Phase 1b Study of INO-5401 Alone or INO-5401 in Combination With INO-9012 Followed by Electroporation in Adult Cancer and Non-Cancer Patients With BRCA1 or BRCA2 Mutations

The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Start Date20 Apr 2021

Sponsor / Collaborator

University of Pennsylvania

[+1]

NCT04251117 / Active, not recruitingPhase 1/2

An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) in Combination With Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma

This is a single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report.

Start Date01 Mar 2020

Sponsor / Collaborator

Geneos Therapeutics, Inc.Startup

EUCTR2018-000309-21-ES / Not yet recruitingPhase 1/2

An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination with Atezolizumab in Subjects with Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

Start Date31 Oct 2018

Sponsor / Collaborator

Inovio Pharmaceuticals, Inc.

100 Clinical Results associated with Rocakinogene Sifuplasmid

100 Translational Medicine associated with Rocakinogene Sifuplasmid

100 Patents (Medical) associated with Rocakinogene Sifuplasmid

Literatures (Medical) associated with Rocakinogene Sifuplasmid

01 Mar 2023·Cancer prevention research (Philadelphia, Pa.)

Phase I Trial of a Therapeutic DNA Vaccine for Preventing Hepatocellular Carcinoma from Chronic Hepatitis C Virus (HCV) Infection

Article

Author: Pawlicki, Jan M. ; Barranco, Eduardo ; Zahrieh, David ; Mandrekar, Sumithra J. ; Marrero, Idania ; Boyer, Jean ; Rodriguez, Luz Maria ; Umar, Asad ; Roberts, Lewis R. ; Gillespie, Elisabeth ; Kraynyak, Kimberly A. ; Limburg, Paul J. ; Strand, Carrie A. ; Weiner, David B. ; Sylvester, Albert J. ; Pungpapong, Surakit ; Richmond, Ellen ; Morrow, Matthew P. ; Jacobson, Jeffrey M. ; Cruz-Correa, Marcia

Abstract:

Chronic hepatitis C can lead to cirrhosis and hepatocellular carcinoma. We studied the safety and immunogenicity of a novel therapeutic hepatitis C virus (HCV) genotype 1a/1b consensus DNA vaccine, INO-8000, encoding HCV NS3, NS4A, NS4B, and NS5A proteins alone or co-administered with DNA-encoding IL12 (INO-9012), a human cytokine that stimulates cellular immune function, in individuals with chronic hepatitis C. This was a phase I, multisite dose-escalation trial with an expansion cohort evaluating doses of 0, 0.3, 1.0, and 3.0 mg of INO-9012 (IL12 DNA) as an addition to 6.0 mg of (INO-8000; HCV DNA vaccine). Vaccines were administered by intramuscular injection followed by electroporation at study entry and at weeks 4, 12, and 24. HCV-specific CD4+ and CD8+ T-cell immune responses were measured by IFNγ ELISpot and flow cytometry–based assays. Transient, mild-to-moderate injection site reactions unrelated to IL12 DNA dose were common. Increases in HCV-specific IFNγ production occurred in 15/20 (75%) participants. Increases in the frequency of HCV-specific CD4+ and CD8+ T cells occurred at all dose levels, with the greatest increases seen at 1.0 mg of INO-9012. HCV-specific CD8+ and CD4+ T-cell activities increased in 16/18 (89%) and 14/17 (82%) participants with available data, respectively. The vaccine regimen was safe and induced HCV-specific CD4+ and CD8+ cellular immune responses of modest magnitude in most HCV-infected participants. The addition of 1.0 mg of IL12 DNA provided the best enhancement of immune responses. The vaccine regimen had little effect on controlling HCV viremia.

Prevention Relevance::

The administration of IL12 DNA along with a hepatitis C viral antigen DNA vaccine enhanced the HCV-specific immune responses induced by the vaccine in individuals with chronic hepatitis C, an important cause of hepatocellular carcinoma. IL12 could be an effective adjuvant in vaccines targeting HCV and other oncogenic viruses.

01 Jul 2021·Journal for immunotherapy of cancerQ2 · MEDICINE

Phase 1 study of safety, tolerability and immunogenicity of the human telomerase (hTERT)-encoded DNA plasmids INO-1400 and INO-1401 with or without IL-12 DNA plasmid INO-9012 in adult patients with solid tumors

Q2 · MEDICINE

ArticleOA

Author: Shields, Anthony F ; Boyer, Jean D ; Chintakuntlawar, Ashish V ; Humeau, Laurent ; Morrow, Matthew P ; Sun, Weijing ; Samuels, Robert ; Kim, Joseph J ; Johnson, Jennifer M ; Pawlicki, Jan ; Skolnik, Jeffrey M ; McMullan, Trevor ; Weiner, David ; McRee, Autumn J ; Kraynyak, Kimberly A ; Sylvester, Albert J ; Vonderheide, Robert H

Background:

Human telomerase reverse transcriptase (hTERT) is frequently classified as a ‘universal’ tumor associated antigen due to its expression in a vast number of cancers. We evaluated plasmid DNA-encoded hTERT as an immunotherapy across nine cancer types.

Methods:

A phase 1 clinical trial was conducted in adult patients with no evidence of disease following definitive surgery and standard therapy, who were at high risk of relapse. Plasmid DNA encoding one of two hTERT variants (INO-1400 or INO-1401) with or without plasmid DNA encoding interleukin 12 (IL-12) (INO-9012) was delivered intramuscularly concurrent with the application of the CELLECTRA constant-current electroporation device 4 times across 12 weeks. Safety assessments and immune monitoring against native (germline, non-mutated, non-plasmid matched) hTERT antigen were performed. The largest cohort of patients enrolled had pancreatic cancer, allowing for additional targeted assessments for this tumor type.

