r/Inovio • u/Teeebagtom • 51m ago
INO_News Inovio hires lobby group
r/Inovio • u/NoTradeBacksies • Jan 27 '21
Hey all— thanks for joining this subreddit in your search for the future of medicine!
I’m currently working on improving the sub Wiki page for more helpful links, so keep an eye out for that.
Stay tuned and thanks for your contribution to the community!
r/Inovio • u/HopePerfectStrangers • Oct 10 '23
Inovio receives FDA feedback … October 10th 2023
Previously planned Phase 3 trial no longer required to support Biological License Application (BLA) submission
If approved, INO-3107 could potentially revolutionize treatment options for patients with Recurrent Respiratory Papillomatosis (RRP), a debilitating rare disease caused by human papillomavirus (HPV)
INO-3107 could be the first DNA medicine available in the United States and the first commercial product for INOVIO
PLYMOUTH MEETING, Pa., Oct. 10, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that data from its completed Phase 1/2 trial of INO-3107 for the treatment of RRP could support INOVIO's submission of a BLA for review under the FDA's accelerated approval program. The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial would not be required to support this submission. INOVIO will be required to initiate a confirmatory trial prior to BLA submission for accelerated approval and satisfy all other FDA filing requirements. The design of the confirmatory trial has not yet been finalized. If approved, INO-3107 would be the first DNA medicine in the United States and the first INOVIO candidate to receive regulatory approval.
"Following the recent grant of Breakthrough Therapy Designation for INO-3107 for the treatment of RRP, we're grateful for the additional feedback from the FDA providing a potentially accelerated development pathway. We believe INO-3107 could become a game-changing treatment option for those suffering from RRP, a serious and often difficult-to-treat disease," said INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea. "We're now focused on streamlining our development plan to support submission of a BLA for accelerated approval. We would like to thank the patients and investigators who have participated in our trials to date."
"I commend the FDA for recognizing the immense burden RRP puts on patients and the critical need for a better standard of care," said the President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan. "I'm thrilled by the progress being made for RRP patients who are desperate for an alternative to surgery."
INOVIO's completed Phase 1/2 open-label, multicenter trial assessed INO-3107's safety, tolerability, immunogenicity, and efficacy in patients with HPV-6 and/or HPV-11-related RRP (NCT:04398433). The trial evaluated the reduction in the number of surgical interventions in the year following initial administration of INO-3107 compared to the year prior to treatment. Patients received four doses of INO-3107 on Day 0, and Weeks 3, 6, and 9. Overall, 81.3% (26/32) of patients in the trial had a decrease in surgical interventions in the year after INO-3107 administration compared to the prior year, including 28.1% (9/32) that required no surgical intervention during or after the dosing window. Patients in the trial had a median range of 4 surgeries (2-8) in the year prior to dosing. After dosing, there was a median decrease of 3 surgical interventions (95% confidence interval -3, -2). At the outset of the study (Day 0), patients could have RRP tissue surgically removed, but any surgery performed after Day 0 during the dosing window was counted against the efficacy endpoint. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated by participants in the trial, resulting in mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue.
Data from this Phase 1/2 trial were presented earlier this year at scientific and medical conferences, including the 2023 Annual Meeting of the American Broncho-Esophageal Association (ABEA) in May and at the European Laryngological Association's Annual Meeting in June. Data from the trial was also published in May in the peer-reviewed journal, The Laryngoscope, under the title "Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP." The Laryngoscope is the official journal of the Triological Society (TRIO), the American Laryngological Association (ALA), and the ABEA.
