A Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children

The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.

Start Date15 Feb 2018

Sponsor / Collaborator

GSK Plc

NCT03264157 / CompletedPhase 2/3

A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects

A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.

Start Date08 Dec 2017

Sponsor / Collaborator

Bio Products Laboratory USA, Inc.

NCT03276962 / CompletedPhase 2

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.

Start Date28 Sep 2017

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Rabies vaccine(Novartis)

100 Translational Medicine associated with Rabies vaccine(Novartis)

100 Patents (Medical) associated with Rabies vaccine(Novartis)

Literatures (Medical) associated with Rabies vaccine(Novartis)

01 Dec 2024·VACCINE

Safety and immunogenicity of a ChAd155-vectored rabies vaccine compared with inactivated, purified chick embryo cell rabies vaccine in healthy adults

Article

Author: Scherer, Erin M ; Girmay, Tigisty ; Leary, Maranda ; Rouphael, Nadine G ; Min, Ji-Young ; Gromer, Daniel J. ; Sherman, Amy C ; Gromer, Daniel J ; Sherman, Amy C. ; McCullough, Michele P ; Seetahal, Janine ; Mulligan, Mark J ; Rouphael, Nadine G. ; Phadke, Varun K ; Phadke, Varun K. ; Graciaa, Daniel S. ; Graciaa, Daniel S ; Koller, Mark ; Retallick, Jamie ; Rebolledo, Paulina A. ; Tsong, Rachel ; Mulligan, Mark J. ; McCullough, Michele P. ; Capone, Stefania ; Sommella, Andrea ; Rebolledo, Paulina A ; Scherer, Erin M. ; Vitelli, Alessandra ; Wiley, Zanthia ; Neill-Gubitz, Hannah

BACKGROUND:

Rabies is a zoonotic viral encephalitis that is endemic in many countries and confers a high mortality. Licensed vaccines require several doses to ensure efficacy. To investigate a logistically favorable approach, we assessed the safety and immunogenicity of ChAd155-RG, a novel investigational rabies vaccine using a replication-defective chimpanzee adenovirus vector.

METHODS:

We conducted a first-in-human, phase 1, randomized, double-blind, dose-escalation trial comparing ChAd155-RG with a licensed inactivated vaccine (RabAvert) in healthy adults. Participants received either RabAvert at standard dosing or ChAd155-RG at a low dose for one immunization or a high dose for one or two immunizations. To assess safety, we evaluated reactogenicity, unsolicited adverse events, and thrombotic events. To measure immunogenicity, we measured rabies viral neutralizing antibody (VNA) titers and anti-ChAd155 neutralizing antibodies.

RESULTS:

Mild to moderate systemic reactogenicity and transient lymphopenia and neutropenia were more common among recipients of ChAd155-RG compared with those who received RabAvert. No thrombotic events or serious adverse events were reported. Only the groups receiving RabAvert or two doses of high-dose ChAd155-RG achieved 100 % seroconversion, and seroprotection was most durable in the RabAvert group. Most participants had preexisting anti-vector antibodies, which were boosted by ChAd155-RG. Baseline and post-vaccination anti-vector antibody titers were negatively associated with post-vaccination rabies VNA titers.

CONCLUSIONS:

In this phase 1 clinical trial, a novel rabies vaccine using a simian adenovirus vector was safe and tolerable, but generated lower, less durable rabies VNA titers than a standard inactivated rabies virus vaccine, which may be due to preexisting, anti-vector immunity.

05 Apr 2023·Journal of travel medicine

Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial

Article

Author: van Gucht, Steven ; Stijnis, Cornelis ; Goorhuis, Abraham ; Grobusch, Martin P ; Garcia Garrido, Hannah M ; Terryn, Sanne ; Spuls, Phyllis I ; van Put, Bridget ; van de Sande, Marleen G ; D’Haens, Geert R ; de Pijper, Cornelis A

Abstract:

Background:

For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.

Methods:

In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.

Results:

We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.

Conclusion:

In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.

01 Sep 2021·VaccineQ3 · MEDICINE

Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial

Q3 · MEDICINE

Article

Author: Chuang, Ariel ; Moore, Susan M ; Reid, Caroline ; McClain, J Bruce ; Tsao, Eric

BACKGROUND:

SYN023-002 is a randomized, blinded, controlled study comparing rabies virus neutralizing activity (RVNA) and safety of SYN023, a monoclonal anti-rabies antibody mixture, to human-serum derived anti-rabies immunoglobulin (RIG) when administered with commercially available vaccines to healthy adult volunteers.