Results:

Of the 93 enrolled patients who received at least one dose, 88 had at least one adverse event; the majority were grade 1 or 2, related to injection site. At 18 months, 54.8% (51/93) patients were disease-free, with median disease-free survival (DFS) not reached by end of study. For patients with pancreatic cancer, the median DFS was 9 months, with 41.4% of these patients remaining disease-free at 18 months. hTERT immunotherapy induced a de novo cellular immune response or enhanced pre-existing cellular responses to native hTERT in 96% (88/92) of patients with various cancer types. Treatment with INO-1400/INO-1401±INO-9012 drove hTERT-specific IFN-γ production, generated hTERT-specific CD4+ and CD8+ T cells expressing the activation marker CD38, and induced hTERT-specific activated CD8 +CTLs as defined by cells expressing perforin and granzymes. The addition of plasmid IL-12 adjuvant elicited higher magnitudes of cellular responses including IFN-γ production, activated CD4+ and CD8+ T cells, and activated CD8+CTLs. In a subset analysis of pancreatic cancer patients, the presence of immunotherapy-induced activated CD8+ T cells expressing PD-1, granzymes and perforin correlated with survival.

Conclusions:

Plasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer.

01 May 2020·Molecular therapy : the journal of the American Society of Gene TherapyQ1 · MEDICINE

CD8+ T Cells Impact Rising PSA in Biochemically Relapsed Cancer Patients Using Immunotherapy Targeting Tumor-Associated Antigens

Q1 · MEDICINE

Article

Author: Shore, Neal D ; Boyer, Jean D ; Garcia, Jorge A ; Sylvester, Albert ; Cheung, Jocelyn ; McMullan, Trevor ; Bhatt, Khamal ; Whang, Young E ; Heath, Elizabeth I ; Appleman, Leonard J ; Tagawa, Scott T ; Sacchetta, Brian ; Cheng, Heather H ; Skolnik, Jeffrey M ; Nordquist, Luke ; Weiner, David B ; Bagarazzi, Mark L ; Liu, Li ; Morrow, Matthew P ; Kelly, W Kevin ; Tutrone, Ronald ; Kraynyak, Kimberly A ; Rosencranz, Samantha

The management of men with prostate cancer (PCa) with biochemical recurrence following local definitive therapy remains controversial. Early use of androgen deprivation therapy (ADT) leads to significant side effects. Developing an alternative, clinically effective, and well-tolerated therapy remains an unmet clinical need. INO-5150 is a synthetic DNA therapy that includes plasmids encoding for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA), and INO-9012 is a synthetic DNA plasmid encoding for interleukin-12 (IL-12). This phase 1/2, open-label, multi-center study enrolled men with PCa with rising PSA after surgery and/or radiation therapy. Patients were enrolled into one of four treatment arms: arm A, 2 mg of INO-5150; arm B, 8.5 mg of INO-5150; arm C, 2 mg of INO-5150 + 1 mg of INO-9012; and arm D, 8.5 mg of INO-5150 + 1 mg of INO-9012. Patients received study drug with electroporation on day 0 and on weeks 3, 12, and 24, and they were followed for up to 72 weeks. Sixty-two patients were enrolled. Treatment was well tolerated. 81% (50/62) of patients completed all visits. 85% (53/62) remained progression-free at 72 weeks. PSA doubling time (PSADT) was increased when assessed in patients with day 0 PSADT ≤12 months. Immunogenicity was observed in 76% (47/62) of patients by multiple assessments. Analysis indicated that CD38 and perforin co-positive CD8 T cell frequency correlated with attenuated PSA rise (p = 0.05, n = 50).

