Genexine’s First-in-Class SOX2 Degrader GX-BP1 Demonstrates Up to 96% TGI and Eliminates Tumor Regrowth in Preclinical Models
Genexine, Inc. (KOSDAQ: 095700), a clinical-stage biotechnology company, today announced new preclinical data for its SOX2-targeting bioPROTAC candidate, GX-BP1, presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego.
Genexine and KGbio received the first market approval for novel long-acting Erythropoietin, Efepoetin alfa, from The Indonesian Food and Drug Authority (BPOM)
Genexine (KQ 095700, CEO Sungjune Hong), a publicly-listed clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, together with PT Kalbe Genexine Biologics (KGbio), a joint venture clinical-stage biotechnology company between Genexine and PT Kalbe Farma that focused on bringing biologics medical innovation to international markets, announced the approval of its long-acting erythropoietin, Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anemia in non-dialysis patients. This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio.
Genexine’s long-acting growth hormone meets Phase 3 primary endpoint
Genexine (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.
Genexine Abstract on GX-188E and GX-I7 Triple Combination Therapy in HNSCC Is Released at 2023 ASCO Annual Meeting
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).
Genexine’s Long-acting Anemia Treatment GX-E4 Phase 3 Clinical Trial Interim Result Is Presented at WCN2023, Confirmed Non-inferiority Compared to Mircera
A clinical-staged proprietary platform technology biotech company Genexine (KQ 095700, CEO Neil Warma) and its Asian regional partner, KG Bio unveiled the interim results of phase 3 clinical trial of GX-E4 (Efepoetin alfa), a candidate for CKD (Chronic Kidney Disease) induced anemia. Its non-inferiority results compared to Mircera (Methoxy Polyethylene Glycol-epoetin beta) were presented at the World Congress of Nephrology (WCN2023).
Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for its promising DNA vaccine for advanced cervical cancer
Genexine (KOSDAQ: 095700), 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 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.
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
Genexine (KOSDAQ: 095700), a publicly traded, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, 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.
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)
Genexine (KOSDAQ: 095700), 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 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 OpdivoR (nivolumab), a marketed PD-1 immune checkpoint inhibitor.
Genexine Announces Completion of Enrollment in Phase 3 Clinical Trial with Its Proprietary Long-acting Growth Hormone, GX-H9/TJ101 (Eftansomatropin alfa)
Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced that its partner, I-Mab (Nasdaq: IMAB), recently completed patient enrollment in a phase 3 clinical trial of its proprietary long-acting growth hormone, eftansomatropin alfa, also known as GX-H9/TJ101, in China, taking it one step closer to commercialization in a key market.
Genexine reports encouraging top-line results of the Phase 1b/2 clinical trial with GX-I7 (efineptakin alfa) in refractory or recurrent (R/R) metastatic Triple Negative Breast Cancer
Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced top-line results from the KEYNOTE-899 phase 1b/2 clinical trial of GX-I7 (efineptakin alfa) in combination with pembrolizumab. The results indicated that GX-I7 in combination with pembrolizumab was safe and well tolerated and demonstrated promising early anti-tumor activity in patients with R/R metastatic TNBC. Genexine presented these data in a poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting taking place from June 3-7, 2022.
Genexine Appoints Industry Veteran Neil Warma as Chief Executive Officer to Accelerate Global Growth, Product Commercialization and Innovation
Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, announced the appointment of Neil Warma as its President and Chief Executive Officer. Mr. Warma who has over 25 years of experience as a global entrepreneur, company builder and successful CEO will lead Genexine onto the world stage with a focus on advancing Genexine’s key products to market, expanding its pipeline and focusing on global drug development.
Genexine to Present at H.C. Wainwright Global Investment Conference
Genexine (KOSDAQ: 095700), a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced that Neil Warma, CEO of Genexine will be presenting virtually at the H.C. Wainwright Global Investment Conference being held on May 23-26, 2022.