METHODS:

Participants were randomized among 4 treatment groups (SYN023 + Imovax, SYN023 + RabAvert, HyperRab + Imovax, HyperRab + RabAvert). On Day 0, subjects received 1 dose of RIG (0.3 mg/kg SYN023 or 20 IU/mL HyperRab) and their first of 5 vaccine doses. The primary objective was to compare cumulative RVNA between SYN023 and HyperRab recipients. Secondary objectives were to compare safety and to assess SYN023 pharmacokinetics and immunogenicity.

RESULTS:

All 164 randomized subjects initiated treatment and were included in safety analyses. At least 34 subjects/treatment group received all treatment and had complete RVNA results, thus were included in the primary endpoint analysis. Mean RVNAs were approximately ten-fold higher in SYN023 recipients compared to HyperRab recipients until Day 14. From Day 14 onwards, mean RVNA was lower in SYN023 recipients, but remained above the RVNA level widely considered adequate (≥0.5 IU/mL) through Day 112 (study end). The point estimate of the cumulative RVNA (83.22% SYN023/HyperRab), but not the lower CI bound (90% CI: 66.06%, 104.83%), fell within the protocol-defined similarity margin. Each RIG + vaccine regimen appeared safe with mostly mild AEs and no serious or severe related events observed. Except injection site pain (22% HyperRab recipients vs. 6% SYN023 recipients), treatment-related AEs incidences were similar between RIGs. Anti-SYN023 antibodies were observed but had no apparent effects on PK or safety.

CONCLUSIONS:

SYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period.

REGISTRATION:

ClinicalTrials.gov #NCT02956746.

FUNDING:

Synermore biologics.

News (Medical) associated with Rabies vaccine(Novartis)