News (Medical) associated with Rocakinogene Sifuplasmid

06 Mar 2024

·www.prnewswire.com

INOVIO Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Announced substantial progress with lead program, INO-3107, as potential treatment for Recurrent Respiratory Papillomatosis (RRP) Positive data announced from Phase 1/2 trial Orphan Drug Designation granted by European Union Breakthrough Therapy Designation granted by U.S. Food and Drug Administration (FDA) Received FDA feedback that data from completed Phase 1/2 trial can be used to submit Biological License Application (BLA) under accelerated approval program Announced plan to submit BLA to FDA under accelerated approval program in second half of 2024 Announced clinical collaboration and supply agreement with Coherus BioSciences to advance development of INO-3112 in combination with LOQTORZI™ (toripalimab-tpzi) Combination therapy to be evaluated in a planned Phase 3 trial in patients with locoregionally advanced, high-risk, HPV-16/18-positive throat cancer Clinical trial design submitted to FDA in first quarter 2024; feedback expected in second quarter Reported positive Phase 1b results for INO-4201 as a potential Ebola booster vaccine for rVSV-ZEBOV (Ervebo®) Prioritized pipeline and reduced 2023 operating expenses by 48% from 2022 Ended 2023 with $145.3 million in cash, cash equivalents, and short-term investments Projects cash runway into second quarter 2025 Management will host conference call today at 4:30 p.m. ET PLYMOUTH MEETING, Pa., March 6, 2024 /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 its financial results and operational highlights for the fourth quarter and full year ended December 31, 2023. INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea, said, "The past year has been transformative as we've reshaped INOVIO into a company that is focused on commercializing its first product candidate and bringing the benefits of DNA medicine to patients. We've done so by focusing on the strengths of our platform and our strategic objectives: advancing candidates with scientific promise, achievable pathways to market, and strong commercial potential, and maintaining an ongoing commitment to financial discipline and operational excellence." Dr. Shea continued, "In the past year we have taken our lead candidate, INO-3107 for RRP, from positive Phase 1/2 trial results to Breakthrough Therapy designation and an established path to BLA submission under the FDA's accelerated approval program. We've also announced a new clinical collaboration and supply agreement with Coherus BioSciences to advance our development of INO-3112 in combination with LOQTORZI™ (toripalimab-tpzi) for throat cancer, shared encouraging results for INO-4201 as an Ebola vaccine booster, continued to advance other clinical-stage candidates, and progressed important preclinical research opportunities. The year ahead will provide a critical opportunity to carry this positive momentum forward across our pipeline, particularly for INO-3107 as we prepare for BLA submission and the initiation of a confirmatory trial in the second half of 2024 and accelerate commercialization efforts for a potential 2025 launch." Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) INOVIO made significant progress with INO-3107 as a potential treatment for RRP. Key milestones included positive clinical results, regulatory progress, and the acceleration of commercialization efforts to be prepared to launch in 2025. INOVIO announced and published positive data from a completed Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV-6 and HPV-11-related RRP in adults. In the trial, 81.3% (26/32) of patients had a decrease in surgical interventions in the year after INO-3107 administration compared to the year prior to treatment, 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). Prior to the outset of the trial (Day 0), patients had 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. This data was presented at the 103rd Annual Meeting of the American Broncho-Esophageal Association at the 2023 Combined Otolaryngology Spring Meetings in May 2023, and published in The Laryngoscope in June 2023. INOVIO announced its plans to submit its BLA for INO-3107 in the second half of 2024. Breakthrough Therapy designation was granted by the FDA in September 2023. FDA advised in October 2023 that INOVIO's completed Phase 1/2 trial could be used to submit its BLA under the accelerated approval program. European Commission granted Orphan Drug designation in May 2023, building upon the U.S. Orphan Drug designation granted by the FDA in 2020 and the CE marking issued by the European Union in 2018 to INOVIO's delivery device, CELLECTRA®. INOVIO has accelerated its commercialization strategy to support a product launch in 2025 if regulatory approval is obtained on the anticipated timeline. Plans underway include strategies for product distribution and logistics, payor engagement and reimbursement, specialty pharmacy identification, customer service programs, field force design, and other sales and marketing activities. Continuing to deepen its market understanding of RRP as a disease, including patient and healthcare provider needs. INO-3112 – Oropharyngeal Squamous Cell Carcinoma (OPSCC) In January 2024, INOVIO announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc. to evaluate the combination of INO-3112 and LOQTORZI as a potential treatment for patients with locoregionally advanced, high-risk, HPV-16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer. Under the terms of the agreement, Coherus will provide LOQTORZI for a planned clinical trial at no cost to INOVIO. LOQTORZI is a PD-1 inhibitor recently approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma. INO-3112 is a DNA medicine candidate targeting HPV-16/18 combined with a DNA plasmid for IL-12 as an immune activator. INOVIO has submitted the proposed design of a Phase 3 trial to the FDA with the intent to evaluate the clinical benefit of INO-3112 in combination with a PD-1 inhibitor. Feedback on the clinical development plan is expected in the second quarter of 2024. If cleared to proceed by the FDA, the trial will investigate if LOQTORZI can help boost the tumor-infiltrating abilities of the antigen-specific T cells generated by INO-3112. INO-4201 – Ebola Booster for rVSV-ZEBOV (Ervebo®) INOVIO announced results from a Phase 1b clinical trial 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% (36 of 36) of treated participants. INOVIO believes these data indicate that DNA medicines could be an important part of global medical countermeasures against infectious diseases, either as primary vaccines or boosters to existing vaccines. The FDA has provided feedback on a potential development pathway to licensure and INOVIO expects to finalize these plans and discuss with collaborators and potential partners in the first half of 2024. INO-5401 – Glioblastoma (GBM) INOVIO is finalizing its clinical study report from a Phase 1/2 trial of INO-5401 and INO-9012 in combination with Regeneron's PD-1 inhibitor Libtayo® (cemiplimab) in newly diagnosed GBM patients. The data from this trial showed encouraging median overall survival results from 52 patients and evidence of antigen-specific T cells that may infiltrate GBM tumors. Through 2023, patients involved in the trial continued to receive drug. In the first half of 2024, INOVIO expects to finalize next steps for further development of INO-5401 in conjunction with Regeneron and investigators. Fourth Quarter and Full Year 2023 Financial Results Cash, Cash Equivalents and Short-term Investments: As of December 31, 2023, cash, cash equivalents and short-term investments were $145.3 million compared to $253.0 million as of December 31, 2022. Revenues: Total revenue was $103,000 and $832,000 for the quarter and year ended December 31, 2023, respectively, compared to $125,000 and $10.3 million for the same periods in 2022, respectively. The revenue generated in 2022 was associated with a Procurement Contract with the U.S. Department of Defense for INOVIO's devices and accessories to be used for delivery of its COVID-19 vaccine candidate, INO-4800, which the company has discontinued. Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2023 were $17.3 million and $86.7 million, respectively, compared to $42.1 million and $187.7 million, respectively, for the same periods in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses, outside services and expensed inventory related to INO-4800 and other COVID-19 studies and lower employee and consultant compensation, including stock-based compensation, among other variances. General and Administrative (G&A) Expenses: G&A expenses were $10.2 million and $47.6 million, respectively, for the quarter and year ended December 31, 2023, versus $14.0 million and $90.2 million, respectively, for the same periods in 2022. The decrease in G&A expenses was primarily due to significant costs incurred in the second quarter of 2022 related to the settlement of class action litigation and related legal expenses, severance expenses incurred in 2022 and lower employee and consultant compensation in 2023, including stock-based compensation, among other variances. Total Operating Expenses: Total operating expenses were $27.5 million and $144.8 million for the quarter and year ended December 31, 2023, respectively, compared to $56.1 million and $277.8 million for the same period in 2022. During the third quarter of 2023, the company recognized a non-cash goodwill impairment charge of $10.5 million. Reverse Stock Split: INOVIO effected a reverse stock split of its outstanding shares of common stock on January 24, 2024, as a result of which every twelve shares of its common stock issued and outstanding was combined into one share of common stock. Any fractional post-split shares as a result of the reverse split were eliminated and redeemed in cash. Outstanding share amounts and per share amounts included in this press release have been restated to reflect the reverse stock split on a retroactive basis for all periods presented. Net Loss: INOVIO's net loss for the quarter and year ended December 31, 2023 was $25.0 million, or $1.10 per basic and diluted share, and $135.1 million, or $6.09 per basic and diluted share, respectively, compared to net loss of $54.5 million, or $2.61 per basic and diluted share, and $279.8 million, or $14.07 per basic and diluted share, for the quarter and year-ended December 31, 2022, respectively. Shares Outstanding: As of December 31, 2023, INOVIO had 22.8 million common shares outstanding and 24.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt. INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's annual report on Form 10-K for the year ended December 31, 2023, which can be accessed at: . Cash Guidance INOVIO estimates its cash runway to extend into the second quarter of 2025. This projection includes an operational net cash burn estimate of approximately $26 million for the first quarter of 2024. This amount excludes the repayment of $17 million in remaining principal and accrued interest on convertible senior notes that matured on March 1, 2024. Including the repayment, the total net cash burn for the first quarter of 2024 is expected to be approximately $43 million. These cash runway projections do not include any funds that may be raised through the company's existing at-the-market program or other capital-raising activities. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at . About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA®. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA® delivery devices help ensure its DNA medicines enter the body's cells for optimal effect, without chemical adjuvants or nanoparticles and without the risk of the anti-vector response seen in viral vector platforms. About INOVIO 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. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit . Contacts Media: Jennie Willson (267) 429-8567 [email protected] Investors: Thomas Hong (267) 440-4298 [email protected] Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, the planned submission of a BLA in the second half of 2024, the potential commercial launch of INO-3107 if regulatory approval is obtained, and expectations with respect to our cash resources and expected operating expenses through the first quarter of 2024. 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, 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, 2023, 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 the 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. SOURCE INOVIO Pharmaceuticals, Inc.

