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VIR-2482 Monoclonal Antibody 2023

Vir Biotechnology VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody (mAb) designed to protect people against seasonal and pandemic influenza. Due to its broad strain coverage of diseases, it has the potential to overcome the limitations of current influenza vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on individuals to create their protective antibody response. In vitro, VIR-2482 has been shown to protect all significant strains of influenza A. VIR-2482 incorporates Xencor's Xtend™ Technology and has also been half-life engineered so that a single dose can last the entire flu season.

Under the collaboration agreement signed with GlaxoSmithKline (GSK) in 2021. GSK has an exclusive option to lead the post-Phase 2 development and commercialization of VIR-2482. VIR-2482 is partly funded with federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081. BARDA's initial investment of approximately $55 million will support the Phase 2 PENINSULA trial. In addition, the multi-year contract also allows for a potential total investment of up to $1 billion for the clinical development of additional future pandemic influenza monoclonal antibodies, as well as the possible development of up to 10 emerging infectious disease or Chemical, Biological, Radiological, and Nuclear medical countermeasure candidates.

VIR-2482 has completed a Phase 1 clinical trial. On July 20, 2023, Vir Biotechnology, Inc. announced that the phase 2 PENINSULA trial evaluating VIR-2482 for preventing symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.

Vir Biotechnology is a commercial-stage immunology company in San Francisco, CA, focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. 

VIR-2482 Indication

VIR-2481 is currently being developed to prevent influenza A viruses and pandemic influenza. Seasonal influenza is a highly contagious respiratory disease that can cause severe illness and life-threatening complications. Pandemic influenza is an infectious airborne respiratory disease that is unpredictable in timing and severity and for which humans have little or no immunity.

VIR-2482 News

July 20, 2023 - "Although, these topline data are disappointing, further analysis is necessary to better understand these outcomes, which we plan to present at a major medical congress," said Phil Pang, M.D., Ph.D., Vir's Executive Vice President, Chief Medical Officer and Interim Head of Research.

December 21, 2022 - Vir Biotechnology has enrolled approximately 3,000 participants in their Phase 2 PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) trial.

October 18, 2022 - Vir Biotechnology, Inc. announced that the first participant had been dosed in the Phase 2 PENINSULA trial evaluating VIR-2482 for preventing illness due to influenza A.

October 4, 2022 - The U.S. Government's Biomedical Advanced Research and Development Authority announced an initial investment of $55 million for the ongoing and rapid development of VIR-2482. The multi-year contract has the potential for up to $1 billion to aGovernment'sevelopment of a full portfolio of innovative solutions to address influenza and potentially other infectious disease threats.

February 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses.

December 31, 2022 - the U.S. NIH published: VIR-2482: A potent and broadly neutralizing antibody for preventing influenza A illness.

March 25, 2020 - Xencor, Inc. announced it has entered into a technology license agreement with Vir Biotechnology, Inc., in which Vir will have non-exclusive access to Xencor's Xtend™ Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.

VIR-2482 Clinical Trials

VIR-2482 has been studied in a phase 1 clinical trial. The Phase 2 PENINSULA study was last Updated on December 20, 2022.

CervaVac HPV Vaccine 2026

Serum Institute of India (SII) CERVAVAC® is India's first quadrivalent human papillomavirus (qHPV) vaccine, protecting people against HPV types 6, 11, 16, and 18. Cervavac efficacy was evaluated in HPV vaccine clinical trials initiated in September 2018. The Drugs Controller General of India (DCGI) granted market authorization to the Pune-based SII to manufacture the CervaVac vaccine in 2021. In the application to the DCGI, SII stated that Cervavac had demonstrated a robust antibody response higher than the baseline against targeted HPV types and in doses and age groups. Cervavac is the result of a partnership among SII, the Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), and the Bill & Melinda Gates Foundation.

The Lancet Oncology published an Editorial on October 1, 2022, HPV vaccination in South Asia: new progress, old challenges. A myriad of factors, including poor awareness of cervical cancer, low screening uptake, insufficient availability of and access to vaccines, and screening and vaccine reluctance, all contribute to the high burden of disease in the region, as we highlighted in a 2019 Editorial. Cervavac should be welcomed in India, where the incidence of cervical cancer accounts for a fifth of the global burden, with more than 124,000 cases and 75,000 deaths annually. On November 7, 2023, The Lancet Oncology published an article reporting that Cervavac's efficacy has significant implications for future vaccine uptake and HPV-associated cancer prevention among young people in India. The journal Nature Medicine published a Research Highlight on November 13, 2023, indicating that Cervavac is an affordable, noninferior HPV vaccine.

Pune-based Serum Institute of India is now the world's largest vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses).

