HPV 16-positive and/or HPV 18-positive recurrent and/or For patients with metastatic head and neck cancer to evaluate GX-188E DNA vaccination, GX-I7 and nivolumab combination therapyOpen-label Phase 2 Clinical Trial with Lead-In Safety Cohort

Start Date02 May 2022

Sponsor / Collaborator

Yonsei University Severance Hospital

NCT05280457

/ RecruitingPhase 2IIT

HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy Open-label Phase 2 Clinical Trial With Lead-In Safety Cohort

This study is to explore the efficacy and safety of GX-188E DNA vaccination, GX-I7, and nivolumab combination therapy in HPV 16-positive and/or HPV-18 positive R/M HNSCC patients. The objective of this study is as follows.
* Primary objective: Objective response rate (ORR) according to RECIST v1.1
* Secondary objectives: disease control rate (DCR) according to RECIST v1.1, progression-free survival (PFS) at 6 months, median progression-free survival (PFS), median overall survival (OS), biomarker correlation, safety and tolerability.

Start Date15 Apr 2022

Sponsor / Collaborator

Yonsei University

NCT05286060

/ Active, not recruitingPhase 2IIT

Open-label Phase II Trial for the Combination of GX-188E HPV DNA Vaccine With GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer (Expanded Cohort)

The study is open label, phase II clinical trial for the Combination of GX-188E HPV DNA Vaccine with GX-I7 or Pembrolizumab OR the Triple Combination of GX-188E HPV DNA Vaccine, GX-I7, and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 or 18 Positive Head and Neck Cancer.

Start Date01 Mar 2022

Sponsor / Collaborator

Yonsei University

[+2]

100 Clinical Results associated with Tirvalimogene Teraplasmid

100 Translational Medicine associated with Tirvalimogene Teraplasmid

100 Patents (Medical) associated with Tirvalimogene Teraplasmid

Literatures (Medical) associated with Tirvalimogene Teraplasmid

01 Aug 2024·EClinicalMedicine

GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial

Article

Author: Woo, Jung Won ; Kim, Yong-Man ; Park, Jong Sup ; No, Jae Hong ; Choi, Yoon-Jeong ; Lim, Myong Cheol ; Choi, Youn Jin ; Cho, Chi Heum ; Kim, Byoung-Gie ; Lee, Jae-Kwan ; Kim, Ji Hyun ; Kim, Sung Hoon ; Jeong, Dae Hoon ; Sung, Young Chul ; Hur, Soo-Young

Background:

In an interim analysis of this phase 2 trial, adding the GX-188E vaccine to pembrolizumab resulted in manageable toxicity with antitumor activities in patients with recurrent or advanced cervical cancer. Here, we report the final safety and efficacy results after a long-term follow-up at the study's completion.

Methods:

This open-label, single-arm, phase II trial was conducted in nine hospitals in South Korea (ClinicalTrials.gov identifier, NCT03444376). Eligible patients were aged ≥18 years with recurrent or advanced inoperable cervical cancer, Eastern Cooperative Oncology Group Performance status of 0 or 1, and positivity for HPV 16/18, who failed the available standard-of-care therapy. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, 19, and 46 and intravenous 200 mg pembrolizumab every 3 weeks for up to 2 years or until disease progression. The primary endpoint was the objective response rate (ORR) within 24 weeks.

Findings:

Between June 19, 2018, and December 24, 2021, 65 patients were enrolled and received at least one dose of the study treatment. Sixty patients received combination treatment with GX-188E and pembrolizumab and underwent efficacy analysis. After a median follow-up of 14.72 months, the confirmed ORR was 35.0% (95% CI, 23.1-48.4). Five patients (8.3%) had a complete response, and 16 (26.7%) had a partial response. In addition, patients with PD-L1-positive and PD-L1-negative tumors had an ORR of 38.9% (95% CI, 23.1-56.5) and 29.2% (95% CI, 12.6-51.1), respectively. The median duration of response of all the patients was 12.3 months (95% CI, 5.3-not reached [NR]). For those with PD-L1-positive tumors, it was 12.3 months (95% CI, 3.5-NR), and for those with PD-L1-negative tumors, it was NR (95% CI, 2.4-NR). The median progression-free survival of the 60 patients was 4.4 months (95% CI, 2.1-8.3), and the median overall survival was 23.8 months (95% CI, 14.0-NR). 22 (33.8%) of 65 patients had treatment-related adverse events (TRAEs) of any grade and four (6.2%) had grade 3-4 TRAEs. No treatment-related deaths occurred.

