Rubius Therapeutics Provides Update on Clinical Trial Progress for its Lead Oncology Product Candidate RTX-240 and Announces Planned Leadership Transition
“After the successful completion of the first monotherapy dose escalation cohort in our Phase 1/2 clinical trial of RTX-240, with no observed adverse events to date, we have initiated the portion of the trial where we expect to see the biological effects of RTX-240 on innate and adaptive immunity, including potential activation and increased numbers of NK cells and T cells,” said
The Phase 1/2 clinical trial of RTX-240 is evaluating the safety, tolerability, pharmacokinetics, maximum tolerated dose and recommended Phase 2 dose and dosing regimen of RTX-240 in adult patients with relapsed/refractory or locally advanced solid tumors. The trial is also assessing the pharmacodynamic effects of RTX-240 as measured by increased proliferation and effector function of the NK and T cell populations relative to baseline. In addition to these proliferation biomarkers, the study will also evaluate production of granzyme B, which is an indicator of activated NK and T cells capable of tumor killing. The trial is evaluating anti-tumor activity as measured by overall response rate, progression-free survival and overall survival. The ongoing dose escalation phase will be followed by expansion cohorts in specified tumor types during Phase 2 of the trial. The extent to which the COVID-19 pandemic may impact Rubius’ ability to enroll patients in the trial is uncertain and will depend on future developments.
With this clinical update, Rubius also announced the planned transition of
“Andy joined Rubius in 2017, when the company was privately held, and, since that time, he has helped us raise more than
RTX-240 is an allogeneic cellular therapy product candidate that simultaneously presents hundreds of thousands of copies of the costimulatory 4-1BB ligand (4-1BBL) and the trans-presented cytokine interleukin-15 (IL-15TP) in their native forms to activate and expand NK and T cells. 4-1BBL is a costimulatory molecule that can drive T and NK cell proliferation and activation and interferon gamma (IFNγ) production. IL-15 is a cytokine that bridges innate and adaptive immunity by promoting NK and T cell proliferation and NK cell cytotoxicity. IL-15TP is a fusion of IL-15 and IL-15 receptor alpha.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the, our expectations regarding the therapeutic potential of our Red Cell Therapeutics, including RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors, our expectations regarding the timing, enrollment, data from and success of the future cohorts and phases of the clinical trial of RTX-240, the timelines for us to file an IND for RTX-321, our expectations and timing in connection with our search for a new chief financial officer, and our strategy, business plans and focus, including our plans to present preclinical data at the AACR Annual Meeting. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the development of our Red Cell Therapeutic product candidates and their therapeutic potential and other risks identified in our
Lori Melançon, Vice President, Corporate Communications and Investor Relations
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Source: Rubius Therapeutics