INO Inovio Pharmaceuticals Inc.

8.7
+0.06  (+1%)
Previous Close 8.64
Open 8.59
52 Week Low 5.81
52 Week High 33.79
Market Cap $1,821,773,562
Shares 209,399,260
Float 205,960,187
Enterprise Value $1,293,100,504
Volume 3,037,948
Av. Daily Volume 8,777,134
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Upcoming Catalysts

Drug Stage Catalyst Date
INO-5401 and INO-9012 with LIBTAYO (cemiplimab)
Glioblastoma (GBM)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
VGX-3100 - REVEAL-2
Cervical Dysplasia
Phase 3
Phase 3
Phase 3 initiation announced March 4, 2019.
PENNVAX-GP
HIV
Phase 2
Phase 2
Phase 2 trial ongoing.
INO-4800
COVID-19 vaccine
Phase 2
Phase 2
Phase 2 data released May 10, 2021 - generally safe and well-tolerated. Phase 3 trial to commence 2Q 2021.
VGX-3100 - REVEAL-1
Cervical dysplasia
Phase 3
Phase 3
Phase 3 data released March 1, 2021. Including subjects with missing endpoint data, the percentage of subjects meeting the primary endpoint was 22.5% (31/138) versus 11.1% (7/63) in the placebo group (p=0.029; 11.4% difference in percentage, 95%CI: -0.4,21.2), which was not statistically significant.
INO-4500
Lassa Fever
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced February 23, 2021.
VGX-3100
Human papilloma virus (HPV)-related anal dysplasia
Phase 2
Phase 2
Phase 2 data noted 63% showed reduction of lesions of greater than 25%. Phase 3 trial planned in 2021
INO-A002
Zika virus
Phase 1
Phase 1
Phase 1 trial ongoing.
INO-3107
Recurrent respiratory papillomatosis
Phase 2
Phase 2
Phase 2 dosing of first patient announced November 23, 2020.
MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
Phase 2 trial ongoing.
INO-4700 / GLS-5300
MERS virus (Middle East Respiratory Syndrome)
Phase 1/2
Phase 1/2
Phase 2 trial planned.
INO-5151
Castration-resistant Prostate Cancer
Phase 1
Phase 1
Phase 1 trial announced July 29, 2019.

Latest News

  1. PLYMOUTH MEETING, Pa., June 8, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced an expansion of its previously announced partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). Together, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects 18 years and older across several countries, primarily…

    PLYMOUTH MEETING, Pa., June 8, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced an expansion of its previously announced partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy). Together, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects 18 years and older across several countries, primarily in Latin America and Asia. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. The 2.0 mg dose was selected from the Phase 2 segment, where INO-4800 was shown to be generally well-tolerated and immunogenic in all tested age groups.

    Dr. J. Joseph Kim, President and CEO of INOVIO, said, "With most countries in the world currently registering COVID vaccination rates of less than 10%, INOVIO and Advaccine feel the urgency to advance INO-4800 into a global Phase 3 trial this summer. INOVIO is encouraged by our recently published Phase 2 data for INO-4800, which showed the vaccine to be well-tolerated and immunogenic in all tested age groups. In a previously announced study, INO-4800 was also found to generate broad cross-reactive immune responses against tested SARS-CoV-2 variants of concern, which may enable it to provide greater protection for more people globally."

    Dr. Kim continued, "We believe that INO-4800, if approved, will be well-positioned to serve the vaccine needs of the global community. Based on trial results to date, this vaccine has shown to be well-tolerated; produces balanced neutralizing antibodies and favorable T cell response (CD8 and CD4) and is easy to administer. It is uniquely positioned to support vaccine rollout to underserved countries globally with a strong thermostability profile that is stable at room temperature for more than a year and does not require cold or ultra-cold-chain transport. In addition to the potential approval as a primary vaccine, INO-4800 also has the potential to be used as a booster vaccine since the early clinical data supports that INO-4800 can be safely re-administered."

    Founder and Chairman of Advaccine, Dr. Bin Wang said, "The expansion of our partnership with INOVIO has a lot of synergy and we are excited about the global Phase 3 trial of INO-4800. We look forward to bringing a well-tolerated and immunogenic COVID-19 vaccine to more people around the world. Advaccine has built up large scale GMP manufacturing facilities of DNA vaccine and recently obtained the vaccine manufacturing permit from Chinese regulatory authorities, becoming one of a few companies in China that have the license. We are working to expand our manufacturing capacities further, in order to meet the unmet global need for nucleic acid-based COVID-19 vaccines."