Interpretation:

The GX-188E vaccine combined with pembrolizumab in recurrent or advanced HPV-positive cervical cancer was safe and showed a promising overall survival and clinical response rate. This combination therapy might provide a new potential treatment option for patients with recurrent or advanced cervical cancer.

Funding:

National Cancer Center Onco-Innovation Unit, Korea.

01 Feb 2021·Toxicology and applied pharmacologyQ3 · MEDICINE

Preclinical safety assessment of a therapeutic human papillomavirus DNA vaccine combined with intravaginal interleukin-7 fused with hybrid Fc in female rats

Q3 · MEDICINE

Article

Author: Kim, Sang Kyum ; Park, Ki Seok ; Choi, Donghoon ; Jeong, Hye Gwang ; Han, Hyoung-Yun ; Moon, Kyoung-Sik ; Jang, Min Seong ; Han, Kang-Hyun ; Im, Wan-Jung ; Jung, Kyung Jin

This study was conducted to establish the toxicological profile of combination treatment with therapeutic HPV DNA vaccines (GX-188E) and the long-acting form of recombinant human interleukin-7 fused with hybrid Fc (IL-7hyFc). GX-188E was administered intramuscularly by electroporation with or without IL-7hyFc intravaginally once per 2 weeks for 8 weeks (five times) in female Sprague-Dawley rats. Because up-regulation of immune responses and migration of antigen-specific T cells in cervicoviginal tissue were predicted as therapeutic effects, we distinguished adverse effects from therapeutic effects based on the severity of the systemic immune response, reversibility of lymphoid tissue changes, target tissue damage, and off-target immune responses. We observed that the number of neutrophils was increased, and the number of lymphocytes was decreased in the blood. Further, myofiber degeneration, necrosis, fibroplasia, and cell infiltration were observed at the GX-188E administration site. These changes were fully or partially recovered over a 4-week period. Analysis of lymphocytes in spleen revealed that CD4⁺ T cells and total T cells decreased in rats treated with GX-188E in combination with a high dose of IL-7hyFc (1.25 mg/animal). However, these changes were not considered adverse because they were transient and may have been related to electroporation-mediated DNA delivery or the local migration of lymphocytes induced by IL-7. Therefore, the potential toxicity of the combination of GX-188E and IL-7hyFc treatment was comparable to that of GX-188E treatment alone, and the no observed adverse effect level for GX-188E with IL-7hyFc was considered as 320 μg/animal for GX-188E and 1.25 mg/animal for IL-7hyFc.

01 Dec 2020·The Lancet. OncologyQ1 · MEDICINE

Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial

Q1 · MEDICINE

Article

Author: Marya F Chaney ; Sang Yoon Park ; Jong Sup Park ; Jung Won Woo ; Jae Hong No ; Soo-Young Hur ; You Suk Suh ; Young Chul Sung ; Yoon-Jeong Choi ; Jin Won Youn ; Myong Cheol Lim ; Kyungun Kim ; Sang Soo Seo ; So Jin Shin ; Yong-Man Kim ; Jae-Kwan Lee ; Byoung-Gie Kim

BACKGROUND:

Survival outcomes for patients with recurrent or advanced cervical cancer are poor. Pembrolizumab has been approved for the treatment of recurrent or metastatic cervical cancer, with an overall response rate of 14·3%. GX-188E vaccination has been shown to induce human papillomavirus (HPV) E6-specific and E7-specific T-cell responses and cervical lesion regression in patients with cervical precancer. We aimed to investigate whether a combination of GX-188E therapeutic DNA vaccine plus pembrolizumab showed antitumour activity against recurrent or advanced cervical cancer.

METHODS:

In this open-label, single-arm, phase 2 trial, patients with recurrent or advanced, inoperable cervical cancer, who were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and histologically confirmed recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer, and who had progressed after available standard-of-care therapy were recruited from seven hospitals in South Korea. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, and 19, with one optional dose at week 46 that was at the investigator's discretion, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was the overall response rate within 24 weeks assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 in patients who received at least 45 days of treatment 45 days of treatment with at least one post-baseline tumour assessment, and this is the report of a planned interim analysis. This trial is registered with ClinicalTrials.gov, NCT03444376.

