- Updated Phase 1b Data for RVU120 in Relapsed/Refractory Acute Myeloid Leukemia (r/r AML) or High-Risk Myelodysplastic Syndromes (HR-MDS) Presented at the 2022 American Society of Hematology (ASH) Annual Meeting
- Positive clinical and novel preclinical data for RVU120 in advanced solid tumors MTA-coordinated PRMT5 inhibitor presented at the EORTC-NCI-AACR symposium
KRAKOW, POLAND, November 23, 2022 (GLOBE NEWSWIRE) — Ryvu Therapeutics (WSE:RVU), a clinical-stage drug discovery and development company focused on novel small molecule therapeutics addressing novel targets in oncology ) today announced Q3 2022. Provided financial results and company updates.
“We have made significant progress across our pipeline, particularly in Phase Ib efficacy of RVU120 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome. and safety data updates.Preclinical data on (HR-MDS) and SEL24 (MEN1703) were presented at this year’s ASH meeting.” Complete response and disease stabilization in 10 patients with /r AML and HR-MDS, and recently published data from a Phase I/II dose escalation study in advanced solid tumors. , demonstrating the therapeutic effect of RVU120 in the form of disease stabilization.We are pleased with the efficacy of RVU120 against hematologic diseases and solid tumors, and we believe that RVU120 has the potential to improve outcomes in cancer patients. I think it will be useful.”
Q3 2022 and recent highlights
Clinical and preclinical data update on RVU120 at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium: Updated data from an ongoing dose escalation phase I/II trial in relapsed/refractory metastatic or advanced solid tumors showed four disease stabilizations in the heavily pretreated patient group, three of which Lasted >4 months. RVU120 was safe and well tolerated, and data support continued dose escalation.
In addition, preclinical data were presented showing that RVU120 enhances the efficacy of ADCC enhancers in vivo When in vitroCombination therapy resulted in complete tumor regression in preclinical models.
Finally, preclinical data of a unique MTA-cooperating PRMT5 inhibitor were presented.These inhibitors selectively targeted MTAP deficiency, which occurs in 10-15% of all tumors, and demonstrated anti-tumor efficacy and target engagement In vivo.
Upcoming clinical and corporate milestones:
- Safety and efficacy data from the ongoing Phase Ib clinical trial in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) will be published at the 2022 American Society of Hematology (ASH) year It will be announced at the next general meeting. To date, RVU120 has shown single-agent activity with complete responses and disease stabilization in her 10 patients with r/r AML or HR-MDS.
- The on-target activity of RVU120 in AML and HR-MDS patient samples will also be presented at ASH. At the cut-off date, pSTAT5 inhibition was greater than 50%, a threshold based on preclinical predictions sufficient for robust efficacy in a specific group of superresponder patients.
- Identification of novel targets
- Ryvu’s partner, Menarini Group, will announce at an upcoming ASH Meeting that SEL24 (MEN1703) is clinically relevant in multiple myeloma (MM), Hodgkin’s lymphoma (HL), and diffuse large B-cell lymphoma (DLBCL). We present preclinical data that demonstrate potential efficacy.
Third Quarter 2022 Financial Results
cash position – On November 17, 2022, Ryvu Therapeutics had cash, cash equivalents, and short-term investments of $6.9 million, compared with $20.5 million at the end of 2021.
operating costs, Excluding non-cash valuation charges for the nine-month incentive program ($4.5 million) that ended September 30, 2022 and the valuation of NodThera stock ($1.8 million), totaled $19.2 million, primarily in research and development related to costs. Meanwhile, operating costs, excluding incentive programs and the NodThera stock valuation for the same period last year, totaled $17.3 million.
Net loss attributable to common shareholders – For the nine months ended September 30, 2022, net loss attributable to common stockholders, excluding non-cash valuation charges for incentive programs, was $12.5 million, compared with net loss for the nine months ended September 30, 2022, excluding incentive programs The loss was $12 million. 2021 years.
About Liv Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small molecule therapies addressing emerging targets in oncology. The internally discovered pipeline candidates harness diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed to kinases, synthetic lethality, and immuno-oncology targets. I’m here.
Ryvu’s most advanced program is RVU120. It is currently a Phase I/II study for the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS), and r/r metastatic or advanced solid tumors — SEL24 (MEN1703 ), a dual PIM/FLT3 kinase inhibitor approved by the Menarini Group, currently in phase II clinical trials in acute myeloid leukemia. and a license agreement.
The company was founded in 2007 and is headquartered in Krakow, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index. For more information, please visit www.ryvu.com.
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