You are currently viewing Israel Ministry of Health Gives Clearance for Mirror Biologics’ GMP Manufacturing New Facility Design

Mirror Biologics, Inc., a clinical-stage biopharmaceutical company has announced that their GMP manufacturing design for their new facility has received clearance from the Israel Ministry of Health. The new facilities are expected to open in nine months’ time. Mirror Biologics Inc will be hiring the staff for its new expanded facility in the coming months.

Mirror Biologics is producing AlloStim®, a patented, non-genetically engineered, off-the-shelf living immune cell immunotherapy vaccine derived from normal blood donors for 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 the USA and in 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 Phase I/II clinical study in healthy adults over 65 yo as a universal anti-respiratory viral vaccine in the USA.

Neo-antigen-specific immunity to cancer has been long desired for therapeutic cancer vaccination. This goal has been difficult to achieve due to the scarcity of identified immunogenic tumor-specific antigens and due to needing to overcome immunosuppression in the tumor microenvironment.

Mirror Biologics’ novel in-situ vaccination protocols using AlloStim represents a possible method for overcoming the past technical difficulties in achieving immune tumor control over existing chemotherapy-refractory metastatic tumors through therapeutic vaccination.

The Mirror in-situ vaccination protocol with AlloStim eliminates the need to define tumor-specific neoantigens. In-situ vaccination creates neo-antigen-specific immunity customized to the patient’s tumors without the need for knowledge of specific neoantigens.

AlloStim is an off-the-shelf living immune cell immunotherapy. Incorporating the in-situ vaccination protocol step creates a one size fits all therapeutic cancer vaccine that uniquely results in tumor-specific immunity customized to an individual patient for any type of solid tumor.

The Mirror Biologics initial AlloStim priming protocol causes an increase in circulating allospecific Th1 cells (helper cells that help other cells of the immune system). When activated by intravenous AlloStim infusion, the resulting cytokine release elicits a wave of activated NK cells (a type of specialized immune cells with granules with enzymes that can kill tumor cells or cells infected with a virus). along with the activated allospecific Th1 cells which extravasate and enter the tumor microenvironment (cold to hot).

The activated NK cells will cause non-specific immunological tumor cell lysis, which releases heat shock proteins (e.g, HSP70) and DAMP into the tumor microenvironment. The heat shock proteins released into the microenvironment chaperone the entire tumor neoantigen repertoire. The microenvironment is conditioned with inflammatory cytokine production from the infiltrating activated allospecific Th1 cells and NK cells which counter-regulate suppressive and immune avoidance mechanisms.

Under these local inflammatory conditions, immature dendritic cells in the tumor bed process the chaperoned neoantigens, mature to IL-12+ DC1 cells, and migrate to the draining lymph nodes, creating patient-specific, tumor-specific immunity. After each priming and intravenous cycle, the tumor-specific and non-specific immunity is amplified.

Major Expansions  to the Mirror Biologics Team

In August 2022, Mirror Biologics announced the appointments of Dr. Michael Kauffman, Mr. Gregory Schiffman, and Dr. Taneli Jouhikainen as independent, non-executive members of the Board of Directors.  Dr. Kauffman was the co-founder and CEO of Karyopharm Therapeutics (NASDAQ) from inception to commercialization. Dr. Kauffman currently serves as lead director of Verastem Oncology, Inc. (NASDAQ). He also serves on the boards of Kezar (NASDAQ), Adicet (NASDAQ), and BiVictriX Therapeutics (LON). Mr. Schiffman currently serves as CFO of AbSci (NASDAQ). He previously served as Executive Vice President and CFO of Dendreon Corporation, which secured marketing authorization from the FDA and the European Commission for the world’s first cell-based immunotherapy. Dr. Jouhikainen has extensive experience in pharmaceutical industry leadership and the commercialization of pharmaceutical products. Dr. Jouhikainen is the founder and CEO of Altius Therapeutics, a pulmonary gene, and cell therapy company. Previously, he was a Co-Founder of Savara (NASDAQ), a public orphan lung disease company and served as its President and Chief Operating Officer from 2009 to 2020.