Clinical ResultBreakthrough TherapyPhase 1Phase 3Drug Approval

01 May 2023

·www.prnewswire.com

Significant Positive Shift in the Glioma Market with 13% CAGR During the Study Period (2019-2032) Expected by Analysts at DelveInsight

The dynamics of the glioma market are anticipated to change in the coming years owing to the positive outcomes of the emerging pipeline candidates during the developmental stage by key players, such as Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Chimerix, KaryoPharma, VBI Vaccines, Kazia Therapeutics, and others LAS VEGAS, May 1, 2023 /PRNewswire/ -- DelveInsight's Glioma Market Insights report includes a comprehensive understanding of current treatment practices, glioma emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Glioma Market Report As per DelveInsight analysis, the glioma market size in the 7MM was approximately USD 1 billion in 2022. According to the assessment done by DelveInsight, the estimated total incident glioma cases in the 7MM were approximately 47K in 2022. Leading glioma companies such as Bayer, Chimerix, Aivita Biomedical, Denovo Biopharma, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, MedImmune, DNAtrix, Immunomic Therapeutics, Imvax, MimiVax, CNS Pharmaceuticals, Epitopoietic Research Corporation (ERC), Istari Oncology, SonALAsense, Kintara Therapeutics, Bristol Myers Squibb, Medicenna Therapeutics, BioMimetix, Eisai and Merck Sharp & Dohme, Kazia Therapeutics, Oblato, Genenta Science, Enterome, Inovio Pharmaceuticals, Karyopharm Therapeutics, VBI Vaccines, TME Pharma, Day One Biopharmaceuticals, Servier, Orbus Therapeutics, TVAX Biomedical, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Forma Therapeutics, Hoffmann-La Roche, Incyte Corporation, Eli Lilly, and others are developing novel glioma drugs that can be available in the glioma market in the coming years. The promising glioma therapies in the pipeline include Regorafenib, ONC201, AV-GBM-1, Enzastaurin (DB-102), DCVax-L, Ofranergene Obadenovec (VB-111), LAM561 (2-OHOA), MEDI4736 (durvalumab), Tasadenoturev (DNX-2401), ITI-1000 (pp65 DC Vaccine), IGV-001, SurVaxM, Berubicin, GLIOVAC (Sitoiganap), Lerapolturev + Pembrolizumab, SONALA-001 + Exablate 2.0 Device, VAL-083 (dianhydrogalactitol), Pomalidomide, MDNA55, BMX-001, Lenvatinib ± Pembrolizumab, Paxalisib (GDC-0084), OKN-007, Temferon, EO2401, INO-5401+ INO-9012+ LIBTAYO (cemiplimab), Selinexor (KPT-330), Olutasidenib (FT-2102), VBI-1901, NOX-A12 (Olaptesed Pegol), Tovorafenib (DAY101), Vorasidenib (AG-881), Eflornithine, TVI-Brain-1, AB-218, BGB-290, Mirdametinib, FT-2102 (Olutasidenib), Vinblastine + Bevacizumab, Cobimetinib, PEMAZYRE (Pemigatinib), VERZENIO (abemaciclib) , and others. In December 2022, Chimerix announced the successful launch of the ONC201 Phase III ACTION study in patients with H3 K27M-mutant glioma. In June 2022, Day One Biopharmaceuticals announced positive initial data from its pivotal Phase II (FIREFLY-1) study with tovorafenib (DAY101) in relapsed pediatric low-grade glioma (pLGG). Discover which therapies are expected to grab the major glioma market share @ Glioma Market Report Glioma Overview Glioma is the most common kind of glial cell tumor in the central nervous system (CNS). Gliomas are infiltrative tumors that affect the brain tissue surrounding them. Glioblastoma is the most hazardous type of brain tumor, whereas pilocytic astrocytomas are the least dangerous. Previously, diffuse gliomas were classified into subgroups and grades depending on histopathologies, such as diffuse astrocytomas, oligodendrogliomas, or mixed gliomas/oligoastrocytomas. The specific etiology of glioma, like other primary brain tumors, remains unknown. However, certain variables may increase the risk of getting a brain tumor. Glioma symptoms vary depending on tumor type, size, location, and growth rate. Some common glioma symptoms include headache, nausea or vomiting, memory loss, urine incontinence, speech problems, and others. A medical history and a physical examination are used for glioma diagnosis. Glioma Epidemiology Segmentation DelveInsight estimates that there were approximately 47K incident cases of glioma in the 7MM in 2022. As per our analysis, the United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022. The glioma market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total glioma incident cases Glioma grade-specific cases Glioma age-specific cases Glioma type-specific cases Download the report to understand which factors are driving glioma epidemiology trends @ Glioma Epidemiological Insights Glioma Treatment Market Glioma treatment is based on the type of glioma, its size and location, and the patient's unique characteristics. Chemotherapy and radiation therapy will be administered after surgery, particularly in individuals when the tumor cannot be removed entirely because it has invaded critical parts of the brain or is inaccessible. The typical glioma treatment protocol comprises surgery, chemotherapy, and radiation. Chemotherapy may include carmustine (BCNU), lomustine (CCNU), or gleostine (generic), cisplatin, carboplatin, etoposide, and irinotecan in case of low-grade glioma whereas temozolomide (TEMODAR) is the standard chemotherapy used in case of high-grade glioma majorly, Gliadel wafer implants (biodegradable discs injected with BCNU) are usually given as adjunctive treatment after surgery, although usage of Gliadel wafers remains a point of controversy due to its questionable survival benefits. Avastin (Genentech) and Temodar/Temodal (Merck), among others, are approved medications for HGG. However, due to patent expiration, the generic version of Temodar and biosimilars of Avastin are available on the glioma market. As generics and biosimilars are more cost-effective for patients than new medicines, intense competition exists among them. Furthermore, due