Menarini Group and Ryvu Therapeutics Announce First Clinical Data from the Phase II JASPIS-01 Study of dapolsertib (MEN1703, SEL24) in Heavily Pretreated Relapsed/Refractory Aggressive B-cell non-Hodgkin Lymphoma at the 2026 ASH Annual Meeting

• First clinical data for dapolsertib monotherapy: initial results from the Phase II JASPIS-01 study of dapolsertib (MEN1703), a first-in-class oral dual PIM/FLT3 kinase inhibitor, in patients with relapsed/refractory (r/r) aggressive B-cell non-Hodgkin lymphoma (B-NHL) who have exhausted available standard treatment options.
  
  
• Clinical activity observed in a heavily pretreated population: clinical activity was observed in a population with a median of four prior lines of therapy; 53% of patients had previously received CAR-T cell therapy and 60% CD3×CD20 bispecific antibodies.
  
  
• New treatment options needed: patients whose disease progresses after CAR-T cell therapy and/or CD3×CD20 bispecific antibodies have limited therapeutic options and poor outcomes.
  
  
• Poster presentation at ASH 2026: the data will be presented on December 13, 2026, at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, U.S.

FLORENCE, Italy and KRAKOW, Poland, Nov. 4, 2026 /CNW/ -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Ryvu Therapeutics (WSE: RVU), today announced that the first clinical data from the ongoing Phase II JASPIS-01 study (NCT06534437) of dapolsertib (MEN1703, SEL24) in patients with r/r aggressive B-NHL  will be presented in a poster session at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 12-15, 2026, in New Orleans, Louisiana, and virtually.

Dapolsertib is a first-in-class oral dual PIM/FLT3 kinase inhibitor that has demonstrated preclinical antitumor activity and synergy with anti-CD20-directed therapies. The abstract reports the first clinical results from Group 2 of the JASPIS-01 study, which evaluates dapolsertib monotherapy (125 mg orally once daily on days 1-14 of 21-day cycles) in adults with r/r aggressive B-NHL who have exhausted available standard treatment options following at least two prior systemic therapies. Clinical activity was observed in heavily pretreated patients. The safety profile was manageable and allowed dosing of dapolsertib at the intended dose level.

"Patients with aggressive B-cell lymphoma whose disease progresses after CAR-T cell therapy and bispecific antibodies have limited treatment options and face very poor outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "The encouraging initial findings in heavily pretreated patients support the continued clinical development of dapolsertib, a first-in-class oral dual PIM/FLT3 inhibitor, as a potential option for this grim disease, and we look forward to further results from the ongoing study."

"We are very pleased that the first clinical data from JASPIS-01 will be presented at ASH, a leading hematology meeting. The activity seen in the JASPIS-01 study are particularly encouraging, given the highly aggressive biology of the disease in this population," said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics. "As dapolsertib inventors and Menarini's operational partner for the study, we remain committed to advancing dapolsertib for patients with aggressive B-cell lymphoma, who urgently need new treatment options."

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

The abstract is available on the ASH website: https://www.hematology.org/meetings/annual-meeting 

About JASPIS-01
JASPIS-01 (NCT06534437) is an ongoing multicenter, open-label Phase II study evaluating dapolsertib as monotherapy and in combination with glofitamab in adults with r/r aggressive B-NHL, including diffuse large B-cell lymphoma (DLBCL), after at least two prior systemic therapies. Group 1 evaluates dapolsertib in combination with glofitamab in patients naïve to CD3×CD20 bispecific antibodies. Group 2 evaluates dapolsertib as monotherapy in patients who have exhausted available standard treatment options. The primary endpoint is overall response rate (ORR) per the Lugano Classification; secondary endpoints include duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety.

About dapolsertib
Dapolsertib (MEN1703, SEL24) 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. Since September 2023, Ryvu has been Menarini's operational partner for Phase II study execution, with Menarini funding all research and development costs. Dapolsertib is an investigational agent and has not been approved by any regulatory authority.

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com.

About Stemline Therapeutics Inc.
Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.

About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immune-oncology targets.

Ryvu's most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. Romaciclib is currently in Phase II development in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study – and is also being evaluated in an investigator-initiated Phase I study in pediatric medulloblastoma – the MEDWAY study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study – with a further Phase II study in myelofibrosis (SPHENE-01) planned to start in Q1 2027. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, has completed IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis, and offers dedicated early clinical development services to biotech and pharma partners through its Keelira business.

Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.

For more information, please visit www.ryvu.com 

SOURCE Menarini Industrie Farmaceutiche Riunite

Ryvu Therapeutics: Anna Wilk, [phone], [email protected], The Menarini Group: Valeria Speroni Cardi, Email: [email protected], Stemline Therapeutics, Inc.: Cheya Pope, Email: [email protected]