Mirror Biologics, Inc. announced the clearance of the “ALIVE” Phase II/III randomized, controlled clinical trial for subjects with advanced, treatment-naïve, Hepatocellular Carcinoma (HCC) by the Malaysia Research Ethics Committee (MREC) and the Thailand Central Research Ethics Committee (CREC) (ClinicalTrials.gov ID: NCT05033522). Mirror Biologics is a clinical-stage immunotherapy company specializing in the development, manufacturing, and clinical translation of next-generation therapeutic in-situ vaccine immunotherapy for cancer and infectious diseases. The active ingredients are living immune cells taken from healthy donors.

Mirror Biologics is an international biopharmaceutical company with technology originally spun out from Hadassah-Hebrew University Medical Center in Jerusalem. Its corporate headquarters are in Tampa, Florida USA where they operate a 21 CFR 1271-compliant blood donor and cell processing center and conduct research and development on the design and testing of novel bioreactors and commercial manufacturing systems. Mirror Biologics‘s GMP cell production and formulation operations are done at their Israel-based subsidiary in Jerusalem. Their Bangkok, Thailand office coordinates their clinical, business, and technology transfer operations in Asia.

The ALIVE trial is evaluating AlloStim® immunotherapy in Asian patients with advanced HCC (BCLC stage C) unable to access, or not eligible for, sorafenib first-line treatment and without any other prior treatment. 180 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physician’s Choice of palliative chemotherapy (FOLFOX4) plus best supportive care or best supportive care alone at 9 academic and private medical center sites located in Thailand and Malaysia.

Hepatocellular Carcinoma (HCC) is the predominant primary liver cancer and is the third most common cause of cancer-related death in the Asia-Pacific region. HCC is endemic in Asia, with 55% of all HCC cases worldwide reported from China. Significant differences exist between Eastern and Western populations on many key aspects of HCC, contributing to different treatment outcomes. Eastern populations tend to have worse prognoses and shorter life expectancy than Western populations. The worse prognosis is related to the high incidence of chronic hepatitis B virus infection, which is the major cause of HCC in Asia-Pacific countries.

ClinActis Pte. Ltd., a CRO specialized in managing clinical trials in the Asia-Pacific region, was appointed to manage the ALIVE trial.

Christophe Tournerie, MD, the CEO of ClinActis, stated: “The ALIVE trial is specifically designed to address the ‘real-life’ situation for treatment of advanced HCC in SE Asia. Many patients initially present with advanced disease when treatment options are limited. In most Asian countries, sorafenib is largely accepted as the standard of care, but availability and use are limited by cost and toxicity, resulting in the majority of advanced HCC cancer patients being provided only supportive care. A subset of these patients is provided palliative FOLFOX4 chemotherapy, which is an accepted treatment option under East Asian Guidelines for patients unable to obtain access to sorafenib. The ALIVE study is powered to detect a 40% or greater difference in overall survival between AlloStim® and the standard of care for most patients in SE Asia.”

Adi Raviv, CEO of Mirror Biologics stated: “This will be the first randomized, controlled study for AlloStim®. This study design is the gold standard for clinical evaluation of oncology drugs. Our earlier Phase IIA clinical study in advanced liver cancer conducted at Khon Kaen University Medical Center in Thailand reported 5 of 15 subjects living over 1 year compared to 4.2 months (range: 3.75-5.46 months) life expectancy reported in the placebo arm of the Asian-Pacific sorafenib historical control study for this population. It is our hope that the ALIVE trial will provide evidence of statistically significant extension of survival while maintaining the quality of life, and upon achieving such evidence we will seek to obtain regulatory approval to provide patients in the region a new affordable treatment option.”

The ALIVE trial is expected to launch in early 2022.

The lead principal investigator for the ALIVE study in Malaysia, Dr. Kanathan a/l Ratnavelu, of Nilai Medical Center, stated, “Our group has had previous experience in providing AlloStim® on a compassionate basis to some of our chemotherapy-refractory metastatic cancer patients. In these trials, AlloStim® was well tolerated and provided benefit to some of these terminally-ill patients that had exhausted all available treatments. There is a great unmet medical need in Asia for effective, low cost and non-toxic treatment options for patients with advanced liver cancer. We are looking forward to participating in the ALIVE study with our colleagues in Malaysia and Thailand to evaluate whether AlloStim® can qualify as a first-line treatment option for advanced HCC in SE Asia.”

About Mirror Biologics, Inc.

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 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 Mirror Effect technology platform is protected by over 200 patents issued worldwide. 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. The unique feature of AlloStim® is that 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 scale-up of AlloStim® and novel frozen dosage forms enable extended shelf life and economical distribution. Mirror Biologics purchased the exclusive, worldwide rights to AlloStim® and the Mirror Effect technology platform from Immunovative Therapies Inc., a Jerusalem-based company.

For more information on Mirror Biologics technology visit the website: www.mirrorbio.com