Papitrol (tirvalimogene teraplasmid) / Genexine, National OncoVenture - LARVOL DELTA

GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial. (PubMed, EClinicalMedicine) - P1/2 | "This combination therapy might provide a new potential treatment option for patients with recurrent or advanced cervical cancer. National Cancer Center Onco-Innovation Unit, Korea."

Journal • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Genexine Announces Phase 2 Results of Combination with Cervical Cancer Treatment ’GX-188E’ [Google translation] (HIT News) - P1b/2 | N=65 | NCT03444376 | Sponsor: Genexine, Inc. | "Genexine...announced on the 19th that a paper on the results of a phase 2 clinical trial of a combination therapy between its human papillomavirus (HPV) DNA anticancer vaccine, GX-188E (tivalimozine theraplasmid) and Merck's (MSD) immune checkpoint inhibitor Keytruda (active ingredient pembrolizumab) was published in the online edition of Clinical Medicine....The objective response rate (ORR) for the 60-patient efficacy evaluation group was 35%, and the objective response rates for patients who expressed PD-L1 and those who did not were 38.9% and 29.2%, respectively, which were high results in both cases. In particular, the median duration of response (mDOR) was 12.3 months, and the median overall survival (mOS) was 23.8 months, showing an improvement of about 2-fold compared to the overall survival rate (OS) of existing second-line treatments for advanced cervical cancer."

P2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Yonsei University | N=25 ➔ 56 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Enrollment change • Metastases • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

KEYNOTE-567: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov) - P1/2 | N=65 | Completed | Sponsor: Genexine, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cervical Cancer • Oncology • Solid Tumor • PD-L1

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. (ASCO 2023) - P2 | "Neoadjuvant pembrolizumab, GX-188E, and GX-I7 showed promising activity and manageable safety profile in patients with resectable HPV-16 and/or 18-positive HNSCC. Therapeutic induction of brisk immune responses significantly reshaped the tumor microenvironment and associated with pathologic regression, warranting further investigation of pembrolizumab, GX-188E, and GX-I7 for patients with HPV-positive HNSCC. Clinical trial information: NCT05286060."

Clinical • Omic analysis • P2 data • Head and Neck Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • BCL6 • CD28 • CD8 • CXCR5 • IL7 • TCF7

Genexine Abstract on GX-188E and GX-I7 Triple Combination Therapy in HNSCC Is Released at 2023 ASCO Annual Meeting (Businesswire) - P2 | N=25 | GENUINE (NCT05286060) | "Genexine...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)....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."

P2 data • CNS Tumor • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Lunit to Present 16 Abstracts at the 2023 ASCO Annual Meeting (PRNewswire) - "Lunit...announced the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, Illinois, on June 2-6."

Clinical data • P2 data • CNS Tumor • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer

TRINITY: 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 (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Yonsei University | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for its promising DNA vaccine for advanced cervical cancer (Businesswire) - "Genexine...announced it received Fast Track Designation (FTD) from the Korean Ministry of Food and Drug Safety (MFDS) for GX-188E (tirvalimogene teraplasmid), its first-in-class proprietary therapeutic DNA vaccine....Following an evaluation of the full set of Phase 2 data from the recently completed clinical trial in advanced cervical cancer, Korea’s Health Authority (MFDS) concluded that GX-188E met the criteria for fast-track designation."

Non-US regulatory • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Genexine to Present Final Phase 2 Clinical Data on Its Cervical Cancer Program Showing a 35.0% Overall Response Rate and Provide a Corporate Overview During JP Morgan Conference (Businesswire) - P1/2 | N=60 | NCT03444376 | Sponsor: Genexine, Inc. | "Genexine...announced updated results following the completion of its Phase 2 clinical study using GX-188E....in combination with KEYTRUDA....The final efficacy analysis evaluated in 60 patients (efficacy evaluable population) showed a Objective Response Rate (ORR) of 35.0% (21 of 60 patients) indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either an over 30% reduction in tumor size or complete remission....Genexine management will present these data together with a corporate update at various meetings during the upcoming JP Morgan conference to be held January 9-13, 2023 in San Francisco....Genexine is also conducting two ongoing clinical studies with GX-188E in combination with a check point inhibitor and a long-acting interleukin 7 in squamous cell carcinoma of head and neck (SCCHN). Results from these trials are expected in 2023."