    Under their expanded collaboration, INOVIO and Advaccine intend to share equally, subject to specified limitations and conditions, the total cost of the planned global Phase 3 trial, which is estimated to be approximately $100 million. The expanded partnership is an extension of an existing relationship between the two companies, including an exclusive agreement announced in January 2021 under which Advaccine has the exclusive rights to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of mainland China, Hong Kong, Macao and Taiwan. Under the expanded agreement, Advaccine obtains rights to additional Asian countries outside of Greater China. Advaccine has extensive experience in co-development of INO-4800 with INOVIO, including sponsoring both Phase 1 and Phase 2 clinical trials in China for INO-4800.

    The global Phase 2/3 trial builds upon INOVIO's Phase 2 segment, which was funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency. Results from the trial can be found in the paper entitled "Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A Preliminary Report of a Randomized, Blinded, Placebo-controlled, Phase 2 Clinical Trial in Adults at High Risk of Viral Exposure," which has been published as a pre-print in MedRxiv prior to peer review.  Early INO-4800 research and development funding were provided by the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation.

    In addition to the initiation of the clinical trial itself, INOVIO is in discussions with several countries which are expected to provide clinical trial sites, regarding advanced market contracts to potentially supply INO-4800 upon respective regulatory approvals in those countries.

    About the INO-4800 "INNOVATE" Phase 2/3 Clinical Trial

    The Phase 2 segment of INNOVATE Phase 2/3 trial was designed to evaluate the safety, tolerability and immunogenicity of INO-4800 in a two-dose regimen (1.0 mg or 2.0 mg) in a three-to-one-randomization to receive either INO-4800 or placebo in three age groups (18-50 years, 51-64 years and 65 years and older). The Phase 2 data showed that INO-4800 was well-tolerated and immunogenic in all tested age groups, and the 2.0 mg dose was selected to advance into the Phase 3 segment of the trial.

    The global Phase 3 segment of the trial intends to enroll healthy men and non-pregnant women 18 years of age and older, to evaluate the efficacy of INO-4800 (2.0 mg) in a two-dose regimen based on the Phase 2 dose-confirmation data. The trial will be predominantly conducted in vaccine underserved countries in Latin America and Asia. Participants will be enrolled in a two-to-one randomization to receive either INO-4800 or a placebo. The Phase 3 segment will be case-driven with the final number of enrollees to be determined by the incidence of COVID-19 during the Phase 3 segment. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. 

    About INO-4800

    INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2, the novel coronavirus that causes COVID-19. INOVIO has extensive experience working with coronaviruses and was the first company to initiate a Phase 2a trial for INO-4700, a DNA vaccine candidate for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

    Composed of a precisely designed DNA plasmid, INO-4800 is injected intradermally followed by electroporation using a proprietary smart device delivering the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response. INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year, at 37o C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage – all of which are important considerations when preparing for mass immunizations.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development and focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 that are being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of precisely designed DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA® device uses 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. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody mediated immune responses. Administration with the CELLECTRA® device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are the relative speed at which DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, and tolerability that have been observed in clinical trials.

    With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with the potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated positive Phase 2 efficacy results in separate trials evaluating the treatment of precancerous vulvar dysplasia and anal dysplasia. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,  

    Investors: Ben Matone, 484-362-0076,

    * * * *

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

     

    Cision View original content:http://www.prnewswire.com/news-releases/inovio-expands-partnership-with-advaccine-to-conduct-global-phase-3-efficacy-trial-of-covid-19-dna-vaccine-candidate-ino-4800-301307352.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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  2. PLYMOUTH MEETING, Pa., June 3, 2021 /PRNewswire/ -- Geneos Therapeutics, a clinical stage company focused on the development of tumor neoantigen targeted personalized immunotherapies for cancer, announced today positive preliminary results of its ongoing first-in-human trial.  GT-30 is a phase I/II trial of personalized vaccine, GNOS-PV02, in combination with plasmid pIL-12 and pembrolizumab in patients in second line advanced hepatocellular carcinoma (HCC).

