Hemispherx Biopharma (NYSE American:HEB) reports that Roswell Park Comprehensive Cancer Center will kick off an oncology study to evaluate its experimental drug Ampligen along with the Merck & Co (NYSE:MRK) blockbuster cancer drug Keytruda in patients with metastatic triple-negative breast cancer.
The trial will enroll at least six participants and be conducted by Drs. Mateusz Opyrchal and Pawel Kalinski at Roswell Park, a National Cancer Institute-designated comprehensive cancer center in Buffalo, New York.
The study will assess how well Ampligen-based chemokine modulation therapy works when given prior to Keytruda in treating patients with triple-negative breast cancer that has spread to other places in the body.
“At Team Hemispherx, we are determined to pursue an aggressive R&D program focused on improved immune therapies for lethal malignancies, and we are grateful for the support and attention we are getting from big pharma and these major research institutions,” said Hemispherx CEO Thomas Equels in a statement.
Drugs used in this chemokine modulation therapy – celecoxib, recombinant interferon alfa-2b and Ampligen – work by boosting cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules.
The clinical trial aims to determine whether chemokine modulation therapy before Keytruda will work better than Keytruda alone in patients with metastatic triple-negative breast cancer by altering the tumor microenvironment to favor immune rejection.
Investors applauded news of the trial, sending Hemispherx shares up 18.3% to $0.23 in Tuesday’s afternoon trading session.
The study will assess patients with metastatic triple-negative breast cancer who will undergo a pre-treatment biopsy. Participants then receive two cycles of chemokine modulation therapy followed by an additional biopsy. After the biopsy and chemokine modulation therapy, participants will receive Keytruda every three weeks for two cycles.
A second clinical trial combining Ampligen with Keytruda to treat 40 patients with ovarian cancer is set to launch later this month at the University of Pittsburgh. It will be an important and more extensive test of Ampligen as an immune system primer that can change cold tumors into hot tumors and make the formerly cold tumors more responsive to Keytruda, according to the company.
“Relevant preclinical experiments in several types of solid tumors and conducted at different major US cancer research centers support the proposition that Ampligen can change the micro-environment of tumors so as to create a robust and significant positive synergy with check point blockade therapies,” explained Equels.
Hemispherx is making great strides in using its therapy Ampligen as an immuno-oncology agent to fight multiple types of cancer.
The company is currently supporting the evaluation of Ampligen’s use in fighting eight solid tumors (urothelial carcinoma, renal cell carcinoma, melanoma, triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas) as part of a number of separate clinical studies at major research institutions.
Contact Ellen Kelleher at [email protected]