| |
MESSAGE _ENGLISH VERSION_ |
|
| |
First clinical data from the Phase II JASPIS-01 study of dapolsertib
_MEN1703, SEL24_ and initial data from the expansion cohort of the Phase
II RIVER-81 study of romaciclib _RVU120_ in combination with venetoclax
to be presented at the 2026 ASH Annual Meeting
The Management Board of Ryvu Therapeutics S.A. with its registered
office in Krakow, Poland _"Company", "Ryvu"_ informs that the first
clinical data from the ongoing Phase II JASPIS-01 study _NCT06534437_ of
dapolsertib _MEN1703, SEL24_ in patients with relapsed/refractory _R/R_
aggressive B-cell non-Hodgkin lymphoma _B-NHL_, as well as the initial
data from the expansion cohort of the ongoing Phase II RIVER-81 study
_NCT06191263_ of romaciclib _RVU120_ in combination with venetoclax,
will be presented in poster sessions at the 68th American Society of
Hematology _ASH_ Annual Meeting and Exposition, held December 12-15,
2026, in New Orleans, Louisiana, USA, and virtually.
Phase II JASPIS-01 study of dapolsertib _MEN1703, SEL24_:
Dapolsertib is a first-in-class, oral, selective small-molecule dual
inhibitor of PIM and FLT3 kinases, discovered by Ryvu. Global
development and commercial rights to dapolsertib are licensed to the
Menarini Group _"Menarini"_. Since September 2023, Ryvu has been
Menarini's operational partner for Phase II study execution, with
Menarini funding all research and development costs.
The abstract published on November 4, 2026 reports the first clinical
results from Group 2 of the JASPIS-01 study, which evaluates dapolsertib
monotherapy in adults with R/R aggressive B-NHL who have exhausted
available standard treatment options following at least two prior
systemic therapies. The data cutoff date was June 18, 2026. Enrollment
in the study is ongoing.
Clinical activity was observed in a heavily pretreated population, with
a median of four prior lines of therapy; 53% of patients had previously
received CAR-T cell therapy and 60% had received CD3CD20 bispecific
antibodies. At the data cutoff, 15 patients had received dapolsertib
monotherapy, and clinical benefit was observed in 4 of them despite
extensive prior therapy, including one complete response. The safety
profile was manageable and no new signal was observed. These initial
findings support the continued clinical development of dapolsertib in
aggressive B-cell lymphoma.
The poster to be presented at ASH 2026 may include additional and
updated information.
Details on the poster presentation are as follows:
Poster Title: Preliminary clinical activity and safety of dapolsertib
_MEN1703_, a first-in-class dual PIM/FLT3 inhibitor, in heavily
pretreated relapsed/refractory aggressive B-cell non-Hodgkin lymphoma:
Initial results from the Phase II JASPIS-01 trial
Publication Number: 3662
Session: 627. Aggressive Lymphomas: Targeted and Pharmacologic
Therapies: Poster II
Session date and time: Sunday, December 13, 2026, 6:00-8:00 PM CST
_1:00-3:00 AM CET on December 14_
Location: Ernest N. Morial Convention Center, Hall F, New Orleans,
Louisiana
Phase II RIVER-81 study of romaciclib _RVU120_ in combination with
venetoclax:
Venetoclax _VEN_ in combination with a hypomethylating agent _HMA_ is
the standard of care for older or unfit patients with acute myeloid
leukemia _AML_; however, most patients relapse, and outcomes after
failure of VEN-based therapy remain poor. Romaciclib _RVU120_ is a
first-in-class, selective CDK8/CDK19 inhibitor with single-agent
activity in AML, discovered and fully owned by Ryvu. The RIVER-81 study
evaluates romaciclib in combination with VEN in patients with AML after
failure of frontline VEN+HMA therapy.
The abstract published on November 4, 2026 contains data as of the July
1, 2026 cutoff date, i.e. prior to the initiation of the expansion
cohort initiated on August 26, 2026, and does not provide any
significant update compared with the data presented in the poster at the
2026 European Hematology Association _EHA_ Congress, as reported by the
Company in current report No. 12/2026 of June 11, 2026.
The poster to be presented at ASH 2026 will include additional and
updated information.
Details on the poster presentation are as follows:
Poster Title: Phase II RIVER-81 updated Results: Romaciclib plus
venetoclax after first-line venetoclax and hypomethylating-agent failure
in adults with relapsed or refractory acute myeloid leukemia
Publication Number: 5153
Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular
Therapies: Poster III
Session date and time: Monday, December 14, 2026, 6:00-8:00 PM CST
_1:00-3:00 AM CET on December 15_
Location: Ernest N. Morial Convention Center, Hall F, New Orleans,
Louisiana
The abstracts are now available online and can be obtained from the
conference site:
https://www.hematology.org/Meetings/Annual-Meeting/Abstracts
The posters will be available on the Company's website after the
presentations: https://ryvu.com/investors-media/publications/
Disclaimer: This English language translation has been prepared solely
for the convenience of English-speaking readers. Despite all the efforts
devoted to this translation, certain discrepancies, omissions or
approximations may exist. In case of any differences between the Polish
and the English versions, the Polish version shall prevail. Ryvu
Therapeutics S.A., its representatives and employees decline all
responsibility in this regard.
|
|
|
RB: Prezentacja pierwszych danych klinicznych z badania fazy II JASPIS-01 dapolsertibu
(MEN1703, SEL24) oraz wstępnych danych dotyczących skuteczności z kohorty ekspansyjnej
badania fazy II RIVER-81 romacyklibu (RVU120) w skojarzeniu z wenetoklaksem podczas
konferencji ASH 2026 / First clinical data from the Phase II JASPIS-01 study of dapolsertib
(MEN1703, SEL24) and initial data from the expansion cohort of the Phase II RIVER-81
study of romaciclib (RVU120) in combination with venetoclax to be presented at the
2026 ASH Annual Meeting
