Genexine’s long-acting growth hormone meets Phase 3 primary endpoint
[20230830, Seoul South Korea] 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, 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 profile of eftansomatropin alfa was comparable to Norditropin®. The Company is planning to file a 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 to challenge for commercialization developed based on the hyFc® technology, Genexine's proprietary long-acting 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 hyFcâ 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.
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 hyFcâ 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 (https://dart.fss.or.kr/) 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.