Biothera Pharmaceuticals, Inc. has developed Imprime PGG which is a Pathogen Associated Molecular Patterning (PAMP) molecule that works like an immunological switch to coordinate innate and adaptive immune responses. It does so by more fully engaging the entire immune system whereby they alter the protective microenvironment tumors often create to avoid detection and destruction. Thus, the cancer cells become more vulnerable to immune attack. Imprime PGG enhances the efficacy of multiple classes of anti-tumor monoclonal antibodies, including tumor-targeting anti-angiogenic and checkpoint inhibitors (PD-1, PD-L1 antibodies). Imprime PGG has strong proof of concept based on extensive clinical experience and widespread signals of efficacy across a range of tumor types. Unlike other PAMPs, Imprime PGG can be administered systemically and is well tolerated. Biothera has assembled a broad intellectual property portfolio for Imprime PGG consisting of more than 100 US and International patents and patents pending. They are striving to become the leader in innate immune modulation. Ultimately, they envision that there novel therapeutics will become essential components of multiple cancer immunotherapy combinations that enable more patients to live longer and healthier lives. That is the promise of cancer immunotherapy.
They have continued to produce meaningful data from all their ongoing clinical trials including the 4 research collaborations they have with Merck with Imprime PGG in combination with Merck’s checkpoint inhibitor drug Keytruda in the treatment of melanoma, triple negative breast cancer and non-small cell lung cancer. Keytruda is Mercks’ major checkpoint inhibitor drug. Merck has been heavily promoting Keytruda in TV and print advertising and is pursuing a growing number of human trials using Keytruda combined with Biothera’s Imprime PGG to treat an increasing number of late stage cancers. They also have a collaboration agreement with Genentech/Roche that would include both preclinical research and clinical research. They have had active collaboration deals for some time now with Eli Lily, 4 with Merck, Big 10 Cancer Research Consortium, Dana-Farber Cancer Institute, Mayo Clinic, Johns Hopkins, The Wistar Institute and Genentech/Roche and possibly Pfizer. They recently stated that the encouraging preliminary results from their ongoing TNBC study, they are in planning discussions with a third major pharmaceutical company in the immune-oncology field to collaborate on a Phase 2 clinical study combining Imprime PGG with the partner’s checkpoint inhibitor that, if finalized, will be conducted and funded by this new partner. They also recently announced that they are planning Phase 2 studies in head and neck cancer and melanoma using Imprime PGG plus CPIs as neoadjuvant therapies designed to shrink tumors prior to surgical removal. They believe that the neoadjuvant setting may provide proof of concept data more quickly and less expensively than traditional clinical trials because treatment durations are short —typically six to 12 weeks. Also, the study designs may provide a more accurate response assessment as they generate and analyze extensive translational data from the removed tumors. This is critical to linking patient responses to Imprime PGG’s mechanism of action. These results will be noted at the 6th week interval and at the 12th week interval. The total study will start in early September and end in December 2018.
Biothera continues to raise capital to support their ongoing clinical trials of Imprime PGG combined with a growing number of checkpoint inhibitors for the treatment of late stage cancers. They expect to very soon announce the additional collaboration deal with the third major pharmaceutical company. Biothera is continuing the process required for an IPO in the next 6 to 18 months. I believe the value of Biothera increases each time a major pharmaceutical company signs a new collaboration agreement with them and as the collaborator pharmaceutical companies add new cancer targets. Their website is www.biothera.com.