Mirror Biologics is building a 1200m² GMP cell production and research facility in Har Hotzvim’s Bio Park. The new facility will produce AlloStim, a patented, non-genetically engineered, off-the-shelf living immune cell immunotherapy vaccine derived from normal blood donors being investigated in cancer and infectious disease treatment and prevention in the USA and SE Asia.
AlloStim® is currently being evaluated in a Phase IIB pre-registration study in chemotherapy and immunotherapy-refractory metastatic colorectal cancer in USA and in a Phase II/III randomized, controlled study in advanced, metastatic liver cancer in SE Asia. In addition, under a separate IND, AlloStim® is being evaluated in a Phase I/II clinical study in healthy adults over 65yo as a universal anti-respiratory viral vaccine in USA.
The new state-of-the-art manufacturing facility in Jerusalem will feature Mirror Biologics’ proprietary Artificial Lymph Node bioreactor systems capable of producing thousands of AlloStin doses from a single donor. The ALN bioreactor features an artificial heart, lung and kidney with sophisticated bioprocess control systems simulating lymphocyte expansion that occurs in an inflamed lymph node. The ALN systems are designed to meet Mirror’s goal of providing an affordable treatment accessible to patients in community out-patient settings.
Dr. Michael Har-Noy, founder and acting CEO stated: “we are excited to be part of the revival of the Teva manufacturing facility and effort to establish Jerusalem as the world leader in biopharmaceutical manufacturing.”
The Allostim® Immunotherapy is a non-genetically manipulated, disease agnostic, therapeutic vaccine that creates a customized immune response against a patient’s own resident tumor or viral infection without the need for prior knowledge of the genetic or antigenic structure of the tumor or virus. Unlike CAR-T cells, which are genetically engineered and derived from a patient’s own blood, Allostim® is capable of treating solid tumors and is “off-the-shelf”. Unlike checkpoint inhibitors, which show activity only in a small subset of human metastatic tumors which have high mutational burdens (“hot tumors”), AlloStim® is applicable to human “cold” tumors and is capable of converting “cold” tumors to “hot” tumors as well as counter-regulating the tumor microenvironment to eliminate tumor-derived immunosuppression and immunoavoidance mechanisms. AlloStim® is disease agnostic because it triggers an “in-situ vaccine” mechanism where the resident disease provides the antigens for the vaccine, similar to the abscopal effect mechanism that occurs rarely after radiation therapy or the oncolytic viral immunotherapy mechanism without the need for engineered viruses or concern for delivery or off-target toxicity.
AlloStim® is also being evaluated as a universal anti-respiratory virus vaccine for the elderly. AlloStim® can modulate the immune system of the elderly with senescent immune systems by increasing Th1 cells in circulation through an immune mechanism called “Allopriming”. Th1 cells produce high levels of IFN-γ (interferon-gamma). Non-specific activation of this Th1 is responsible for both phagocyte activation and the production of opsonizing (the process by which a pathogen is marked for phagocytosis) and complement-fixing antibodies, thus playing an important role in protection against intracellular pathogens.
About Mirror Biologics
Mirror Biologics is an international biopharmaceutical company founded in 2019 and is headquartered in Tampa, Florida where it conducts advanced bioengineering research and development is establishing a 21 CFR 1271-compliant blood donor and cell processing center. Mirror Biologics operates a GMP cell manufacturing facility in Jerusalem, Israel, and has clinical and distribution partner offices in Bangkok, Thailand, and Kuala Lumpur, Malaysia. The lead drug, AlloStim®, is an “off-the-shelf,” non-genetically manipulated, patented, living immune cell differentiated from precursor cells purified from the blood of healthy donors and formulated with monoclonal antibody-coated microparticles. Proprietary “artificial lymph node” bioreactors are expected to enable the economical high cell density scale-up of AlloStim® and a novel frozen dosage form enables extended shelf life and economical distribution. Mirror Biologics purchased the exclusive, worldwide rights to AlloStim® and the Mirror Effect technology platform from Immunovative Therapies, Ltd, a Jerusalem company. The Mirror Effect(R) technology platform and related applications are protected by over 200 worldwide patents.
For more information on Mirror Biologics technology visit the website: www.mirrorbio.com
or info AT mirrorbio.com
Mirror Bio site: https://www.mirrorbio.com/
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