Inovio Pharmaceuticals ( NASDAQ: INO ) stock rose ~7% on Thursday after the company reported results from a phase 3 trial and provided other clinical updates with its Q4 results.
Phase 3 trial for VGX-3100 in Cervical HSIL:
The study, dubbed REVEAL2, evaluating VGX-3100 to treat cervical high-grade squamous intraepithelial lesions (HSIL) did not meet the main goal in the biomarker-selected population.
However, the study results did achieve statistical significance in the all-participants population, as per the company.
HSIL are abnormal cells that forms on certain organs, such as the cervix. It is usually caused by infection with certain types of human papillomavirus (HPV). If untreated, these abnormal cells could become cancerous.
Inovio noted that it had previously announced that the trial was no longer pivotal and will not lead to a biologics license application (BLA) for a biomarker-selected population, as the U.S. Food and Drug Administration (FDA) had suggested that one or more additional studies would be needed.
REVEAL2 was the second phase 3 study testing VGX-3100 to treat HPV-16/18-related cervical HSIL. The trial included 203 women with histologically-confirmed cervical HSIL linked with HPV-16 and/or HPV-18, but who were otherwise healthy. The participants received either VGX-3100 or placebo.
The company said that the percentage of people in the investigational biomarker-selected population meeting the main goal of lesion regression and viral clearance was 28.6% (6/21) in drug group, versus 0% (0/4) in the placebo group, which was not statistically significant.
The secondary goal of regression of HSIL and clearance of virus in the all 203 participants (134 in the treatment group, 69 in the placebo group) was statistically significant, with 27.6% (37/134) on the drug meeting the objective, compared to 8.7% (6/69) in the placebo group, according to the company.
In addition, viral clearance was seen in 37.3% (50/134) in the 3-dose treatment group, compared to 8.7% (6/69) in the placebo group.
The company added that an ad-hoc integrated efficacy analysis of the results of both REVEAL1 and REVEAL2 showed statistical significance in both the biomarker-selected and all-participants populations.
INOVIO noted the combined data set will be used as supportive data in future regulatory interactions for VGX-3100. The company intends to continue evaluating the results to decide the path forward for VGX-3100 in its HPV programs.
Inovio said that a phase 3 trial of VGX-3100 in Greater China is ongoing and it is working with its development partner ApolloBio.
CEO comments :
"The last year has been one of transition for INOVIO. We chose to make some difficult but essential decisions to best position our pipeline and organization for the future," said Inovio's President and CEO Jacqueline Shea.
Shea added that, "Discussions are underway regarding next steps for our candidates with the greatest potential for impact, including INO-3107 as a potentially life-changing treatment for Recurrent Respiratory Papillomatosis (RRP) and INO-4201 as an Ebola vaccine booster."
Trials in RRP and Ebola :
The company noted that it reported positive preliminary data from a phase 1/2 trial of INO-3107 for RRP and positive phase 1b data for INO-4201 as Ebola booster for Ervebo as primary series.
Inovio's noted that INO-4201 was found to be well-tolerated and boosted humoral responses in 36 of 36 people treated.
Q4 Results :
Q4 net loss narrowed to -$54.5M, compared to -$106.9M in Q4 2021.
Q4 total revenue declined to $125K, compared to $839K in the year ago period.
Full year revenue grew to $10.26M, compared to $1.77M in 2021. Inovio's said that the increase was due to fulfillment of obligations under the company's contract with the U.S. Department of Defense.
For further details see:
Inovio stock rises amid mixed trial results for cervical lesions drug; Q4 clinical updates