P2 data • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Efficacy and safety of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab in HPV 16- and/or 18- positive advanced cervical cancer (phase II): Safe and effective in both PD-L1 positive and negative (ESMO 2022) - P1/2 | "Conclusions GX-188E vaccine combined with pembrolizumab in advanced cervical cancer was safe and tolerable, and showed significant efficacy compared with pembrolizumab alone particularly in patients with PD-L1 negative. This combination therapy could represent a new potential treatment for this patient population."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

GX-188E Plus Pembrolizumab Proves Safe, Effective in HPV16/18+ Recurrent or Metastatic Cervical Cancer (OncLive) - P1b/2 | N=60 | NCT03444376 | Sponsor: Genexine, Inc | "Participants underwent a tumor assessment at 10 weeks; they were evaluated every 9 weeks thereafter. Four weeks after disease progression, a confirmatory assessment was conducted. ORR by RECIST v1.1 criteria served as the primary objective for the research. Key secondary objectives included DCR, DOR, PFS, OS, and safety. Exploratory objectives comprised T-cell response analysis, as well as evaluation of biomarkers such as PD-L1, CEA, TA4, and others.The regimen induced an ORR of 36.1% (95% CI, 20.8%-53.8%) in those with PD-L1–positive status (n = 36) vs 25.0% (95% CI, 9.8%-46.7%) in those with negative status (n = 24); the CBRs in these groups were 55.6% (95% CI, 38.1%-72.1%) and 37.5% (95% CI, 18.8%-59.4%), respectively."

P1/2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Genexine’s First-in-Class Therapeutic DNA Vaccine Shows Significant Potential to Extend Survival in Late-Stage Cervical Cancer (Businesswire) - P1/2 | N=60 | NCT03444376 | Sponsor: Genexine, Inc. | "Late-Breaking presentation of phase 2 results from a clinical trial of GX-188E in combination with KEYTRUDA® (pembrolizumab) demonstrates anti-tumor benefit in heavily pre-treated, recurrent and advanced cervical cancer....Top line results showed a Best Overall Response Rate (BORR) of 31.7% (19 of 60 patients). 6 patients (10.0%) had a complete response and 13 patients (21.7%) had a partial response. Median duration of response (DOR) was 12.3 months and overall survival (OS) was 17.2 months. The BORR increased to 38.5% in PD-L1 positive patients with HPV 16+ and Squamous Cell Carcinoma."

Late-breaking abstract • P2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Genexine selected for Late-Breaking Oral Presentation of Phase 2 Study of GX-188E in Combination with KEYTRUDA (pembrolizumab) in Cervical Cancer at European Society for Medical Oncology (ESMO) Congress 2022 (Businesswire) - "Genexine..announced today that late-breaking results from the Phase 2 clinical trial study of its therapeutic DNA vaccine GX-188E in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), were selected for an oral presentation at the 2022 European Society for Medical Oncology Congress which is being held from September 9-13 in Paris, France."

Late-breaking abstract • P2 data • Cervical Cancer • Gynecologic Cancers • Oncology

Genexine Announces Dosing of First Patient in Phase 2 clinical trial with Triple Combination Therapy in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) (Businesswire) - "Genexine...announced the dosing of the first patient in phase 2 clinical trial using triple combination therapy in patients with recurrent/metastatic HNSCC. The combination therapy consists of two of Genexine’s proprietary drugs, GX-188E (a first-in-class therapeutic DNA vaccine), GX-I7 (a first-in-class long-acting interleukin 7), and Opdivo (nivolumab), a marketed PD-1 immune checkpoint inhibitor. The phase 2 clinical trial is being conducted in South Korea...at Yonsei Severance Hospital Cancer Center. The trial will evaluate the safety and efficacy in 21 patients with HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)."