07 Nov 2024

·www.globenewswire.com

Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates

Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidance between €160 million to €170 million and currently anticipated total revenues between €170 million and €180 millionExpected R&D investments between €65 million and €75 millionExpected Other income between €100 million and €110 million, including €95 million from the PRV sale Launch of the world’s first chikungunya vaccine in Canada and Europe underway; Further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025); Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution Secured exclusive worldwide license for S4V2 Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva’s R&D pipeline3 - recently granted FDA Fast Track4Submitted key label extension(s) for IXCHIQ® in Europe and Canada5Published IXCHIQ® two-year antibody persistence and safety data in the Lancet Infectious Diseases6 further demonstrating the vaccine’s highly differentiated immunological profileAwarded new $41.3 million CEPI grant7 to contribute significantly to IXCHIQ® Phase 4 costs and other studies supporting broader access to the vaccine Pfizer completed primary vaccination (three doses) in Phase 3 VALOR Lyme disease trial8Advancing Phase 1 clinical trial for second-generation Zika vaccine candidate toward expected data readout and further decision on potential development path in 20259 Financial Information(Unaudited results, consolidated per IFRS) € in millionNine months ended September 30, 20242023Total Revenues116.6111.8Product Sales112.5106.1Net profit/(loss)24.7-69.3Adjusted EBITDA1048.6-46.0Cash156.3171.3 Saint-Herblain (France), November 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2024. The condensed consolidated interim financial results are available on the Company’s website (Financial Reports – Valneva). Valneva will provide a live webcast of its nine-month 2024 results conference call beginning at 3 p.m. CET / 9 a.m. ET today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/6wzgxkji. Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our objective is to become sustainably profitable in 2027, based on potential milestone and commercial revenues from our Lyme disease vaccine candidate, if approved. We remain focused on growing sales of our travel vaccines and believe we are sufficiently capitalized, while maintaining the flexibility to continue investing in the future development of the Company by leveraging our proven R&D capabilities. As we approach the conclusion of the Phase 3 Lyme disease trial at the end of next year, we believe we are entering a pivotal time in Valneva’s evolution.” Commercial Portfolio Valneva’s commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and recently launched IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure. Valneva’s sales in the first nine months of 2024 were €112.5 million compared to €106.1 million (€100.4 million excluding final COVID-19 vaccine sales) in the first nine months of 2023. JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT® In the first nine months of 2024, IXIARO®/JESPECT® sales increased by 31% to €66.0 million compared to €50.3 million in the first nine months of 2023. Sales to both travelers and the U.S. military showed double digit growth compared to the first nine months of 2023. Valneva has been supplying additional doses of IXIARO® to the U.S. Department of Defense (DoD) under the current contract, signed in September 202311, which allowed the DoD to purchase additional doses during the following twelve months. Valneva expects to receive new orders in 2025. CHOLERA / ETEC12-DIARRHEA VACCINE DUKORAL® In the first nine months of 2024, DUKORAL® sales were €22.3 million compared to €21.1 million in the first nine months of 2023. At the end of June, DUKORAL® sales remained below prior year but sales in the third quarter grew 85% year-over-year, as marketing investments resumed in the third quarter following successful regulatory inspection of Valneva’s new manufacturing site in Sweden. CHIKUNGUNYA VACCINE IXCHIQ® IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is now approved in the U.S.13, Europe14, and Canada15 for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The U.S. launch is underway while first sales in Canada and Europe are anticipated in the fourth quarter of 2024. Following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations by the U.S. Centers for Disease Control and Prevention (CDC)16 at the beginning of March 2024, Valneva recognized initial sales of €1.8 million in the first nine months of 2024. Valneva is focused on growing IXCHIQ® sales in the U.S., particularly among older adults (65+ years old) who are at high risk for severe chikungunya infection and for whom ACIP recommends vaccination for certain travelers. Valneva remains confident in the long-term prospects for IXCHIQ®, and while U.S. sales have started slow, several factors are expected to drive future growth, including expanded access to the retail channel via publication of the ACIP recommendations in the Morbidity and Mortality Weekly Report (MMWR)17 and anticipated label expansion(s). The U.S. Defense Health Agency – Immunization Healthcare Division (DHA-IHD) also recently published chikungunya and vaccines guidance, which authorizes IXCHIQ® as a Department of Defense CHIKV countermeasure. Key launch metrics, that are expected to enable future sales growth, including stocking and re-stocking across all sales channels, active customer accounts, as well as reimbursement for IXCHIQ® by commercial and MediCare insurance plans, continue to track in line with expectations, providing confidence in future sales growth. The