On June 1, 2021 Ryvu Therapeutics (WSE: RVU) reported that the latest results from the DIAMOND-01 clinical trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) will be disclosed through poster presentations at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congresses, to be held on June 4-8, and June 9-17, respectively (Press release, Ryvu Therapeutics, JUN 1, 2021, View Source [SID1234583353]).

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DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24 (MEN1703), a first in class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini Group from Ryvu Therapeutics, which is currently investigated as single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

In the dose escalation part of DIAMOND-01 trial, SEL24(MEN1703) demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) posters refers to the patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24 (MEN1703) in AML, with a potential to focus on the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24 (MEN1703) in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

"We are very happy to see that SEL24 (MEN1703), developed in collaboration with Menarini, continues to build momentum in the clinic demonstrating promising single agent efficacy in a genetically well-defined patient population after earlier encouraging safety and efficacy data in all-comer AML setting" – said Setareh Shamsili, MD, PhD, Chief Medical Officer of Ryvu Therapeutics.

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Code. 7023, Poster presentation

EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia
Session: Acute myeloid leukemia – Clinical

Abstract Code: EP455, Poster presentation

About SEL24 (MEN1703)

SEL24 (MEN1703) is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

On June 1, 2021 The Menarini Group reported that additional data have been generated on SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, as part of the DIAMOND-01 trial (Press release, Menarini, JUN 1, 2021, View Source [SID1234583352]). The results will be presented at both the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congresses, held on June 4-8, and June 9-17, respectively.
DIAMOND-01 (CLI24-001; clinicaltrials.gov identifier NCT03008187) is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor licensed by Menarini from Ryvu Therapeutics and currently investigated as a single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In the dose escalation part of the DIAMOND-01 trial, SEL24/MEN1703 demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) posters refer to patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24/MEN1703 in AML, with a potential to focus in the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24/MEN1703 in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.
Topic: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Abstract Code: 7023, Poster presentation
EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia
Topic: Acute myeloid leukemia – Clinical
Abstract Code: EP455, Poster presentation
About SEL24/MEN1703

SEL24/MEN1703 is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

About Menarini in Oncology

At Menarini, we understand that patients’ hope for a better life is inextricably linked to the progress of scientific and medical research – that is what drives us forward.

Menarini Ricerche is the Menarini Group’s division dedicated to R&D, with a strong commitment to oncology research and development, focused both on therapeutics and diagnostics. We invest in the development of precision medicine through our pipeline of investigational drugs, which includes both small molecules and biologics investigated for the treatment of hematologic and solid tumors. We are also committed to developing innovative technologies for the detection and analysis of circulating tumor cells through the work of Menarini Silicon Biosystems.

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, marked the entry of the Menarini Group into the U.S. biopharmaceutical oncology market and, together with the license agreement reached with Radius Health, strengthened Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets.

For further information about Menarini’s pipeline, please visit the dedicated page on our website at View Source

On June 1, 2021 Eucure Biopharma reported that it will present findings from two Phase I clinical trials at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from June 4th to 8th (Press release, Eucure, JUN 1, 2021, View Source [SID1234583351]).

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The first trial (poster #2580; NCT04481009) is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of YH003 (an anti-CD40 monoclonal antibody (mAb)) combined with Toripalimab (Tuoyi; an anti-PD-1 mAb) in subjects with advanced solid tumors. As of December 31, 2020, there were no dose-limiting toxicity (DLT) events or severe adverse events (AE) observed in 9 subjects/3 dose levels (ranging from 0.03 to 0.3 mg/kg). Of the 5 subjects that completed at least one tumor assessment, one subject with ocular melanoma who failed prior Opdivo and Opdivo/Yervoy combination therapy achieved partial remission (PR), and two patients maintained stable disease (SD).

The second trial (poster #2577; NCT04357756) is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of an anti-CTLA-4 antibody, YH001, combined with Toripalimab in subjects with advanced solid tumors. As of December 31, 2020, no DLT or severe AE were observed at 4 dose levels (ranging from 0.05 to 1 mg/kg). Seven of 10 subjects completed at least one tumor assessment, of which 4 subjects maintained SD. As of March 1, 2021, one subject with GEJ cancer that maintained SD in the first tumor assessment achieved PR in the second assessment, with a 60.9% reduction in the target lesion compared to baseline.

About YH003
YH003 is a humanized IgG2 agonistic monoclonal antibody that targets CD40 signaling. Preclinical studies demonstrated that YH003 promotes antigen-presenting cell activation and infiltration of effector T cells into tumors. YH003 demonstrated potent anti-tumor effects in Biocytogen’s humanized CD40 mice, both alone and in combination with anti-PD-1 monoclonal antibodies. YH003 has been approved to enter Phase II trials in Australia for pancreatic cancer and PD1-resistant melanoma.