Cervavac Vaccine Availability 2026

As of early 2026, Cervavac has been seeking WHO prequalification, a prerequisite for inclusion in international programs such as Gavi, the Vaccine Alliance. The Cervavac vaccine became available in India on January 24, 2023, and is scheduled to be launched internationally in 2024. Cervavac is not available or approved in the United States or Europe in 2026.

Cervavac Indication

CERVAVAC® is indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) types 16, 18; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18; and genital warts caused by HPV types 6 and 11. CERVAVAC® is indicated in males 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16, 18; anal precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18; and genital warts caused by HPV types 6 and 11.

Cervical cancer is the most common HPV-related disease in women. In India, cervical cancer is the second-most common cancer, especially among women between 15 and 44 years of age. Every year, 122,844 Indian women are diagnosed with cervical cancer, and 67,477 die from the disease, according to figures from 2012, says NHP. In 2021, the International Taskforce on Cervical Cancer Elimination in the Commonwealth was launched by the Commonwealth Secretariat (May/2021) and the Union for International Cancer Control to step up efforts towards preventing and treating cervical cancer to align withthe  WHO's Global Strategy (Nov/2020) to accelerate the elimination of cervical cancer as a public health problem. 

Cervavac Administration

CERVAVAC® should be administered with a 2-dose schedule (0.5 mL at 0 and 6 months). For individuals aged 15 to 26 years, CERVAVAC® should be administered according to a 3-dose schedule (0.5 ml at 0, 2, and 6 months). The second dose should be administered at least 1 month after the first, and the third dose at least 3 months after the second. All three doses should be given within one year. CERVAVAC® should be administered intramuscularly in the upper arm's deltoid region or the thigh's higher anterolateral area and must not be injected intravascularly, subcutaneously, or intradermally. The safety and efficacy of CERVAVAC® in children below nine years of age have not been established.

Cervavac Vaccine News

November 7, 2023 - The Lancet Oncology published "An HPV vaccine from India: broadening possibilities for cervical cancer control."

January 24, 2023 - The SII launched the first indigenously developed HPV vaccine against cervical cancer in women. 

October 21, 2022 - Serum Institute of India will start supplying the government with small quantities of the CervaVac vaccine in early 2023.

October 1, 2022 - The peer-reviewed journal The Lancet published an Editorial - HPV vaccination in South Asia: new progress, old challenges.

September 1, 2022 - News article: Serum Institute's qHPV vaccine is a game changer.

September 1, 2022 - Announcing the scientific completion of the quadrivalent Human Papilloma Virus (qHPV) vaccine in the presence of Mr. Adar C. Poonawalla, CEO, Serum Institute of India, Pune, and other prominent scientists and dignitaries, Dr. Jitendra Singh said, this affordable and cost-effective vaccine marks an essential day for DBT and BIRAC as it takes India a step closer to PM Modi's vision of Atmanirbhar Bharat.

July 18, 2022 - The Serum Institute of India received regulatory approval to sell an indigenously developed HPV vaccine that can prevent cervical cancer. The Drugs Controller General of India granted market authorization for the Quadrivalent Human Papillomavirus vaccine (qHPV). 

June 15, 2022 - ANI reported the Drugs Controller General of India's Subject Expert Committee recommended granting market authorization to the Serum Institute of India to manufacture India's indigenously-developed CERVAVAC Quadrivalent Human Papillomavirus vaccine (qHPV).

Cervavac Vaccine Clinical Trials

Serum Institute of India applied for market authorization after completing the phase 2/3 clinical trial with the support of the Department of Biotechnology to ensure its early availability in the country," said the sources.