FINDINGS:

Between June 19, 2018, and March 20, 2020, 36 patients were enrolled and received at least one dose of the study treatment. 26 patients were evaluable for interim activity assessment, with at least one post-baseline tumour assessment at week 10. At the data cutoff date on March 30, 2020, median follow-up duration was 6·2 months (IQR 3·5-8·1). At 24 weeks, 11 (42%; 95% CI 23-63) of 26 patients achieved an overall response; four (15%) had a complete response and seven (27%) had a partial response. 16 (44%) of 36 patients had treatment-related adverse events of any grade and four (11%) had grade 3-4 treatment-related adverse events. Grade 3 increased aspartate aminotransferase, syncope, pericardial effusion, and hyperkalaemia, and grade 4 increased alanine aminotransferase were reported in one patient each. No treatment-related deaths were reported.

INTERPRETATION:

Treatment with GX-188E therapeutic vaccine plus pembrolizumab for patients with recurrent or advanced cervical cancer was safe and treatment-related adverse events were manageable. This combination therapy showed preliminary antitumour activity in this interim analysis, which could represent a new potential treatment option for this patient population. This trial is ongoing.

FUNDING:

National OncoVenture.

News (Medical) associated with Tirvalimogene Teraplasmid

27 Oct 2023

·www.prnewswire.com

Cervical Intraepithelial Neoplasia Pipeline Research Report 2023 Featuring Inovio Pharmaceuticals, Frantz Viral Therapeutics, Antiva Biosciences, Genexine, and Merck Sharp & Dohme

DUBLIN, Oct. 27, 2023 /PRNewswire/ -- The "Cervical Intraepithelial Neoplasia - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. The "Cervical Intraepithelial Neoplasia - Pipeline Insight, 2023" report offers a comprehensive overview of the Cervical Intraepithelial Neoplasia (CIN) pipeline landscape, featuring insights into more than 8 companies and over 10 pipeline drugs. The report provides detailed profiles of pipeline drugs, encompassing both clinical and nonclinical stage products. It offers a comprehensive assessment of these therapeutics based on product type, development stage, route of administration, and molecule type. Additionally, the report highlights inactive pipeline products within this domain. This report furnishes a thorough understanding of the current scenario and growth prospects related to Cervical Intraepithelial Neoplasia. It encompasses a detailed depiction of the CIN pipeline landscape, encompassing an overview of the disease and treatment guidelines. The assessment section of the report includes a deep dive into the commercial and clinical evaluation of pipeline products in development. It provides an in-depth description of each drug, including its mechanism of action, clinical studies, NDA approvals (if any), and product development activities. This encompasses technological aspects, collaborations, licensing agreements, mergers and acquisitions, funding, designations, and other product-related details. Cervical Intraepithelial Neoplasia Emerging Drugs Chapters: This section of the Cervical Intraepithelial Neoplasia report provides a detailed analysis of various drugs at different stages of clinical development, including phase II, I, preclinical, and discovery. It offers insights into clinical trial details, the pharmacological action of these drugs, agreements, collaborations, and the latest news and press releases in the field. Report Highlights: Companies and researchers are actively working to assess challenges and explore opportunities that could influence the research and development of treatments for Cervical Intraepithelial Neoplasia. Emerging therapies in development focus on innovative approaches to enhance the treatment of Cervical Intraepithelial Neoplasia. Cervical Intraepithelial Neoplasia Emerging Drugs VGX-3100: Inovio Pharmaceuticals INOVIO's product candidate VGX-3100 is designed to significantly increase T cell immune responses against the E6 and E7 antigens of HPV types 16 and 18 that are present in both precancerous and cancerous cells transformed by these HPV types. INOVIO's lead candidate VGX-3100, currently in Phase III trials for precancerous cervical dysplasia. In the Phase IIb clinical trial the drug demonstrated that it had eliminated high grade dysplasia in nearly 50% of women; in 80% of those whose high grade dysplasia was eliminated, the HPV infection was also cleared by VGX-3100. Artesunate: Frantz Viral Therapeutics Artesunate is a derivative of artemisinin. The drug is self-administered via vaginal inserts (similar to yeast infection treatment), anal suppositories, or as an ointment for pre-cancers of cervical, perianal and vulvar/vaginal tissues respectively. The safe and effective Phase I study of artesunate for the treatment of CIN results are published in Gynecologic Oncology, the journal of the Society of Gynecologic Oncology: A First-in Human Proof-of Concept Trial of Intravaginal Artesunate and were found safe and well-tolerated, at clinically effective doses to treat CIN. Currently, the drug is being evaluated in the Phase II stage of development. Cervical Intraepithelial Neoplasia: Therapeutic Assessment This segment of the report provides insights about the different Cervical Intraepithelial Neoplasia drugs segregated based on following parameters that define the scope of the report, such as: Cervical Intraepithelial Neoplasia: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cervical Intraepithelial Neoplasia therapeutic drugs key players involved in developing key drugs. Key Questions Answered How many companies are developing Cervical Intraepithelial Neoplasia drugs? How many Cervical Intraepithelial Neoplasia drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Cervical Intraepithelial Neoplasia? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Cervical Intraepithelial Neoplasia therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Cervical Intraepithelial Neoplasia and their status? What are the key designations that have been granted to the emerging drugs? Pipeline Development Activities Cervical Intraepithelial Neoplasia Report Insights Cervical Intraepithelial Neoplasia Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Cervical Intraepithelial Neoplasia Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Inovio Pharmaceuticals Frantz Viral Therapeutics Antiva Biosciences Genexine, Inc. Merck Sharp & Dohme Key Products VGX-3100 Artesunate ABI-2280 GX-188E Pembrolizumab For more information about this clinical trials report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Phase 2Phase 3Phase 1Clinical Result

