| Friday | ||||
Health authorities and… Story temporarily locked. | ||||
| Tuesday | ||||
Chinese authorities are… Chinese authorities are in the process of strengthening the "vaccine arsenal" for the country amid fears that a Covid-19 break out of approximately 65M infections a week are expected toward the end of June, Bloomberg News reports. Omicron variant, XBB among the fastest-spreading is at the source of a spike in cases in China since late April, according to Bloomberg. XBB is "expected to result in 40M infections a week by the end of May, before peaking at 65 million a month later," added the Bloomberg story. Publicly traded companies in the Covid vaccine space include: Moderna, Inc. (MRNA) CanSino Biological (CASBF) S BioNTech (BNTX), Inovio Pharmaceuticals (INO), and Pfizer (PFE). Reference Link | ||||
INOVIO announced that the… INOVIO announced that the European Commission, or EC, has granted orphan drug designation for INO-3107, the company's product candidate for the treatment of Recurrent Respiratory Papillomatosis, or RRP. INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11, the HPV types that cause RRP and other HPV-related diseases. | ||||
| Over a week ago | ||||
Reports Q1 revenue… Reports Q1 revenue $115,000, consensus $420,000. | ||||
Inovio presented new data… Inovio presented new data from a Phase 1/2 trial of INO-3107 for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis on May 5th as part of the scientific program of the American Broncho-Esophagological Association at the Combined Otolaryngology Spring Meetings in Boston. INO-3107 was well-tolerated, with the most frequently reported treatment-emergent adverse events related to administration, and all related TEAEs were low-grade. No treatment-related SAEs and no TEAEs led to treatment discontinuation Immunological data highlights include: treatment with INO-3107 induced cellular responses against both HPV 6 and HPV 11, including cytotoxic CD8 cells thought to be important for clearance of virally infected cell. T-cell responses against HPV 6 and HPV 11 were still observed at Week 52, indicating persistent cellular memory response. Overall, 81.3% patients had a decrease in surgical interventions in the year after INO-3107 administration versus the prior year, including 28.1% that required no surgical intervention. | ||||
| Over a month ago | ||||
Inovio announced that the… Inovio announced that the European Committee for Orphan Medicinal Products has provided a positive opinion on Inovio's application for orphan drug designation in the European Union for INO-3107. INO-3107 is the company's product candidate that may contribute to the treatment of Recurrent Respiratory Papillomatosis. The opinion is now with the European Commission, which will provide a final decision on the application within 30 days. | ||||
Inovio announced that… Inovio announced that data from a Phase 1b trial evaluating INO-4201 as an Ebola booster vaccine candidate for rVSV-ZEBOV was presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases. "Preliminary data showed that INO-4201 was well tolerated and produced a strong immune response," said Dr. Huttner. "This suggests that a booster dose of IN0-4201 has the potential to extend protection against Ebola and could be an important tool in future Ebola Virus Disease prevention." In February 2023, Inovio announced positive initial results from the Phase 1b trial that evaluated INO-4201 as a booster in healthy adult participants who previously received a single injection of Ervebo. These initial results showed that INO-4201 was well-tolerated and boosted humoral responses in 100% of 36 treated participants. The full data was presented at ECCMID indicates the potential of INO-4201 to restore antibody titers to levels thought to be required to provide protection against Zaire ebolavirus infection. These new data include the assessment of binding antibodies showing that all 36 vaccine recipients responded to the boost. the Phase 1b trial for INOVIO's vaccine candidate, INO-4201, was spearheaded by Global Urgent and Advanced Research and Development, sponsored by Geneva University Hospitals, and funded by the U.S. Defense Advanced Research Projects Agency. | ||||
Reports Q4 revenue $125K,… Reports Q4 revenue $125K, consensus $340K. CEO Jacqueline Shea, said, "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, and we are a stronger company because of it. We've honed our strategic vision, strengthened our financial position, and maintained our cash runway into 1Q2...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 and INO-4201 as an Ebola vaccine booster. Today we also shared data from REVEAL2, the second trial in our program evaluating VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions (HSIL). While the investigational biomarker-selected population did not achieve statistical significance, trial results did achieve statistical significance in the all-participants population. The overall evidence of viral clearance observed is encouraging as it builds upon the growing body of work pointing to the potential of our DNA Medicines platform in HPV diseases. We will certainly take that into consideration as we assess next steps for VGX-3100 and our broader portfolio. I believe that our increased experience with HPV therapeutics, coupled with our strengthened strategic focus over the past year, positions INOVIO to make meaningful advancements in our mission to bring innovative, life-saving DNA medicines to market." | ||||
| Over a quarter ago | ||||
Innovio announced… Innovio announced positive preliminary results from the second cohort of its Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis - RRP - in adults. In the second cohort of 11 patients who were administered INO-3107 via the exploratory side port needle, 10 of the 11 patients - 91% - saw a reduction in surgical interventions in the year following initial treatment. Of these 10 patients, four did not require surgery. There was a statistically significant median decrease of three surgical interventions when comparing the year following treatment to the year prior. In the year prior to treatment, the number of surgical interventions for these 11 patients ranged between 2 and 8, and the median was 5. INO-3107 was well-tolerated and immunogenic among patients in the second cohort. The safety and efficacy results for the second cohort were consistent with results announced for the first cohort in October 2022. INO-3107 was well-tolerated in the trial, with all 11 patients completing the trial follow-up. | ||||
Inovio announced positive… Inovio announced positive results from a Phase 1b clinical trial evaluating INO-4201, a DNA vaccine candidate targeting Zaire Ebola virus, as a booster in healthy adult participants who previously received a single injection of Ervebo. In the trial, INO-4201 was well-tolerated and boosted humoral responses in 100% of 36 treated participants. INO-4201 was evaluated in a Phase 1b trial to assess its safety, tolerability, and immunogenicity in healthy adult participants who previously received a single injection of Ervebo, a vaccine approved by the FDA for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The trial was designed to test whether INO-4201 can be used as a booster in healthy participants previously vaccinated with Ervebo. | ||||
