AmMax Bio, a private clinical-stage biopharmaceutical company developing an innovative portfolio of antibody-drug conjugates (ADC) in oncology, and Lonza, the world’s leading contract development and manufacturing organization (CDMO), have signed a non-exclusive licensing agreement for the use of the exatecan-based SYNtecan™ linker-payload platform
AmMax has engineered AMB-104, a novel, first-in-class ADC designed to address resistance to venetoclax (Venclexta®; AbbVie and Genentech) + azacitidine (Vidaza®; Bristol Myers Squibb/Celgene) in acute myeloid leukemia (AML).[1] The investigational agent combines Lonza’s technologies with AmMax’s clinically validated antibody to deliver a tumor-targeted cytotoxic payload for treating hematological cancers. AMB-104 directly kills monocytic AML cells by delivering a cytotoxic payload.
CSF1R (Colony-Stimulating Factor 1 Receptor) is a transmembrane tyrosine kinase receptor primarily responsible for regulating the survival, proliferation, and differentiation of macrophages, monocytes, and microglia (immune cells in the brain), which is overexpressed across different segments of the AML patient population, including both newly diagnosed patients and Relapsed/Refractory patients. [2]
AMB-104 leverages the overexpression of CSF1R to target AML cancer cells with a proven cytotoxic exatecan payload (part of the SYNtecan platform), a potent topoisomerase I inhibitor, which has broad applicability across a range of AML patient populations.
The development of AMB-104 for AML is supported by a robust preclinical data package that includes, among other things, confirmed overexpression of CSF1R on AML patient samples, efficient internalization into AML cells, and robust in vitro and in vivo efficacy data.
AmMax plans to submit an IND in early 2027.
Enhancing ADC tolerability and efficacy
Under the terms of the agreement, AmMax will gain access to the exatecan-based SYNtecan™ linker-payload platform, a clinically validated platform designed to enhance ADC tolerability and efficacy. Lonza will manufacture components related to the licensed technologies, while AmMax will be responsible for the research, development, manufacturing, and commercialization of the ADC. Lonza, through one of its affiliated companies, will be eligible to receive upfront payments, potential milestone payments, and royalty payments on net sales of the resulting products.
“The continued evolution of the ADC landscape underscores the demand for robust, differentiated technologies that unlock the differentiated therapeutic potential of novel ADCs,” said Jan Vertommen, Vice President, Commercial Development, Advanced Synthesis, Lonza.
“Our collaboration with AmMax reflects this market development, and we are pleased to support their program across the development phases,” he added.
Significant milestone
“This licensing agreement marks a significant milestone in our efforts to address critical unmet needs in oncology. We are excited to leverage Lonza’s validated conjugation and linker-payload technologies with our monoclonal antibody to optimize the therapeutic potential of AMB-104. We look forward to advancing AMB-104 through clinical trials and benefit patients with significant unmet medical needs,” concluded Larry Hsu, Ph.D., Chairman and Chief Executive Officer, AmMax.
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Highlights of prescribing information
Venetoclax (Venclexta®; AbbVie and Genentech)[Prescribing Information]
Azacitidine (Vidaza®; Bristol Myers Squibb/Celgene)[Prescribing Information]
Reference
[1] Garciaz S, Hospital MA, Collette Y, Vey N. Venetoclax Resistance in Acute Myeloid Leukemia. Cancers (Basel). 2024 Mar 8;16(6):1091. doi: 10.3390/cancers16061091. PMID: 38539426; PMCID: PMC10969100.
[2] Sletta KY, Castells O, Gjertsen BT. Colony Stimulating Factor 1 Receptor in Acute Myeloid Leukemia. Front Oncol. 2021 Mar 25;11:654817. doi: 10.3389/fonc.2021.654817. PMID: 33842370; PMCID: PMC8027480.
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