Company plans to review its mid-term IXCHIQ® sales guidance in the coming months, taking into account sales trends in the U.S., early insights into sales performance in Canada and first European Union (EU) countries, as well as demand from existing and potential future Low- and Middle-Income Countries (LMIC) partners. Regulatory review is ongoing in Brazil and the UK and the Company recently filed18 and is preparing further filings for label extension to adolescents in markets where IXCHIQ® is approved, including key antibody persistence data to further establish IXCHIQ® as a differentiated brand. Phase 3 antibody persistence results two years after vaccination with a single dose were recently published in The Lancet19 showing that IXCHIQ®’s robust immune response was sustained by 97% of participants and was equally durable in younger and older adults. Valneva now expects to report three-year persistence data later this year. These important label updates, combined with anticipated ex-U.S. and endemic product launches are expected to significantly expand access of IXCHIQ® and contribute to its future revenues. Additionally, Valneva recently expanded its partnership with CEPI20 to support broader access to the vaccine in LMICs, post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the EU’s Horizon Europe program. THIRD-PARTY DISTRIBUTION Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. During the first nine months of 2024, third-party sales decreased by 23% to €22.5 million compared to €29.1 million in the first nine months of 2023 as a result of external supply constraints in the first half of the year. Valneva continues to expect a 20 to 30% reduction in third-party sales in 2024 and to gradually wind down third-party sales to less than 5% of overall product sales by 2026/2027, resulting in overall gross margin improvement. Clinical Vaccine Candidates LYME DISEASE VACCINE CANDIDATE – VLA15 Phase 3 primary vaccination completed VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. It leverages an established mechanism of action against Lyme borreliosis infection by targeting the six most prevalent serotypes of the Borrelia outer surface protein A (OspA). Pfizer and Valneva are currently executing the Phase 3 field efficacy study for VLA15 called VALOR (Vaccine Against Lyme for Outdoor Recreationists). Enrollment in the trial was completed in December 2023 and primary vaccination series was completed in July 202421. Participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025. Pfizer aims to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive Phase 3 data. If approved and commercialized, Valneva will be eligible to receive $143 million in initial sales milestones from Pfizer, plus ongoing sales royalties ranging from 14% to 22% and an additional $100 million in cumulative sales milestones. Based on the agreement with Pfizer, Valneva’s expected cost contributions for the Lyme disease program were completed in the second quarter of 2024, contributing to a substantially lower expected cash burn in the second half of 2024. SHIGELLA VACCINE CANDIDATE – S4V2 The World’s most clinically advanced tetravalent Shigella vaccine candidate In August 2024, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech Biologics AG for the development, manufacturing and commercialization of Shigella4V2 (S4V2), a tetravalent bioconjugate vaccine candidate against shigellosis22. The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need23. Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year24, particularly among children in LMICs. No approved Shigella vaccine is currently available and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)25. Shigellosis also affects international travelers from high-income countries and deployed military personnel in endemic regions. The global market for a vaccine against Shigella is estimated to exceed $500 million annually26. The anticipated development path follows a staggered and risk-mitigated strategy, allowing for efficient capital allocation. LimmaTech will conduct a Phase 2 Controlled Human Infection Model study (CHIM) in the U.S. and a Phase 2 pediatric study in LMICs expected to begin in the second half of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide if approved. Under the terms of the agreement, LimmaTech received an upfront payment of €10 million and is eligible to receive additional regulatory, development and sales-based milestone payments of up to €40 million as well as low double-digit royalties on sales. ZIKA VACCINE CANDIDATE – VLA1601 Phase 1 ongoing with second-generation vaccine candidate VLA1601 is a second-generation adjuvanted inactivated vaccine candidate against the mosquito-borne disease caused by the Zika virus (ZIKV). In March 2024, Valneva initiated a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA160127. The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Participants will receive a low, medium or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant. Sentinel recruitment and vaccinations have been completed and the start of the randomized phase is imminent. Data from the trial are expected in the first half of 2025. Zika disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, in the Americas. Zika virus transmission persists in several countries in the Americas and in other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection28; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available and, as such, Zika remains a public health threat and is included in the FDA’s Tropical Disease Priority Review Voucher Program29. A vaccine against ZIKV could be a valuable addition to Valneva’s portfolio against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®. Nine