30 Aug 2023

·www.biospace.com

Genexine’s long-acting growth hormone meets Phase 3 primary endpoint

Phase 3 clinical trial in China meets primary endpoint On track to in China in 2024 SEOUL, South Korea--(BUSINESS WIRE)-- Genexine Co. Ltd. (KOSDAQ:095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced positive topline results from the multi-center, randomized, open-label, active-controlled pivotal phase 3 study (CTJ101PGHD301) being conducted in China to evaluate the efficacy and safety of eftansomatropin alfa (Genexine’s proprietary long-acting growth hormone, also known as GX-H9) in children with growth hormone deficiency. The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®. Eftansomatropin alfa was given by weekly injection vs. Norditropin® given by daily injection. The mean AHV was 10.76 (cm/year) for eftansomatropin alfa vs. 10.28 (cm/year) for Norditropin®, with a difference of 0.47 [95% CI -0.06,1.00] and non-inferiority p-value <0.0001. Eftansomatropin alfa was well tolerated and no drug discontinuation was reported due to treatment related adverse events. The safety pro eftansomatropin alfa was comparable to Norditropin®. The Company is planning to BLA submission in China in 2024. “We are pleased with the results from this registration trial as this demonstrates clear safety and efficacy in this potential best-in-class drug to treat children with growth hormone deficiency,” said Neil Warma, Genexine President and CEO. “This is a significant milestone for Genexine as we demonstrate our ability to bring our novel products to market and the value of our proprietary long-acting hyFc® platform. We are excited to be preparing to submit the BLA in 2024 and advancing this product to market and to patients in China. We remain committed to our efforts to commercialize our leading products in various key markets.” About Eftansomatropin alfa (long-acting recombinant human growth hormone) GX-H9 has been developed utilizing Genexine’s hyFc® platform as a treatment for growth hormone deficiency (GHD). GX-H9 is currently being evaluated in a phase 3 registration trial in pediatric GHD in China with a BLA submission expected in 2024. GX-H9 is a potential best-in-class product that is differentiated by its extended half-life resulting in significantly fewer injections (weekly versus daily) and its improved safety profile. Patient compliance has been dramatically improved, which is critical for the pediatric population. GX-H9 is being co-developed with Handok under a strategic partnership and with I-Mab for development in greater China. I-Mab has partnered with Jumpcan for product launch and commercialization of eftansomatropin alfa in China. About Genexine Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The Company has multiple products in clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188E (tirvalimogene teraplasmid) for head and neck cancer and cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. Forward Looking Statements This press release contains forward-looking statements regarding the business of Genexine, Inc. ("Genexine"). Any statement describing Genexine's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Genexine's drug development pipeline, including without limitation GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), GX- E4 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Genexine's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Genexine's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Genexine. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Genexine's programs are described in additional detail in Genexine's annual reports on the DART (Data Analysis, Retrieval and Transfer System) internet site ( ) of the Korean Financial Services Commission. Genexine assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Phase 3Clinical ResultVaccinePhase 2

26 May 2023

·www.biospace.com

Genexine Abstract on GX-188E and GX-I7 Triple Combination Therapy in HNSCC Is Released at 2023 ASCO Annual Meeting

