Cancer Vaccine Breaking News

Moderna Inc.'s respiratory vaccine franchise is targeting an approximately $30 billion annual market, comprised of a $15 billion COVID-19 market, a $10 billion RSV market, and a $6 billion flu market, with the potential for growth with more effective vaccines.

According to Modern'a press release on September 13, 2023, the Company's respiratory products sales in 2027 are expected to be in the range of $8 billion to $15 billion, depending on certain variables.

"With today's positive Phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive Phase 3 data," commented Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

Modera's press release specifically highlighted its Seasonal Influenza Vaccine business today.

The mRNA-1010 vaccine candidate has demonstrated an acceptable safety and tolerability profile across all clinical trials to date, including three Phase 3 trials (P301, P302, P303), and independent data and safety monitoring boards have raised no safety concerns.

In an interim analysis of the P303 study,mRNA-1010 met all co-primary endpoints across all four A and B strains (A/H1N1, A/H3N2, influenza B/Yamagata, B/Victoria).

Higher HAI geometric mean titers and seroconversion rates were observed for all four strains compared to a licensed comparator (Fluarix).

And local and systemic solicited adverse reactions were similar to those reported in previous mRNA-1010 studies.

Furthermore, improved immunogenicity was observed across age groups and, importantly, was seen in older adults.

mRNA-1010 also elicited higher HAI titers against A/H1N1, A/H3N2, B/Victoria, and comparable titers to B/Yamagata compared to Fluzone HD in a separate Phase 1/2 head-to-head study.

As the previous P302 efficacy study has not accrued its target case numbers by the end of the most recent season, the Company would need to enroll in a second season to accrue enough cases.

In light of P303 meeting all its primary endpoints, the Company has decided not to enroll in a second season in the P302 study.

The Company continues to advance a portfolio of influenza vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains (mRNA-1011 and mRNA-1012) and candidates that incorporate both HA and neuraminidase antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030).

As of early September 2023, over 100 million influenza vaccines have been distributed in the U.S., preparing for the 2023-2024 flu season.

Replicate Bioscience, a clinical-stage company pioneering its novel self-replicating RNA (srRNA) technology to overcome the limitations of current mRNA modalities, today announced the dosing of the first participant in a Phase 1 trial of its RBI-4000 vaccine for the prevention of rabies.

The Phase 1 trial will evaluate the safety, tolerability, and immunogenicity of RBI-4000 in 84 participants in the U.S.

In preclinical studies, intramuscular administration of RBI-4000 provided durable protection against the rabies virus, inducing antibody production and robust virus-specific T cells.

"Replicate's srRNA technology offers the potential for more robust and durable immune responses and improved tolerability at lower doses than existing mRNA approaches," commented Zelanna Goldberg, M.D., CMO of Replicate, in a press release on September 12, 2023.

"In infectious disease specifically, our srRNA technology unlocks opportunities to effectively address more complex infectious disease indications and allows us to rapidly develop vaccine candidates to treat or prevent illness — a crucial capability for future pandemic readiness."

According to the World Health Organization, Rabies is a vaccine-preventable viral disease found in more than 150 countries and territories. Rabies vaccination can prevent infections before and after exposure to the rabies virus.

Various rabies vaccines are approved and available in 2023.

The only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older has been listed in 26 provinces and municipalities in China.

Clover Biopharmaceuticals, Ltd. today announced the launch of AdimFlu-S (QIS) in mainland China.

“The launch of AdimFlu-S in mainland China – our second commercialized product – strengthens Clover’s leading respiratory vaccine franchise and contributes to our financial sustainability and future growth,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover, in a press release on September 12, 2023.

AdimFlu-S (QIS) is a quadrivalent split inactivated vaccine that can be used to prevent influenza. It contains hemagglutinin from four influenza virus strains (two A and two B).

This quadrivalent improves its ability to achieve high vaccine effectiveness, regardless of which influenza B strain becomes seasonally prevalent, compared to trivalent flu shot options, says the company.

AdimFlu-S gained approval from the China National Medical Products Administration in January 2022.

As of September 2023, over 100 flu shot candidates are in development globally.

To support an innovative bladder cancer vaccine candidate, ImmunityBio, Inc. today announced that it has executed financing transactions resulting in approximately $200 million of proceeds to the Company.

This financing includes an exchange into equity of current debt and a new convertible debt instrument from Nant Capital, LLC, an entity affiliated with Dr. Patrick Soon-Shiong, the Company's Founder, Executive Chairman, and Global Chief Scientific and Medical Officer.

With this new financing from Dr. Soon-Shiong, confirmed on September 11, 2023, includes the extension of the maturity date of the current debt.