Months 2024 Financial Review(Unaudited, consolidated under IFRS) Revenues Valneva’s total revenues were €116.6 million in the nine months ended September 30, 2024 compared to €111.8 million in the nine months ended September 30, 2023. Valneva’s total product sales reached €112.5 million in the first nine months of 2024 compared to €106.1 million in the same period of 2023. The impact of currency fluctuations of €0.1 million was minimal. Excluding COVID-19 vaccine sales in the nine months ended September 30, 2023, travel vaccine sales showed a growth of €12.1 million or 12% year-over-year. IXIARO®/JESPECT® sales were €66.0 million in the first nine months of 2024 compared to €50.3 million in the nine months ended September 30, 2023. The 31% increase reflects double digit growth in sales to both travelers (11%) and the US military. The impact of foreign currency movements in IXIARO®/JESPECT® sales was negligible. DUKORAL® sales were €22.3 million in the first nine months of 2024 compared to €21.1 million in the comparative period of 2023. This 6% increase was due to marketing investments resuming in the third quarter of 2024 following successful regulatory inspection of Valneva’s new manufacturing facility in Sweden. Foreign currency fluctuations had an immaterial impact on DUKORAL® sales. Following adoption of the U.S. ACIP’s recommendations by the U.S. CDC at the beginning of March 2024, Valneva recognized initial sales for IXCHIQ® of €1.8 million in the first nine months of 2024. Third Party product sales were €22.5 million in the first nine months of 2024 compared to €29.1 million in the same period of 2023. This 23% decrease was mainly driven by lower sales of Rabipur®/RabAvert® and Encepur®, under the distribution agreement with Bavarian Nordic, as a result of external supply constraints in the first half of the year. Other revenues, including revenues from collaborations, licensing and services amounted to €4.2 million in the first nine months of 2024 compared to €5.7 million in the same period of 2023. The reduction mainly resulted from lower revenue recognition related to the R&D collaboration activities for chikungunya with Instituto Butantan. Operating Result and adjusted EBITDA Costs of goods and services sold (COGS) were €71.3 million in the nine months ended September 30, 2024. The gross margin on commercial product sales, excluding IXCHIQ®, amounted to 48.6% compared to 43.7% in the nine months ended September 30, 2023. COGS of €27.2 million related to IXIARO® product sales, yielding a product gross margin of 58.8%. COGS of €14.5 million related to DUKORAL® product sales, yielding a product gross margin of 34.8%. Product gross margins continued recovering during the third quarter of 2024 as the supply shortages during the first half were resolved. Of the remaining COGS in the first nine months of 2024, €15.2 million related to the third-party products distribution business, €4.6 million to IXCHIQ®, €3.6 million to idle capacity costs and €6.3 million to cost of services. In the first nine months of 2023, overall COGS were €74.8 million, of which €67.6 million related to cost of goods and €7.2 million related to cost of services. Research and development expenses amounted to €48.6 million in the first nine months of 2024, compared to €42.2 million in the first nine months of 2023. This increase was mainly driven by higher costs related to the ongoing transfer of operations into the new Almeida manufacturing facility. Marketing and distribution expenses in the first nine months of 2024 amounted to €35.7 million compared to €33.9 million in the first nine months of 2023. The increase is mainly related to €16.2 million of expenses associated with launch activities for IXCHIQ® (first nine months of 2023: €13.8 million). In the first nine months of 2024, general and administrative expenses reduced to €32.6 million after €35.1 million in the same period of 2023. The largest expense categories were employee-related expenses of €15.0 million and consulting and other services of €13.1 million. During the first nine months of 2024, a net gain of €90.8 million from the sale of the PRV was recorded. The gross proceeds of $103 million were reduced by transaction costs as well as contractual payment obligations related to the sale of the PRV. Other income, net of other expenses decreased to €14.9 million in the nine months ended September 30, 2024 from €17.0 million in the nine months ended September 30, 2023. In the first nine months of 2024 Valneva recorded €6.2 million income from the recently awarded CEPI grant. The first nine months of 2023 included income of €10.3 million awarded by Scottish Enterprise (SE) for non-COVID-19 vaccine development (IXCHIQ® and IXIARO®). Valneva recorded an operating income of €34.2 million in the first nine months of 2024 compared to an operating loss of €57.2 million in the comparative period of 2023. The increase was mainly the result of the PRV sale. Adjusted EBITDA (as defined below) profit in the first nine months of 2024 was €48.6 million, whereas in the first nine months of 2023 an adjusted EBITDA loss of €46.0 million was recorded. Net Result In the first nine months of 2024, Valneva generated a net profit of €24.7 million, mainly resulting from the sale of the PRV in February 2024. This compared to a net loss of €69.3 million in the first nine months of 2023. Finance expense and currency effects in the first nine months of 2024 resulted in a net finance expense of €13.4 million, compared to a net finance expense of €13.2 million in the first nine months of 2023. This increase was mainly due to €5.2 million higher interest expenses on loans resulting from