Modified vaccinia ankara

Novel Mpox Nanoparticle Vaccine Shows Superior Protection in Preclinical Studies

10 days ago

• Researchers have developed a multiprotein virus-like nanoparticle vaccine that successfully induces potent neutralizing antibodies against Mpox in both mice and non-human primates. • The innovative vaccine design combines modified M1, A35, and B6 proteins from Mpox virus onto a nanoparticle scaffold, demonstrating superior protection compared to soluble proteins and existing vaccines. • Preclinical studies show the vaccine provides cross-protection against different Mpox clades and related orthopoxviruses, offering a promising alternative to traditional vaccine approaches with enhanced safety profile.

NanoViricides' Broad-Spectrum Antiviral NV-387 Advances to Phase II Trials for MPox Treatment

15 days ago

• NanoViricides has received approval from the Democratic Republic of Congo's National Ethics Committee to proceed with Phase II clinical trials of NV-387 for MPox treatment, addressing a significant unmet need as no effective treatment currently exists. • NV-387 employs a revolutionary host-mimetic mechanism that "looks like a cell" to viruses, potentially making it effective against 90-95% of human pathogenic viruses while being highly resistant to viral escape mutations. • The drug has demonstrated superior efficacy in animal models against multiple viruses including influenza, RSV, coronavirus, and orthopoxviruses, outperforming existing treatments like Tamiflu, remdesivir, and matching tecovirimat against MPox-like infections.

GeoVax's Multi-Antigen COVID-19 Vaccine Shows Promising Results in Immunocompromised Patients

a month ago

• GEO-CM04S1, a next-generation COVID-19 vaccine expressing both Spike and Nucleocapsid proteins, demonstrated robust immune responses in both healthy adults and immunocompromised populations. • In a Phase 2 trial comparing GEO-CM04S1 to Pfizer-BioNTech's vaccine in chronic lymphocytic leukemia patients, GEO-CM04S1 showed significantly higher T cell response rates, leading to early termination of the Pfizer arm. • Recent data presented at scientific conferences suggests GEO-CM04S1 may offer dual protection against both COVID-19 and Mpox, with cross-reactive immunity comparable to licensed Mpox vaccines.

China's First Monkeypox Vaccine Enters Phase I Clinical Trials with Diverse Volunteer Cohort

a month ago

• China's first monkeypox vaccine, an MVA-based live attenuated vaccine developed by Shanghai Institute of Biological Products Co, has begun Phase I clinical trials at Henan Infection Diseases Hospital. • The trial will recruit 120 volunteers including healthy individuals, men who have sex with men, and people living with HIV, targeting key populations based on WHO guidance for monkeypox vaccination. • Preclinical studies have demonstrated the vaccine's safety and strong immune protection against monkeypox in non-human primate models, potentially filling a significant gap as no monkeypox vaccine is currently approved in China.

Jynneos Vaccine Shows Reduced Efficacy Against Mpox in HIV Patients, Study Reveals

2 months ago

• A recent study published in The Lancet Infectious Diseases found Bavarian Nordic's Jynneos vaccine was 84% effective in preventing mpox in individuals without HIV, but only 35% effective in those with HIV. • The research, conducted at Charité Universitätsmedizin Berlin with over 6,000 participants, highlights a significant unmet need for effective mpox prevention strategies in immunocompromised populations. • While the vaccine showed an overall 58% effectiveness after one dose, researchers emphasize the importance of completing the two-dose regimen, particularly for HIV-positive individuals who demonstrated reduced T-cell responses.

FDA Approves Freeze-Dried Jynneos Vaccine for Mpox and Smallpox Prevention

2 months ago

• The US FDA has approved Bavarian Nordic's freeze-dried formulation of Jynneos vaccine for mpox and smallpox prevention in adults, offering significant advantages in storage, transportation, and shelf life over the liquid-frozen version. • Clinical trials demonstrated comparable immune responses between the freeze-dried and liquid-frozen formulations, with no serious adverse events reported, supporting the supplemental Biologics License Application submitted in May 2024. • The approval represents a milestone in public health preparedness, with Bavarian Nordic manufacturing the freeze-dried vaccine under a contract with BARDA, with first deliveries expected later in 2025.

