The first patient was dosed in a phase 1/2 study assessing the safety and efficacy of next-generation immunotherapy to treat patients with metastatic breast cancer whose disease did not respond to at least two systemic therapies.
A press release from BriaCell Therapeutics, the manufacturer of Bria-OTS, the personalized next-generation immunotherapy, noted that Bria-OTS will be investigated alone and in combination with the immune checkpoint inhibitor Tevimbra (tislelizumab).
“Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients,” Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell, said in the release. “This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy.”
Glossary
Immunotherapy: a therapy that uses materials to suppress or stimulate the immune system to help the body fight cancer
Immune checkpoint inhibitor: a drug that blocks certain proteins that are made by some types of immune system cells and some cancer cells. By blocking these proteins, this may lead to an improved approach to killing cancer cells
Overall response rate: the percentage of patients who have a partial or complete response to treatment
Progression-free survival: the time during and after treatment when a patient with cancer lives with the disease without worsening
Overall survival: the time when a patient with cancer is still alive
In this phase 1/2 trial, researchers are enrolling patients with metastatic or locally recurrent breast cancer previously treated with at least two systemic therapies such as chemotherapy and whose disease did not respond to those treatments, according to the release. Patients will be treated with Bria-OTS as monotherapy, then in combination with Tevimbra.
There are several measures of interest in this study, including safety, overall response rate, progression-free survival and overall survival.
“Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy,” Dr. William V. Williams, President and CEO of BriaCell, said in the release.
BriaCell-OTC, according to the pharmaceutical company’s website, is a personalized off-the-shelf immunotherapy that is engineered to express 15 types of human leukocyte antigens (HLAs). The National Cancer Institute noted that HLA is a type of molecule found on the surface of most cells and plays a part in the body’s immune response to foreign substances. Of note, HLAs can vary from person to person.
“Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug conjugates and immune checkpoint inhibitors,” Dr. Sant P. Chawla, Head of the Sarcoma Oncology Center in Santa Monica, California, and principal investigator for the study, said in the release. “We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes.”
According to BriaCell’s website, Bria-IMT is an off-the-shelf targeted cell-based immunotherapy for the treatment of patients with metastatic breast cancer. In particular, it is a genetically engineered human breast cancer cell line that includes immune cells.
Bria-IMT was granted fast-track designation by the Food and Drug Administration in 2022, meaning that the agency agreed to increase communication with the drug’s manufacturer to potentially approve the therapy earlier than originally anticipated.
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