Metaclipse Therapeutics Corporation is developing novel personalized vaccine immunotherapies for cancer. MembrexTM, a proprietary platform approach tailored to each patient and their specific tumor, consists of ‘membrane vesicles’ prepared from a patient’s tumor tissue that Metaclipse modifies with a ‘protein transfer’ method using proven immunostimulatory proteins. After intradermal administration, these modified vesicles deliver both immunostimulatory proteins, which act as adjuvants, and an array of patient-specific tumor-membrane antigens simultaneously to the immune system. This creates robust tumor-specific immunity that Metaclipse anticipates will destroy and/or suppress the growth of metastatic cancer cells. Our preclinical studies demonstrated that our vaccine immunotherapy acts via T cells and thus potentially inducing immune memory against cancers.
Metaclipse has demonstrated the effectiveness of its proprietary membrane-based tumor-specific immunotherapy in eliminating and/or suppressing the growth of cancer cells in several animal models of cancer. The first indication the Company is pursuing with its personalized cancer therapy is triple negative breast cancer (TNBC). TNBCs represent a class of highly variable tumors, and patients with TNBC have considerable unmet medical need.
The MembrexTM approach has several inherent advantages over competitive immunotherapies that utilize whole cells and gene transfer: (1) production of TMVs from a patient’s tumor does not require establishment of immortalized tumor cell lines, T cell cultures or the use of viral vectors; (2) rapid, cost-effective manufacture and administration of the therapy to the patient within 2 weeks; (3) multi-valent immune response generated against all membrane-bound tumor antigens and tumor-specific peptides associated with Major Histocompatibility Complex Class I molecules; and (4) the therapy’s synergy with immune checkpoint blockade inhibitors, enhancing response rates for checkpoint blockade-resistant indications
Clinical, technical, regulatory, and market considerations have guided Metaclipse to select the treatment of certain metastatic head and neck, and lung cancers as subsequent landing indications. Additional vaccine products include a modified influenza vaccine using the membrane-bound adjuvants to enhance immunity in older adults. Metaclipse intends to commercialize its products through licensing agreements with major pharmaceutical companies after establishing safety and effectiveness.
We demonstrated effectiveness of the Membrex™ approach in combination with anti-CTLA4 antibody in an aggressive, highly metastatic mouse model of TNBC. We also showed that our approach is safe when given alone or in combinantion with checkpoint inhibitors and an independent GLP toxicology study. We have already participated in a pre-IND meeting with the FDA and expect to enter into Phase I clinical trials by early 2020 for metastatic TNBC. We anticipate that our vaccine will be used as a combination therapy with an approved checkpoint blockade inhibitor.
We showed that the MembrexTM approach protects both alone and in combination with checkpoint inhibition in a number of HER-2+ mouse breast cancer models.
We demonstrated effectiveness of our approach, both alone and in combination with checkpoint blockade, in several mouse head and neck cancer models.
We established efficacy of the approach in combination with checkpoint blockade in a mouse lung cancer model.
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Metaclipse participates in Georgia BIO Innovation Summit in Atlanta, Georgia on October 8, 2019.
Metaclipse completes an independent GLP-compliant toxicology/safety study performed by IIT Research Institute in Chicago, Illinois in August. The study was conducted in mice on vaccine alone and in combination with checkpoint inhibitors. No adverse related events are detected other than injection site cell infiltration.
Metaclipse Therapeutics receives SBIR Contract Phase II award for influenza vaccine development for the elderly. This product development award from the NIAID/NIH in September for $1.95M supports cGMP vaccine production efforts, further preclinical studies to assess immune response and viral challenge, as well as vaccine safety studies.