Company Description
Inovio Pharmaceuticals, Inc. (NASDAQ: INO), also referred to as INOVIO, is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. According to the company’s public statements, its technology is designed to teach the body to manufacture its own disease-fighting tools by delivering precisely designed DNA plasmids into cells.
INOVIO’s DNA medicines platform combines two core elements: DNA plasmids and the company’s proprietary investigational medical device, CELLECTRA. The plasmids are described as small circular DNA molecules that function like software the body’s cells can download to produce specific proteins that target and fight disease. The CELLECTRA delivery devices are designed to optimally deliver these DNA medicines to the body’s cells without using chemical adjuvants or lipid nanoparticles and without triggering the anti-vector immune responses historically associated with viral vector platforms.
Focus on HPV-Related Diseases and RRP
A central area of INOVIO’s work is HPV-related diseases, including recurrent respiratory papillomatosis (RRP), a rare and debilitating disease of the respiratory tract caused primarily by HPV-6 and HPV-11. RRP is characterized by the growth of benign papillomas in the respiratory tract that can obstruct the airway and impair speech. Surgery to remove papillomas is the current standard of care, but papillomas often recur, leading to repeated procedures that may damage the vocal cords and affect quality of life and finances.
INOVIO’s lead DNA medicine candidate for RRP is INO-3107, an investigational DNA medicine designed to elicit an antigen-specific T cell response against HPV-6 and HPV-11 proteins. The goal is for these targeted T cells to seek out and kill HPV-6 and HPV-11 infected cells, potentially preventing or slowing the growth of new papillomas. INOVIO has submitted a Biologics License Application (BLA) for INO-3107 to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway, and the FDA has accepted the BLA for review with a Standard review classification.
Clinical Data and Regulatory Designations for INO-3107
Clinical data disclosed by the company indicate that in a Phase 1/2 trial (RRP-001) of 32 adult patients with RRP who had two or more surgeries in the year before treatment, a majority of patients experienced a reduction in the number of surgeries after receiving INO-3107. A retrospective follow-up study (RRP-002) of 28 of the original participants suggested that many patients continued to see clinical benefit in the second 12-month period after treatment without additional dosing. The company reports that INO-3107 generated a strong immune response, inducing activated CD4 and CD8 T cells with lytic potential and showing T cell responses at Week 52, consistent with a persistent cellular memory response. INO-3107 was described as well tolerated, with mostly low-grade treatment-emergent adverse effects such as injection site pain and fatigue.
Regulatory authorities have recognized INO-3107 with several designations. The FDA has granted Orphan Drug and Breakthrough Therapy designations for INO-3107, and the European Commission has granted Orphan Drug designation. INOVIO also states that it has CE-marked its CELLECTRA delivery device in the European Union, which allows the device to be commercialized in the EU and other geographies that recognize CE-marking. In the United Kingdom, INO-3107 has received the Innovation Passport, which serves as the entry point to the Innovative Licensing and Access Pathway (ILAP), a framework intended to accelerate time to market and facilitate patient access to medicines.
DNA Medicines Platform and Next-Generation Programs
Beyond INO-3107, INOVIO describes a broader DNA medicines platform that it is advancing. The platform’s design emphasizes the ability to generate antigen-specific T cell responses without the limitations associated with anti-vector immunity seen in some other T cell–generating platforms. The company has highlighted DNA-Encoded Monoclonal Antibody (DMAb) technology and DNA-encoded protein (DPROT) programs as part of its next-generation DNA medicine candidates.
Results from a Phase 1 proof-of-concept trial evaluating next-generation DMAbs for COVID-19 were published in Nature Medicine, demonstrating that monoclonal antibodies, which are complex proteins, could be durably and tolerably expressed in humans using this approach. INOVIO has stated that it is building on this research to evaluate in vivo therapeutic protein production and is preparing preclinical data presentations from its DPROT program, which aims to address limitations of conventional therapeutic protein replacement and gene therapy approaches.
Capital Markets Activity and Nasdaq Listing
INOVIO’s common stock is listed on The Nasdaq Stock Market LLC under the trading symbol INO. The company has used public equity offerings and warrants to support its operations and development programs. For example, INOVIO has entered into underwriting agreements with Piper Sandler & Co. for public offerings of common stock and warrants, as disclosed in Form 8-K filings. These offerings provide capital to fund clinical development, regulatory activities, and corporate operations.
In addition, INOVIO has adopted and used an Inducement Plan to grant stock options to newly hired employees, as reported in multiple press releases. These options typically vest over several years and are granted in accordance with Nasdaq listing rules, aligning employee compensation with the company’s long-term performance.
Geographic Base and Sector Classification
Regulatory filings state that Inovio Pharmaceuticals, Inc. has its principal executive offices in Plymouth Meeting, Pennsylvania, in the United States. While some third-party classifications may place the company in manufacturing-related categories, INOVIO consistently describes itself as a biotechnology company centered on DNA medicines, HPV-related diseases, cancer, and infectious diseases.
Business Model Characteristics
Based on the company’s public disclosures, INOVIO’s activities are concentrated in research, clinical development, regulatory submissions, and preparation for potential commercialization of DNA medicines. The company’s statements emphasize advancing INO-3107 toward potential approval and commercial launch, while also progressing next-generation DNA medicine candidates such as DMAb and DPROT programs. INOVIO also highlights financial discipline and capital-raising activities, including public offerings, to support its pipeline and operations.
Position Within the Biotechnology Landscape
Within the broader biotechnology sector, INOVIO is distinguished in its own description by a focus on DNA-based immunotherapies and DNA medicines delivered via its proprietary CELLECTRA devices. Its work targets HPV-related diseases such as RRP, as well as cancer and infectious diseases, and it has reported peer-reviewed publications and conference presentations related to its clinical and preclinical programs. Investors and observers use these disclosures, along with SEC filings and regulatory milestones, to evaluate the company’s progress and risk profile.