FDA Approves Bavarian Nordic's Freeze-Dried JYNNEOS Vaccine for Smallpox and Mpox Prevention

2 months ago

• The U.S. FDA has approved Bavarian Nordic's freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox in adults 18 years and older, offering improved storage stability and transportation advantages. • Clinical data demonstrated comparable immune responses and safety profiles between the new freeze-dried formulation and the previously approved liquid-frozen version, which has been in use since 2019. • Manufacturing of the freeze-dried JYNNEOS under a BARDA contract began in 2024, with first deliveries expected later in 2025, strengthening U.S. public health preparedness against potential outbreaks.

Tonix Pharmaceuticals Receives MCDC Grant to Advance TNX-801 Vaccine Against Smallpox and Mpox

2 months ago

• Tonix Pharmaceuticals has secured funding from the Medical CBRN Defense Consortium to develop TNX-801, a recombinant horsepox virus-based vaccine targeting both mpox and smallpox. • The single-dose vaccine demonstrates improved tolerability compared to traditional vaccinia-based vaccines, with preclinical studies showing effectiveness against monkeypox amid ongoing global outbreaks. • The grant will support comprehensive market analysis, target market identification, and commercialization planning for both government and private sectors.

Bavarian Nordic Partners with Serum Institute of India for Global Mpox Vaccine Manufacturing

5 months ago

• Bavarian Nordic and Serum Institute of India (SII) have established a license and manufacturing agreement for the MVA-BN mpox vaccine, expanding global manufacturing capacity and distribution. • The profit-sharing partnership includes technology transfer to SII, granting them rights to sell and distribute the vaccine in India without requiring upfront or milestone payments. • This collaboration aims to enhance epidemic preparedness and increase vaccine accessibility, with Bavarian Nordic pursuing additional partnerships, particularly with manufacturers in Africa.

Tecovirimat Fails to Improve Mpox Outcomes in NIH-Sponsored STOMP Trial

5 months ago

• The STOMP trial found that tecovirimat did not significantly reduce lesion resolution time or pain in adults with mild to moderate mpox. • The Data Safety and Monitoring Board recommended halting further enrollment due to the lack of efficacy, leading NIAID to close the study. • Tecovirimat remains available through the CDC's expanded access program for eligible patients with severe mpox or immunocompromised conditions. • Researchers emphasize the importance of randomized clinical trials during outbreaks, despite the disappointing results for tecovirimat.

Pharmaceutical R&D Highlights of 2024: GLP-1s, CRISPR, and More

5 months ago

• GLP-1 receptor agonists like semaglutide and tirzepatide showed potential beyond diabetes and weight loss, including cardiovascular and mental health benefits. • CRISPR gene editing entered the market with Casgevy for sickle cell disease and β-thalassemia, though uptake has been slow due to complex treatment requirements. • Protein-folding algorithms developed by Nobel laureates revolutionized biochemical research and found applications in pharmaceutical drug discovery. • Antibody-drug conjugates (ADCs) saw major investment, with firms focusing on novel linker chemistries to enhance their efficacy and target specificity.

Barinthus Bio's VTP-300 Shows Promise in Achieving Functional Cure for Chronic Hepatitis B

6 months ago

• Barinthus Bio announced Phase 2b HBV003 trial results showing HBsAg loss in eight participants treated with VTP-300 and low-dose nivolumab. • Two participants met the criteria for functional cure, demonstrating the potential of VTP-300 in chronic hepatitis B treatment. • Two participants achieved HBsAb seroconversion after discontinuing NUC therapy, indicating a possible immune response shift. • The HBV003 trial is evaluating VTP-300 with nivolumab in 121 participants, including those with low HBsAg levels.

NanoViricides' NV-387 Advances to Phase II Trials for Multiple Viral Infections

6 months ago

• NanoViricides' broad-spectrum antiviral NV-387 is set to advance to Phase II clinical trials, targeting MPOX, RSV, influenza, and COVID-19 infections. • A Phase Ia/Ib trial of NV-387 was completed with no adverse events reported, showing promising results and paving the way for further clinical development. • NV-387 has demonstrated superior effectiveness in animal trials compared to existing treatments for various viral infections, offering a potential breakthrough. • The company faces funding challenges for Phase II trials despite recent capital raises, highlighting the need for additional financial resources.

Bavarian Nordic Initiates Phase II Trial of MVA-BN Mpox Vaccine in Young Children

7 months ago

• Bavarian Nordic has commenced a Phase II trial to assess the safety and immunogenicity of its MVA-BN mpox vaccine in children aged 2 to 11 years. • The trial (NCT06549530), partially funded by CEPI, will compare the vaccine's performance in children with that in adults, potentially including sites in the Democratic Republic of Congo and Uganda. • MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, received EMA approval in September for adolescents and has a GAVI agreement for 500,000 doses in Africa. • This study aims to inform mpox vaccination strategies for protecting children and managing outbreaks, building on the precedent of Mvabea's approval for Ebola prevention in young individuals.

