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Bird flu viruses infect mammals including humans

January 19, 2023

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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

Image:

Image Caption:

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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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

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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

VIS:

PDF

Availability:

N/A

Generic:

NGoXIM

Drug Class:

Intransal Vaccine

Condition:

Gonorrhea

Last Reviewed:

Wednesday, June 28, 2023 - 07:50

Brand:

Avacc 11

Status:

Candidate

Manufacturer Country ID:

Gonorrhea Vaccines

Gonorrhea Vaccines 2024

The WHO Global Health Sector Strategy on Sexually Transmitted Infections (STIs) set goals for reducing gonorrhea incidence by vaccination by 90% by 2030. As of September 2024, no gonorrhea vaccines have been approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to prevent gonorrhea infection. However, the United Kingdom supports vaccinations to prevent gonorrhea. A systematic review of 12 studies published in 2024 evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea and a non-OMV-based vaccine (MenB-FHbp). This study concluded that 4CMenB and MenB-OMV vaccines show moderate effectiveness against gonorrhea infection.

Repurposed Vaccines Against Gonorrhea

On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) advised the government of a routine targeted vaccination program to prevent gonorrhea. The JCVI agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. In addition, a modeling study indicated that vaccinating at-risk people could prevent 110,000 gonorrhea cases in England. Meningococcal (MenB-4C, Bexsero) vaccination is recommended in France against Gonorrhea.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29. These results are consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea. Other STI vaccine news (herpes, HPV, mpox) is posted at this link.

On February 19, 2023, Mark Mascolini reported a meningococcal vaccine (4CMenB) continued to cut the risk of STIs in MSM using preexposure prophylaxis (PrEP) in the DOXYVAC trial. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. Clinical studies (April 22) published in the Lancet Infectious Diseases reported that two doses of the 4CMenB vaccine were around 33% to 40% effective against gonorrhea in adolescents and young adults.

On July 17, 2017, a GSK-funded study concluded that exposure to MeNZB was associated with reduced rates of gonorrhea diagnosis. This is the first time a vaccine has shown any protection against gonorrhea. The results of this study provide proof of principle that can inform prospective vaccine development not only for gonorrhea but also for meningococcal vaccines.

Gonorrhea Vaccine Candidates

GSK announced on June 27, 2023, that the U.S. FDA had granted a Fast Track designation for its Neisseria gonorrhea (NgG) investigational vaccine. GSK is conducting a Phase I/II first-time in-human clinical study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50. Phase I of the study was a completed dose-escalation safety lead-in conducted in healthy adults; the Phase II segment of the study is ongoing and aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

Intravacc's Avacc 11® is an experimental gonococcal vaccine consisting of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) that induces Th1-driven immunity. The prophylactic intranasal gonorrhea candidate vaccine is being developed in partnership with Therapyx Inc. Clinical study results were published in the journal MSphere of the American Society of Microbiology in December 2022. In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. On January 16, 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator awarded $633k to Intravacc to develop a Neisseria gonorrhoeae preventive vaccine.

LimmaTech Biologics AG is advancing the development of its novel vaccine candidate targeted to prevent Neisseria gonorrhoeae infections.

UMass Chan Medical School received a U.S. National Institutes of Health (NIH) grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion. A report was published in the journal mBio in 2019.

Evaxion Biotech A/S EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate. The novel preclinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities.

Gonorrhea Vaccine News

September 9, 2024 - Evaxion Biotech A/S announced new preclinical data demonstrating the ability of its novel EVX-B2 mRNA gonorrhea vaccine candidate to eliminate gonorrhea bacteria by triggering a targeted immune response.

March 28, 2024 - The U.S. CDC Morbidity and Mortality Weekly Reports confirmed the China Gonococcal Resistance Surveillance Program revealed that the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae was 8.1% in 2022, nearly three times the 2.9% prevalence reported in 2017.

February 27, 2024 - "Resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. LimmaTech's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

January 16, 2024 - "Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. With an appropriate vaccination strategy, Intravacc's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

November 10, 2023—The U.K.'s Joint Committee on Vaccination and Immunisation published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine to prevent gonorrhea in those at the highest risk of infection.

