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Since the Mpox outbreak began in May 2022, over 1.1 million doses of the Jynneos® vaccine have been administered in the United States (U.S.).

The city of Boston began offering Jynneos vaccinations to healthcare staff on May 24, 2022, followed by New York City (NYC).

In September 2022, NYC Health began offering second doses of Jynneos to qualifying people.

As of January 17, 2023, 57 U.S. Jurisdictions have offered first and second doses to men and women at no charge.

From an effectiveness perspective, the U.S. Centers for Disease Control and Prevention (CDC) posted data on December 8, 2022, suggesting the effectiveness of a single dose of Jyennos was 87% protective.

Overall, the CDC has confirmed 30,026 Mpox cases and 23 related fatalities, a case-fatality rate of less than 1%.

Demetre Daskalakis, M.D., deputy coordinator of the CDC's pox response efforts in the U.S., recently posted on Twitter, 'Supply is there! We need to keep the drumbeat going for demand even as cases go down.'

'Getting vaccinated for #mpox now means protection in the future! Oh… that means two doses of the vaccine!

Find out where to obtain the Jynneos vaccine at http://mpoxvaxmap.org or your local/state health department.

Vaccine Treats:

mpox

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JYNNEOS Vaccine 1st and 2nd Doses

Live Blog Update Author:

Don Hackett

Location Tags:

Atlanta

Vaccine:

JYNNEOS Smallpox (Mpox) Vaccine

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ImmunityBio, Inc. today announced positive results in its fully-enrolled metastatic pancreatic cancer study in third-line or greater subjects (QUILT 88), showing that the overall survival (OS) rate for patients continues to be double compared to historical survival rates after two or more prior lines of therapy.

The median OS in this highly advanced group of patients, up to seven lines (N=83) of treatment, was 5.8 months (95% CI: 4.9, 6.4 months), exceeding the approximately 2- to 3-month historical median OS.

In the third-line setting (N=41), the median OS in this group was 6.3 months (95% CI: 5.0, 7.2 months), more than doubling the historical OS.

The baseline median CA 19-9 level (a marker of metastatic pancreatic disease) of the enrolled subjects (N=83) was very high at 4120 IU/ml, a significant increase from normal levels of 40 IU/ml.

In subjects with CA 19-9 levels less than 4120 IU/ml (N=40), the median OS was 6.9 months (95% CI: 5.7,10.9).

"We are encouraged by the positive results in these patients with 3rd, 4th, 5th, and even 7th line advanced pancreatic cancer and the considered and helpful feedback from the FDA," said Patrick Soon-Shiong, M.D., Executive Chairman, and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on January 19, 2023.

"Treatments for pancreatic cancer in the advanced setting remain an unmet need."

"We are committed to confirming our hypothesis that orchestrating the innate and adaptive immune system will advance the care of these patients."

This therapy is essential since pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. annually.

The QUILT 88 study results were presented at the American Society of Clinical Oncology Gastrointestinal conference on January 19-21, 2023.

ImmunityBio also announced that it held two productive Type B meetings with the U.S. FDA in December 2022.

Vaccine Treats:

Pancreatic Cancer

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ImmunityBio, Inc. 2023

Live Blog Update Author:

Don Hackett

Location Tags:

Culver City

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The Janssen Pharmaceutical Companies of Johnson & Johnson and a consortium of global partners announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen's investigational HIV vaccine regimen.

The study's independent Data and Safety Monitoring Board (DSMB) determined that the regimen was ineffective in preventing HIV infection compared to placebo.

In light of the DSMB's determination, the Mosaico clinical trial was discontinued.

Mosaico began in 2019 and completed vaccinations in October 2022.

The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the U.S.

"We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV," said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC., in a press release on January 18, 2023.

"We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine."

The Mosaico findings align with developments in the Phase 2b “Imbokodo” clinical trial, which tested a similar HIV vaccine regimen in women in sub-Saharan Africa.

That DSMB determined in August 2021 that the experimental vaccine regimen was also ineffective in protecting against HIV acquisition.

As of January 19, 2023, the U.S. Food and Drug Administration had not approved an HIV vaccine candidate.

Vaccine Treats:

HIV

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by Gerd Altmann

Live Blog Update Author:

Don Hackett

Location Tags:

Leiden

Vaccine:

HIV Vaccines 2023

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LinKinVax and Gustave Roussy today announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV).

LinKinVax develops CD40HVac based on an innovative technology directly targeting dendritic cells, which play a crucial role in the immune system by stimulating and regulating immune responses.

Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is essential to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients, says LinkinVax.

The objectives of the study (EUCT n° 2022-502930-25-00), sponsored by Gustave Roussy, are to demonstrate the safety and immunogenicity of the CD40HVac vaccine candidate with the Poly-ICLC adjuvant (Hiltonol®) against oncogenic HPV in patients with head and neck cancer and to determine the recommended Phase 2 dose based on the safety profile of the vaccine candidate and its ability to induce immune responses.

