On June 14, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported that they have entered into a license agreement with CrystalGenomics, Inc. (KOSDAQ:083790) for China rights to CG-806 (including People’s Republic of China, Hong Kong and Macau) (Press release, Aptose Biosciences, JUN 14, 2018, View Source;p=RssLanding&cat=news&id=2354544 [SID1234527312]). Aptose will now own worldwide rights (excluding Korea) to develop and commercialize CG-806, a first-in-class, highly potent oral small molecule being developed for acute myeloid leukemia (AML), B-cell malignancies and other hematologic malignancies.
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Under the agreement, CrystalGenomics will receive an upfront payment of US $3 million and is eligible for development, regulatory and commercial-based milestones, as well as single-digit royalties on product sales in China. Total deal value for the China territory, including the upfront payment, is up to US $125 million.
On May 7, 2018, Aptose exercised its option to obtain the exclusive license from CrystalGenomics to develop and commercialize CG-806 worldwide outside of China and Korea. This new agreement extends that license agreement to include China.
"Licensing rights to CG-806 to include the China territory was a strategic decision," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Our preclinical work with CG-806 has demonstrated its superior activity to other FLT3 inhibitors on AML patient samples, its superior ability to kill B-cell malignancy patient samples relative to ibrutinib, and a favorable safety profile. We believe that CG-806 has the potential to serve as a transformational agent for multiple hematologic cancers, including AML, CLL and others."
"We are pleased to continue our relationship with the Aptose team, which recognized the exciting potential of CG-806 very early in its development," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "They have been laser focused on IND-enabling studies of CG-806, and we look forward to seeing CG-806 enter the clinic."
About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor that represents a potential best-in-class therapeutic for patients with AML.
Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.