Bavarian Nordic Initiates Phase II Trial to Expand Mpox Vaccine Label to Toddlers

7 months ago

• Bavarian Nordic has commenced a Phase II trial to assess the safety and immunogenicity of its MVA-BN mpox vaccine in children aged 2 to 11 years. • The trial, partly funded by CEPI, will compare the vaccine's performance in children with that in adults, with recruitment planned in the Democratic Republic of Congo and Uganda. • MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, has already received label expansions for adolescents and is a significant revenue driver for Bavarian Nordic. • A recombinant version of the vaccine, Mvabea, was previously approved by the EMA in 2020 as part of a prime-boost vaccine regimen for the prevention of disease caused by Ebola virus in individuals one year of age and older.

Bavarian Nordic Initiates Phase II Trial to Expand Mpox Vaccine Label to Toddlers

7 months ago

• Bavarian Nordic has commenced a Phase II trial to assess the safety and immunogenicity of its MVA-BN mpox/smallpox vaccine in children aged 2-11 years. • The trial, partially funded by CEPI, will compare the vaccine's performance in children to that in adults, with recruitment planned in the Democratic Republic of Congo and Uganda. • MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, has already received label expansions for adolescents and secured a purchase agreement with GAVI for distribution in Africa. • This study aims to inform mpox vaccination strategies for protecting children and addressing outbreaks, particularly in endemic populations, with potential implications for future vaccine guidance.

Bavarian Nordic Initiates Phase II Trial of Mpox Vaccine in Toddlers

7 months ago

• Bavarian Nordic has commenced a Phase II clinical trial to assess the safety and immunogenicity of its MVA-BN mpox vaccine in children aged 2-11 years. • The trial, partly funded by CEPI, aims to expand the vaccine's approval label to include younger children, addressing a critical gap in mpox prevention. • MVA-BN, known as Jynneos in the US and Imvanex in Europe, has already been approved for adults and adolescents, demonstrating its potential against mpox. • The study will enroll participants in the Democratic Republic of Congo and potentially Uganda, regions affected by recent mpox outbreaks.

Mpox Vaccine Protection Wanes Within a Year, Boosters Needed

8 months ago

• New research indicates that antibodies from mpox vaccination diminish significantly within 6 to 12 months, highlighting the necessity for booster doses. • The study, published in JAMA, assessed immune responses in vaccinated individuals and those with confirmed mpox diagnoses over a 12-month period. • Researchers emphasize the importance of completing the recommended two-dose mpox vaccine series to boost immunity, regardless of the interval between doses. • A new, potentially more severe, strain of mpox in the Democratic Republic of Congo has prompted WHO to declare a public health emergency.

Vaccine Updates: FDA Approves Self-Administered FluMist, Updated Novavax COVID-19 Vaccine

8 months ago

• The FDA has approved FluMist, a nasal spray flu vaccine, for self- or caregiver-administration, making it the first flu vaccine with this capability, indicated for individuals aged 2 to 49 years. • Novavax's updated COVID-19 vaccine has received FDA emergency use authorization for individuals aged 12 years and older, set to be available in pharmacies and grocers across the United States. • GSK reported positive topline data from a phase 3 study for co-administration of its RSV vaccine (Arexvy) with its shingles vaccine (Shingrix) in adults 50 years and older. • The WHO has added the MVA-BN (Imvanex) vaccine to its prequalification list, marking the first mpox vaccine to receive this designation, indicated for adults and potentially for off-label use in younger populations.

Mpox Vaccine Shows Safety and Robust Immune Response in Adolescents

8 months ago

• A NIH-funded clinical trial found the MVA-BN mpox vaccine safe and effective in adolescents aged 12-17, generating antibody responses similar to those in adults. • Interim analysis showed adolescents had higher geometric mean titers (GMT) compared to adults after two doses of the MVA-BN vaccine, indicating a strong immune response. • The EMA has recommended extending the use of the Imvanex vaccine to adolescents, based on data showing similar immune responses and safety profiles as in adults. • These findings support the use of the MVA-BN vaccine in adolescents, especially in areas with ongoing mpox outbreaks, while further studies in younger children are needed.

Modified vaccinia ankara

Drug Development Updates