Findings: Between September 20, 2018, and February 9, 2021, 2341 individuals were screened, of whom 2307 eligible individuals were enrolled and vaccinated: 1107 (738 girls and 369 boys) in the cohort aged 9-14 years and 1200 (819 women and 381 men) in the cohort aged 15-26 years. No race or ethnicity data were collected. Three hundred fifty girls and 349 boys in the SIIPL quadrivalent HPV vaccine group and 338 women in the comparator vaccine group were included in the modified per-protocol population for the primary endpoint analysis. The median follow-up for the analyses was 221 days (IQR 215-231) for girls and 222 days (217-230) for boys in the SIIPL quadrivalent HPV vaccine group, 223 days (216-232) for girls in the comparator vaccine group, and 222 days (216-230) for women in the comparator vaccine group. GMT ratios were non-inferior in girls and boys receiving the SIIPL quadrivalent HPV vaccine compared with women receiving the comparator vaccine: GMT ratios for girls were 1·97 (98·75% CI 1·67-2·32) for HPV type 6, 1·63 (1·38-1·91) for HPV type 11, 1·90 (1·60-2·25) for HPV type 16, and 2·16 (1·79-2·61) for HPV type 18. For boys, the GMT ratios were 1·86 (1·57-2·21) for HPV type 6, 1·46 (1·23-1·73) for HPV type 11, 1·62 (1·36-1·94) for HPV type 16, and 1·80 (1·48-2·18) for HPV type 18. The safety population comprised all 1107 participants (369 girls and 369 boys in the SIIPL quadrivalent HPV vaccine group and 369 girls in the comparator group). Solicited adverse events occurred in 176 (48%) of 369 girls and 124 (34%) of 369 boys in the SIIPL vaccine group, and 179 (49%) of 369 girls in the comparator vaccine group. No grade 3-4 solicited adverse events occurred within seven days of each dose. Unsolicited adverse events occurred in 143 (39%) girls and 147 (40%) boys in the SIIPL vaccine group, and 143 (39%) girls in the comparator vaccine group. The most common grade 3 unsolicited adverse event was Dengue fever in one (<1%) girl in the SIIPL vaccine group and three (1%) girls in the comparator group. There were no grade 4 or 5 adverse events. Serious adverse events occurred in three (1%) girls and three (1%) boys in the SIIPL vaccine group and five (1%) girls in the comparator vaccine group. No vaccine-related serious adverse events were reported. There were no treatment-related deaths.

LC16 KMB Mpox Smallpox Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Japan-based KM Biologics LC16 KMB (LC16m8) is formulated as a freeze-dried cell culture smallpox and mpox vaccine. LC16 is a 3rd-generation, live-attenuated vaccine containing the vaccinia virus (LC16m8 strain) used to prevent smallpox (market-authorized for all ages in 1975 in Japan / licensed under the emergency investigational new drug program). LC16m8 is currently licensed in Japan, where it was safely used by over 50,000 children in the 1970s. The WHO Strategic Advisory Group of Experts on Immunization has recommended its use. On August 2, 2022, Japan's Ministry of Health, Labour, and Welfare (MHLW) announced the approval of this smallpox vaccine for voluntary vaccinations as pre-exposure prophylaxis against the monkeypox virus. This approval followed an advisory committee review.

On November 19, 2024, the World Health Organization (WHO) granted Emergency Use Listing for the LC16m8 vaccine. The EUL application was submitted on August 23, 2024, and accepted for evaluation on August 30, 2024. "LC16 (KMB)" (LC16m8 vaccine) is indicated for active immunization to prevent mpox disease, and the vaccine is given by multiple puncture vaccination using a bifurcated needle. It is given as a one-dose vaccine at one year of age.

The LC16m8 was an attenuated cell culture–adapted Lister vaccinia smallpox vaccine missing the B5R protein. In contrast to replication-deficient vaccines such as Modified Vaccinia Ankara, LC16m8 retains most of the vaccinia genome. Therefore, it can replicate at the inoculation site, producing a "take lesion" in vaccines. The strain LC16m8 is derived from strain Lister-Elstree by multiple passages in PRK cells at 30°C, followed by additional plaque cloning. The highly attenuated strain seems to have the same potential to induce a protective immune response as the old type of vaccines, as evaluated by the old criteria for immunity to the smallpox vaccine.

A study led by Associate Professor Kouji Kobiyama from the Division of Vaccine Science, Institute of Medical Science, The University of Tokyo, and Professor Ken J. Ishii, also from the University of Tokyo, was made available in Volume 115 of the journal eBioMedicine on May 1, 2025. The vaccine elicited neutralizing antibodies against multiple MPXV variants, with no serious adverse events during the follow-up period, suggesting LC16m8's broad coverage and reinforcing its safety.

KM Biologics (SVRG Kaketsuken) is a unit of Meiji Holdings, a Japanese food and pharmaceuticals company based in Kumamoto, 860-8568. Click here for the Meiji Group 2026 Vision.

LC16 KMB Mpox Vaccine Availability 2025

The LC16 KMB vaccine is available in Japan (September 2024) and will be delivered to Africa in late 2024.

LC16 KMB Mpox Vaccine Indication

LC16 KBM vaccine has been approved in Japan for smallpox and mpox pre-exposure prophylaxis (PrEP). A phase 3 clinical trial, NCT06223919, sponsored by Universidad Nacional de Colombia, was launched in December 2023. The study, Efficacy/​Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia (MPOX-COL). The study's completion date is August 2024. On August 3, 2023, the journal Human Vaccines & Immunotherapeutics published an open-label, non-randomized study investigating the safety and efficacy of smallpox vaccine LC16 as post-exposure prophylaxis for mpox. The findings of this study suggest that vaccination with LC16 is effective post-exposure prevention in individuals who have had close contact with patients with mpox.

