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Clinical Trial Tests In-Tumor Breast Cancer Therapy

Breast cancer self exam

(NIEHS, nih.gov)

24 Mar. 2021. A clinical trial is set to begin that tests a treatment for early-stage breast cancer delivered directly into the tumor before surgery is scheduled. The study, now authorized by Health Canada, will be conducted in Ottawa, Ontario, testing the therapy code-named INT230-6, made by Intensity Therapeutics Inc. in Westport, Connecticut.

Intensity Therapeutics is a developer of solid tumor cancer therapies that act directly on tumors and also generate an immune response against tumors that may spread elsewhere in the body. The company’s technology uses a sodium salt compound with the abbreviation SHAO that both attracts and repels water, combined with chemotherapy drugs. This combination, says the company, disperses throughout tumors, then penetrates, concentrates in, and attacks cancer cells. The mutated and weakened cancer cells from the tumor also act as antigens to stimulate a systemic immune response that neutralizes escaping tumor cells.

Intensity’s first product is INT230-6, designed to treat solid tumor cancers. INT230-6 contains the chemotherapy drugs cisplatin and vinblastine combined with SHAO for delivery to cancer cells. In preclinical studies with lab mice induced with colon cancer, conducted by the company and with National Cancer Institute, INT230-6 is shown to disperse through tumors and inflitrate cancer cells, as well as generate an immune response. Compared to the chemotherapy drugs alone, animals receiving INT230-6 reduced tumor growth and improved survival time. The study with NCI found similar results when testing INT230-6 in mice induced with breast cancer.

Looking for reductions in malignancy

The clinical trial plans to enroll 60 women at Ottawa Hospital Cancer Center with early-stage breast cancer, and tumors either still confined to the breast or spread no further than nearby lymph nodes. Participants are randomly assigned to receive three doses of INT230-6 injected directly into the tumors seven days apart, or receive standard care in preparation for surgery. Tissue samples from the affected breast will then be analyzed in the three to six-week period between diagnosis and surgery.

The study team led by Ottawa Hospital research oncologist Angel Arnaout is looking primarily for reductions in the antigen Ki67, a protein indicator of cancer malignancy in the tissue samples. Researchers are also tracking adverse effects of the treatments prior to surgery, residual cancer burdens, tumor proliferation, and indicators of immune system cells such as T-cells, macrophages, or natural killer cells.

“There currently is no drug treatment available in the early presurgical setting with the ability to kill a tumor rapidly in the typical 4-week period from diagnosis to surgery,” says Arnaout in an Intensity Therapeutics statement. “Using INT230-6 to rapidly reduce a patient’s cancer cell burden and shut down proliferation in the timeframe from diagnosis to surgery is exciting and could offer increased clinical benefit.”

“Killing cancer immediately after its diagnosis,” adds Intensity Therapeutics chief medical officer Ian Walters, “may give patients more peace of mind that all effort is being made to stop the cancer from growing or spreading prior to resection, as well as improve the cosmetic and functional outcome of the surgery.”

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