Rubius Therapeutics Inc. (NASDAQ: RUBY) was one of Monday’s biggest winners after the company announced initial clinical, pharmacodynamic and tumor trafficking data from its ongoing Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors.

Separately, the firm shared tumor trafficking data from one patient with relapsed/refractory acute myeloid leukemia in the second Phase 1 arm of the study.

Management believes that this provides initial proof-of-concept of its Red Platform by providing evidence that red blood cells can be engineered to mimic the human immune system and stimulate adaptive and innate immunity to generate clinical responses in cancer patients with refractory disease.

Five dose cohorts were completed in the solid tumor trial, with 16 patients evaluable for safety (primary outcome measure) and 15 patients evaluable for efficacy.

Considering, the encouraging initial safety and preliminary efficacy data for RTX-240, Rubius plans to initiate a Phase 2 expansion cohort in the first quarter of 2022, and a new Phase 1 arm of the ongoing RTX-240 clinical trial to evaluate RTX-240 in combination with anti-PD-1 therapy in patients with advanced solid tumors during the second half of 2021.

Looking ahead, the firm expects to do the following:

• Report initial clinical results for the second Phase 1 arm.
• Initiate the Phase 1 clinical trial of RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors in the second half of 2021.
• Report initial Phase 1 clinical results for RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022.
• And submit an Investigational New Drug Application for RTX-224 by year-end.

Rubius stock traded up 82% to $29.82 on Monday, in a 52-week range of $3.35 to $38.71. The consensus price target is $13.90.

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