    As of May 13, 2021, 12 patients had initiated treatment in the GT-30 trial and received at least 1 dose of their combination therapy. The treatment was generally safe and well tolerated with no treatment related serious adverse events noted on the trial. Ten patients had reached at least…

    PLYMOUTH MEETING, Pa., June 3, 2021 /PRNewswire/ -- Geneos Therapeutics, a clinical stage company focused on the development of tumor neoantigen targeted personalized immunotherapies for cancer, announced today positive preliminary results of its ongoing first-in-human trial.  GT-30 is a phase I/II trial of personalized vaccine, GNOS-PV02, in combination with plasmid pIL-12 and pembrolizumab in patients in second line advanced hepatocellular carcinoma (HCC).

    As of May 13, 2021, 12 patients had initiated treatment in the GT-30 trial and received at least 1 dose of their combination therapy. The treatment was generally safe and well tolerated with no treatment related serious adverse events noted on the trial. Ten patients had reached at least the first on-treatment imaging timepoint of 9 weeks to enable evaluation of objective response by RECIST 1.1. The best overall response by the data cut-off date consisted of 3 patients achieving a partial clinical response (PR); 4 patients demonstrated stable disease (SD); and 3 patients had progressive disease (PD); representing an overall response rate (ORR) of 3/10 (30%) and a disease control rate of 7/10 (70%). The observed ORR of anti-PD1 alone monotherapy is 14%-17% in the 2nd line advanced HCC setting. Immune analysis of the pre-treatment and on-treatment patient samples demonstrated the induction and expansion of T cell clones in the peripheral blood and infiltration of T cells in the tumor tissue following vaccination.

    Dr. Mark Yarchoan, Assistant Professor of Oncology, Johns Hopkins University will discuss the clinical trial design and advantages of Geneos' GT-EPIC platform in an oral poster presentation titled:

    Abstract #: TPS2680

    "Personalized DNA neoantigen vaccine in combination with plasmid IL-12 and pembrolizumab for the treatment of patients with advanced hepatocellular carcinoma." – Yarchoan et al

    Geneos is also presenting data from its ongoing collaboration with Dr. Tanner Johanns and colleagues at Washington University School of Medicine to treat a patient with newly diagnosed anaplastic astrocytoma/GBM under a single patient compassionate use IND. The patient is undergoing monotherapy treatment with their personalized cancer vaccine (GNOS-PV)  and pIL12 in an adjuvant setting following resection of their tumor. As of the ASCO 2021 conference date the patient remains recurrence free 36 months since primary surgery and 23 months since initiation of the GNOS-PV + pIL12 treatment. The interim data demonstrated that the treatment was generally well tolerated with no treatment related serious adverse events. The patient received a vaccine comprising of 30 tumor antigens including 27 cancer neoantigens and 3 shared antigens. On-treatment immune analysis showed the induction and persistence of neoantigen directed T cells in the patient's blood to 28 of 30 (93%) encoded antigens following GNOS-PV + pIL12 treatment.

    Abstract #: e14561

    "Personalized DNA neoantigen vaccine in combination with plasmid IL-12 for the treatment of a patient with anaplastic astrocytoma." – Johanns et al

    "We are encouraged by the interim data from our personalized cancer vaccine program showing tumor shrinkage in combination with anti-PD1. Our GT-EPIC™ platform's ability to drive CD8 T cells leading to meaningful clinical responses in intractable tumors is exciting," said Dr. Niranjan Y. Sardesai, President and CEO of Geneos Therapeutics. "A distinguishing feature of our HCC trial is that all the patients receive their first dose of GNOS-PV02+pIL12 at the same time as they receive their first dose of PD1 thus enabling direct comparison to the historical responses achieved by PD1 alone. These early data represent the first objective responses reported in HCC patients with plasmid DNA encoded cancer vaccines."

    About Geneos Therapeutics

    At Geneos Therapeutics, we believe that personalized therapies are the future of cancer treatment. Our passion is to develop personalized therapies to unleash the most powerful force against cancer – the patients' own immune system. Our approach using our GT-EPIC™ platform is to target unique neoantigens (abnormal mutations produced by cancer cells) from individual patient tumors to develop novel and personalized treatments for cancer. 

