Blood cancer patients undergoing chemotherapy could soon have a reduced dependence on blood transfusions thanks to a new clinical study announced, run in partnership between biotech company Syntara (ASX: SNT), the University of Newcastle and the Australasian Leukaemia and Lymphoma Group (ALLG). 

The Phase 2 clinical study has been backed by a $0.83m grant to the partners, awarded through a competitive tender process, by the Australian Medical Research Future Fund (MRFF). 

Expected to commence in the second half of 2024, the study will evaluate the combination treatment of SNT-5505 with chemotherapy in patients diagnosed with low and intermediate risk myelodysplastic syndrome (MDS). 

MDS is a significant subset of blood cancers where abnormal tissue growth leads to bone marrow failure. The resulting impact often leads to low blood counts, making it difficult for the body to fight off infections. At present, the standard of care involves blood transfusions but the dependence of these creates its own problems within the healthcare system. 

The overall 5-year survival rate for transfusion dependent MDS is only 37%. 

Through the new clinical trials, Associate Professor Anoop Enjeti is hopeful that SNT-5505 can help reduce dependency on transfusions, slowing the potential progression to acute myeloid leukaemia (AML), a more aggressive form of blood cancer. 

“Transfusion dependent myelodysplasia has no approved treatments available for Australian patients,” said Dr Enjeti. 

“It is exciting that MRFF funding will facilitate the collaboration between multiple partners translating the pre-clinical synergies between SNT-5505 and hypomethylating agents, into an early phase clinical trial with potential for improving the survival and quality of life for our patients.” 

The Phase 2 trial will comprise a dose escalation phase followed by a dose expansion phase, with endpoints including the reduction in transfusion dependency, haematological parameters, and quality of life. Results from the dose escalation phase, including safety and preliminary efficacy endpoints, are anticipated by mid-2025, offering hope for significant advancements in the treatment landscape for MDS patients.

Gary Phillips, CEO of Syntara, underscored the strategic importance of expanding the haematology indications for SNT-5505, emphasising the company’s commitment to addressing high unmet needs and delivering value to shareholders. 

“The grant from the MRFF and the support of University of Newcastle and the ALLG enables us to expand the haematology indications for SNT-5505 beyond the current international myelofibrosis study and into another area of high unmet need and commercial value,” said Phillips. 

“The possibility of seeing safety and efficacy data in this additional indication in the same time frame as the other phase 2 studies in myelofibrosis, neurodegenerative disease and burn scars is a win for the company and its shareholders and will generate significant interest in SNT-5505 amongst companies with a focus on haematology.” 

SNT-5505, Syntara’s lead asset, is a pan-LOX inhibitor currently being evaluated in a Phase 2 multinational study targeting myelofibrosis, with promising data from preliminary studies presented at the American Society of Haematology (ASH) conference in December 2023.

Syntara’s contribution to the MDS study encompasses financial support totalling $700k over the expected three-year duration of the trial phases, in addition to supplying the study drug and LOX assays on tissue samples collected during the study.

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