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MESSAGE _ENGLISH VERSION_
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Clinical data on romaciclib presented at the 2026 European Hematology
Association Congress
The Management Board of Ryvu Therapeutics S.A. with its registered
office in Krakow, Poland _"Company", "Ryvu"_ announces that the Compmany
has presented clinical data on romaciclib _RVU120_ at the European
Hematology Association Congress _EHA_, June 11-14, 2026, inStockholm,
Sweden.
Program updates:
In the RIVER-81 trial of patients with r/r AML, Ryvu is initiating an
expansion cohort of approximately 30 patients to confirm the positive
efficacy demonstrated in the dose cohort of 150 mg QD romaciclib
combined with 400 mg QD venetoclax, as the Company informed in the
current report no. 9/2026 dated May 20, 2026. Following completion of
the required regulatory steps, including an updated study protocol and
submission of documentation under the existing IND, the FDA reactivated
the IND for RIVER-81 study on May 28, 2026.
In the POTAMI-61 study investigating romaciclib's efficacy in MF, eight
patients will be transferred into the ROVER-01 study rollover protocol,
underscoring that a subset of patients continue to derive meaningful
clinical benefit from romaciclib treatment. These patients will continue
to receive treatment with romaciclib as long as they benefit in ROVER-01.
EHA poster presentations:
Poster _PF529_: Updated findings from the Phase 2 RIVER-81 study of
romaciclib _RVU120_ combined with venetoclax in acute myeloid leukemia
after first-line venetoclax and hypomethylating agent failure
Poster session date and time:Friday, June 12 _6:45 - 7:45 PM CEST_
Venetoclax _VEN_ combined with hypomethylating agents is the standard
first-line treatment forpatients with acute myeloid leukemia _AML_
ineligible for intensive chemotherapy, yet ~70% experience
relapsed/refractory disease with a median survival of under three
months. Romaciclib, afirst-in-class CDK8/CDK19 inhibitor, has shown
single-agent activity in AML and preclinical synergy with VEN through
enhanced apoptotic signaling and attenuation of resistance pathways.
In the ongoing Phase 2 RIVER-81 trial, romaciclib in combination with
VEN demonstrates anti-leukemic activity in patients with poor prognostic
AML. While responses have been observed across dose levels, the most
consistent responses were seen at romaciclib 150mgQD + VEN 400 mg QD,
including two complete remissions with _CR_ and one without _CRi_ full
hematologic recovery, resulting in a CR/CRi rate of 43% _3/7_. The mean
duration of response _DoR_ of the CRs was 156 days, reported with a
cut-off date of 12 May 2026. Based on safety, PK, and preliminary
efficacy findings, this regimen was selected as the recommended dose for
expansion.
Poster _PS2008_: Romaciclib _RVU120_, a selective CDK8/19 inhibitor,
as monotherapy orincombination with ruxolitinib in patients with
myelofibrosis: Updated results from the phase II POTAMI-61 study
Poster session date and time:Saturday, June 13 _6:45 - 7:45 PM CEST_
Myelofibrosis _MF_ is driven by dysregulated JAK/STAT signaling, and
while JAK inhibition with ruxolitinib _RUX_ improves splenomegaly and
symptoms, cytopenias and suboptimal responses remain clinical
challenges. Romaciclib is a first-in-class, oral CDK8/19 inhibitor that
modulates STAT-dependent transcription and shows synergy with RUX in
preclinical MF models.
In the ongoing Phase II POTAMI-61 study, romaciclib administered as
monotherapy or combined with RUX demonstrates a manageable safety
profile in patients with MF without significant treatment-related
cytopenias. Prolonged exposure, spleen volume reductions, including in
patients with high-molecular-risk mutations, and favorable hematologic
tolerability support continued clinical development.
The posters are available online and can be accessed via the conference
website: https://ehaweb.org/ and Ryvu's website: https://ryvu.com/
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.
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RB: Dane kliniczne romacyklibu zaprezentowane podczas Kongresu Europejskiego Stowarzyszenia
Hematologicznego (EHA) 2026 / Clinical data on romaciclib presented at the 2026 European
Hematology Association Congress