to a lack of knowledge concerning bevacizumab's overall survival benefit, it is not recommended in unselected patients with newly diagnosed GBM. Currently, only one medication for LGG is approved, Tafinlar (dabrafenib) plus Mekinist (trametinib). Moreover, the current therapeutic market lacks a viable method for curing glioblastoma; therefore, the survival rate of people diagnosed with glioma remains poor. Glioma is incurable, and treatment choices are limited. Furthermore, the tumor has a high recurrence rate and a poor patient prognosis. In addition, there is currently no approved therapy for the unmethylated MGMT patient pool. To know more about glioma treatment guidelines, visit @ Glioma Management Glioma Therapies and Key Companies Regorafenib: Bayer ONC201: Chimerix AV-GBM-1: Aivita Biomedical Enzastaurin (DB-102): Denovo Biopharma DCVax-L: Northwest Therapeutics Ofranergene Obadenovec (VB-111): VBL Therapeutics LAM561 (2-OHOA): Laminar Pharmaceuticals MEDI4736 (durvalumab): MedImmune Tasadenoturev (DNX-2401): DNAtrix ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics IGV-001: Imvax SurVaxM: MimiVax Berubicin: CNS Pharmaceuticals GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC) Lerapolturev + Pembrolizumab: Istari Oncology SONALA-001 + Exablate 2.0 Device: SonALAsense VAL-083 (dianhydrogalactitol): Kintara Therapeutics Pomalidomide: Bristol Myers Squibb MDNA55: Medicenna Therapeutics BMX-001: BioMimetix Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme Paxalisib (GDC-0084): Kazia Therapeutics OKN-007: Oblato Temferon: Genenta Science EO2401: Enterome INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals Selinexor (KPT-330): Karyopharm Therapeutics VBI-1901: VBI Vaccines NOX-A12 (Olaptesed Pegol): TME Pharma Tovorafenib (DAY101): Day One Biopharmaceuticals Vorasidenib (AG-881): Servier Eflornithine: Orbus Therapeutics TVI-Brain-1: TVAX Biomedical AB-218: AnHeart Therapeutics BGB-290: Beigene Mirdametinib: SpringWorks Therapeutics FT-2102 (Olutasidenib): Forma Therapeutics Vinblastine + Bevacizumab: Hoffmann-La Roche Cobimetinib: Hoffmann-La Roche PEMAZYRE (Pemigatinib): Incyte Corporation VERZENIO (abemaciclib): Eli Lilly Learn more about the FDA-approved drugs for glioma @ Drugs for Glioma Treatment Glioma Market Dynamics Glioma market growth can be ascribed to various factors, including an aging population, evolving research, better diagnostic tests, developing surgical procedures, improved radiotherapy techniques, and novel systemic medicines. Commercially, there is a greater emphasis on high-grade glioma than low-grade glioma because patients with low-grade glioma often live longer than those with high-grade glioma. As a result, just a few therapies are in late-stage studies, while the majority are in early-stage trials. In the case of GBM, on the other hand, the pipeline is robust, with numerous potential therapies in late and mid-stage research that have yet to be marketed. The pipeline includes drugs with varied modes of action and administration routes. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the glioma market dynamics in the upcoming years. The current glioma market has been categorized based on the dominant treatment pattern across the 7MM, which shows slight variances in the overall prescription pattern. The forecast model considers surgery, chemotherapy/radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide. The anticipated launch of new therapies and improved integration of early patient screening, medication in secondary care and other clinical settings, research on optimum implementation methods, and increased awareness may eventually facilitate the development of successful treatment alternatives. However, there are a few challenges to the timely identification and treatment of these patients, such as a lack of a reliable biomarker that can aid in diagnosis and patient classification and identifying recurrence and signaling medication response. Furthermore, the failure rate of high-phased drug trials is significant, making it impossible to predict trial success, exacerbating the need for medicines that could assist ease the patient segment with this severe kind of cancer. Scope of the Glioma Market Report Therapeutic Assessment: Glioma current marketed and emerging therapies Glioma Market Dynamics: Conjoint Analysis of Emerging Glioma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Glioma Market Access and Reimbursement Discover more about glioma drugs in development @ Glioma Clinical Trials Table to Contents Related Reports Glioma Epidemiology Forecast Glioma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted glioma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Glioma Pipeline Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioma companies, including PTC Therapeutics, Ono Pharmaceuticals, Philogen, SpringWorks Therapeutics, Xennials Therapeutics, AnHeart Therapeutics, Istari Oncology, among others. High-Grade Glioma Pipeline High-Grade Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key high-grade glioma companies, including PTC Therapeutics, Aadi, Lee's Pharmaceutical, among others. Malignant Glioma Pipeline Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key malignant glioma companies, including Bexion Pharmaceuticals, Inc., Lee's Pharmaceutical Limited, Merck & Co, Oblato, Inc., OncoSynergy, Inc, among others. Recurrent Malignant Glioma Pipeline Recurrent Malignant Glioma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent malignant glioma companies, including Bexion Pharmaceuticals, Inc., Merck, Oblato, OncoSynergy, Inc, among others. Glioblastoma Pipeline Glioblastoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key glioblastoma companies, including AstraZeneca, BioNTech, Merck, Pfizer, Roche, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2VaccineImmunotherapy