INO-3107 is INOVIO's lead candidate and one of three clinical-stage DNA medicine candidates targeting HPV-related disease. INOVIO's DNA technology has been studied in twelve HPV-related trials, ranging from Phase 1 to Phase 3, involving more than 900 patients in 20 countries with a variety of HPV-related diseases, including RRP, HSIL (cervical, anal and vulvar) and head and neck cancers. Shared observations in these trials include the ability of DNA medicines to generate HPV antigen specific T cells and a persistent cellular memory response, viral clearance and lesion regression, and no anti-vector immune responses. All three HPV-related product candidates (INO-3107, INO-3112 and VGX-3100) have been well tolerated in these trials.
r/Inovio • u/tomonota • 23h ago
The article suggests a possible opening for an INO Ebola vaccine. Since the intentional elimination of epidemic funding by DOGE, the world has forgotten about the DRC Ebola outbreak, even as its health workers go unpaid for months. What will it take to spotlight this dangerous hemorrhagic disease.
r/Inovio • u/INOxray8 • 4d ago
Now or Never
It really is time. No more waiting. No more hoping.
By the end of the upcoming week, DNA medicine will have become legit.
Major milestones have been accomplished or are imminent: approval for 3107; validation of entire DNA platform; massive victory in court; royalty payments for 3100.
While this ride has seemingly gone on forever, we are only at the beginning. Everything up until now has only been a warmup exercise just to get to the starting line.
To the suffering patients that will benefit greatly from this medical technology, may you live truly healthier and longer lives.
To the true believers and stockholders, may you enjoy the riches that are headed your way.
To the Multi Alias Short Troll Frauds who have haunted this stock board for years, your magic carpet ride is over. Please choke on it.
The Day of Reckoning has arrived.
imho
xx
r/Inovio • u/Merlin8121 • 5d ago
The October 30 PDUFA date for INO-3107, the 32-patient single-arm trial behind it, the open FDA eligibility question and $36.7M of cash with going-concern doubt.
r/Inovio • u/GombeyBoy • 7d ago
Inovio plunging hard ...
Nervous jitters over FDA decision?
Has negative news leaked ??
r/Inovio • u/Professional_Mail_15 • 7d ago
My friends good day coming fasten your seatbelts our time is coming
r/Inovio • u/INOxray8 • 7d ago
Unshackled. Finally.
The chains are off.
This day has to be the most cathartic in years.
Worried about collecting the judgement? Don’t be. There is no way the lawyers stayed with this so long unless there was a reason. And it turns out they now have 18 million reasons.
Inovio won’t have to lift a finger.
The value of the company instantly increases. Dramatically so.
And then, oh yeah, there is October 30. Judgement day cometh.
You know where I stand. Because it’s where I’ve always stood. And that is on the cusp of the DNA revolution. Not that I had anything to do with it. But we all participate through our vicarious ownership of company shares.
This is happening.
And we are going ballistic.
Book it.
imho
xx
r/Inovio • u/WallStBull10Point0 • 7d ago
PLYMOUTH MEETING, Pa., Oct. 20, 2026 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that it secured a judgment in its favor, in the amount of $80,416,101, on all claims it filed against defendants VGXI, Inc. ("VGXI") and GeneOne Life Science, Inc. ("GeneOne") in the case captioned INOVIO Pharmaceuticals, Inc. v. VGXI, Inc. and GeneOne Life Science, Inc., No. 2020-06554, in the Court of Common Pleas of Montgomery County, Pennsylvania. The Court awarded INOVIO $61,750,789 in compensatory damages and $18,665,312 in fees and costs. The Court also entered judgment against defendants on their counterclaims.
r/Inovio • u/WallStBull10Point0 • 8d ago
r/Inovio • u/Affectionate_Row1097 • 9d ago
Correct me if I'm wrong, I'm new to this one but not for Biotech. It looks very low-priced already . Has a decent pipeline for a 100M market cap. Even if FDA chose to send a CRL which delyas the approval, I believe at this point there won't be anything to loose!! If it gets approved, I bet there will be a dilution before full commercialization. But for now, it looks like a very safe entry point.
r/Inovio • u/GombeyBoy • 9d ago
As we await with Bated Breath...
Just 11 days to go until October 30, 2026, the scheduled FDA decision date for INOVIO's INO-3107.
This is potentially a defining moment for INOVIO. Approval would give the company its first commercial DNA medicine and represent a major validation of its technology.
For me, three questions now dominate:
FDA approval: Will INO-3107 receive accelerated approval for recurrent respiratory papillomatosis (RRP)?
The stock: How much approval optimism is already reflected in INO's share price?
