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Kairos sets its prostate cancer expectations

With eight patients' worth of lead-in data Kairos Pharma has tried to stoke enthusiasm for its anti-endoglin MAb carotuximab, in combination with Erleada in metastatic castration-resistant prostate cancer. The headline number is median PFS of 13 months, which the group claims is well above the 3.7-5.6 months seen in two separate studies in similar, post-Zytiga/Xtandi, settings. However, Kairos's shares fell 20% on Thursday, so there are doubts about whether this will translate into a benefit in the next part of Kairos's study, which uses an Erleada-only control and will enrol 90 patients. The uncontrolled dataset is tiny, and excludes two subjects who withdrew; Kairos's cash, $3m at mid-year cash plus a subsequent $3.7m loan, is expected to last only to mid-2026. And there's no accounting for the Erleada part of the carotuximab combo; the control in the two comparator studies Kairos cites was a switch to Xtandi or Zytiga, and not to Erleada, which is approved in other prostate cancer settings. Targeting endoglin (CD105), which is thought to be expressed in response to AR signalling inhibition, is intended to resensitise tumours to AR pathway drugs, but whether carotuximab actually does this will only become evident in a controlled setting. Carotuximab's convoluted journey to KairosDateNoteMar 2014Tracon licenses carotuximab to Santen for opthalmology use, for $10m up frontFeb 2016Tracon doses first patient in Tappas study of carotuximab + Vortient in angiosarcomaMar 2018Carotuximab + Erleada trial begins at Cedars-Sinai Medical CenterApr 2019Tappas study is terminated for futilityMar 2020Tracon and Santen scrap deal after carotuximab fails in age-related macular degenerationMay 2021Tracon licenses carotuximab to Enviro for $100,000 + 7% equity stakeJul 2021Kairos buys Enviro in all-stock deal, inheriting carotuximab rightsSep 2024Kairos raises $6m in an IPONov 2024Tracon shareholders vote to liquidate the company, and carotuximab passes to KairosSource: company disclosures.
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