August 24, 2021
Gennova’s vaccine gets a nod from the Drugs Controller General of India to start Phase II and Phase III trials
India’s first mRNA-based vaccine found to be safe – reveals Phase I study data.
The trial is to commence in early September
Pune, 24th August 2021: In a significant development towards India’s vaccination efforts, the Drug Controller General of India, has approved Phase II and Phase III study protocols for HGCO19, India’s first mRNA-based COVID-19 vaccine, developed by Gennova Biopharmaceuticals Limited (“Gennova”).
Gennova, the subsidiary of Pune based Emcure Pharmaceuticals Limited had submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India’s National Regulatory Authority (NRA).
Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data, and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Commenting on the development, Dr. Sanjay Singh, CEO-Gennova Biopharmaceuticals Limited said, “The approval for Phase II and III protocol for what could be country’s first mRNA platform-based COVID-19 vaccine brings us immense satisfaction and highlights the grit of scientists unified for a common cause. The global pandemic has brought into the foray R&D that is safe, reliable, accessible and quickly available. HGCO19 was developed keeping the same objectives in mind and using the exciting possibilities of mRNA technology. We are determined to protect members of our global community from the devastating impact of the novel coronavirus.”
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.
mRNA vaccines present various benefits as they are non-infectious, non-integrating in nature, and degraded by normal cellular mechanisms. These are highly efficacious because of their inherent capability to be translatable into the cell cytoplasm’s protein structure, and are developed at a rate faster than traditional vaccines under the cGMP conditions.
Gennova’s mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Government of India under Ind-CEPI, way back in June 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC.
About Emcure Pharmaceuticals Limited
Emcure Pharmaceuticals Limited (“EPL”) is one of the leading Indian pharmaceutical companies (Source: Report titled “Assessment of the global and Indian pharmaceuticals industry” dated August 2021 prepared by CRISIL Research) headquartered in Pune with global footprint. Driven by strong in-house research and development with focus on technology and innovation, the company’s mission has been to develop a differentiated portfolio of pharmaceutical products and address unmet patient needs. Established in 1981, the firm was founded by Mr. Satish Mehta and is ranked as the 12th largest pharmaceutical company in India (Source: CRISIL). It is the largest pharmaceutical company in India in gynaecology, blood-related and HIV antiviral therapeutic areas based on sales in India in the Financial Year 2021 (Source: CRISIL). Emcure’s subsidiary Gennova is developing India’s first mRNA COVID-19 vaccine for the novel coronavirus using its in-house developed indigenous mRNA platform. To know more about EPL, please visit: https://www.emcure.com/ Follow us on LinkedIn: https://www.linkedin.com/company/emcure-pharmaceuticals-limited/
About Gennova Biopharmaceuticals
Gennova Biopharmaceuticals Limited, the subsidiary of EPL is headquartered in Pune. The company is dedicated to biotherapeutics’ research, development, production, and commercialization to address life-threatening diseases across various indications. It has commercialized 6 biologics in India and Emerging Markets. Gennova has over years collaborated with global academia and leading institutions, including the USFDA and Bill & Melinda Gates Foundation. It is in a unique position to provide an end-to-end solution for vaccine development rapidly. The group has made a novel mRNA based vaccine candidate HGCO19, using spike protein of the virus, reported to interact with receptor on host cells, along with nano-lipid carrier as mRNA vaccine delivery system. To know more, visit https://gennova.bio
“Emcure Pharmaceuticals Limited is proposing, subject to receipt of requisite approvals, market conditions and other considerations, an initial public offering of its equity shares and has filed a draft red herring prospectus dated 18 August 2021 (“DRHP”) with the Securities and Exchange Board of India (“SEBI”). The DRHP is available on the websites of SEBI, Axis Capital Limited, BofA Securities India Limited, Credit Suisse Securities (India) Private Limited, JM Financial Limited and BOB Capital Markets Limited at www.sebi.gov.in, www.axiscapital.co.in, www.ml-india.com, www.credit-suisse.com, www.jmfl.com and www.bobcaps.in respectively. Investors should note that investment in equity shares involves a high degree of risk and for details refer to the Red Herring Prospectus, including the section titled “Risk Factors” of the Red Herring Prospectus when available. Potential investors should not rely on the DRHP for any investment decision.”
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