National Institute of Virology

Kinarus Therapeutics Engages Great Health Companion Group to Explore Partnerships in China

Retrieved on: 
Sunday, November 27, 2022
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Kinarus Therapeutics Holding AG (SIX: KNRS) (Kinarus), a clinical-stage biopharmaceutical company developing novel therapeutics to treat viral, respiratory, and ophthalmic diseases, announced today that it has engaged Great Health Companion Group Ltd (GHCG), a subsidiary of Hakim Unique Group, a global conglomerate from China, to explore partnering options to initiate Phase 2 testing of KIN001 to treat wet age-related macular degeneration (wAMD) and idiopathic pulmonary fibrosis (IPF).

Key Points: 
  • Kinarus Therapeutics Holding AG (SIX: KNRS) (Kinarus), a clinical-stage biopharmaceutical company developing novel therapeutics to treat viral, respiratory, and ophthalmic diseases, announced today that it has engaged Great Health Companion Group Ltd (GHCG), a subsidiary of Hakim Unique Group, a global conglomerate from China, to explore partnering options to initiate Phase 2 testing of KIN001 to treat wet age-related macular degeneration (wAMD) and idiopathic pulmonary fibrosis (IPF).
  • In addition, Kinarus and GHCG will explore further business opportunities which may include licensing or strategic partnerships.
  • Dr Alexander Bausch, CEO of Kinarus Therapeutics Holding AG, commented: China has the worlds largest population and second largest economy.
  • Kinarus Therapeutics Holding AG (www.kinarus.com) was founded in 2017 by experienced pharmaceutical executives in Basel, Switzerland.

DGAP-News: Biotest AG: Biotest grants Renate & Hans Schleussner Research Award for the first time

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Monday, July 25, 2022
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Biotest is currently also conducting a phase III clinical trial with CMV hyperimmunoglobulin in pregnant women.

Key Points: 
  • Biotest is currently also conducting a phase III clinical trial with CMV hyperimmunoglobulin in pregnant women.
  • Dr.PhilippKolb from the Institute of Virology at the University of Freiburg is the first winner of the Renate&HansSchleussner Research Award.
  • The award supports a research project of the excellent winner in the field of cytomegalovirus (CMV) infection.
  • The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

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Thursday, June 23, 2022
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SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

Retrieved on: 
Thursday, June 23, 2022
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SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).

Key Points: 
  • SINGAPORE, June 23, 2022 /PRNewswire/ --Singapore-based SCG Cell Therapy Pte Ltd ("SCG") today announced interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC).
  • This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.
  • The safety profile of SCG101 was consistent with the side effects expected in T cell therapy.
  • SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg).

Ocugen Announces Publication of Positive Results of COVID-19 Vaccine Trial for Children 2-18 in The Lancet Infectious Diseases

Retrieved on: 
Tuesday, June 21, 2022
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MALVERN, Pa., June 21, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s partner Bharat Biotech International Limited (“Bharat Biotech”), a global leader in vaccine innovation based in Hyderabad, India, and is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

Key Points: 
  • Ocugen is continuing its effort to bring this vaccine to the North American Market.
  • We congratulate Bharat Biotech on the publication of the COVAXINpediatric data in this prestigious peer-reviewed medical journal, said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
  • Safety of the vaccine is critical for children, and we are glad to share that COVAXINhas proven data for safety and immunogenicity in children.
  • COVAXINis formulated uniquely such that the same dosage can be administered to adults and children alike, making it truly a universal vaccine.

Ocugen Announces FDA Removes Clinical Hold on Phase 2/3 Clinical Trial for COVAXIN™ (BBV152)

Retrieved on: 
Monday, May 23, 2022
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Were extremely pleased that we can proceed with our clinical trials for COVAXIN, our whole virus inactivated COVID-19 vaccine candidate.

Key Points: 
  • Were extremely pleased that we can proceed with our clinical trials for COVAXIN, our whole virus inactivated COVID-19 vaccine candidate.
  • Thank you to our clinical trial partners and site collaborators for their ongoing support.
  • Ocugen will now work with study sites to fully resume this clinical development program immediately.
  • People interested in learning about how to participate in this clinical trial (NCT05258669) can visit the clinical trials section of Ocugen.com.

Ocugen, Inc. to Commercialize COVAXIN™ in Mexico, Rights Now Encompassing All of North America

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Monday, April 18, 2022
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MALVERN, Pa. and HYDERABAD, India, April 18, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, and Bharat Biotech (BBIL), a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply and Commercialization Agreement to expand Ocugen’s exclusive territory to include commercialization of COVAXIN™ in Mexico. This gives Ocugen COVAXIN™ commercialization rights for all of North America.

Key Points: 
  • This gives Ocugen COVAXIN commercialization rights for all of North America.
  • Were excited to commercialize COVAXIN in Mexico, as authorities there have made conquering this pandemic a major priority.
  • As a whole virion, inactivated vaccine, it elicits robust cellular immune memory to SARS-CoV-2 and Variants of Concern.
  • Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release.

Ocugen, Inc. Announces U.S. FDA Lifts Clinical Hold on the Submission of Its Investigational New Drug Application for Its COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

Retrieved on: 
Friday, February 18, 2022
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COVAXIN is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.

Key Points: 
  • COVAXIN is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
  • COVAXIN (BBVI52) 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 is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

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

Retrieved on: 
Saturday, January 8, 2022
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The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

Key Points: 
  • The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.
  • 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.

Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

Retrieved on: 
Friday, November 26, 2021
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The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies.

Key Points: 
  • The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies.
  • 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 is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.