FDA Grants Investigational New Drug Status to Combination of ACTR707 and Rituxan for Lymphoma

FDA Grants Investigational New Drug Status to Combination of ACTR707 and Rituxan for Lymphoma

The U.S. Food and Drug Administration has granted Investigational New Drug status to Unum Therapeutics’ ACTR707, in combination with Genentech’s Rituxan (rituximab), for treating non-Hodgkin lymphoma.

Regulators’ approval applies to relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma. A CD20-positive lymphoma is one that expresses — or produces — the CD20 protein at its surface.

“In pre-clinical testing, ACTR707 has demonstrated potent activity in combination with a broad range of tumor-targeting antibodies for use in a variety” of cancers, Dr. Michael Vasconcelles, chief medical officer of Unum, said in a press release. “As a first step, we are eager to explore the potential of ACTR707, in combination with rituximab, as a new treatment option for underserved patients with relapsed/refractory B-cell non-Hodgkin lymphoma.”

ACTR707 is an engineered T-cell therapy that combines components of different human immune cells to improve their attack on cancer cells. It is based on Unum’s proprietary antibody-coupled T-cell receptor, or ACTR, technology.

The new strategy is aimed at overcoming some of the limitations of other engineered T-cell technologies, such as chimeric antigen receptors, or CARs, and high affinity T-cell receptors, or TCRs.

Unum developed ACTRs as combination therapies. They are designed to be used with tumor-targeting antibodies as treatments for both blood cancers and solid tumors.

“Given ACTR’s universal cellular immunotherapy potential, Unum has undertaken a comprehensive screening effort to identify ACTR variants with a range of biological activities, selecting the most promising for development in hematologic [blood] and solid tumors,” said Dr. Charles Wilson, president and chief executive officer of Unum.

The company is evaluating another therapy, ACTR087, in combination with Rituxan, in a Phase 1 clinical trial (NCT02776813). The study covers patients with CD20-positive B-cell non-Hodgkin lymphoma whose cancer has progressed or failed to respond to previous therapy.

Urum expects the New Investigational Drug status to help advance ACTR707 through its clinical-trials program.

The company plans a U.S.-based, multicenter, dose-escalating Phase 1 trial (NCT03189836) of the treatment that begins with patient enrollment in the second half of 2017.

This trial is expected to include up to 38 adults with relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma. Its main objective is to assess the safety and tolerability of ACTR707 in combination with Rituxan. Researchers will also assess the combo’s anti-tumor activity and effectiveness, and ACTR707’s stability, ability to distribute itself through the body, and the length of time it stays in patients’ blood.

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