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Favorable VLA15 Phase 2 Study Results Might Boost VALN Stock
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Valneva SE (VALN - Free Report) and Pfizer Inc. recently reported positive immunogenicity and safety data from their VLA15-221 Phase 2 study. Data from the study showed a strong immune response one month after a second booster dose in pediatric and adult populations.
The safety and tolerability profile of VLA15 after a second booster dose was compared with that observed after the first booster. No safety concern was observed by an independent Data Monitoring Committee (“DMC”) in any treatment or age group.
The new favorable data from the Phase 2 trial helped Valneva advance the furthest along the clinical development timeline. In line with this, two Phase 3 trials for VLA15 are in progress.
About Valneva’s VLA15
VLA15 is an investigational multivalent protein subunit vaccine that uses an established mechanism of action for a Lyme disease vaccine. It targets the outer surface protein A (OspA) of Borrelia burgdorferi — the bacteria that causes Lyme disease. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.
For investors’ note, Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans from the bite of infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere.According to the Centers for Disease Control and Prevention (“CDC”), approximately 476,000 people in the United States are diagnosed and treated for Lyme disease each year. 129,000 such cases are reported annually in Europe.
About Valneva’s VLA15-221 Phase 2 study
The participants of this Phase 2 study received VLA15 during the primary vaccination phase in two immunization schedules — months 0-2-6 or months 0-6, followed by a first booster dose at month 18 and a second at month 30.
The latest results from the VLA15-221 Phase 2 study demonstrate a significant anamnestic antibody response across all six serotypes covered by the vaccine candidate in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age). The study was measured one month after the administration of the second booster dose.
A large number of participants seroconverted after the second booster dose, yielding seroconversion rates* (SCRs) above 90% for all outer surface protein A (OspA) serotypes in all age groups. The response was in line with the results achieved from SCRs after the first booster. Geometric Mean Titers at one month post the first and second boosters were comparably high.
More on Valneva’s Clinical Study for VLA15
In 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study — vaccine against Lyme for outdoor recreationists (VALOR). The study is aimed at investigating the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe.
The initial vaccination series for all participants was completed in July 2024. A second Phase 3 study (VLA15-1012) is also in progress. The second Phase 3 study is aimed at providing further evidence on the safety profile of VLA15 in the pediatric population.
Pfizer also expects to submit a Biologics License Application (“BLA”) to the Food and Drug Administration (“FDA”) and a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2026, subject to positive Phase 3 data.
Image Source: Zacks Investment Research
Industry Prospects Favor Valneva
Per a report from BCC Research, the Lyme disease preventive vaccine & shot market was valued at $21.12 million in 2020 and is projected to reach $1.53 billion by 2028, at a CAGR of 191.8% during the period. Key factors driving market growth are undergoing development of vaccines, invariant environmental conditions and an expanding population of ticks.
Hence, Valneva’s progress with VLA15 vaccines turns out to be in favor of the market potential.
Other Recent Developments by Valneva
Last month, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech Biologics AG for the development, manufacturing and commercialization of Shigella4V (S4V). S4V is a tetravalent bioconjugate vaccine candidate against shigellosis.
Under the terms of the agreement, LimmaTech will receive an upfront payment and be eligible for future milestone and royalty payments. It will be responsible for conducting a Phase 2 Controlled Human Infection Model (“CHIM”) and a Phase 2 pediatric study for S4V.
In July, VALN expanded its partnership with the Coalition for Epidemic Preparedness Innovations (“CEPI”) to support broader access to the IXCHIQ - chikungunya vaccine, in Low- and Middle-Income countries (“LMICs”). Valneva will receive funding from CEPI to support clinical trials in vulnerable groups, such as children and pregnant women. The partnership will also support technology transfer to an additional manufacturer to supply IXCHIQ to Asian LMICs.
Price Performance of Valneva
Shares of VALN have lost 29.4% year to date against the industry’s 12.3% growth.
Intuitive Surgical’s shares have surged 58.8% in the past year. Estimates for the company’s earnings have remained constant at $6.67 per share for 2024 in the past 30 days.
ISRG’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 8.97%. In the last reported quarter, it posted an earnings surprise of 16.34%.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 48.1% to $1.20 in the past 30 days. Shares of the company have soared 143.2% in the past year compared with the industry’s 11% growth.
TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for Boston Scientific’s 2024 EPS have increased 1.7% to $2.40 in the past 30 days. In the past year, shares of BSX have risen 52.5% compared with the industry’s 15% growth.
In the last reported quarter, BSX delivered an earnings surprise of 6.90%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.18%.
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Favorable VLA15 Phase 2 Study Results Might Boost VALN Stock
Valneva SE (VALN - Free Report) and Pfizer Inc. recently reported positive immunogenicity and safety data from their VLA15-221 Phase 2 study. Data from the study showed a strong immune response one month after a second booster dose in pediatric and adult populations.