Several exploratory objectives are also planned to estimate progression-free survival and overall survival.

Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented in a press release on January 19, 2023, "This partnership ... represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients."

"Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to treating HPV-related cancers."

A recent U.S. population-based study by the Centers for Disease Control and Prevention showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18.

LinKinVax's vaccine platform is built around a humanized monoclonal antibody fused with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells.

The results demonstrate this strategy's benefits due to the small number of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response.

The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years.

Vaccine Treats:

HPV Cancers

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Image Caption:

by Manuel Alvarez

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Paris

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Evaxion Biotech A/S recently announced that the U.S. Food and Drug Administration (FDA) determined that the Company may proceed with its Phase 2b clinical trial of EVX-01 targeting malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia and in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®.

The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial.

The Company anticipates a response from the FDA to the Fast Track designation submission in the first quarter of 2023.

“Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma. Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,” says Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2023.

Vaccine Treats:

Melanoma

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Image Caption:

from Pixabay

Live Blog Update Author:

Don Hackett

Location Tags:

Copenhagen

Vaccine:

EVX-01

0 min read

Novavax, Inc. today announced that partner SK bioscience had received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373), a protein-based booster for active immunization to prevent COVID-19 in adults aged 18 and older.

KFMDS previously approved Nuvaxovid as a primary series in adults aged 18 and older in January 2022 and as a primary series in adolescents aged 12 through 17 in August 2022.

"We are pleased to collaborate with SK bioscience to offer our protein-based vaccine, Nuvaxovid, for use as a booster in adults regardless of previous vaccine history," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on January 18, 2-23.

"This is an important step in ensuring broad access to diversified vaccine options."

Novavax' COVID-19 vaccine is authorized as an adult booster in more than 35 countries.

In addition, several other countries have policy recommendations allowing the use of the vaccine as a booster dose.

Vaccine Treats:

COVID-19

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Staff Review

Location Tags:

Gaithersburg

Vaccine:

Novavax COVID-19 Vaccine

Avacc 11 Gonorrhea Vaccine

Avacc 11® Gonorrhea Vaccine 2023

Intravacc's Avacc 11® (NGoXIM) is the prophylactic intranasal gonorrhea candidate vaccine being developed in partnership with Therapyx Inc. This vaccine candidate consists of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) induced Th1-driven immunity, with circulating and genital antibodies to Neisseria gonorrhoeae, after intravaginal (i.vag.) administration.

Since intranasal immunization has previously been shown to induce antibody responses in both male and female genital tracts, the companies evaluated this route of immunization with gonococcal OMVs plus IL-12 ms. The administration is not a practical means of delivery. It is inapplicable to males and may not be acceptable to women. The Company's proprietary OMV platform-based gonorrhea vaccine candidate, combined with encapsulated IL-12, showed protection against subsequent infection with Neisseria gonorrhea (NG). Results were published in the peer-reviewed journal MSphere of the American Society of Microbiology on December 20, 2022.

In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. In December 2023, mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria Gonorrhea. And in January 2023, the Company announced preclinical data of Avacc 11® demonstrated protection against gonorrhea infection.

Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. Therapyx is a privately held pharmaceutical company headquartered in Buffalo, New York.

Avacc 11® Indication

Avacc 11 is being developed to prevent infection with NG (i.e., gonorrhea). Gonorrhea remains highly prevalent, with an estimated 87 million new infections yearly. In the United States, incidence increased by 66% from 2014 to 2018, exceeding 580,000 reported cases in 2018, although the actual incidence is believed to be even greater. N. gonorrhoeae is listed by the WHO as an "urgent threat" among human pathogens because of the emergence of resistance to currently available antibiotics, and cases of extreme resistance have been reported.

Avacc 11® Vaccine News 2023

January 16, 2023 - Dr. Jan Groen, Intravacc's CEO, says: "Together with our partner Therapyx, we are very pleased with the preclinical data of the intranasal candidate vaccine Avacc 11®. This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments.

October 5, 2022 – Intravacc announced that it had been awarded a contract with base and options that may total US$14.6 million from the US National Institute of Allergy and Infectious Diseases to develop a prophylactic intranasal vaccine against NG. Intravacc will develop a prophylactic vaccine based on its proprietary OMV platform technology.

Avacc 11® Clinical Trials

This candidate is currently being studied in mice. These study results show that i.n. immuImmunizationh gonococcal OMVs plus IL-12 ms as an adjuvant is at least as effective as i.vag. immunImmunization of the same vaccine in mice.

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Manufacturer:

Intravacc

Reviewer:

Robert Carlson, MD

Vaccine:

Avacc 11 Gonorrhea Vaccine

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