Amphivena announces initial data from Phase 1 study of AMV564
Category: #health  By Saipriya Iyer  Date: 2019-12-12
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Amphivena announces initial data from Phase 1 study of AMV564

Amphivena Therapeutics, Inc., a clinical stage immuno-oncology firm developing T cell engager therapies for cancer, has recently presented data from Phase 1 trial of AMV564, a bivalent T cell engager clinical candidate, at the American Society of Hematology (ASH) annual meeting.

Dr. Jorge E. Cortes from Augusta University’s Georgia Cancer Center said that the findings show early proof of clinical activity and safety with evidence of T cell activation, proliferation in anti-leukemic blast activity and bone marrow T cells. The test discovered that, out of the overall 38 subjects, five of them had shown partial or complete response as defined by the European LeukemiaNet (ELN) criteria.

Dr. Cortes added that AMV564 was well-tolerated and was concluded to be safe, with no Grade 3+ CRS (Cytokine Release Syndrome) and no dose-limiting toxicities, at dosages up to 450 mcg/day in pre-treated refractory/ relapsed AML patients.

Patients were administered by continuous IV infusion with a fourteen-day dosing program. Additionally, these results offer a distinguished product portfolio that could make substantial clinical development in the future, said Dr. Cortes.

As per Curtis Ruegg, Ph.D., President and CEO, Amphivena, the company is delighted with the early indications of safety and efficacy in this First in Human clinical study. Their firm is studying chronic and subcutaneous dosing of AMV564 in a separate clinical study.

Moreover, the drug’s remarkable safety profile reinforces the other combination studies of AMV564 with different agents and the company is looking forward to conducting more AMV564 development activities in the coming years, cites Ruegg.

Supposedly, a total of 41 patients were administered with AMV564 and eleven cohorts were examined in a continuous 14-day IV dosing routine. The main purpose of this Phase 1 dose-escalation trial was to know AMV564’s safety as well as to ascertain a recommended Phase 2 dose and a maximum tolerated dose of the drug.
 

Source Credit: https://finance.yahoo.com/news/amphivena-reports-data-phase-1-224500283.html



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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