The safety and tolerability profile of VLA15 after a second booster dose was compared with that observed after the first booster. No safety concern was observed by an independent Data Monitoring Committee (“DMC”) in any treatment or age group.
The new favorable data from the Phase 2 trial helped Valneva advance the furthest along the clinical development timeline. In line with this, two Phase 3 trials for VLA15 are in progress.
About Valneva’s VLA15
VLA15 is an investigational multivalent protein subunit vaccine that uses an established mechanism of action for a Lyme disease vaccine. It targets the outer surface protein A (OspA) of Borrelia burgdorferi — the bacteria that causes Lyme disease. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the Borrelia burgdorferi sensu lato species in North America and Europe.
For investors’ note, Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans from the bite of infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere.According to the Centers for Disease Control and Prevention (“CDC”), approximately 476,000 people in the United States are diagnosed and treated for Lyme disease each year. 129,000 such cases are reported annually in Europe.
About Valneva’s VLA15-221 Phase 2 study
The participants of this Phase 2 study received VLA15 during the primary vaccination phase in two immunization schedules — months 0-2-6 or months 0-6, followed by a first booster dose at month 18 and a second at month 30.
The latest results from the VLA15-221 Phase 2 study demonstrate a significant anamnestic antibody response across all six serotypes covered by the vaccine candidate in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age). The study was measured one month after the administration of the second booster dose.
A large number of participants seroconverted after the second booster dose, yielding seroconversion rates* (SCRs) above 90% for all outer surface protein A (OspA) serotypes in all age groups. The response was in line with the results achieved from SCRs after the first booster. Geometric Mean Titers at one month post the first and second boosters were comparably high.
More on Valneva’s Clinical Study for VLA15
In 2022, Pfizer and Valneva initiated the currently ongoing Phase 3 clinical study — vaccine against Lyme for outdoor recreationists (VALOR). The study is aimed at investigating the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe.
The initial vaccination series for all participants was completed in July 2024. A second Phase 3 study (VLA15-1012) is also in progress. The second Phase 3 study is aimed at providing further evidence on the safety profile of VLA15 in the pediatric population.
Pfizer also expects to submit a Biologics License Application (“BLA”) to the Food and Drug Administration (“FDA”) and a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in 2026, subject to positive Phase 3 data.
Image Source: Zacks Investment Research
Industry Prospects Favor Valneva
Per a report from BCC Research, the Lyme disease preventive vaccine & shot market was valued at $21.12 million in 2020 and is projected to reach $1.53 billion by 2028, at a CAGR of 191.8% during the period. Key factors driving market growth are undergoing development of vaccines, invariant environmental conditions and an expanding population of ticks.
Hence, Valneva’s progress with VLA15 vaccines turns out to be in favor of the market potential.
Other Recent Developments by Valneva
Last month, Valneva entered into a strategic partnership and exclusive licensing agreement with LimmaTech Biologics AG for the development, manufacturing and commercialization of Shigella4V (S4V). S4V is a tetravalent bioconjugate vaccine candidate against shigellosis.
Under the terms of the agreement, LimmaTech will receive an upfront payment and be eligible for future milestone and royalty payments. It will be responsible for conducting a Phase 2 Controlled Human Infection Model (“CHIM”) and a Phase 2 pediatric study for S4V.
In July, VALN expanded its partnership with the Coalition for Epidemic Preparedness Innovations (“CEPI”) to support broader access to the IXCHIQ - chikungunya vaccine, in Low- and Middle-Income countries (“LMICs”). Valneva will receive funding from CEPI to support clinical trials in vulnerable groups, such as children and pregnant women. The partnership will also support technology transfer to an additional manufacturer to supply IXCHIQ to Asian LMICs.
Price Performance of Valneva
Shares of VALN have lost 29.4% year to date against the industry’s 12.3% growth.
VALN’s Zacks Rank and Other Key Picks
VALN currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are Intuitive Surgical (ISRG - Free Report) , TransMedics Group (TMDX - Free Report) and Boston Scientific (BSX - Free Report) . While Intuitive Surgical and TransMedics sport a Zacks Rank #1 (Strong Buy) each, Boston Scientific currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Intuitive Surgical’s shares have surged 58.8% in the past year. Estimates for the company’s earnings have remained constant at $6.67 per share for 2024 in the past 30 days.
ISRG’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 8.97%. In the last reported quarter, it posted an earnings surprise of 16.34%.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 48.1% to $1.20 in the past 30 days. Shares of the company have soared 143.2% in the past year compared with the industry’s 11% growth.
TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for Boston Scientific’s 2024 EPS have increased 1.7% to $2.40 in the past 30 days. In the past year, shares of BSX have risen 52.5% compared with the industry’s 15% growth.
In the last reported quarter, BSX delivered an earnings surprise of 6.90%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.18%.