Total 1,600 healthy volunteers participated. Out of which, 100 participated in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.
The vaccine was well tolerated, with no reported safety issues and is shelf-stable for over six months at room temperature at 25° celsius and potency for one month at 37° celsius. The interim analysis showed 91% seroconversion rate at day 56.
Seroconversion is the development of specific antibodies in the blood serum as a result of infection or immunization, including vaccination.
The vaccine will be produced at Stelis Biopharma, the biotech contract development and manufacturing company (CDMO) of Strides group.
The company said the results will be submitted as a prime vaccine in India for emergency use authorization (EUA). Later, clinical studies are planned to support approval for use as a booster shot to itself and other approved vaccines. Earlier studies in the Netherlands have demonstrated robust antibody neutralization of variants, including Delta and Omicron.
Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-C. Under the agreement, Biolexis has the right to manufacture and commercialize AmbiVax-C in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low and middle income countries.
The vaccine is a reliable, accessible alternative in these regions, allowing immunization and longevity of immunity with the boosters against the covid variants of concern. The partnership will leverage the capabilities of Strides group, which has an 'in Africa for Africa' strategy and will offer the vaccine to countries with a deep market presence and established relationships, said the company.
Arun Kumar, founder of Strides group added, We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.
Todd Zion, Ph.D., president & CEO of Akston Biosciences said, The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.
Biolexis is an emerging biotech and vaccine company capable of developing and commercializing products for the Global markets. The company is a wholly owned subsidiary of Stelis and is focused on building and in-licensing a portfolio of advanced biosimilars, peptides, and vaccines.
Stelis Biopharma (Stelis) is an emerging global biopharmaceutical CDMO with a complete and integrated end-to-end offering. It is equipped with world-class process development PD) and manufacturing infrastructure for both drug substances and drug products.
Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies.
Bengaluru-based Strides Pharma Science is a global pharmaceutical company. It mainly operates in the regulated markets and has an in Africa for Africa strategy and an institutional business to service donor-funded markets. The company focuses on difficult to manufacture products sold in over 100 countries.
The drug maker reported a 36.6% decline in consolidated net profit to Rs 29.22 crore on a 4.7% fall in net revenue from operations to Rs 866.02 crore in Q4 FY22 over Q4 FY21.
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