1st Patient Enrolled in Phase 1 Trial of Antibody Therapy BHV-1100

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by Somi Igbene |

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Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100.

The trial (NCT04634435) seeks to recruit 25 adults with newly diagnosed multiple myeloma who have minimal residual disease in first remission before a stem cell transplant. One patient has now been enrolled. The trial will assess the safety and effectiveness of BHV-1100 in combination with cytokine-induced memory-like natural killer (NK) cells and low-dose interleukin (IL)-2.

“This is an important milestone in the development of the ARM therapeutic platform — taking a novel technology from ‘benchtop to bedside,’ ” David Spiegel, MD, PhD, inventor of the ARM technology and professor of chemistry and pharmacology at Yale University, said in a press release. “It also highlights Biohaven’s commitment to benefit patients in need.”

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NK cells are immune cells that recognize and destroy foreign molecules and diseased cells. Unlike T-cells and other immune cells, NK cells cannot target specific proteins on cells they plan to destroy.

ARMs such as BHV-1100 are small molecules that recruit antibodies to destroy cancerous or infected cells. They work by binding to specific proteins on the tumor surface and simultaneously to antibodies present in the patient and the environment surrounding the cancer cells; this process marks the cancer cell for destruction by NK cells and macrophages, which are specialized cells that help detect and destroy bacteria and other harmful organisms.

BHV-1100, formerly known as KP1237, binds to the CD38 protein on multiple myeloma cells and recruits cytokine-induced memory-like NK cells to destroy them. Because BHV-1100 specifically detects CD38 on myeloma cells, scientists can combine it with pre-harvested, primed NK cells to help boost the patient’s ability to kill cancer cells.

“While many recent advances have been made to benefit multiple myeloma patients, most patients will unfortunately still relapse,” Charlie Conway, PhD, chief scientific officer at Biohaven, said. “We are excited to investigate BHV-1100 for its ability to recruit [cytokine-induced memory-like] NK cells to the site of the tumor.”

Biohaven also expects BHV-1100 to recruit other immune memory cells to encourage patients’ immune systems to adapt to CD38 proteins, thereby potentially instilling long-term immunity.

“Based on preclinical data from Biohaven Labs, we anticipate that our CD38 targeting ARM-enabled NK cells will kill CD38-positive multiple myeloma cells, and recruit other immune effector cells to assist in reducing the tumor burden,” Conway said.

In the trial, participants will receive an infusion of their own (autologous) cytokine-induced memory-like NK cells with BHV-1100 and a low dose of IL-2.

BHV-1100 has received orphan drug status (for therapies that show promise in treatment, prevention, or diagnosis) for multiple myeloma by the U.S. Food and Drug Administration. The therapy was developed through a strategic alliance between Biohaven and PeptiDream.

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