    About GT-30 trial:

    The GT-30 trial (NCT04251117) is a single-arm phase I/II clinical trial to assess the safety, immunogenicity, and preliminary efficacy of GNOS-PV02 in combination with cytokine IL-12 (pIL12; INO-9012) and pembrolizumab in patients with advanced HCC. Twenty-four patients are anticipated to be enrolled. After progression or intolerance with first-line therapy, patients can commence trial therapy with concurrent personalized vaccine and pembrolizumab. Patients are recruited upon diagnosis or during first-line treatment with tyrosine kinase inhibitors (TKI). Tumors are biopsied for exome and transcriptome sequencing. The tumor specific vaccine is designed, optimized and manufactured during first-line therapy. Each vaccine encodes up to 40 neoantigens, which includes all detected neoantigens for the majority of HCC patients. GNOS-PV02 + pIL12 are administered Q3w for the first 4 doses and Q9w thereafter until disease progression. Pembrolizumab is delivered Q3w until disease progression. Immunogenicity of each of the vaccine epitopes is  determined by ex vivo ELISpot and flow cytometry. Clinical activity is assessed by RECIST1.1 at baseline and every 9 weeks. Serial biopsies are obtained at 9 weeks and upon disease progression to evaluate changes in the exome, transcriptome and changes to the tumor microenvironment.

    About GT-EPIC™ Platform:

    Geneos Therapeutics' GT-EPIC™ Neoantigen-Targeting Platform is based on clinically-validated DNA medicines technology exclusively licensed from Inovio Pharmaceuticals, Inc. (NASDAQ:INO) for use in developing personalized, neoantigen-targeting immunotherapies. The GT-EPIC™ platform allows Geneos to develop exquisitely personalized DNA-based therapies tailored to each patient's unique tumor mutations. The platform is developed to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos believes that these are three key differentiators that will drive the company, and the oncology space, into the next generation of neoantigen targeted immunotherapies.

    This press release contains certain forward-looking statements relating to our business, including our plans regarding the development of tumor neoantigen targeted personalized immunotherapies for cancer, our expectations regarding our research and development programs, including the planned expansion and conduct of clinical trials and the availability and timing of data from those trials, and the use of our capital resources. Actual events or results may differ from the expectations set forth herein. There can be no assurance that any product candidate in Geneos' pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and Geneos undertakes no obligation to update or revise these statements, except as may be required by law. 

    Cision View original content:http://www.prnewswire.com/news-releases/geneos-therapeutics-announces-clinical-updates-on-personalized-cancer-vaccine-program-301305022.html

    SOURCE Geneos Therapeutics, Inc.

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  3. PLYMOUTH MEETING, Pa., May 25, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO) a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, announced today that Dr. Joseph Kim, President and CEO, is scheduled to participate in a fireside chat and 1x1 investor meetings at the Jefferies 2021 Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:00 PM EDT. A webcast of the event will be available at this link: https://wsw.com/webcast/jeff174/ino/1702890.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including…

    PLYMOUTH MEETING, Pa., May 25, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO) a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, announced today that Dr. Joseph Kim, President and CEO, is scheduled to participate in a fireside chat and 1x1 investor meetings at the Jefferies 2021 Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:00 PM EDT. A webcast of the event will be available at this link: https://wsw.com/webcast/jeff174/ino/1702890.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA® device uses 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. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody mediated immune responses. Administration with the CELLECTRA® device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

    With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated positive Phase 2 efficacy results in separate trials evaluating the treatment of precancerous vulvar dysplasia and anal dysplasia. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

     

    Cision View original content:http://www.prnewswire.com/news-releases/inovio-to-present-at-the-jefferies-2021-virtual-healthcare-conference-301298425.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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  4. PLYMOUTH MEETING, Pa., May 17, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced the appointment of Roger D. Dansey, M.D. to its Board of Directors. The appointment adds extensive expertise in drug development to the INOVIO Board as the company strengthens its focus on its late stage product development programs. Currently the Chief Medical Officer at Seagen (formerly Seattle Genetics), Dr. Dansey has played a central role in Seagen's efforts to become a globally recognized, multi--product oncology company.

    Dr. Dansey previously served as the Therapeutic Area…

    PLYMOUTH MEETING, Pa., May 17, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced the appointment of Roger D. Dansey, M.D. to its Board of Directors. The appointment adds extensive expertise in drug development to the INOVIO Board as the company strengthens its focus on its late stage product development programs. Currently the Chief Medical Officer at Seagen (formerly Seattle Genetics), Dr. Dansey has played a central role in Seagen's efforts to become a globally recognized, multi--product oncology company.