Trial status • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Yonsei University | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

KEYNOTE-567: The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov) - P1/2 | N=60 | Active, not recruiting | Sponsor: Genexine, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2021 ➔ Dec 2022

Enrollment closed • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • PD-L1

TRINITY: 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 (clinicaltrials.gov) - P2 | N=21 | Not yet recruiting | Sponsor: Yonsei University

Combination therapy • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Non-Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Yonsei University

New P2 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

The Efficacy of Therapeutic DNA Vaccines Expressing the Human Papillomavirus E6 and E7 Oncoproteins for Treatment of Cervical Cancer: Systematic Review. (PubMed, Vaccines (Basel)) - "Five different DNA therapeutic vaccines (GX-188E, VGX-3100, pNGVL4a-CRT/E7(detox), pNGVL4a-Sig/E7(detox)/HSP70, MEDI0457) were well-tolerated and clinically effective. Clinical implementation of DNA therapeutic vaccines into treatment regimen as a sole approach or in combination with conservative treatment holds great potential for effective cancer treatment."

Journal • Review • Cervical Cancer • Gene Therapies • Gynecology • Oncology • Solid Tumor

[VIRTUAL] Efficacy and safety results of pembrolizumab combined with GX-188E, a therapeutic DNA vaccine administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase II interim analysis results (AACR-I 2020) - "Pembrolizumab combined with GX-188E demonstrated a higher response rate than pembrolizumab monotherapy in patients with cervical cancer showing great synergy regardless of PD-L1 expression. The safety profile was manageable and similar to that of pembrolizumab monotherapy. Further evaluation of anti-tumor response and antigen specific immune response is ongoing in a larger number of patients with and without PD-L1 expression."

Clinical • IO Biomarker • P2 data • CD8 • PD-L1

[VIRTUAL] Efficacy and safety results of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase II interim analysis results (KEYNOTE-567). (ASCO 2021) - P1/2 | "GX-188E vaccine combined with pembrolizumab in recurrent/advanced cervical cancer was safe and tolerable, and showed an enhanced clinical response rate compared with pembrolizumab alone in particular in patients with PD-L1 positive, HPV-16 and squamous cell carcinoma . The combination therapy could represent a new potential treatment option for this patient population."

Clinical • IO biomarker • P2 data • Cervical Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1

2 Korean drugmakers report improved cervical cancer vaccines at ASCO 21 (Korea Biomedical Review) - P1/2, N=60; NCT03444376; Sponsor: Genexine; "Genexine said its cervical cancer therapy, GX-188E vaccine, combined with Mercks’ Keytruda (ingredient: pembrolizumab), showed an enhanced response rate compared to Keytruda alone in phase 2 clinical trials. The company assessed the data of 48 patients with recurrent or advanced cervical cancer in the study and confirmed that five patients had a complete response to the combo therapy. Ten patients also showed partial response, showing at least a 30 percent decrease of the target region. The combination treatment showed a 31.3 percent overall response rate and 48 percent response rate in patients with PD-L1 and HPV 16-positive squamous cell carcinoma."

P2 data • Cervical Cancer • Gynecologic Cancers • Oncology

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. (PubMed, Lancet Oncol) - P1/2 | "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."

Clinical • Journal • P2 data • Cardiovascular • Cervical Cancer • Oncology • Solid Tumor

Preclinical safety assessment of a therapeutic human papillomavirus DNA vaccine combined with intravaginal interleukin-7 fused with hybrid Fc in female rats. (PubMed, Toxicol Appl Pharmacol) - "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."

Journal • Fibrosis • Oncology • IL7