Yiannis Kiachopoulos and Artur Saudabayev, co-founders of Causaly

Lon­don AI up­start, which counts No­var­tis as a cus­tomer, can teach your com­put­er to read

When Ama­zon de­vel­oped a ma­chine-learn­ing tool to make its re­cruit­ment process more ef­fi­cient — the man-made sys­tem ab­sorbed the gen­der-bias of its hu­man mak­ers, and the project was abort­ed. In the field of bio­phar­ma­ceu­ti­cals, the way re­searchers train their ma­chine learn­ing al­go­rithms can skew the out­come of pre­dic­tions. But be­fore those pre­dic­tions can be made, the en­gine must learn to read to make sense of ex­plo­sive vol­ume of knowl­edge out there.

That is what Lon­don-based Causaly has set out to do, and has raised $4.8 mil­lion as it works on re­fin­ing its tech­nol­o­gy, co-founder Yian­nis Ki­a­chopou­los told End­points News in an in­ter­view.

The key is­sue is find­ing ev­i­dence in the first place be­cause 90% to 95% of search re­sults are noise, he said. “The prob­lem that we’re solv­ing is find­ing the ev­i­dence in the first place. The read­ing part and the judg­ment part is still up to the hu­man.”

Mil­lions of bio­med­ical ar­ti­cles have been pub­lished so far, and thou­sands are added each month. The tiny 11-per­son start­up Causaly, which is work­ing with No­var­tis and a host of oth­er bio­phar­ma­ceu­ti­cal com­pa­nies, has de­vel­oped ar­ti­fi­cial in­tel­li­gence tech­nol­o­gy that process­es lan­guage from this avalanche of pub­lished bio­med­ical da­ta — and is de­signed to ex­tract causal re­la­tion­ships the way hu­mans can — ex­cept faster and more ef­fi­cient­ly.

The tech­nol­o­gy is de­signed to iso­late rel­e­vant da­ta and make it vi­su­al­ly ac­ces­si­ble and that’s what sci­en­tists want, Ki­a­chopou­los said. “Our users are specif­i­cal­ly ask­ing us not to make these judg­ments for them…and that’s how we see our­selves as aug­ment­ing hu­mans and not kind of re­plac­ing judg­ments or any­thing like that, that gets more prob­lem­at­ic.”

Users are giv­en the op­tion of us­ing fil­ters, for in­stance, they can iso­late da­ta that em­anates on­ly from ran­dom­ized clin­i­cal tri­als or from jour­nals with a de­fined ‘im­pact fac­tor’ or ar­ti­cles that have been pub­lished dur­ing a spe­cif­ic time pe­ri­od. The plat­form is not judg­ing whether that ev­i­dence is cred­i­ble, he said. “We leave the judg­ment to the hu­man, but we give the hu­man the tools to make the judg­ment in a bet­ter way.”

There is an­oth­er lay­er of bias en­trenched in da­ta — and that is lin­guis­tic bias. Nei­ther Causaly’s tech­nol­o­gy nor hu­mans can ful­ly elim­i­nate that be­cause cul­tur­al con­texts play a key role in the way da­ta is processed and ar­tic­u­lat­ed, he added.

Causaly raised $1 mil­lion in seed fund­ing last year, and this in­jec­tion of se­ries A cap­i­tal was led by Pen­tech and EBRD Ven­ture Cap­i­tal, with par­tic­i­pa­tion from ex­ist­ing in­vestors, in­clud­ing Marathon Ven­ture Cap­i­tal.

It is hard­ly the first AI com­pa­ny at­tempt­ing to as­sist de­ci­sion-mak­ers in the fields of phar­ma­ceu­ti­cals and health care to ag­gre­gate and syn­the­size in­for­ma­tion. A grow­ing list of star­tups in­clud­ing Am­plion, Biore­late, Da­ta4Cure, Ev­id Sci­ence, Inno­plexus, In­ve­ni­AI, Lin­gua­mat­ics, Meta, Plex Re­search, Quer­tle, Re­search­ably and nfer­ence are all work­ing on ways to help sci­en­tists and re­searchers di­gest and make in­fer­ences from the del­uge of bi­o­log­i­cal da­ta on of­fer to­day.

Mean­while the tra­di­tion­al, and large­ly free, search tools haven’t ex­act­ly be­come ob­so­lete. “When I talk to our cus­tomers, our biggest com­peti­tor is the sta­tus quo,” not­ed Ki­a­chopou­los. “And that is Google Schol­ar, PubMed.”

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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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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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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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.

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.

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.