Triple combination using Genexine’s DNA vaccine GX-188E, its long-acting Interleukin-7 GX-I7 and Keytruda showed a major pathological response rate of 63.6% in a phase 2 trial, satisfying primary evaluation criteria A promising new therapeutic option for HPV-positive HNSCC patients as a neoadjuvant therapy SEOUL, South Korea--(BUSINESS WIRE)-- Genexine (KQ 095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, announced the publication of an abstract of its phase 2 clinical trial on triple combination neoadjuvant therapy for HNSCC (head and neck squamous cell carcinoma) in the ASCO (American Society of Clinical Oncology). The study evaluated the DNA vaccine GX-188E (tirvalimogene teraplasmid) and the lymphopenia-correcting immune-oncology drug GX-I7 (efineptakin alfa) in combination with immune checkpoint inhibitor Keytruda® (pembrolizumab). The phase 2 investigator-initiated clinical trial (IIT) being conducted in South Korea led by Professor Hye-Ryun Kim, Division of Medical Oncology of Yonsei University Severance Hospital, and jointly conducted with a research team of Professor Yoon Woo Koh, Department of Otolaryngology, enrolled a total of 11 patients with HPV-positive cervical cancer who were scheduled for surgery. The patients received Keytruda 200mg on day 1 and 22, Genexine’s GX-188E DNA vaccine 2mg on day 1, 8, 22 and GX-I7 on day 8 to amplify the number of T cells before surgery. The primary endpoint evaluated the major pathological response (MPR) and other evaluation criteria included safety, recurrence rate and survival rate. All 11 patients who participated in the trial underwent surgery as planned after neoadjuvant therapy with no increase in surgical delay or surgical complications. Seven patients (63.6%) showed a major pathological response (MPR), and four patients (36.3%) achieved a pathological complete response (pCR), indicating satisfactory primary evaluation variables. Furthermore, comparative analysis of the tissue before and after combination therapy revealed an increase in follicular helper T cells (CD4+) and reactivation of killer T cells (CD8+) in the tumor microenvironment. Using AI-based analysis technology, the triple combination therapy was found to increase the density of tumor-infiltrating lymphocytes (TIL) and completely transform tumors classified as immune-desert or immune-excluded types into inflamed tumors. Professor Hye-Ryun Kim, who led the clinical trial, said, “Through this clinical study conducted for human papillomavirus (HPV)-positive HNSCC patients, the efficacy and safety of the triple combination therapy appear to be confirmed, and the therapy could become an effective new treatment strategy for HPV positive HNSCC patients in the future." "We are pleased by these early data in this important trial as this is the first time this combination therapy has been used,” said Neil Warma, President and CEO of Genexine. “Head and neck cancer remains such a serious unmet need and we believe there is potential to expand the label for GX-188E beyond cervical cancer to include HNSCC." HNSCC cancer is one of the malignant tumors that occur on the patient's facial area and is commonly caused by factors such as smoking and high-risk HPV infection. While various treatment methods such as surgery, radiation therapy and chemotherapy have been used in the past, the size of the surgical area can significantly impact the patient's quality of life. Therefore, immunotherapy has been gaining attention as a treatment option along with the development of immune checkpoint inhibitors. The results of this study will be presented in a poster session at the ASCO 2023 Annual Meeting, which will be held in Chicago from June 2 to 6, 2023. Details of the poster presentation are as follows: Abstract Title Neoadjuvant pembrolizumab, GX-188E, and GX-I7 in patients with human papillomavirus-16- and/or 18-positive head and neck squamous cell carcinoma: Single-arm, phase 2 trial with single cell transcriptomic analysis and artificial intelligence-powered spatial analysis. Session Title Head and Neck Cancer Abstract Number 6075 Date and Time June 5, 2023, 1:15 - 4:15 PM About Genexine Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFcR fusion technology. The Company has multiple products in clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 (tirvalimogene teraplasmid) for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. Forward Looking Statements This press release contains forward-looking statements regarding the business of Genexine, Inc. ("Genexine"). Any statement describing Genexine's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Genexine's drug development pipeline, including without limitation GX-I7 (efineptakin alfa), GX-188E, GX-H9 (eftansomatropin alfa), GX- E4 is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Genexine's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Genexine's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Genexine. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Genexine's programs are described in additional detail in Genexine's annual reports on DART (Data Analysis, Retrieval and Transfer System) internet site ( ) of the Korean Financial Services Commission. Genexine assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. View source version on businesswire.com: Contacts For further information, please contact: Mr. Jongsoo Lee Investor Relations, Genexine, Inc. jongsoo.lee@genexine.com Source: Genexine, Inc. View this news release online at:

Clinical ResultPhase 2ImmunotherapyASCOVaccine

100 Deals associated with Tirvalimogene Teraplasmid

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Head and neck cancer metastatic	Phase 2	South Korea	Yonsei University	15 Apr 2022
Squamous Cell Carcinoma of Head and Neck	Phase 2	South Korea	Yonsei University	15 Apr 2022
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	South Korea	NeoImmuneTech, Inc.	01 Mar 2022
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	South Korea	Genexine, Inc.	01 Mar 2022
Advanced Cervical Carcinoma	Phase 2	South Korea	Genexine, Inc.	19 Jun 2018
Carcinoma in situ of uterine cervix	Phase 2	South Korea	Genexine, Inc.	01 Jul 2014
Cervical Intraepithelial Neoplasia	Phase 2	South Korea	Genexine, Inc.	01 Jul 2014
Uterine Cervical Cancer	Phase 2	South Korea	Genexine, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03444376 (GX-188E DNA vaccine plus pembrolizumab \| KEYNOTE-567, CTgov)	Phase 1/2	Advanced Cervical Carcinoma	65	KEYTRUDA®+GX-188E	oaiwqsecig = olylsmwmpt llruljvfft (prkaqjlaoy, guzmyeerow - bspzxmkpcl) View more	-	30 Jul 2025
NCT03444376 (GX-188E DNA vaccine plus pembrolizumab, Pubmed \| EClinicalMedicine)	Phase 2	Recurrent Cervical Cancer HPV 16-	65	GX-188E vaccine + Pembrolizumab	ykxzestedv(hisobuhwei) = xeuspsuehu ujkacvqozm (rxgipmwrza, 23.1 - 48.4) View more	Positive	01 Aug 2024
NCT02139267 (phase 1/2a, Pubmed \| J Gynecol Oncol)	Phase 1/2	Cervical Intraepithelial Neoplasia human papillomavirus (HPV) viral load	86	RKP00156 25mg	bmunixwqbm(boveywhsri) = yrxeguxpoe bpmssginfg (fbkcwsiyab, -99.83% - 4.52%)	Positive	01 Jan 2024
NCT05286060 (GENUINE, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Human Papillomavirus-Related Squamous Cell Carcinoma of Head and Neck Neoadjuvant HPV-16 Positive \| HPV-18 Positive	11	GX-I7+GX-188E+pembrolizumab	yhfoiiispp(kiuimclaxk) = ouscvrifqt fsablevloj (vtlkrtuccr ) View more	Positive	26 May 2023
NCT03444376 (ESMO2022) Manual	Phase 2	Human Papillomavirus-Related Cervical Carcinoma HPV Positive \| PD-L1 Expression	65	GX-188E 2 mg+pembrolizumab 200 mg	rzqzorlkce(rhioiayawq) = kjxagalnmk szrgclhoia (mgkzsgzsul ) View more	Positive	10 Sep 2022
NCT03444376 (ESMO2022) Manual	Phase 2		65	GX-188E 2 mg+pembrolizumab 200 mg (PD-L1 negative population)	rzqzorlkce(rhioiayawq) = hvckehbwep szrgclhoia (mgkzsgzsul ) View more	Positive	10 Sep 2022
NCT03444376 (KEYNOTE-567, ASCO2021)	Phase 2	Advanced Cervical Carcinoma	52	GX-188E therapeutic DNA vaccine + Pembrolizumab	gwfidapxyh(wnygfwjlma) = luuwxqssxc dqrbagbmvu (etbjdsbdvs ) View more	-	28 May 2021
NCT03444376 (Pubmed \| Lancet Oncol) Manual	Phase 2	Uterine Cervical Cancer HPV-16-positive \| HPV-16-positive	36	GX-188E+Pembrolizumab	jplravzvbi(arpgyawxkb) = svankdxegi deykdeyidj (fpmopeiico, 23 - 63) View more	Positive	01 Dec 2020
NCT02139267 (Pubmed \| Clin Cancer Res) Manual	Phase 2	Cervical Intraepithelial Neoplasia	72	GX-188E	xlcfqzmvdz(dcmrcudoqh) = ldfjyxnavh ofgsujlxmi (ntnukjpqzt ) View more	Positive	01 Apr 2020

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