    Dr. Dansey previously served as the Therapeutic Area Head for Late-Stage Oncology at Merck & Co., Inc., where he oversaw registration efforts for Keytruda® (pembrolizumab) across multiple tumor types. Earlier in his career, he was the Vice President of Oncology Clinical Research at Gilead Sciences and the Global Development Lead for Xgeva® (denosumab) at Amgen, where he held multiple roles in both oncology and hematology. Dr. Dansey holds an M.D. from the University of Witwatersrand in Johannesburg, South Africa.

    Simon X. Benito, Chairman of INOVIO's Board, said, "We are pleased to welcome Dr. Dansey to INOVIO's Board of Directors. His impressive efforts at Seagen coupled with his track record of achievement in cancer drug development at Merck, Gilead, and Amgen will be invaluable to the organization as the company evolves its oncology, HPV and vaccine portfolio – including INO-5401, its DNA medicine for Glioblastoma Multiforme (GBM) and INO-4800 for COVID-19 – and prepare for commercialization."

    Dr. Dansey said, "I'm pleased to join INOVIO at a pivotal time for the company. This is the time for DNA medicines. I believe they offer an innovative approach to fighting cancer. I am looking forward to working with the team and supporting their mission of rapidly bringing to market life-saving DNA medicines to meet urgent global health needs in oncology and infectious diseases."

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA® device uses 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. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody mediated immune responses. Administration with the CELLECTRA® device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

    With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100 is the first DNA medicine to achieve efficacy endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated positive Phase 2 efficacy results in separate trials evaluating the treatment of precancerous vulvar dysplasia and anal dysplasia. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

     

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    SOURCE INOVIO Pharmaceuticals, Inc.

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  5. PLYMOUTH MEETING, Pa., May 12, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies and T cell responses against the original Wuhan strain as well as against B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant) in preclinical models. These results demonstrate the potential of INOVIO's Pan-COVID-19 vaccine to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine, or potentially…

    PLYMOUTH MEETING, Pa., May 12, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies and T cell responses against the original Wuhan strain as well as against B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant) in preclinical models. These results demonstrate the potential of INOVIO's Pan-COVID-19 vaccine to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine, or potentially as a boost for individuals previously immunized with various Wuhan-matched vaccines.

    Dr. Laurent M. Humeau, INOVIO's Chief Scientific Officer, said, "INOVIO is taking a dual-track approach in developing a COVID-19 vaccine because we recognize the need to support both pandemic and endemic considerations. In addition to our work on INO-4800, which we expect to enter a global Phase 3 trial this summer, we are also developing our next-generation Pan-COVID-19 variant vaccine, INO-4802, which is designed to protect against current and potentially future variants of concern. The study data we report today confirms our two-tiered development path is the best strategy for the short- and long-term fight against this virus."

    First-generation COVID-19 vaccines were matched against the original Wuhan strain. These vaccines may have reduced efficacy against emerging COVID variants. In response, many of the next-generation vaccines under development are matched to a single variant currently circulating. INOVIO's Pan-COVID-19 vaccine approach is designed to provide cross-strain protection, immune coverage, reduced susceptibility to escape mutants, and non-restricted geographical use against both known and potentially unknown variants. Preclinical data with INO-4802 in multiple models revealed both broader and increased levels of neutralizing antibodies against a panel of variants than strain-matched vaccines. Building on this initial work, INOVIO plans to conduct Phase 1/2 clinical trials this year with INO-4802.

    To create INOVIO's Pan-COVID-19 vaccine candidate, variant sequences were identified over a four-month period starting in October 2020 from multiple geographic regions (Brazil, Canada, India, Italy, Japan, Nigeria, South Africa, United Kingdom, and the United States). Mutations in the spike sequences were aggregated for each region. The sequence results from these regions were then further engineered to determine a common set of overlapping mutations from emerging variations in the COVID spike protein sequences to generate INO-4802.

    More information from this pre-clinical study can be found in the paper entitled: "Design and immunogenicity of a Pan-SARS-CoV-2 synthetic DNA vaccine," which has been published as a preprint in BioRxiv prior to peer review.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA® device uses 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. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody mediated immune responses. Administration with the CELLECTRA® device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

    With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, in the first of two Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV 16 and 18. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2 clinical trial in the U.S., as well as Phase 2 trials in China and South Korea. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

     

    Cision View original content:http://www.prnewswire.com/news-releases/inovios-pan-covid-19-vaccine-candidate-ino-4802-induces-broad-immunity-against-major-viral-variants-in-preclinical-studies-301289520.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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