Regulators in 2 countries OK clinical testing of new blood cancer treatment
'Potent' therapy being developed for AML, CCML and myeloma
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Regulatory authorities in two countries have given the green light for clinical testing of a novel treatment from Mabwell Bioscience — which the company says has “potent tumor-killing effects” — that’s being developed for use in multiple types of blood cancer, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and myeloma.
The Shanghai-based developer announced in a company press release that it received the go-ahead from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) to test its experimental therapy 6MW5311. The company did not provide details on trial design or when a study would be expected to begin.
In noting the FDA and NMPA clearances, Mabwell said its therapy candidate has shown effectiveness in patient-derived samples, and “demonstrated a favorable safety profile” in a primate model.
AML, CMML, and myeloma are all forms of blood cancer characterized by the abnormal growth of certain immune cells. These cancerous immune cells often express a protein marker called LILRB4.
6MW5311 belongs to a recently developed class of immunotherapies called T-cell engager (TCE) bispecific antibodies. These types of therapy are designed to simultaneously stick to a target on cancer cells, and also to proteins that are expressed by cancer-killing immune cells called T-cells.
By sticking to both the cancer and T-cells, TCE bispecific antibodies aim to trigger T-cells to destroy cancer cells. 6MW5311 specifically targets the LILRB4 protein on cancer cells and a T-cell protein called CD3.
New treatment needed for aggressive blood cancer, developer says
Several TCE bispecific antibodies are approved for the treatment of myeloma and other blood cancers. However, no therapies in this class have won approval for treating AML or CMML, according to Mabwell.
The developer noted that treatments for these aggressive forms of blood cancer are mainly limited to chemotherapy, stem cell transplant, or targeted agents aimed at cancers carrying specific mutations. Mabwell also noted that 6MW5311 is the first therapy to enter clinical testing that is designed to target both LILRB4 and CD3.
In vitro studies — that is, tests done in a lab using cells in dishes — have shown that 6MW5311 has powerful cancer-killing abilities in multiple lab models of blood cancers, as well as samples derived from patients, per Mabwell. Tests done in vivo, or in living animals, have shown that the therapy can significantly inhibit cancer growth in AML tumor models expressing either low or high amounts of the LILRB4 protein, the developer said.
According to Mabwell, the therapy achieved complete clearance of cancer cells in AML models with high LILRB4 expression. The company also said that 6MW5311 has been shown safety in experiments using nonhuman primates.
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