Date: 2016-08-10
Type of
information: Clinical trial authorisation
phase: 1
Announcement: clinical trial authorization
Company: Amphivena Therapeutics (USA - CA)
Product: AMV564,
Action
mechanism:
- bispecific antibody. AMV564 is a tetravalent, bispecific TandAb antibody that recruits T-cells to eliminate cancer cells that express CD33, a receptor that is expressed on the majority of AMLs and is present on other hematologic
malignancies. AMV564 is bivalent for both CD33 on AML cells and CD3 on T-cells, and maintains the avidity
for antigen as found in typical monoclonal antibodies to mediate potent and efficient tumor cell lysis. Results of preclinical studies showed that AMV564 only induced T-cell activation and mediated cytotoxicity in the presence of CD33+ target cells. The compound also demonstrated potent and selective cytotoxic activity in newly diagnosed and relapsed or refractory AML patient samples, independent of CD33
expression level. Additionally, near complete elimination of leukemic blasts from blood, bone marrow and spleen has been observed in an AML patient-derived xenograft model.
Disease: acute myeloid leukemia (AML)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This study is a first in human, Phase 1, open label, multicenter, dose escalation study of AMV564 in patients with relapsed or refractory AML. Patients must have documented diagnosis of AML according to World Health Organization (WHO) criteria. After providing signed informed consent, patients will be screened for entry into the study. The study will be conducted in 2 stages. In a dose escalation stage, approximately 32 patients will be enrolled. Escalation cohorts of 3 to 6 patients will receive repeat doses of AMV564 to determine the MTD and RP2D. AMV564 will be administered daily for 14 days. In a second expansion phase, a total of 18 patients will receive AMV564 at the established RP2D. (NCT03144245)
Latest
news:
- • On August 10, 2016, Amphivena Therapeutics announced that the FDA has accepted an investigational new drug (IND) application for AMV564, the company’s proprietary T-cell redirecting bispecific CD33/CD3 antibody. The company plans to initiate a Phase 1 dose escalation and expansion trial
of AMV564 in acute myeloid leukemia (AML) patients this year.
- The Phase 1 study will evaluate the safety, pharmacokinetics and pharmacodynamics of escalating AMV564 doses in AML patients. This will be followed by a preliminary evaluation of the antitumor activity of AMV564. Importantly, the study will allow for the identification of the maximum tolerated dose (MTD) of AMV564, as well as the recommended dose of AMV564 to be evaluated in the Phase 2 clinical studies.
Is
general: Yes