01 Mar 2023

·www.prnewswire.com

INOVIO Reports Fourth Quarter and Full Year 2022 Financial Results and Clinical Highlights

Announces topline results from REVEAL2, the second Phase 3 trial evaluating VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions (HSIL) Trial results did not meet the primary endpoint in the biomarker-selected population Trial results did achieve statistical significance in the all-participants population Highlights progress of promising product candidates: Positive preliminary data from Phase 1/2 trial of INO-3107 for the treatment of Recurrent Respiratory Papillomatosis Positive Phase 1b data for INO-4201 as Ebola booster for Ervebo® as primary series Positive data from a Phase 1/2 trial with INO-5401 in patients with glioblastoma Updated results published for INO-3112, a product candidate being evaluated for the treatment of HPV-related cancers Ended 2022 with $253 million in cash, cash equivalents, and short-term investments and maintains cash runway projections to first quarter 2025 Management will host conference call today at 4:30 p.m. ET PLYMOUTH MEETING, Pa., March 1, 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 reported financial results for the quarter and year ended December 31, 2022, and provided a business update. INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update for the fourth quarter. The live webcast and replay may be accessed by visiting INOVIO's website at . INOVIO's President and Chief Executive Officer, Dr. 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 first quarter 2025, enabling us to focus energy and resources on advancing candidates with scientific promise, achievable pathways to market, and strong commercial potential. Our continued commitment to financial discipline and operational excellence will guide us as we work to get those candidates across the finish line and ultimately deliver on the promise of DNA medicines for patients." Dr. Shea continued, "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. 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." Corporate Updates REVEAL2 Data Results for VGX-3100 in Cervical HSIL INOVIO today announced results for REVEAL2. The company previously announced this trial was no longer pivotal and would not lead to a biologics license application (BLA) for a biomarker-selected population, as the U.S. Food and Drug Administration (FDA) had indicated that one or more additional trials would be required. REVEAL2 was the second Phase 3 trial evaluating VGX-3100 for efficacy, safety, tolerability, and immunogenicity in treating HPV-16/18-related cervical HSIL. Trial participants included 203 women, 18 years of age or older, with histologically-confirmed cervical HSIL associated with HPV-16 and/or HPV-18, but who were otherwise healthy (NCT03185013). Participants received either VGX-3100 or placebo at weeks 0, 4 and 12 (randomized 2:1). In April 2022, the trial was amended to utilize a biomarker-selected population as the primary population, based on prior analysis that this investigational biomarker had the potential to identify women more likely to respond to treatment with VGX-3100. In this trial, statistical significance was not achieved in the investigational biomarker-selected population for the endpoint of lesion regression and viral clearance. However, statistical significance was achieved in the all-participants population for the endpoint of lesion regression and viral clearance. The percentage of participants in the investigational biomarker-selected population meeting the primary endpoint was 28.6% (6/21) in the treatment group, versus 0% (0/4) in the placebo group (p=0.115; difference in percentage 28.6, 95%CI: -24.6, 50.4), which was not statistically significant. The result for the secondary endpoint of regression of HSIL and clearance of virus in the all-participants population of 203 participants (134 participants in the treatment group, 69 in the placebo group) was statistically significant, with 27.6% (37/134) of the participants meeting the endpoint in the treatment group, versus 8.7% (6/69) in the placebo group (p=0.001; difference in percentage 18.9, 95%CI: 7.8, 28.6). In particular, in the all-participants population of REVEAL2, viral clearance was observed in 37.3% (50/134) in the 3-dose treatment group versus 8.7% (6/69) in the placebo group. Given the importance of viral clearance in removing the underlying cause of the HPV-related diseases, this data may have positive implications for our other HPV-related programs. An ad-hoc integrated efficacy analysis of the results for both REVEAL1 and REVEAL2 shows statistical significance in both the biomarker-selected and all-participants populations. For the combined biomarker-selected population of 92 participants (68 participants in the treatment group, 24 in the placebo group), the percentage of participants meeting the endpoint was 54.4% (37/68 in the treatment group, versus 12.5% (3/24) in the placebo group (p<0.001; difference in percentage 41.9, 95%CI: 20.4, 57.0). For the combined all-participants population of 404 participants (272 participants in the treatment group, 132 in the placebo group), the percentage of participants meeting the endpoint was 25.0% (68/272 in the treatment group, versus 9.8% (13/132) in the placebo group (p<0.001; difference in percentage 15.2, 95%CI: 7.4, 22.1). This combined data set will be used as supportive data in future regulatory interactions involving VGX-3100. As in REVEAL1, VGX-3100 was well-tolerated in REVEAL2. There were no treatment-related serious adverse events and most adverse events were considered to be mild to moderate. INOVIO will continue to evaluate the results to determine the path forward for VGX-3100 in our HPV programs and plans to submit the data for publication in a peer-reviewed journal later this year. The Phase 3 trial of VGX-3100 in Greater China is currently ongoing, and INOVIO is working together with its development partner ApolloBio under our collaboration agreement, with the shared goal of advancing a treatment with the potential to improve the lives of patients in that market. Clinical Highlights Over the last year, positive data were announced for multiple programs in clinical development, including: INO-3107 – RRP INOVIO announced positive results from a Phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-related RRP in adults. Results from the first cohort of 21 participants showed a statistically significant improvement in the clinical endpoint of the number of surgical interventions needed to control papilloma growth, with a median decrease of three surgical interventions. In the second cohort of 11 patients, which delivered INO-3107 via exploratory side port needle, 10 of the 11 patients (91%) saw a reduction in number of surgeries in the year following initial treatment, with measurement beginning at Day 0, the start of trial therapy. Of these 10, four patients needed no surgery. There was a median decrease of three surgical interventions when comparing the year following treatment to the year prior, which was also statistically significant. In the year prior to treatment, the range of surgical interventions for these 11 patients was 2 to 8 and the median was 5. In both cohorts, INO-3107 was