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Blackstone announced today a new collaboration with Moderna, Inc. through a development and commercialization funding agreement which will provide up to $750 million to fund Moderna's influenza vaccine program.
Under the terms of the agreement announced on March 27, 2024, Blackstone Life Sciences (BXLS) will be eligible to receive milestones and royalties on resultant Moderna's influenza products.
Moderna will recognize the funding as a reduction in research and development expenses and will retain full rights and control of the Company's influenza program.
"Moderna has demonstrated a remarkable ability to impact human health through mRNA vaccines targeting respiratory illnesses. This landmark collaboration is another example of our long-standing strategy to partner with the world's leading life science companies to advance their critical path vaccines, medicines, and medical technologies to patients," said Nicholas Galakatos, Ph.D., Global Head of BXLA, in a press release.
Updated information about Moderna's flu program can be found at https://investors.modernatx.com/.
In the United States, flu shot distributions have been decreasing.
As of March 2024, the U.S. CDC reported about 158 million flu vaccines, egg, cell, and nasal-based, had been distributed during the 2023-2024 season. This data compares with 173 million distributed during the 2022-2023 flu season and 194 million during the 201-2022 season.
Defence Therapeutics Inc. today announced the successful testing of a second-generation anti-cancer vaccine, ARM-002TM, using its lead anti-cancer molecule AccuTOX®.
When tested as a therapeutic vaccine in a melanoma cancer model, ARM-002TM led to an 80% complete response when combined with the anti-PD-1 immune checkpoint inhibitor.
The ARM-002TM vaccine was tested in vivo in the context of melanoma.
"AccuTOX® is an amazing molecule! AccuTOX® has the capacity to trigger cancer cell death when used as a direct cancer injectable, and AccuTOX®, the same molecule, converts mesenchymal stromal cells into potent antigen-presenting cells capable of priming potent anti-tumoral responses using 10-fold lower antigen preparation," commented Mr. Sébastien Plouffe, Chief Executive Officer and Director of Defence Therapeutics, in a media statement on March 26, 2024.
Vaccination can stimulate specific immune responses capable of potentially curing established tumors compared to current anti-cancer strategies.
In addition, developed immune cells can lead to a long-lasting memory response capable of further protecting the patient from subsequent cancer relapses, says the company.
According to Data Bridge Market Research, this vaccine segment is expected to reach revenues of about $900 billion by 2029.
BioNTech SE's chief operating officer issued a U.S. Securities and Exchange Commission (SEC) filing on March 22, 2024, confirming that it previously disclosed that the Company was in discussions with the National Institutes of Health ("NIH") concerning royalties and other amounts allegedly owed on sales of the Company's COVID-19 vaccine since commercialization.
The NIH had delivered a communication threatening to send a notice of default under its license agreement with the Company, and the Company received a notice of default from the NIH relating to alleged amounts owed and breaches under such license.
As previously disclosed, the Company disagrees with the positions being taken by the NIH and intends to vigorously defend against all allegations of breach.
BioNTech's recent annual report filing (20-F) with the SEC disclosed an ongoing royalty disagreement with the NIH.
An SEC notice of default informs a contract partner that they have failed to fulfill an obligation and that legal action will be taken if they continue to default.
Osivax, a biopharmaceutical company, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, a broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs).
Topline results from this study are expected in the second half of 2024. OVX836 has been tested in 5 clinical trials with 1,200 participants, showing promising safety, immunogenicity, and efficacy read-outs.
OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen.
Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response.
Osivax’s oligoDOMTM technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle and thus triggers powerful T- and B-cell immune responses.
“The need for more effective and safe flu vaccines remains high, and the conclusion of our trial, which evaluates OVX836 in combination with QIVs, brings us one step closer to providing improved protection,” said Alexandre Le Vert, CEO and Co-Founder of Osivax, in a press release on March 26, 2024.
According to various reports, most flu shots offered about 50% protection during the 2023-2024 influenza season in the U.S.
Valneva SE today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).
The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Topline data from the trial are expected in the first half of 2025.
The initial Phase 1 study results from Valneva’s first-generation Zika vaccine candidate were reported in 2018, showing a favorable safety profile and immunogenicity in all tested doses and schedules.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on March 26, 2024, “Valneva’s commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus."
There are currently no preventive vaccines or effective treatments available against ZIKV. However, there are over ten Zika vaccine candidates conducting research.
As such, this mosquito-borne disease remains a public health threat and is included in the Food and Drug Administration’s Tropical Disease Priority Review Voucher Program.
As of March 2024, over 1,100 Zika cases have been confirmed in the Americas this year. Ten countries accounted for about 89% of Zika outbreaks recorded between 2014 and 2023.
A new tuberculosis (TB) vaccine candidate, MTBVAC, has started clinical trials in India. This vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human.
Bharat Biotech is conducting the clinical trials in collaboration with Biofabri, S.L.U, the vaccine's owner. The phase 3 clinical trials of the vaccine were announced on March 23, 2024, and plan to start in 2025.
The MTBVAC vaccine has passed several milestones before entering clinical trials in India.
This is a significant development since India has a high incidence of TB cases.
Esteban Rodriguez, CEO of Biofabri, commented in a press release, "It is a giant step to test in adults and adolescents in the country where 28% of the world's TB cases accumulate."
"It should be remembered that the only vaccine in use today, Bacillus Calmette and Guérin (BCG), is an attenuated variant of the bovine TB pathogen. It has a very limited effect on pulmonary tuberculosis, which is responsible for transmitting the (respiratory) disease."
Unlike BCG, which lacks over 100 genes compared to the human pathogen, MTBVAC contains the complete set of antigenic targets of the original pathogen.
According to the World Health Organization (WHO), the number of people who fell ill with TB in 2021 was 4.5% higher than in 2020, with 10.6 million people diagnosed.
In 2023, India reported over 2.2 million TB cases.
Biofabri is part of the Zendal Group, a Spanish pharmaceutical company specializing in human and animal health.