the amendment of the Deerfield Management Company and OrbiMed (D&O) loan facility. Additionally foreign exchange profits of €3.0 million were recorded in the first nine months of 2024 compared to losses of €1.4 million observed in the first nine months of 2023, primarily related to the development of the USD and GBP exchange rates to the EUR. Cash Flow and Liquidity Net cash used in operating activities amounted to €76.7 million in the first nine months of 2024 compared to €136.8 million of cash used in operating activities in the same period of 2023. Cash outflows in the first nine months of 2024 were largely derived from the operating loss for the period (excluding gains from PRV sale) amounting to €66.1 million and from working capital in the amount of €35.1 million which includes Valneva’s final agreed-upon payments to the Lyme disease clinical program. In the first nine months of 2023, changes in working capital were higher, mainly related to higher payments to Pfizer in conjunction with the Lyme disease program, reducing the refund liability. Cash inflows from investing activities amounted to €72.2 million in the first nine months of 2024 compared to cash outflows of €4.3 million in the first nine months of 2023. Both years included outflows from construction activities across production sites in Scotland and Sweden and, in addition, 2024 included outflows from the upfront payment to LimmaTech Biologics AG recorded as purchase of an intangible asset. The sale of the PRV positively impacted 2024 by €90.8 million. Net cash generated in financing activities increased to €35.3 million in the first nine months of 2024 from €26.1 million in the first nine months of 2023. This increase was primarily due to €57.5 million net proceeds from the recent private placement completed in the third quarter of 2024, while the first nine months of 2023 included proceeds from the increase of the loan facility provided by Deerfield Management Company and OrbiMed. Cash and cash equivalents were €156.3 million as at September 30, 2024, compared to €126.1 million at December 31, 2023. Non-IFRS Financial Measures Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provide additional analytical tools. Adjusted EBITDA is defined as net profit / (loss) for the period before income tax, finance income/expense, foreign exchange (gain)/loss, amortization, depreciation, and impairment (excluding impairment loss of disposal). A reconciliation of Adjusted EBITDA net profit / (loss), which is the most directly comparable IFRS measure, is set forth below: € in millionNine months ended September 30,(unaudited results, consolidated per IFRS)20242023Net profit / (loss)24.7-69.3Add: Income tax (benefits)/expense-3.9-1.1Total finance income-1.3-0.7Total finance expense17.712.5Foreign currency (gain)/loss - net-3.01.4Amortization3.74.7Depreciation10.78.4Impairment, excluding impairment loss of disposal0.0-1.9Adjusted EBITDA48.6-46.0 About Valneva SE We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP, Global Communications and European Investor RelationsM +33 (0)6 4516 7099investors@valneva.com Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815 4520joshua.drumm@valneva.com Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to financial results for 2024; mid-term revenue and cash outlook; the progress, timing, results and completion of research, development and clinical trials for product candidates; regulatory approval of product candidates and requested label extensions; and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva2 Valneva Announces the Success of its Private Placement Raising approximately €60 Million - Valneva3 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva4 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva5 Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada - Valneva6 Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study - The Lancet Infectious Diseases7 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine - Valneva8 Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion - Valneva9 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva10 For additional information on Adjusted EBITDA, please refer to the “Non-IFRS Financial Measures” section at the end of the PR11 Valneva Announces New IXIARO® Supply Contract with the U.S. Government Worth a Minimum of $32 Million - Valneva12 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.13 Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ® - Valneva14 Valneva Receives Marketing Authorization in Europe for the World’s First Chikungunya Vaccine, IXCHIQ® - Valneva15 Valneva Announces Health Canada Approval of the World’s First Chikungunya Vaccine, IXCHIQ® - Valneva16 ACIP Vaccine Recommendations and Schedules | CDC17 The MMWR Recommendations and Reports contain in-depth articles that relay policy statements for prevention and treatment on all areas in CDC’s scope of responsibility (e.g., recommendations from the Advisory Committee on Immunization Practices).18 Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ®, to EMA and Health Canada - Valneva19 Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study - The Lancet Infectious Diseases20 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine - Valneva21 Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion - Valneva22 LimmaTech Biologics AG23 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva24 Shigellosis | CDC Yellow Book 202425 Immunization, Vaccines and Biologicals (who.int)26 LEK analysis27 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva28 Zika virus disease (who.int)29 Tropical Disease Priority Review Voucher Program | FDA Attachment 2024_11_07_VLA_Nine-Month_Results_EN_Final