ImmunityBio stated in a press release that it 'believes that it is well-positioned to fund its ongoing business operations and pre-commercialization efforts as it continues to drive toward a potential regulatory approval of N-803 plus BCG for BCG-unresponsive non-muscle invasive bladder cancer.'

"Our Company, scientists, physicians, and Board are grateful to Dr. Soon-Shiong for his continued financial support of our Company and its important mission, as well as for his involvement in our day-to-day operations," commented Richard Adcock, Chief Executive Officer and President of ImmunityBio.

"With this additional financing, we are well positioned to execute our commercialization plans in anticipation of the approval of N-803 plus BCG in bladder cancer."

"This funding will also help support the planned expansion of our current clinical trials and the opening of new studies to explore the untapped potential of N-803 and our other platforms across multiple indications."

N-803 Plus BCG is a therapy to treat adults with non-muscle-invasive Bladder Cancer carcinoma in situ with or without Ta/T1 papillary disease. 

Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation.

The U.S. FDA is reviewing the Biologics License Application for N-803 plus BCG.

A Moderna Inc. funded study published on September 7, 2023, offered positive news ahead of the U.S. Centers for Disease Control and Prevention meeting of the Advisory Committee on Immunization Practices on September 12, 2023, at 10 a.m. ET.

This non-peer-reviewed preprint study of the ongoing phase 2/3 study of Moderna's mRNA-1273.815 monovalent (50-µg omicron XBB.1.5 spike mRNA) or mRNA-1273.231 bivalent (25-µg omicron XBB.1.5 and 25-µg omicron BA.4/BA.5 spike mRNAs) vaccines, administered as 5th doses to adults.

In this interim analysis, XBB.1.5-containing monovalent and bivalent vaccines elicited potent neutralizing responses against variants of the omicron XBB-lineage (XBB.1.5, XBB.1.6, XBB.2.3.2, EG.5.1, and FL.1.5.1) as well as the recently emerged BA.2.86 variant, in about 50 study participants.

And the safety profile of the XBB.1.5-containing vaccine was consistent with those of prior vaccines.

According to these researchers, these results overall indicate that the XBB.1.5-containing mRNA-1273.815 vaccine has the potential to provide protection against these emerging variants and support the Covid-19 vaccine update in 2023-2024 to a monovalent XBB.1.5-containing vaccine.

This study was not powered for a statistical comparison of the immune responses between the vaccine groups or vaccine efficacy. The corresponding author is Spyros Chalkias, MD Moderna, [email protected].

Previously, Moderna announced that clinical trial data from a research assay confirmed its updated COVID-19 vaccine generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola).

Previously known as SpikeVax, this COVID-19 Vaccine is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus to prevent severe COVID-19. On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization.

While most people have heard of norovirus outbreaks on cruise ships, this diarrhea-causing virus also impacts people on land.

The U.S. CDC's Morbidity and Mortality Weekly Report on September 8, 2023, highlighted about 27 cases of acute gastroenteritis among hikers on the Pacific Crest Trail in 2022, suggesting a possible norovirus outbreak.

The CDC wrote preventing future outbreaks will require fostering increased awareness of handwashing and the lack of effectiveness of alcohol-based hand sanitizers against norovirus and more frequent cleaning of public facilities.

These hikers and others are eagerly awaiting news of a norovirus vaccine.

On September 6, 2023, Vaxart, Inc. announced top-line data from the Phase 2b challenge study of its oral tablet monovalent norovirus vaccine candidate, VXA-G1.1-NN.

Vaccination with VXA-G1.1-NN led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis, and a substantial reduction in viral shedding.

The oral vaccine candidate was also safe and well tolerated with no vaccine-related serious adverse events.

Dr. James F. Cummings, Vaxart's Chief Medical Officer, commented in a press release, "The magnitude of the reduction in shedding could have an impact on transmission and may have important public health benefits, as norovirus spreads rapidly among people gathering in large numbers, including settings such as daycare centers, nursing homes, and workplaces, and may reduce the potential spread of the infection to families at home."

"The results of this study highlight the potentially distinctive profile of mucosal vaccination and the potential that our oral pill vaccines may have in protecting against infection and blocking transmission – potential benefits that have also been seen with our influenza vaccine," added Dr. Cummings.

Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the U.S. On average, norovirus causes 19 to 21 million cases, infects 15% of all children under age 5, and leads to 465,000 emergency department visits, 109,000 hospitalizations, and 900 deaths, says the U.S. CDC.

As of September 9, 2023, norovirus vaccine candidate news is posted by Precision Vaccinations.