well-tolerated and immunogenic. In both cohorts, patients received four doses of INO-3107: on Day 0, and Weeks 3, 6, and 9. Surgery was performed once in the two weeks prior to the first dose in order to establish a disease baseline, but any surgery performed following Day 0, including in the dosing window, was counted against the efficacy endpoint. Conversations with regulators regarding development plans for INO-3107 are ongoing. INOVIO will present the Phase 1/2 trial results for INO-3107 at the 103rd Annual Meeting of the American Broncho-Esophageal Association at the 2023 Combined Otolaryngology Spring Meetings in May. INO-4201 – Ebola Booster for rVSV-ZEBOV (Ervebo®) In a recently announced Phase 1b clinical trial in healthy adult participants who previously received a single injection of Ervebo, INO-4201 was found to be well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants. INOVIO believes these data indicate that DNA medicines could be an important part of global medical countermeasures against infectious diseases, either as primary vaccines or boosters to existing vaccines. INOVIO is currently in discussions with collaborators and potential partners regarding the next steps for the program. INO-5401 – GBM In 2022, INOVIO announced promising results from a Phase 1/2 trial of INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo® (cemiplimab) in newly diagnosed GBM patients. The data from this trial showed encouraging median overall survival data from 52 patients and evidence of antigen-specific T cells that may infiltrate GBM tumors. INO-3112 – HPV-Related Cancers In February 2022, updated results were published in Clinical Cancer Research which included an improved Overall Response Rate (ORR) from a Phase 1b/2a trial in which the safety and tolerability, anti-tumor activity, and immunogenicity of INO-3112, when used in combination with durvalumab, a PD-L1 checkpoint inhibitor, was evaluated as a potential treatment for HPV-related head and neck cancer. The ORR was updated from 22.2% with three complete responses and three partial responses, to an ORR of 27.6% with four complete responses and four partial responses. As previously announced, the INO-3112 program was returned to INOVIO in 2021 from AstraZeneca. Fourth Quarter 2022 Financial Results As of December 31, 2022, cash and cash equivalents and short-term investments were $253.0 million compared to $401.3 million as of December 31, 2021. As of December 31, 2022, INOVIO had 253.1 million common shares outstanding and 271.0 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt. Total revenue was $125,000 and $10.3 million for the quarter and year-ended December 31, 2022, respectively, compared to $839,000 and $1.8 million for the same period in 2021, respectively. The year-over-year increase in revenue resulted from the fulfillment of obligations under INOVIO's contract with the U.S. Department of Defense. Total operating expenses were $56.1 million and $277.8 million for the quarter and year-ended December 31, 2022, respectively, compared to $106.3 million and $303.0 million for the same period in 2021. INOVIO's net loss for the quarter and year-ended December 31, 2022 was $54.5 million, or $0.22 per basic and diluted share, and $279.8 million, or $1.17 per basic and diluted share, respectively, compared to net loss of $106.9 million, or $0.50 per basic and diluted share, and $303.7 million, or $1.45 per basic and diluted share, for the quarter and year-ended December 31, 2021, respectively. Operating Expenses Research and development (R&D) expenses for the quarter and year-ended December 31, 2022, were $42.1 million and $187.7 million, respectively, compared to $92.3 million and $249.2 million, respectively, for the same periods in 2021. The year-over-year decrease in R&D expenses was primarily related to lower drug manufacturing, outside services and clinical study expenses related to INO-4800 and VGX-3100, expenses related to the acquisition and installation of manufacturing equipment for INO-4800 during 2021 which were non-recurring, lower engineering services and expensed equipment related to our CELLECTRA® 3PSP device array automation project, lower expensed inventory related to the CELLECTRA 2000 device and lower employee stock-based compensation. These decreases were offset by $29.2 million lower contra-research and development expenses recorded from grant agreements, $14.4 million of increased drug manufacturing costs related to our COVID-19 variant studies and DARPA COVID-19 dMAb grant and other variances. General and administrative (G&A) expenses were $14.0 million and $90.2 million, respectively, for the quarter and year ended December 31, 2022, versus $14.0 million and $53.8 million, respectively, for the same periods in 2021. The year-over-year increase in G&A expenses was primarily due to a $14.0 million non-cash expense related to the settlement of INOVIO's securities class action litigation, including the issuance of INOVIO common stock as part of the settlement, $14.3 million in higher legal expenses, primarily related to litigation matters, $6.9 million in one-time severance expenses and $1.6 million in higher employee compensation, among other variances. INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's annual report on Form 10-K for the year ended December 31, 2022, which can be accessed at: . Financial Guidance INOVIO expects to maintain its cash runway into the first quarter of 2025. This projection includes its cash burn estimate of approximately $32 million for the first quarter 2023 and its ongoing expectation that cash burn will decrease incrementally from there into the first quarter of 2025. These projections do not include any funds that may be raised through the Company's existing at-the-market program or other capital-raising activities. Conference Call / Webcast Information INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at . About INOVIO 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. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device, CELLECTRA®, to produce immune responses against targeted pathogens and cancers. For more information, visit . About CELLECTRA® Delivery Technology INOVIO's DNA medicines in development are delivered into cells either intramuscularly (IM) or intradermally (ID) using its investigational proprietary CELLECTRA smart devices. CELLECTRA devices use brief (millisecond-long) electrical pulses to reversibly create tiny pores in the cell membrane, which enhance cellular uptake of DNA medicines. In 2022, with the support of the U.S. Department of Defense, INOVIO developed its next-generation ID delivery device, 3PSP, and an automated high throughput array manufacturing process. Contacts Media: Jennie Willson (267) 429-8567 [email protected] Investors: Thomas Hong (267) 440-4298 [email protected] Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, and expectations with respect to our cash resources and expected operating expenses through 2024. 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, 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, 2022, 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 the 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. SOURCE INOVIO Pharmaceuticals, Inc.