VaccinePhase 3License out/inPhase 2Phase 1

25 Oct 2024

·pipelinereview.com

LakeShore Biopharma Granted Phase III Clinical Trial Approval to Explore Simplified Regimens for YSJA Rabies Vaccine

GAITHERSBURG, MD, USA I October 25, 2024 I LakeShore Biopharma Co., Ltd (Nasdaq: LSB ) (“LakeShore Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has been granted approval for a Phase III clinical trial (the “Trial”) by the National Medical Products Administration (NMPA) in China to explore the immunogenicity and safety of a simplified four-dose regimen for its YSJA rabies vaccine which is the first generation of the Company’s rabies vaccine and has sold more than 100M doses since its market approval. This simplified immunization schedule has the potential to provide patients with more immunization options, reduce physician workload, minimize hospital visits, improve patient adherence to vaccination and also reduce the financial burden on patients under comparable immunogenicity, boosting the vaccine’s utility and aiding in the prevention of rabies deaths. The Trial, which is expected to begin in December 2024, will evaluate the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization schedules to determine their immunogenicity and safety compared to the existing Essen regimen (1-1-1-1-1). It will be a single center, randomized, double-blind, controlled study. The two four-dose immunization regimens which will be explored are the Zagreb Regimen (2-1-1), which involves two shots in the first session and one shot each across two subsequent sessions; and the Modified Essen Regimen (1-1-1-1), which involves four sessions of a single shot each. Compared to the conventional five-dose, Essen regimen (1-1-1-1-1), both options offer greater flexibility for medical professionals and patients and stand to improve the existing standard of rabies care. Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma, commented, “The approval of this Phase III clinical trial for our YSJA rabies vaccine marks a significant milestone in our efforts to expand the regimen profile of our product. By evaluating simplified immunization schedules, we aim to make our vaccine more competitive in the rapidly expanding rabies vaccine market. We believe that this trial will validate the clinical superiority of the YSJA rabies vaccine, and will help attract increased recognition and support from researchers, academics, and industry players around the world.” “The YSJA rabies vaccine is our flagship product and has already proven to be a game-changer in preventing deaths and disabilities related to rabies,” Mr. Wang continued. “The potential impact of this clinical trial, combined with our efforts to become a leading rabies vaccine supplier, strengthens our confidence in continuing expanding our market share in China. We are proud to be making another critical contribution to the global fight against this disease, and are eager to forge ahead as a leading innovator in rabies vaccine development.” Rabies has an almost 100% fatality rate upon emergence of clinical symptoms. Each year, it claims the lives of approximately 59,000 individuals in more than 150 countries. Transmission through bites from infected dogs accounts for over 95% of rabies-related fatalities, and 40% of these deaths occur in children under the age of 15. Although rabies is typically lethal without treatment, the administration of post-exposure prophylaxis can effectively prevent fatalities when initiated following possible exposure. About LakeShore Biopharma LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.lakeshorebio.com . SOURCE: Lakeshore Biopharma

Phase 3VaccineImmunotherapyDrug Approval

25 Oct 2024

·www.prnewswire.com

LakeShore Biopharma Granted Phase III Clinical Trial Approval to Explore Simplified Regimens for YSJA Rabies Vaccine

GAITHERSBURG, Md., Oct. 25, 2024 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has been granted approval for a Phase III clinical trial (the "Trial") by the National Medical Products Administration (NMPA) in China to explore the immunogenicity and safety of a simplified four-dose regimen for its YSJA rabies vaccine which is the first generation of the Company's rabies vaccine and has sold more than 100M doses since its market approval. This simplified immunization schedule has the potential to provide patients with more immunization options, reduce physician workload, minimize hospital visits, improve patient adherence to vaccination and also reduce the financial burden on patients under comparable immunogenicity, boosting the vaccine's utility and aiding in the prevention of rabies deaths. The Trial, which is expected to begin in December 2024, will evaluate the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization schedules to determine their immunogenicity and safety compared to the existing Essen regimen (1-1-1-1-1). It will be a single center, randomized, double-blind, controlled study. The two four-dose immunization regimens which will be explored are the Zagreb Regimen (2-1-1), which involves two shots in the first session and one shot each across two subsequent sessions; and the Modified Essen Regimen (1-1-1-1), which involves four sessions of a single shot each. Compared to the conventional five-dose, Essen regimen (1-1-1-1-1), both options offer greater flexibility for medical professionals and patients and stand to improve the existing standard of rabies care. Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma, commented, "The approval of this Phase III clinical trial for our YSJA rabies vaccine marks a significant milestone in our efforts to expand the regimen profile of our product. By evaluating simplified immunization schedules, we aim to make our vaccine more competitive in the rapidly expanding rabies vaccine market. We believe that this trial will validate the clinical superiority of the YSJA rabies vaccine, and will help attract increased recognition and support from researchers, academics, and industry players around the world." "The YSJA rabies vaccine is our flagship product and has already proven to be a game-changer in preventing deaths and disabilities related to rabies," Mr. Wang continued. "The potential impact of this clinical trial, combined with our efforts to become a leading rabies vaccine supplier, strengthens our confidence in continuing expanding our market share in China. We are proud to be making another critical contribution to the global fight against this disease, and are eager to forge ahead as a leading innovator in rabies vaccine development." Rabies has an almost 100% fatality rate upon emergence of clinical symptoms. Each year, it claims the lives of approximately 59,000 individuals in more than 150 countries. Transmission through bites from infected dogs accounts for over 95% of rabies-related fatalities, and 40% of these deaths occur in children under the age of 15. Although rabies is typically lethal without treatment, the administration of post-exposure prophylaxis can effectively prevent fatalities when initiated following possible exposure. About LakeShore Biopharma LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.lakeshorebio.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma's ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "potential," "forecast," "intend," "will," "expect," "anticipate," "believe," "goal," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma's management and are not predictions of actual performance. LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (the "SEC"), and other risks described in documents subsequently filed or furnished by the Company from time to time with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements. Investor Relations Contact Robin Yang Partner, ICR, LLC Tel: +1 (212) 537-4035 Email: [email protected] SOURCE LakeShore Biopharma Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Vaccine

