Aveo Oncology signed an exclusive, worldwide license agreement with Novartis for the development and commercialization of Aveo’s humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody.

AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales, and regulatory-based milestone payments totaling $311 million assuming successful advancement of the product. Aveo will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double digit. Novartis will be responsible for all clinical development, manufacturing, and commercialization activities and costs associated with the product.

“AV-380 holds great promise as a potential treatment for cachexia secondary to multiple disease states, including cancer, chronic kidney disease, congestive heart failure, and chronic obstructive pulmonary disease,” said Michael Bailey, Aveo’s president and CEO. “Novartis brings resources and expertise to bear on advancing this program, which we believe provides the optimal path forward toward realizing its full potential.”

Cachexia is a complex metabolic syndrome associated with malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation, and suppression of immune functions. GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Current evidence suggests that a pro-inflammatory state may be responsible for many of the symptoms associated with cachexia. Preclinical data show that inhibition of GDF15 results in a switch from catabolism to anabolism, suggesting that GDF15 inhibition with AV-380 may reverse the effects of cachexia.

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