Investigator-Sponsored Trial Evaluating Biothera’s Imprime PGG In Relapsed Indolent Non-Hodgkin Lymphoma
EAGAN, Minn.--(BUSINESS WIRE)--Biothera today announced that patient dosing has begun in an investigator-sponsored phase 2 trial of its investigational cancer immunotherapy, Imprime PGG, in combination with rituximab (Rituxan®) for relapsed indolent Non-Hodgkin Lymphoma (NHL). The trial is being conducted at the Dana-Farber Cancer Institute under the direction of Caron A. Jacobson, M.D., Instructor in Medicine, Harvard Medical School.
“Imprime PGG’s unique mechanism of action has significant therapeutic potential for a broad range of cancer indications, including those with high unmet medical needs such as relapsed/refractory NHL”
“Rituximab, as a targeted immunotherapy for CD20-positive malignancies, offered a major breakthrough, particularly in the treatment of indolent B-cell lymphomas, given its single agent efficacy and tolerability,” said Dr. Jacobson. “Imprime PGG, in combination with rituximab, is expected to recruit neutrophils to the malignant B cells thus offering an additional mechanism of anti-tumor immunologic attack without expected increased toxicity.”
Biothera recently presented the latest results of a phase 1/2 study of high risk chronic lymphocytic leukemia at the American Society of Clinical Oncology’s (ASCO) annual meeting. The combination of Imprime PGG and the monoclonal antibodies rituximab and alemtuzumab achieved responses in 13 of 14 (93%) patients, including nine (64%) complete responses, meaning blood tests found no trace of cancer. The most common adverse events on the combination treatment were anemia, rash and neutropenia. Overall, the addition of Imprime PGG to rituximab and alemtuzumab was safe and well tolerated. ASCO poster: A Phase (Ph) 1/2 Trial of Rituximab (RX), Imprime PGG (IP), and Alemtuzumab (AL) in the Early Treatment of Patients (Pts) with High Risk Chronic Lymphocytic Leukemia (CLL).
“Imprime PGG’s unique mechanism of action has significant therapeutic potential for a broad range of cancer indications, including those with high unmet medical needs such as relapsed/refractory NHL,” said Ada Braun, M.D., Ph.D., Biothera Chief Medical Officer. “Biothera values opportunities for academic partnerships like this investigator-sponsored study that have the potential to drive meaningful advances in cancer immunotherapy.”
NHL Study Design
The phase 2 open label, single-arm study at
the Dana-Farber Cancer Institute will enroll 25 patients to evaluate the
efficacy and safety of Imprime PGG in combination with rituximab in
relapsed/refractory indolent B cell non-Hodgkin lymphoma. Imprime PGG
will be administered intravenously at a dose of 4mg/kg weekly for 4
weeks. Rituximab will be administered intravenously per institutional
standards concurrently at a dose of 375mg/m2 weekly for 4
weeks.
The primary endpoint of the trial is overall response rate. Secondary endpoints include progression-free survival and duration of response. In addition, researchers will perform correlative laboratory studies using on-treatment peripheral blood samples and post-treatment tumor samples to further assess Imprime PGG’s effects on biomarkers and on the tumor.
About Biothera
Biothera is a privately held biotechnology
company developing Imprime PGG, a late clinical stage immunotherapeutic
drug candidate that modulates key immune cells to recognize and kill
cancer. Proof of concept has been established from single-arm and
randomized Phase 2 studies in non-small
cell lung cancer (NSCLC), colorectal cancer, and chronic lymphocytic
leukemia. Studies are ongoing in metastatic colorectal cancer and
non-Hodgkin lymphoma. In addition, new research shows that Imprime PGG
elicits a coordinated immune response that involves both innate and
adaptive immunity.
More information is available at www.biothera.com/pharma or follow us on Twitter.
Biothera, the Immune Health Company
David Walsh, 651-256-4606
(direct)
SVP Marketing & Communications
dwalsh@biothera.com