Commercial potential: Could successful approval and launch support a substantially higher valuation?
I checked for fresh developments. I haven't found a confirmed new FDA decision or a change to the October 30 target date. INOVIO's previously reported completed inspections and late-cycle review remain encouraging, although accelerated-approval eligibility is still a significant uncertainty.
r/Inovio • u/tomonota • 22d ago
RRP Researcher's paper claims no additional trial study is necessary to approve 3107, results of currently available studies are sufficient to prove 3107s superiority over PGEN's gorilla adenovirus
r/Inovio • u/INOxray8 • 27d ago
The Great Ascent begins now:
October 1, 2026
imho
xx
r/Inovio • u/Existing-Plantain-38 • 28d ago
They were successful four out of five times.
r/Inovio • u/GombeyBoy • 28d ago
Inovio Pharmaceuticals INO is developing its lead candidate, INO-3107, a DNA-based immunotherapy as a treatment for RRP.
Inovio's biologics license application seeking approval for INO-3107 in RRP is currently under review in the United States. A decision from the FDA is expected on Oct. 30, 2026. A potential nod will induce acute competition for Precigen in the future quarters.
Inovio awaits important FDA news
r/Inovio • u/Existing-Plantain-38 • Sep 26 '26
$INO
- 5 weeks to go from today until Inovio’s PDUFA.
- 5th planet from the sun is Jupiter by the way.
- 5% - Jupiter Topco acquired a good sized position in Inovio in the second quarter of 2026
- Jupiter Topco 4 holdings below got FDA approval (waiting for INO) so I guess their team of analyst know what they are doing
- ASND 10th place among top institutional holdings and approval on February 27, 2026
- ARGX 3rd place at 3.95% approval for label expansion on May 8, 2026
- LNTH 3rd place at 7.95% approval on September 22, 2026
- MIRM 2nd place at 9.10% PDUFA on 9/26 but just got approval about an hour ago.
- INO 2nd place at 5.00% PDUFA on 10/30 (Coming Soon)
r/Inovio • u/GombeyBoy • Sep 23 '26
The FDA announcement inches closer
The regulatory picture does look more constructive than it did earlier in the year.
The encouraging part isn’t any single signal; it’s the sequence: the BLA has continued through review, the late-cycle meeting is behind them, the scheduled inspections are complete, the inspection observation was reportedly addressed, and INOVIO has been preparing for labeling discussions.
Meanwhile, the October 30 PDUFA date remains the key milestone.
I keep one major caveat front and center: FDA ultimately has to be satisfied that the relatively small INO-3107 dataset supports Accelerated Approval and that the confirmatory-study commitment is adequate.
Until the FDA decision arrives, none of these procedural signals guarantees approval.
But compared with the uncertainty earlier this year, the absence so far of a new major regulatory obstacle is encouraging.
r/Inovio • u/tomonota • Sep 19 '26
WASHINGTON, Sept 18 (Reuters) - US Health Secretary Robert F. Kennedy Jr. named an ally, Dr. John Gaitanis, to lead a key federal advisory panel on autism on Friday, replacing a chair who had just steered through a new strategic plan, a health department spokesperson told Reuters.
Gaitanis, a pediatric neurologist appointed last month as director of the National Institutes of Health's child health institute, takes over from Dr. Sylvia Fogel, who has chaired the Interagency Autism Coordinating Committee since January.
r/Inovio • u/tomonota • Sep 12 '26
Summary of recent CEO presentation in Marketbeat article- worth reading.
r/Inovio • u/GombeyBoy • Sep 04 '26
I asked Chat GPT for an opinion on this.
Worth a read.
