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GSK plc GSK announced that its therapeutic herpes simplex virus (HSV) vaccine candidate, GSK3943104, did not meet the primary endpoint in the combined phase I/II proof-of-concept study.
The phase I/II TH HSV REC-003 study evaluated the clinical efficacy of the early-stage HSV vaccine candidate GSK3943104.
The company completed the primary objective data analysis from the phase II part of the phase I/II TH HSV REC-003 study, which demonstrated that GSK3943104 failed to meet the study's primary efficacy endpoint.
Following this, the company decided not to progress with phase III development of GSK3943104.
Shares of GSK have rallied 18.1% so far this year against the industry's decline of 1%.
Positive Data From GSK’s mRNA-based Flu Vaccine Program
In a separate press release, GSK announced positive headline data from a phase II study that evaluated certain mRNA-based seasonal influenza vaccine candidates.
The study investigated various mRNA formulations of the seasonal influenza vaccine candidates, which can improve immune responses against influenza A and B strains in older and younger adults versus the current standard of care.
The data showed that mRNA formulations in one of the vaccine candidates demonstrated positive A and B strain immune responses relative to the standard of care in both older and younger adults.
Per the company, the above data shows that the mRNA platform elicits strong overall antibody titers with an acceptable safety profile.
GSK’s seasonal influenza vaccine candidate is currently in phase II development. Building on the success of the above data, the company will now proceed into phase III development of the vaccine candidate.
GSK’s New Licensing Agreement With CureVac
GSK restructured its existing collaboration with German vaccine maker, CureVac CVAC into a new licensing agreement in July 2024.
Per the terms of the new agreement, GSK will assume full control of developing and manufacturing mRNA candidate vaccines for influenza and COVID-19, along with commercialization rights. CVAC retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration.
In addition, CureVaC has the liberty to independently develop and partner mRNA vaccines in any other infectious disease or other indication.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 60.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.53. Year to date, shares of FULC have jumped 31.1%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
Zacks Investment Research
Thursday, GSK plc (LSE/NYSE:GSK) announced headline results of a phase 2 trial for its mRNA seasonal influenza vaccine program.
The trial studied a range of mRNA formulations in older and younger adults to evaluate vaccine candidates that could improve immune responses against influenza A and B strains, compared to the current standard of care.
The data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults.
Also Read: GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech.
Interim data suggest the vaccine candidates have an acceptable safety and reactogenicity profile for all mRNA formulations tested.
These results build on the previous phase 2 trial and confirm the mRNA platform elicits strong overall antibody titres with an acceptable safety profile.
With these results, the GSK mRNA seasonal influenza vaccine program will progress into late-stage clinical development.
Vaccine candidate based on CureVac N.V.’s proprietary second-generation mRNA backbone
The Phase 2 study was initiated following interim data reported in April from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza.
In July, GSK and CureVac restructured their existing collaboration into a new licensing agreement, allowing the companies to prioritize investment and focus on their respective mRNA development activities.
Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases.
Price Action: GSK stock is down 0.91% at $43.37, and CVAC stock is down 1.98% at $2.97 at last check Thursday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
CureVac just reported results for the second quarter of 2024.
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