About Us
10 Key Facts about Biothera’s Oncology Drug, Imprime PGG®
1. Near Term Time to Market. The first approval of Imprime PGG is anticipated in 2014 for third line metastatic colorectal cancer (mCRC). Imprime PGG also has ongoing Phase 2 studies in indications that represent significant unmet needs and may lead to earlier approval.
2. Broad Potential in Multiple Oncology Indications. Based on Biothera’s clinical data to date, Imprime PGG’s Target Product Profile anticipates inclusion in every cancer regimen containing a cancer-targeted antibody.
3. Novel Mechanism Targeting the Innate Immune System. Imprime PGG activates a novel, highly specific innate immune mechanism that engages neutrophils, the largest population of immune cells in the body, to kill antibody-targeted cancer cells.
4. Strong Safety Profile and Pharmacoeconomic Benefit. Imprime PGG has been dosed in more than 275 subjects with no dose-limiting toxicities. Imprime PGG has the potential to replace chemotherapy in some regimens, resulting in better quality of life and lower overall cost of care.
5. Phase 3 Clinical Trial in Progress. Biothera is currently enrolling subjects in a 795-patient Phase 3 mCRC clinical trial at more than 40 sites (U.S., Germany, France, Canada). Biothera also has an extensive biomarker program incorporated into the Phase 3 protocol.
6. CMC is “BLA-Ready.” At our End of Phase 2 meeting with the FDA, the agency indicated the Chemistry, Manufacturing and Control (CMC) package is ready for a Biological License Application.
7. Consistent Clinical Proof of Activity. Imprime PGG has been tested in more than 175 cancer patients in multiple clinical trials, including two phase 2 studies in mCRC (wild type and KRAS mutant), two randomized Phase 2b studies in non-small cell lung cancer and a Phase 2 study in chronic lymphocytic leukemia with consistently positive results.
8. Biologic Drug with Strong Intellectual Property. Patent protection extends to 2025. Additionally, Imprime PGG as a biologic drug is eligible for 12-year regulatory exclusivity in the USA (10 years in the EU).
9. No Venture Capital. Biothera is a privately held company that is exclusively funded (>$125M to date) by angel investors, which gives Biothera a highly flexible approach to partnering. Biothera believes that within 12 to 24 months it will have the efficacy data to support approval and intends to sell the company at that time.
10. Patient-Focused. Biothera intends to partner with a major pharmaceutical company to complete development of Imprime PGG and make this drug available to patients as soon as possible.
For more information, please contact:
Steve Smith
Vice President of Business Development
ssmith@biothera.com