Myeloblasts with Auer rods seen in acute myeloid leukaemia, advanced stage. Credit: Paulo Henrique Orlandi Mourao.

Aptevo Therapeutics has dosed the first patient in a Phase l/lb clinical trial of APVO436 for the treatment of patients with acute myeloid leukaemia (AML) and high-grade myelodysplastic syndrome (MDS).

AML is a type of blood and bone marrow cancer that results in rapid disease progression, while MDS are conditions related to abnormalities in the blood-forming cells in the bone marrow.

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The Phase l/lb trial includes two parts, first of which will enrol up to 60 patients, while the second part will include a larger group of patients.

Part one of the trial will be conducted in an open-label, dose-escalation setting to examine the safety and pharmacokinetic profile of APVO436 to establish a recommended dose for part two.

The second part of the trial is a Phase lb open-label expansion study that aims to evaluate the clinical activity and safety of APVO436 at the recommended dose.

“There is a strong unmet medical need for novel targeted biological therapies to treat patients with relapsed or refractory AML or MDS.”

Aptevo chief medical officer Dr Scott Stromatt said: “There is a strong unmet medical need for novel targeted biological therapies to treat patients with relapsed or refractory AML or MDS.

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“Chemotherapy, which is the standard of care for these patients, is generally poorly tolerated in the elderly, and patients are still confronted with high relapse rates after treatment.

“Recent clinical data has demonstrated that CD123 is a validated target for AML therapy.”

Each year, around 100,000 new cases of AML are diagnosed worldwide. According to the American Cancer Society, around 20,000 new cases of AML are diagnosed annually in the US alone.

Stromatt further added: “APVO436 is our first bispecific antibody candidate developed based on Aptevo’s next-generation ADAPTIR platform to enter the clinic.

“Our next-generation ADAPTIR platform has been optimised to construct novel bispecific antibody therapeutics that maintain the desirable properties of traditional antibodies, such as longer half-life, stability and ease of manufacturing, but with the potential to exploit novel mechanisms of action to achieve enhanced biological activity and an improved therapeutic index.”

Aptevo expect to report preliminary top-line data from the Phase l portion of the Phase l/lb trial next year.