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Genexine Announces Completion of Enrollment in Phase 3 Clinical Trial with Its Proprietary Long-acting Growth Hormone, GX-H9/TJ101 (Eftansomatropin alfa)
Genexine has announced that its partner, I-Mab, completed patient enrollment in a phase 3 clinical trial of eftansomatropin alfa (GX-H9/TJ101) in China. This long-acting growth hormone aims to treat pediatric growth hormone deficiency (PGHD) and is compared to Norditropin® in a study involving 168 patients. This milestone is pivotal for commercialization in a significant market. Final data from the study is expected in 2023, with a potential Biologics License Application to follow. Eftansomatropin alfa could offer advantages over traditional therapies due to its unique formulation.
Positive
Completion of patient enrollment in a phase 3 trial for eftansomatropin alfa.
Study evaluates efficacy, safety, and pharmacokinetics against a leading competitor, Norditropin®.
Expected final data in 2023, leading to a potential Biologics License Application in China.
Negative
None.
SEOUL, South Korea--(BUSINESS WIRE)--
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.
Eftansomatropin alfa (GX-H9/TJ101) was discovered by Genexine and is being co-developed by Genexine and Handok for the potential treatment of pediatric and adult growth hormone deficiency. The phase 3 clinical trial (TALLER) being conducted in China by I-Mab, is a multi-center, randomized, open-label, active-controlled clinical study enrolling 168 patients with pediatric growth hormone deficiency (PGHD). The study is evaluating the efficacy, safety, and pharmacokinetics (PK) of eftansomatropin alfa in PGHD, as compared to Norditropin®, a daily rhGH marketed in China.
“This milestone marks a significant step for us in our efforts to commercialize our key products in important unmet medical disorders,” said Neil Warma, President and CEO of Genexine. “GX-H9/TJ101 is one of our important proprietary drug candidates developed from Genexine’s hyFc® platform and is the first product developed from this novel platform to reach phase 3 clinical studies. China represents a critical and significant market for us and we are very pleased with the progress we and our partner I-Mab are making with what we believe is a best-in-class asset with the potential to treat PGHD. We expect to report final data from this phase 3 study in 2023 followed by an expected Biologics License Application (BLA) submission in China.”
About Eftansomatropin alfa (GX-H9/TJ101)
Eftansomatropin alfa (GX-H9/TJ101) was discovered by Genexine and is being co-developed by Genexine and Handok (KOSPI: 002390) as a differentiated long-acting recombinant human growth hormone. It is being positioned possibly as a more convenient and effective therapy for growth hormone deficiency (GHD). Like endogenous growth hormones, eftansomatropin alfa stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which has growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth. IGF-1 is a reliable pharmacodynamic marker and the key mediator of growth-promoting activity of eftansomatropin alfa. Eftansomatropin alfa is based on Genexine's patented hyFc® technology. The hyFc® portion consists of human immunoglobulin D ("IgD") and G4 ("IgG4"). The former contains a flexible hinge, and the latter is responsible for half-life extension through neonatal Fc receptor ("FcRn")-mediated recycling.
Eftansomatropin alfa is currently in Phase 3 clinical study in China. It is believed that due to its unique molecular features, eftansomatropin alfa may have advantages over the conventional pegylated rhGH drugs and daily injections. In the previous clinical trials, including a Phase 2 study in Europe, eftansomatropin alfa demonstrated its safety and clinical efficacy of weekly or biweekly regimens as compared to that of the daily injected rhGH (Genotropin®).
In October 2015, Genexine licensed the China rights to Tasgen Bio-tech (Tianjin) Co., Ltd. (which was subsequently renamed as I-Mab Bio-tech Tianjin Co., Ltd. and became I-Mab’s subsidiary following an acquisition in 2017). In China, eftansomatropin alfa is also known as TJ101. Genexine retains all rights to the product outside of China in the rest of the world.
About Genexine
Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on the development and commercialization of 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 clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 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 (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.
For further information, please contact:
Mr. Jongsoo Lee Investor Relations, Genexine, Inc. jongsoo.lee@genexine.com
Source: Genexine, Inc.
FAQ
What is the phase 3 trial for I-Mab involving IMAB?
The phase 3 trial is for eftansomatropin alfa (GX-H9/TJ101), focusing on its efficacy and safety in treating pediatric growth hormone deficiency in China.
When is the final data expected from the eftansomatropin alfa trial?
The final data from the phase 3 study is expected to be reported in 2023.
What is the significance of eftansomatropin alfa for Genexine and IMAB?
Eftansomatropin alfa represents a key product for Genexine and IMAB, aimed at addressing unmet medical needs in growth hormone deficiency.
How many patients are enrolled in the eftansomatropin alfa trial?
The trial has enrolled 168 patients with pediatric growth hormone deficiency.
What are the potential advantages of eftansomatropin alfa over traditional treatments?
Eftansomatropin alfa is designed to be a long-acting treatment, potentially offering a more convenient and effective therapy compared to daily injections of conventional growth hormones.