Clinical ResultPhase 3Phase 1Financial StatementVaccine

100 Deals associated with Rocakinogene Sifuplasmid

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Phase 2	US	Inovio Pharmaceuticals, Inc.	31 May 2018
Locally Advanced Urothelial Carcinoma	Phase 2	US	Inovio Pharmaceuticals, Inc.	24 May 2018
Transitional Cell Carcinoma	Phase 2	US	Inovio Pharmaceuticals, Inc.	24 May 2018
Transitional Cell Carcinoma	Phase 2	ES	Inovio Pharmaceuticals, Inc.	24 May 2018
Head and Neck Neoplasms	Phase 2	US	MedImmune LLC	26 Jun 2017
Human Papillomavirus Infection	Phase 2	US	Inovio Pharmaceuticals, Inc.	26 Jun 2017
Human Papillomavirus Infection	Phase 2	US	MedImmune LLC	26 Jun 2017
Squamous Intraepithelial Lesions of the Cervix	Phase 2	US	Inovio Pharmaceuticals, Inc.	26 Jun 2017
Urogenital Abnormalities	Phase 2	US	Inovio Pharmaceuticals, Inc.	26 Jun 2017
Vulvar Diseases	Phase 2	US	Inovio Pharmaceuticals, Inc.	26 Jun 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04251117 (SITC2022) Manual	Phase 1/2	Advanced Hepatocellular Carcinoma Second line	24	Pembrolizumab+GNOS-PV02+INO-9012	isckkyrtfi(zucjktdgwc) = elednzwtfb wdpiqxnchj (mgqnxrhxsd ) View more	Positive	01 Nov 2022
NCT03491683 (ASCO2022) Manual	Phase 1/2	Glioblastoma First line	52	electroporation+cemiplimab+Temozolomide+Radiation Therapy+INO-5401+INO-9012 (unmethylated MGMT)	rnwwikwzvb(glknlkzwca) = akljhpgexb cnhyskgasq (avkjnernoo, 14.5 - 19.8)	Positive	02 Jun 2022
NCT03491683 (ASCO2022) Manual	Phase 1/2	Glioblastoma First line	52	electroporation+cemiplimab+Temozolomide+Radiation Therapy+INO-5401+INO-9012 (methylated MGMT)	rnwwikwzvb(glknlkzwca) = rcvjtepqhu cnhyskgasq (avkjnernoo, 18.4 - NR)	Positive	02 Jun 2022
NCT03491683 (ASCO2020) Manual	Phase 1/2	Glioblastoma First line	52	cemiplimab +RT/TMZ+INO-5401+INO-9012 (Cohort A：32 pts，MGMT unmethylated；Cohort B：20 pts，MGMT methylated)	xmuvjzrvxg(qxiqqgjfku) = 1/69 related to the combination therapy, Grade 1 pyrexia. mchzwhhwyw (ijpnzjnrrj ) View more	Positive	29 May 2020

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