August 31, 2023 - Researchers with the Oregon Public Health Division suggest that the meningococcal group B vaccine may offer protection against gonorrhea infection.

June 27, 2023 - GSK plc announced today the US FDA has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine.

April 29, 2023 - Gonorrhea Risk Reduced with Oral Antibiotic.

April 11, 2023 - The U.S. CDC published - U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate.

March 1, 2023 - Developing advanced vaccines for STI pathogens gains U.S. NIAID support.

February 17, 2023 - Promising gonorrhea vaccine may prevent 40% of cases.

January 16, 2023 - Intravacc announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed with Therapyx Inc. Dr. Jan Groen, Intravacc's CEO, commented, "This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."

December 20, 2022 - 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 gonorrhoeae.

September 29, 2022 - The UMass Chan Medical School received a U.S. NIH grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion, a clinical-stage biotech company in Denmark.

July 27, 2022 - Aidsmap published: Taking antibiotic after sex cuts STIs by two-thirds, 'DoxyPEP' study finds.

April 12, 2022—The Lancet published effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea: a retrospective observational study. MenB-4C vaccination was associated with a reduced prevalence of gonorrhea and could offer cross-protection against Neisseria gonorrhoeae.

April 11, 2022 - The journal Frontiers published: Recent Progress Towards a Gonococcal Vaccine.

January 4, 2022 - The NEJM published Eliminating gonorrhea with a Vaccine?

Gonorrhea Test

On November 15, 2023, the U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test for use in adult patients ages 18. LetsGetChecked is the first OTC diagnostic test for gonorrhea with at-home sample collection to be granted marketing authorization. Before today's authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.

7 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Monday, September 9, 2024 - 11:25

Description:

Vaccination offers protection from bacteria that causes gonorrhea.

Condition:

Gonorrhea

Vaccine:

Bexsero Meningitis B Vaccine

0 min read

Moderna, Inc. announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an mRNA vaccine candidate targeting respiratory syncytial virus (RSV) in older adults.

Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease as defined by two or more symptoms.

Based on these results, Moderna stated on January 17, 2023, it intends to submit for regulatory approval for mRNA-1345 in the first half of 2023.

"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," commented Abdullah Baqui, a principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, in a related press release.

"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."

A concurrent review of available safety data was also conducted by the DSMB.

mRNA-1345 was well tolerated, with no safety concerns identified. To date, most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.

The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo.

The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo.

The study is ongoing, and an updated analysis of safety and tolerability will be provided at the time of regulatory submission.

Vaccine Treats:

Respiratory Syncytial Virus (RSV)

Image:

Image Caption:

from Pixabay

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Boston

Vaccine:

mRNA-1345 Respiratory Syncytial Virus (RSV) Vaccine

0 min read

Jefferson County Public Schools (JCPS) in Kentucky announced yesterday it would begin conducting measles vaccination clinics at local schools for about 10,000 unvaccinated students.

JCPS distributed notices to Louisville-area families whose school records show their students need to be protected against this vaccine-preventable disease.

Measles is highly contagious and often results in the hospitalization of those who contract the virus.

Beginning on January 17, 2023, JCPS students will be able to receive a Measles, Mumps, and Rubella (MMR) vaccine, as well as the COVID-19 and flu vaccines.

'We urge parents and guardians to ensure students are current with all required vaccines, including the MMR.

The U.S. CDC and the Kentucky Department of Public Health urge families to be aware of an ongoing measles outbreak near Columbus, Ohio.

As of January 17, 2023, the Columbus Health Department had confirmed 85 children had been infected with measles since June 2022. Most of these unvaccinated children are under ten years of age.

Previously, the CDC confirmed (118) measles patients in six jurisdictions in 2022. In 2021, a total of 49 measles cases were reported by five jurisdictions.

The CDC's top ten global measles outbreaks as of January 13, 2023, were led by India, with 12,271 cases, and Yemen, with 7,538.

In the U.S., various MMR vaccines are available at most clinics and pharmacies in 2023.

Vaccine Treats:

Measles

Image:

Image Caption:

by Likon Kom

Live Blog Update Author:

Don Hackett

Location Tags:

Louisville

Vaccine:

Priorix Vaccine