100 Deals associated with Rabies vaccine(Novartis)

External Link

KEGG	Wiki	ATC	Drug Bank
D06504	-	J07BG01	-

R&D Status

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Indication	Country/Location	Organization	Date
Rabies	US	Novartis Vaccines & Diagnostics SL	20 Oct 1997
Rabies	US	Bavarian Nordic A/S	20 Oct 1997
Rabies	US	Novartis Vaccines & Diagnostics, Inc.	20 Oct 1997

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02545517 (CTgov)	Phase 3	Rabies	459	Blood sampling+Rabipur (Conv-R/JE Group)	rypfydxkif(wyihtxmmsg) = dbhdoidkqt mlgocukdxe (xpuxfwyrxl, tfdnjqahoa - nxtanwpxep) View more	-	18 Jul 2024
				Blood sampling+Rabipur (Acc-R/JE Group)	rypfydxkif(wyihtxmmsg) = abxlzlzjgp mlgocukdxe (xpuxfwyrxl, yacgokhlnf - aqblqxpyug) View more
NCT03264157 (CTgov)	Phase 2/3	Rabies	162	HRIG+RabAvert (BPL HRIG + RabAvert)	eolqjabchp(xxgikflxyc) = ifexxkqxyp rgtsmmbrnr (ixrpypyeoi, hmfncjapnw - izzwxiupxq) View more	-	11 Feb 2020
				RabAvert+HyperRAB (Comparator HyperRab + RabAvert)	eolqjabchp(xxgikflxyc) = jhnohqkcic rgtsmmbrnr (ixrpypyeoi, vjflypctlh - jijizpaekc) View more
NCT02177032 (CTgov)	Phase 3	Rabies	885	Rabies vaccines (4-sites, 1-week WITH HRIG)	xcfpmbnsmd(ewjlkzpmdm) = lwyqlapiuj fxsblnfikq (zyauamgjpm, ruyvpmvlwz - rizwuhhzsb) View more	-	07 Apr 2017
				Rabies vaccine (4-sites, 1-week WITHOUT HRIG)	xcfpmbnsmd(ewjlkzpmdm) = xexvymdxpl fxsblnfikq (zyauamgjpm, tkxnlwdckq - dcxmwmvbtp) View more
NCT01662440 (CTgov)	Phase 3	Rabies \| Encephalitis, Japanese	661	Japanese Encephalitis+Rabies (R/JE - Acc)	rgztxnbmkx(rnkxusbghw) = vqzbnwgbgi hnlvqewofo (bxmjufxhwg, xaakhlpdrr - butcpcuaex) View more	-	08 Dec 2014
				Placebo+Rabies (R - Conv)	rgztxnbmkx(rnkxusbghw) = dkiqhabrqc hnlvqewofo (bxmjufxhwg, dymavebgyi - mhrhudqypt) View more
NCT01365494 \| CTRI/2011/07/001857 (CTgov)	Phase 4	Rabies	250	Rabipur vaccine+Rabies Vaccine (Zagreb)	zspaccrkxe(vrgwgylvcl) = ieytzwbamm nteymxomlv (ohbikpfwsg, ideykrzclp - xwurkkkqsy) View more	-	05 May 2014
				Rabipur vaccine+Rabies Vaccine (Essen)	zspaccrkxe(vrgwgylvcl) = wfoaibgktv nteymxomlv (ohbikpfwsg, lpgsvyvajy - kudtiwvzfj) View more

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Rabies vaccine(Novartis)

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