The agreement calls for a range of new clinical and translational studies of oral decitabine and cedazuridine tablets as an anticancer agent to be conducted in collaboration with Astex.
The NCI's Cancer Therapy Evaluation Program has announced they are accepting Letters of Intent for evaluation of oral decitabine and cedazuridine tablets in hematological malignancies and solid tumors, including in combination with other investigational agents.
Study proposals will be reviewed by CTEP and by Astex.
On July 7th, 2020, Astex's hypomethylating agent INQOVI (decitabine and cedazuridine) 35mg/100mg tablets, for oral use, was approved simultaneously by the US FDA and by Health Canada for the treatment of intermediate- and high-risk myelodysplastic syndromes and chronic myelomonocytic leukemia patients in the US and Canada, respectively.
The initial study being conducted under the CRADA will investigate the combination of oral decitabine and cedazuridine tablets with venetoclax in the treatment of acute myeloid leukemia.
The CRADA will also include oral decitabine and cedazuridine tablets in the NCI myeloMATCH master trial aimed at evaluating therapies for the treatment of myeloid malignancies. Astex will provide funding, study drug, and personnel to support the proposed studies.
In the US and Canada, INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes, including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
ELIAS Animal Health names new chief revenue officer
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval