Ocugen $OCGN COVAXIN Study Demonstrates Robust Immune Responses

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OCGN stock may have a volatile day ahead on January 10, 2022. Over the weekend news cycle, the company released data that showed a robust immune response with Covaxin.

COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

On January 8, 2022, Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN™ (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

“As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability.”

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN™. After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT50) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 10·9, 161·0, 264·7, and 174·2 fold from baseline at six months post second dose, respectively.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection,” said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit https://www.ocugen.com.

Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data From COVAXIN™ (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS

On December 30, 2021, Ocugen, Inc. (Nasdaq: OCGN), announced that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, COVAXIN™ (BBV152), in children, aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv. Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. Those results demonstrated a greater than 93% reduction in severe disease. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021.

“These data represent the first positive vaccine data in children as young as two years of age and come at an important time as COVID-19 infections are seeing a spike across the globe,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. “The results suggest that COVAXIN™, which is made on the same platform used in traditional polio pediatric vaccines for decades, when administered in a two-dose series to children between 2-18, may offer an option that is safe while delivering a robust immune response.”

In the study, immunogenicity against key COVID-19 proteins was measured using geometric mean titer (GMT), a test that measures the amount of antibodies in the blood in response to the presence of the virus. GMT was measured across three age groups and demonstrated strong immune response after the second dose. There were no serious adverse events such as myocarditis, pericarditis, or blood clots, reported in any of the three age groups.

This immunobridging trial was intended to determine if COVAXIN™ generates the same protective immunity in children as it does in adults. To be considered equivalent, pediatric participants needed to achieve comparable GMT’s to those generated by adults in a large phase 3 clinical trial. At Day 56, across all ages, the mean SARS-CoV-2 antibody GMT was more than 30% higher in children aged 2-18 than the mean GMT from Phase 3 clinical trial involving 25,800 adult subjects aged 18+. These data demonstrate children 2-18 generate antibody response comparable to adults fully vaccinated with COVAXIN™ (BBV152).

The study also showed increased antibody titers against 3 viral antigens (Spike – S1, Receptor Binding Domain – RBD and Nucleocapsid – NP) providing a broad immune response to COVID-19. In each case a more than 4-fold increase in neutralizing antibody titers versus baseline (titers measured in the same participants before being vaccinated) was seen in all age groups after the second dose.

Participants were not reported to have experienced any severe adverse events. The majority of adverse events noted (49%, n=374) were mild (e.g., injection site pain) and a small proportion (19%, n=6) were moderate (e.g., fever, headache). Mild to moderate adverse events resolved within 24 hours.

The data were also submitted to the Drugs Controller General of India (DCGI) to support a pediatric indication as recommended by an independent committee, known as the Subject Expert Committee (SEC), that advises the Indian regulatory agency. Bharat Biotech intends to submit data from the full Phase 3 trial to a peer-reviewed scientific publication soon.

The seven-month Phase 2/3 open label, multicenter, study enrolled 525 children ages 2 years to 18 from 6 clinical trial sites across India. Conducted between May and July 2021, it was designed to evaluate the safety, reactogenicity and immunogenicity of COVAXIN™ (BBV152) on a two-dose schedule (28 days apart) in three age groups: ages 12-18, ages 6-12, and ages 2-6. Children with prior infection of SARS-CoV-2 were not excluded from the trial.

COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

📺 3 Reasons Why I’m Bullish on Ocugen Stock (OCGN)!

3 Reasons Why I’m Bullish on Ocugen Stock (OCGN)!

📉 OCGN Stock Technical Analysis

The short-term trend is negative, as is the long-term trend. OCGN is one of the better-performing stocks in the Biotechnology industry, it outperforms 87% of 630 stocks in the same industry. OCGN is currently trading in the lower part of its 52-week range. The S&P500 Index however is trading in the upper part of its 52-week range, so OCGN is lagging the market.

The technical rating of OCGN is bad and it also does not present a quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when OCGN stock consolidates and is a good long entry.

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