Brian Cregger was appointed as Vice President of Engineering Research and Development effective January 3, 2023. Mr. Cregger assumes the critical role of leading the development of Mirror’s artificial lymph node bioreactor systems and automated manufacturing pods for the commercial production and distribution of living cell products.

Yi Shen, MBA was appointed as Executive Vice President of Corporate Strategy and Planning on November 15, 2022. Ms. Shen assumed the critical role of mapping out the strategic and operational pathways of the Company’s product candidates to successful commercialization.

Manimegalai D/O Ramakasinan was appointed as Country Manager for Mirror Biologics‘ Malaysian wholly-owned subsidiary.

In November 2022, Scott Filosi became Mirror BiologicsChief Executive Officer and Director. Mr. Filosi has broad US and global leadership experience in general management, operations, manufacturing, strategic planning, business development, regulatory affairs, and market access with over 30 years of pharmaceutical industry leadership experience. Mr. Filosi has served in multiple senior leadership roles at large pharmaceutical organizations, including Merck KGaA (Chief Commercial Officer); UCB Pharma (VP US Market Access, Pricing, Distribution and Patient Services); Boehringer Ingelheim (National Accounts Director) and Johnson & Johnson (National Accounts Director). Most recently, Mr. Filosi was selected by Jiangsu Hengrui Pharmaceutical, one of Asia’s largest pharmaceutical organizations, to lead their oncology-focused spin-out, Luzsana Biotechnology, as the founding CEO. At Luzsana, Mr. Filosi led the development of multiple oncology programs from pre-clinical to pre-BLA and established operations in the US, Europe, and Japan.

Dr. Xiangfei “Scott” Cheng was appointed Senior Vice President, Translational Medicine Research. Dr. Cheng holds both M.D. and Ph.D. degrees and brings to us decades of drug development, preclinical, clinical, and management experience. Carter J. Ward became  Mirror Biologics Chief Financial Officer. Mr. Ward has over 30 years of industry experience after starting his career at KPMG and most recently served as CFO at Enveric Biosciences (NASDAQ), a biotechnology company developing psychedelic-derived pharmaceuticals to treat mental ailments stemming from cancer and other conditions.

In Jerusalem, in 2022, Dr. Elena Fingerut to General Manager of Mirror Biologics, Ltd., its wholly-owned Israel subsidiary. Dr. Fingerut has dedicated over 16 years of her career with our predecessor company Immunovative Therapies and has been with Mirror Biologics, Ltd. since its inception in January 2021 with senior roles in research and development and quality control. Oshri Nissan joined  Mirror Biologics‘ Jerusalem management team as Director for CNC and technology transfer. Tali Iluz became Mirror Biologics Manager of Human Resources. Jonathan Grumberg joined last summer Mirror Biologics as Director of Operations.

About Mirror Biologics Inc.

Mirror Biologics, Inc. is a private Delaware corporation incorporated on November 5th, 2018 with headquarters in Tampa, Florida, and with operations in Jerusalem, Israel, Bangkok, Thailand, and Kuala Lumpur, Malaysia. In Tampa, Florida where it conducts advanced bioreactor research and prototype development for commercial manufacturing “pods” and operates a FDA registered 21 CFR 1271-compliant blood donor and cell processing center and a Phase I/II clinical research center. In Jerusalem Mirror Biologics operates a GMP cell manufacturing and research facility and is expected to move into its new facilities in Har Hotzvim. They also have clinical and distribution operations in Bangkok, Thailand, and Kuala Lumpur, Malaysia.

Their lead AlloStim® product candidate is an “off-the-shelf,” non-genetically manipulated, disease agnostic, patented, living immune cell derived from healthy blood donors. Mirror Biologics, Inc. specializes in the discovery, clinical testing, and manufacturing of next-generation therapeutic and prophylactic immunotherapy vaccine products which incorporate living immune cells as active ingredients. Mirror Biologics, Inc. is driven by compassion for patients suffering from incurable diseases and highly toxic therapies to provide non-toxic, affordable alternative immunotherapy treatment options with a curative or life-extending activity that can be made widely accessible and capable of distribution to out-patient clinics in both urban and rural areas worldwide.

For further information on Mirror Biologics, Inc.
Contact: Dr. Michael Har-Noy Tel: 1-619-227 4872

Source: Mirror Biologics

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