Rubius Shares Plunge After Early Data From RTX-240 Solid Tumor Trial

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Rubius Therapeutics Inc RUBY has announced updated data from the ongoing monotherapy Phase 1 arm of the Phase 1/2 trial of RTX-240 in advanced solid tumors.

  • Data were shared at the American Association for Cancer Research Annual Meeting. 
  • Nine dose cohorts (n=34) were completed in the monotherapy solid tumor arm.
  • Disease control was observed in 10 patients (1 partial response, 2 unconfirmed partial responses and 7 with stable disease), 9 of whom had experienced disease progression on prior anti-PD-1/anti-PD-L1 therapy.
  • There were three best responses of partial response (PR) in non-small cell lung cancer (NSCLC), anal cancer, and uveal melanoma patients:​
  • Stable disease was observed in 5 patients, including 3 with metastatic NSCLC and 2 with renal cell carcinoma (RCC) across the 3e10 cohorts.
  • The Company has selected a Phase 2 dose of 5e10 cells administered every 3 weeks. This dose will be further explored in the combination expansion cohort of NSCLC and RCC patients.
  • Rubius also announced final results from the Phase 1 arm of monotherapy RTX-240 in relapsed/refractory AML.
  • Seventeen patients were enrolled across four dose levels. No dose-limiting toxicities were observed, and there were 3 treatment-related Grade 3/4 adverse events. 
  • There were no investigator-reported immune-related AEs. 
  • Five patients had SD greater than 3 months, and 1 patient had a significant blast count reduction (53% to 6%).
  • Price Action: RUBY shares are down 44.4% at $3.26 during the market session on the last check Friday.
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