Tampa, FL, August 02, 2021: Mirror Biologics, Inc., (“Mirror” or the “Company”), a clinical-stage immunotherapy company specializing in the development, manufacturing, and clinical translation of next-generation therapeutic and prophylactic in-situ vaccines for cancer and infectious diseases, where the active ingredients are living immune cells, today announced the appointment of Paraxel International to provide expert regulatory consulting services to assist in the next phase of development for the experimental drug AlloStim®.
AlloStim® is an “off-the-shelf” living immune cell therapy based on the patented Mirror Effect® technology platform. AlloStim® elicits a variety of immuno-modulatory and immuno-stimulatory properties that can be integrated into specially designed protocols to elicit the “Mirror” of proven immune response cascades and then imprint these immune cascades to dominate over a resident failed immune response.
Mirror Effect cancer protocols aim to “mirror” the beneficial anti-tumor effects that occur after allogeneic stem cell transplant procedures while eliminating: the toxic GVHD side effects; requirement for a matched tissue donor; and, need for chemotherapy conditioning. A Mirror Effect infectious disease protocol is designed to “mirror” the beneficial immune response of young healthy adults to respiratory viruses and imprint this response upon the elderly, creating a “Universal Anti-Respiratory Viral Vaccine” for adults over 65 years old.
In the USA, two clinical trials have been launched: a Phase IIB pre-registration open label, multi-site study has been initiated in third line metastatic colorectal cancer; and, a Phase I/II clinical trial in healthy elderly adults. In SE Asia, the Company is seeking regulatory clearance for a Phase II/III randomized, controlled clinical trial in 180 subjects with advanced liver cancer.
Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance world health, has been appointed by Mirror to provide regulatory support for AlloStim clinical development and manufacturing systems. Parexel’s Regulatory & Access Consulting team includes more than 1,000 experts globally, experienced in guiding customers through all aspects of the regulatory process.
“We look forward to working with the experts at Paraxel to accelerate our clinical development and commercial manufacturing system design programs toward regulatory approval. Paraxel expertise is especially beneficial as we navigate regulations in the complex field of advanced living immune cell therapies,” notes Adi Raviv, CEO of Mirror. “This collaboration strengthens our global Regulatory Affairs and allows us to expand our strategic capabilities to support our late stage cancer clinical development programs both in the USA and in SE Asia as well as to execute strategic development and regulatory plans for our novel universal vaccine development program in USA and the world.”
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 and is establishing a 21 CFR 1271-compliant blood donor and cell processing center. Mirror operates a GMP cell manufacturing facility in Jerusalem, Israel and has clinical and distribution partner offices in Bangkok, Thailand and Kuala Lumpur, Malaysia. The Mirror Effect® technology platform is protected by over 200 patents issued worldwide. Mirror purchased the exclusive, worldwide rights to AlloStim® and the Mirror Effect® technology platform from Immunovative Therapies, Ltd., an Israeli company.
The lead drug AlloStim(R), is an “off-the-shelf,” non-genetically manipulated, patented, living immune cell differentiated from precursor cells purified from blood of healthy donors and formulated with monoclonal antibody-coated microparticles. The unique feature of AlloStim® is that it can imprint a protective or therapeutic cellular immune response that is customized to a patient’s resident disease without the need to have prior knowledge of the type of cancer/virus or genetic properties of the disease. Proprietary “artificial lymph node” bioreactors are expected to enable the economical high cell density manufacturing scale-up of AlloStim®. Also, novel frozen dosage forms enable extended shelf life and cost-effective distribution.
