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SAVE AML and AUGMENT-102 Phase 1 Combination Trials","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Salarius Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Investigator-initiated Phase 1\/2 Clinical Trial Using Salarius Pharmaceuticals\u2122 Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Faron Pharmaceuticals","sponsor":"Not 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Find Clinical Drug Pipeline Developments & Deals for Azacitidine
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
The data reinforce the potential of IMGN632 as a new therapy for patients with relapsed/refractory AML and result showed that they manageable safety profile and 38% composite complete remission rate seen in the higher intensity cohorts.
The data demonstrate the promising anti-leukemia activity and manageable safety profile of the IMGN632 triplet in AML, and we are encouraged by its potential in patients with relapsed/refractory AML, where well-tolerated, effective options remain quite limited.
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of VENCLYXTO in combination with hypomethylating agents in adult patients with AML.
In the VIALE-A trial, the median overall survival of patients who received VENCLEXTA plus azacitidine was 14.7 months (11.9, 18.7) vs 9.6 months (7.4, 12.7) in patients who received azacitidine in combination with placebo.
Phase 3 VIALE-A study showed a 34 percent reduction in the risk of death in AML patients who were ineligible for intensive chemotherapy treated with venetoclax plus azacitidine compared to azacitidine plus placebo.
SLS009 (GFH009) is a small molecule, highly selective CDK9 inhibitor, demostrated anti-tumor activity in the study being investigated for the treatment of relapsed/refractory acute myeloid leukemia.
SY-1425 (tamibarotene) is a first-in-class selective retinoic acid receptor alpha (RARα) agonist. It is being evaluated in combination with azacitidine for the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression.
FP-1305 (bexmarilimab) is a first-in-class, humanized monoclonal antibody, which binds to Clever-1, an immunosuppressive receptor found on macrophages. It is being evaluated for the treatment of higher-risk (HR) myelodysplastic syndrome.
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