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MESSAGE _ENGLISH VERSION_
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Clinical data on romaciclib _RVU120_ from REMARK study and dapolsertib
_MEN1703_ from JASPIS-01 study presented at the 2025 Annual Meeting of
the American Society of Hematology _ASH_
The Management Board of Ryvu Therapeutics S.A., headquartered in Kraków
_the "Company" or "Ryvu"_, announces the latest data on romaciclib
_RVU120_ from REMARK study and dapolsertib _MEN1703_ from JASPIS-01
study were presented during the 2025 Annual Meeting of the American
Society of Hematology _ASH_, which is taking place on December 6-10,
2025, in Orlando, USA.
Details on the posters presentations:
Poster Title:REMARK: A phase II, open-label, multicenter study of
orally administered romaciclib _RVU120_ for the treatment of anemia in
patients with lower-risk myelodysplastic neoplasms _LR-MDS_
Session name: 637. Myelodysplastic syndromes: Clinical and
Epidemiological: Poster 3
Session date and time:December 8, 6:00-8:00 PM EST
Poster number: 5649
The Phase II REMARK study evaluates romaciclib _RVU120_, an oral
CDK8/CDK19 inhibitor, in patients with lower-risk myelodysplastic
neoplasms _LR-MDS_, a disease characterized by anemia and limited
treatment options. As of the data cutoff, 42 patients had initiated
treatment. The study follows a Simon's two-stage design, with 21
patients included in the first stage who formed the basis for the
interim analysis. In stage 1, 11 patients completed C9D1 which is the
primary efficacy endpoint. Romaciclib was administered at 150 mg every
other day for 13 days in 21-day cycles, withan option to escalate to
250 mg in non-responders or relapsing patients. Preliminary results
demonstrated early signs of clinical activity in some patients,
including one patient with high transfusion burden _8RBCunits/16
weeks_ and another one with low transfusion burden, who achieved a
primary erythroid response _HI-E_ per IWG 2018 criteria after 24 weeks
of treatment. The first responder carried an SF3B1 mutation and had
previously failed three standard therapies _ESA, luspatercept,
lenalidomide_, while the second one harboured no relevant mutation and
did not receive any prior lines of therapy. No new safety signals were
identified; the most frequent treatment-related adverse events were
nausea, vomiting, asthenia, and decreased appetite. These AEs were
predominantly low grade; however, they led to discontinuation in some
patients. No sign of hematologic toxicity was observed in the studied
patient population. Ongoing analyses aim to define further romaciclib's
erythroid activity, optimal dosing, and molecular predictors of response
in LR-MDS.
Poster Title:An open-label, phase 2 study of dapolsertib _MEN1703,
SEL24_ as monotherapy andincombination with glofitamab in patients
with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
Session name: 627. Aggressive lymphomas: Targeted and pharmacologic
therapies: Poster 3
Session date and time:December 8, 6:00-8:00 PM EST
Poster number: 5481
The Phase II JASPIS-01 study evaluates dapolsertib _MEN1703_, a dual
PIM/FLT3 kinase inhibitor, as monotherapy and in combination with the
CD20xCD3 bispecific antibody glofitamab in patients with relapsed or
refractory _R/R_ aggressive B-cell lymphomas who have received at least
2 prior lines of therapy. Dapolsertib targets key oncogenic and survival
pathways, including MYC- and BCL6-associated signaling, and has
demonstrated preclinical synergy with anti-CD20 antibodies. The study
aims to assess the safety, tolerability, and preliminary efficacy of
dapolsertib while exploring its potential to overcome resistance
associated with CD20 downregulation. In Part 1, patients are enrolled
into two groups: _i_ bispecific-nave patients receiving dapolsertib +
glofitamab in dose-optimization cohorts, and _ii_ heavily pretreated
patients receiving dapolsertib monotherapy. Two dosing schedules are
being explored - 125 mg _2 weeks on/1 week off_ and 150 mg _1 week on/2
weeks off_ - to identify the optimal therapeutic window. Dose selection
for Part 2 will be guided by the Data and Safety Monitoring Board
_DSMB_, following safety review after 2 treatment cycles. As of data
cutoff, enrollment in Part 1 is ongoing across 32 sites in France,
Poland, Spain, and the UK. 12 patients have been treated to date across
the combination and monotherapy cohorts. While enrollment is
progressing, the next program milestone, the Data and Safety Monitoring
Board _DSMB_ review, is anticipated in upcoming weeks. This study
represents the first clinical evaluation of dapolsertib in B-cell
lymphoma and seeks to establish a foundation for novel combination
strategies addressing resistance to CD20-targeted immunotherapies.
All posters are now available online and can be downloaded from the Ryvu
website: https://ryvu.com/publications as well as from the conference
website: https://www.hematology.org/meetings/annual-meeting
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: Prezentacja danych klinicznych dotyczących romacyklibu (RVU120) z badania REMARK oraz
dapolsertibu (MEN1703) z badania JASPIS-01 na dorocznej konferencji Amerykańskiego
Towarzystwa Hematologicznego (ASH) 2025 / Clinical data on romaciclib (RVU120) from
REMARK study and dapolsertib (MEN1703) from JASPIS-01 study presented at the 2025
Annual Meeting of the American Society of Hematology (ASH)
