­form, an­chored by sev­en core as­say sets, and grow the team to 65. In a step up, the biotech has now reaped an­oth­er $47 mil­lion from a big­ger group of pri­vate and in­sti­tu­tion­al in­vestors led by Danske Bank.

Anoc­ca bills it­self, ul­ti­mate­ly, as an an­a­lyt­ics com­pa­ny whose plat­form can touch every­thing from vac­cines to al­ler­gy meds. For the Se­ries B, though, Jarvis ex­pects to fo­cus on push­ing the lead can­di­dates for TCR T cells to­ward the clin­ic.

“Tra­di­tion­al­ly T cell bi­ol­o­gy has been done with PBMC as­says, Elispot, in­ter­fer­on re­lease, and that is a bi­o­log­i­cal read­out, but it’s so high noise and so [low] re­pro­ducibil­i­ty that it’s re­al­ly hard to get quan­ti­ta­tive ac­cu­rate da­ta,” Jarvis said. “So what we’ve done is strip out all the noise in the back­ground, [make it] re­pro­ducible. It’s the same back­ground every time, we get re­al­ly good pre­ci­sion da­ta, very high sen­si­tiv­i­ty.”

Some might ar­gue that no amount of pre­clin­i­cal work could pre­pare you for sur­pris­es when the cells are ad­min­is­tered to pa­tients — as the CAR-T play­ers at Tmu­ni­ty learned in a fa­tal set­back. But oth­ers sub­scribe to the phi­los­o­phy that the more you can mea­sure and quan­ti­fy and de­sign in the pre­clin­i­cal stage, the bet­ter.

The process at Anoc­ca starts with var­i­ous en­gi­neered cells, which the sci­en­tists ma­nip­u­late to add re­cep­tors, HLAs or spe­cif­ic anti­gens. The re­sult­ing “an­a­lyte cells” they as­sem­ble are then sent through mul­ti­ple cus­tom tests, in­clud­ing a mass spec­trom­e­try-based tar­get dis­cov­ery, TCR char­ac­ter­i­za­tion and safe­ty pro­fil­ing all the way to man­u­fac­tur­ing QC.

Al­though the com­pa­ny is ini­tial­ly work­ing on au­tol­o­gous cell ther­a­pies di­rect­ed against well known tar­gets like NY-ESO-1 — which Glax­o­SmithK­line is fa­mous­ly pur­su­ing — Jarvis notes that oth­ers’ pro­grams could on­ly ad­dress lim­it­ed pa­tient pop­u­la­tions due to HLA re­stric­tions. On the oth­er hand, the speed at which its plat­form iden­ti­fies good TCRs means Anoc­ca can quick­ly gen­er­ate a li­brary, or fran­chise, that is man­u­fac­tured the same way but would be matched to dif­fer­ent groups of pa­tients.

“This comes back to how TCR T has to work,” he said. “I mean this is not a sin­gle as­set for every­body. It’s go­ing to be mul­ti­ple as­sets for mul­ti­ple pa­tient seg­ments.”

Sit­ting miles away from cell ther­a­py hotspots in Boston, San Fran­cis­co or Lon­don, where VCs are reach­ing deep in­to their pock­ets to get in on ever more am­bi­tious tech­nolo­gies, Jarvis is set­ting his own pace. Anoc­ca has its own man­u­fac­tur­ing ca­pa­bil­i­ties, and it’s stay­ing open to col­lab­o­ra­tions, whether it’s tar­get char­ac­ter­i­za­tion or clin­i­cal co-de­vel­op­ment.

“It’s one thing to say you’ve got sev­er­al hun­dred mil­lion dol­lars in Boston,” he said. “That’s the same as a hun­dred mil­lion dol­lars in Södertäl­je, quite frankly, in terms of what things cost and HR ex­pens­es. So we’re hap­py with our fund­ing po­si­tion, we’re more than hap­py with our tech­nol­o­gy po­si­tion. We think we are tech­ni­cal lead­ers and we have a dif­fer­en­ti­at­ed sci­en­tif­ic ap­proach, and we don’t re­ly on pre­dic­tive al­go­rithms. We’re do­ing this em­pir­i­cal­ly, it’s not a best guess. It’s ac­tu­al­ly re­al bi­ol­o­gy.”

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to clar­i­fy the name of Anoc­ca’s co-founder, Mikael Blomqvist and cor­rect spellings. 

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.