About YH001
YH001 is a humanized IgG1 monoclonal antibody that blocks the association of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) with CD80/CD86. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to enhance T-cell-mediated antitumor immune responses. Preclinical data indicates that YH001 outperforms Ipilimumab (a currently approved CTLA-4 drug) in CTLA-4 binding affinity and inducing ADCC activity.

On June 1, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that results from twelve studies of selinexor, the world’s first approved oral selective inhibitor of nuclear export (SINE), were selected for the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, taking place in a virtual format on June 9 to 17 (Press release, Antengene, JUN 1, 2021, View Source [SID1234583350]).

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Selected Abstracts:

Phase 2 MARCH study of oral ATG-010 plus low dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma previously exposed to an immunomodulatory agent and a proteasome inhibitor.

Abstract #: PB1670

Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.

Abstract #: S188

Selinexor containing regimens in patients with multiple myeloma previously treated with anti-CD38 monoclonal antibodies.

Abstract #: EP1002

Oral selinexor, pomalidomide, and dexamethasone (XPd) at recommended phase 2 dose in relapsed/refractory multiple myeloma (MM).

Abstract #: EP1008

Ciltacabtagene Autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥ 3 lines of prior therapy: A matching adjusted indirect comparison.

Abstract #: EP1049

Cost effectiveness comparison of belantamab mafodotin and selinexor in relapsed refractory multiple myeloma.

Abstract #: EP1173

Lymphocyte count effect on efficacy and safety of single agent oral selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL): A post-hoc analysis from phase 2B SADAL study.

Abstract #: EP530

Genomic correlates of respones to selinexor in multiple myeloma from the BOSTON study reveal a predictive signature.

Abstract #: EP936

Effects of selinexor on previously treated multiple myeloma (MM) with RAS-mutations.

Abstract #: EP966

Efficacy and safety of selinexor, bortezomib, and dexamethasone based on refractory status to lenalidomide in patients with previously treated multiple myeloma: A post-hoc analysis of the BOSTON study.

Abstract #: EP974

Survival among older patients with previously treated multiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.

Abstract #: EP976

Updated overall survival of eltanexor for the treatment of patients with hypomethylating agent refractory myelodysplastic syndrome.

Abstract #: EP924

On June 1, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that fifteen studies and results of selinexor, the world’s first approved oral selective inhibitor of nuclear export (SINE), will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in a virtual format on June 4 to 8 (Press release, Antengene, JUN 1, 2021, View Source [SID1234583349]).

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Selected Abstracts:

Effects of weekly selinexor, bortezomib, dexamethasone (XVd) versus standard twice weekly bortezomib and dexamethasone (Vd) on RAS-mutated previously treated multiple myeloma (MM).

Abstract #: 8027

Effects of refractory status to lenalidomide on safety and efficacy of selinexor, bortezomib, and dexamethasone (XVd) versus bortezomib and dexamethasone (Vd) in patients with previously treated multiple myeloma.

Abstract #: 8024

Survival among older patients with previously treated multiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.

Abstract #: 8019

Updated overall survival of eltanexor for the treatment of patients with hypomethylating agent refractory myelodysplastic syndrome.

Abstract #: e19037

Results of the phase 2 MARCH Study: Oral ATG-010 (Selinexor) plus low dosedexamethasone in Chinese patients with relapsed/refractory multiple myeloma (RRMM) previously treated with an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI).

Abstract #: e20002

Oral selinexor, pomalidomide, and dexamethasone (XPd) at recommended phase 2 dose in relapsed refractory multiple myeloma (MM).

Abstract #: 8018

SIENDO/ENGOT-EN5/GOG-3055: A randomized phase 3 trial of maintenance selinexor versus placebo after combination platinum-based chemotherapy in advanced or recurrent endometrial cancer.

Abstract #: TPS5610

Open-label phase 1 study evaluating the tolerability and anti-tumor activity of selinexor and pembrolizumab in colorectal cancer.

Abstract #: e15579

A phase 1/2 study of selinexor in combination with standard of care therapy for newly diagnosed or recurrent glioblastoma.

Abstract #: TPS2071

A phase Ib/II study of selinexor in combination with imatinib in patients with advanced gastrointestinal stromal tumor (GIST): SeliGIST/GEIS-41 trial.

Abstract #: 11534

Selinexor in combination with weekly paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multiarm phase 1b study.

Abstract #: 5565

Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.

Abstract #: 8038

A randomized, open-label, phase 3 study of low-dose selinexor and lenalidomide (Len) versus len maintenance post autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma (NDMM): ALLG MM23, Sealand.

Abstract #: TPS8055

Molecular predictors of response to selinexor in advanced unresectable de-differentiated liposarcoma (DDLS).

Abstract #: 11509

Selinexor containing regimens in patients with multiple myeloma (MM) previously treated with anti-CD38 monoclonal antibodies (αCD38 mAbs).

Abstract #: e20020