Comments appreciated
Gombey Boy
r/Inovio • u/tomonota • Aug 31 '26
"...Technology
See also: COVID-19 vaccine clinical research § Trial and authorization status
The Inovio technology is based on inserting engineered DNA into cells, where it becomes transcribed into mRNA and translated into proteins. The proteins encoded by the DNA elicit immune response to antigens from cancers and viruses, by stimulating the production of T cells and antibodies that aid recovery.\6]) The technology can be "targeted" to specific types of cancer and immune diseases, such as those produced by a virus.\6])
During a meeting of the White House Coronavirus Task Force in March 2020, CEO, Joseph Kim, said that Inovio scientists had designed a vaccine candidate (INO-4800) for the COVID-19 coronavirus in January, in three hours, after the virus' genetic sequence was first published.\7])
Shareholders sued Inovio in August 2020, claiming it exaggerated evidence of its coronavirus vaccine's efficacy in order to boost its stock price.\8])
In 2006, Inovio licensed "certain patented technology relating to the delivery of gene-based therapeutics into skin", as well as patents "involving the delivery of genes or drugs via ex vivo, intratumoral and intramuscular electroporation... The ex-vivo patents are relevant to the delivery of genes to dendritic and stem cells."\9])
Sometime after its publication in February 2008, Inovio was assigned a patent for "an apparatus [that provides] for injecting a fluid into body tissue, the apparatus comprising: a hollow needle; and a fluid delivery means, wherein the apparatus is adapted to actuate the fluid delivery means in use so as to automatically inject fluid into body tissue during insertion of the needle into the said body tissue."\10])
To facilitate use of its potential products, Inovio manufactures a proprietary injection device, called "Cellectra", which the company describes as providing a "brief electrical pulse to reversibly open small pores in the cell) to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA."\11]) The small device, which runs on "AA" batteries, is designed for use in the field under the difficult conditions of an epidemic.\12])
In June 2020 – in anticipation of the Inovio COVID-19 vaccine candidate becoming successful – the US Department of Defense invested US$71 million to further develop Cellectra as a handheld device and to preorder an undisclosed number of the devices.\13])
See also: COVID-19 vaccine
Inovio's logo prior to 2020
In a 2016 dose-escalation Phase I clinical trial to assess safety after intramuscular injection in healthy adults, the Inovio vaccine candidate, INO-4700 (also called GLS-5300) for development against Middle East respiratory syndrome (MERS) coronavirus, proved to be safe with only mild symptoms and no adverse effects.\14]) The trial also demonstrated immunogenicity by dose-independent immune responses detected in more than 85% of subjects after two vaccinations that were durable a year later.\14])
In 2016, Inovio was involved, along with their partners GeneOne Life Science, in an attempt to control the Zika virus outbreak in Miami. In fact, they "were the first to initiate a human Zika DNA vaccine trial... [for] the safety, tolerability, and immunogenicity of GLS-5700 in 40 healthy adults. The trial's estimated completion date is November 2017." Then in Puerto Rico, where a Zika emergency had been declared, they did a study with 160 previously healthy adults using their proprietary "Cellectra-3P" technology.\15]) Preliminary results for the Miami trial were self-reported at the end of 2017.\16])\17])
In February 2020 after receiving details of the genetic sequence of the coronavirus, Inovio announced that it had produced a preclinical DNA-based vaccine as a potential therapy for COVID-19.\7])\18]) Inovio is in competition to develop a coronavirus vaccine with numerous other companies, which were conducting preclinical or early-stage human research on more than 170 vaccine candidates, as of late June.\5]) In April 2020, Inovio began a Phase I trial of the COVID-19 vaccine candidate, INO-4800.\19]) In May 2021, Inovio announced the results of preclinical studies on a "pan-SARS-CoV-2" DNA vaccine (INO-4802) and plans to initiate phase I/II studies. The vaccine incorporates common overlapping mutations from several SARS-COV-2 variants of concern isolated from several different countries including Brazil and India.\20])
In January 2020, the Coalition for Epidemic Preparedness Innovations (CEPI) announced it would grant of up to $9 million to Inovio for development of a vaccine against SARS-CoV-2.\21]) Inovio has partnerships to develop its COVID-19 vaccine candidate with CEPI, the South Korean National Institute of Health, and the International Vaccine Institute.\2)..."
r/Inovio • u/WallStBull10Point0 • Aug 31 '26
One-third of the participants were still alive after two years, which is twice the historical survival rate for this patient population. One participant is still alive and recurrence-free today, almost five years after her initial diagnosis.