In 2017, a study concluded that 'Inoculation of LC16m8 into humans induced neutralizing antibodies against smallpox virus, and the effect was similar to that of the ACAM2000 smallpox vaccine. The results were presented at the 19th ACVVR Congress (WHO) in 2017.' Since 1976, the Japanese government has discontinued the national smallpox vaccination program. Japan's government authorized the LC16 KMB vaccine's indication for monkeypox on August 2, 2022.

LC16 KBM Mpox Vaccine Storage

The long-term storage stability of LC16m8 (formulation: 10 years, drug substance: 5 years) confirmed the high storage stability of LC16m8. 

LC16 KBM Mpox Vaccine Dosage

LC16m8 is administered as a single dose using the traditional scarification method. The LC16 vaccine requires intradermal administration.

Japan Smallpox Vaccine

The Japanese government decided in 1876 that all residents should be vaccinated against smallpox, and a smallpox vaccination law took effect in 1910. In the twenty years from 1889 to 1908, there were 171,500 cases of smallpox, and in 1908, there were 18,139 cases. The present immunization law was implemented in 1948 under the occupation by the USA.

The Chiba Serum Institute in Japan received an unconditional license in 1975 the manufacture vaccines of the LC16m8 strain for the indication of "prevention of smallpox." In 1975, Chiba Serum Institute produced the vaccine in a frozen formulation, and in 1980, a lyophilized formulation was developed. The routine vaccination against smallpox in Japan halted in 1976; Chiba Serum Institute ended the vaccine production accordingly, without distributing the product in the market. The license and all product-related rights for the LC16m8 vaccine were transferred to the Chemo-Sero Therapeutic Research Institute (hereafter, "Kaketsuken") in September 2002, and subsequently to KM Biologics in July 2018 due to the transfer of the pharmaceutical business from Kaketsuken. Manufactured vaccine lots have been maintained in the national stockpile. In 2002, a study was published on Japan's smallpox vaccination program.

LC16 KMB Mpox Vaccine News

May 8, 2025 - Researchers from Japan explore the viability and safety of LC16m8, an attenuated vaccinia virus vaccine, to prevent monkeypox.

November 19, 2024 - The WHO listed the LC16 KMB vaccine.

June 26, 2024 - Reuters reported that authorities in the Democratic Republic of Congo are proceeding with vaccinations.

September 15, 2022 - The Lancet published: A rapid review: prevention of monkeypox with vaccines.

August 31, 2022 - Bio Farma Honesti Basyir, Director, said Indonesia's government targets three monkeypox vaccines, including LC16M8 (SVRG Kaketsuken Japan).

August 5, 2022: Australian media reported that Japan's only non-replicating vaccine is the LC16m8. Scaling up production is difficult, so supplies are limited.

August 2, 2022 - Japan's MHLW presented a Plan for Monkeypox Vaccinations with KM Biologics' smallpox vaccine.

August 2, 2022 - WHO Monkeypox Research - What study designs can be used to address the remaining knowledge gaps for monkeypox vaccines?

June 14, 2022: The Ministry of Health, Labour, and Welfare published a press release titled "Vaccines and immunization for monkeypox: Interim guidance."

February 3, 2021 - PLOS Pathogens published a RESEARCH ARTICLE: A highly attenuated vaccinia virus strain LC16m8-based vaccine for severe fever with thrombocytopenia syndrome.

April 28, 2015 - ASM Journals published: Use of the LC16m8 Smallpox Vaccine in Immunocompromised Individuals Is Still Too Risky.

March 11, 2009: The JAMA Network published Clinical and Immunological Response to Attenuated Tissue-Cultured Smallpox Vaccine LC16m8. Conclusion: Administration of an attenuated tissue-cultured smallpox vaccine (LC16m8) to healthy adults was associated with high vaccine take and seroconversion levels in vaccinia-naive individuals and yielded an effective booster response in some previously vaccinated individuals.

LC16 KMB Clinical Trials

A single-arm clinical study was conducted to evaluate the immunogenicity and safety of the smallpox vaccine for monkeypox in healthy Japanese adults (MKP-3 study). The outline of this study and its results have been published in the Clinical Research Implementation Plan and Research Outline Disclosure System (jRCT). In addition, Japan's health ministry vaccinated 50 medical workers at the National Center for Global Health and Medicine for research purposes in July 2022.

2017 - Research on the efficacy, safety, and productivity improvement of cell-cultured smallpox vaccines developed and stockpiled in Japan and on the ideal countermeasures against bioterrorism in Japan and overseas. We analyzed the ability of LC16m8 to induce neutralizing antibodies against the smallpox virus through joint research by the US CDC and this research group. Stability results of LC16m8 during long-term cryopreservation were obtained. In addition, a study on the post-exposure inoculation effect of LC16m8 was carried out.