Genexine’s Long-acting Anemia Treatment GX-E4 Phase 3 Clinical Trial Interim Result Is Presented at WCN2023, Confirmed Non-inferiority Compared to Mircera

SEOUL, South Korea--(BUSINESS WIRE)--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).

Kidneys are responsible for 90% of the EPO produced in our bodies. CKD-induced anemia is caused by the failure to produce EPO (erythropoietin) due to long-term decreased kidney function. GX-E4 is a long-acting EPO formulation that dramatically increases the half-life of EPO in the body by utilizing hyFc, Genexine's proprietary long-acting platform technology.

In 2020, through its partnership with KG Bio in Indonesia, Genexine started phase 3 clinical trials for patients with non-dialysis chronic kidney disease in seven countries in Asia and Oceania. In this clinical trial, 391 adult patients in chronic kidney disease stages 3 and 4 who are naïve ESA (Erythropoiesis Stimulating Agent) or have not received ESA for at least 12 weeks prior to participating in this clinical trial were administered GX-E4 every 2 weeks and later 4 weeks (in an extension period) through an active control, randomized, open-label trial. It is aimed to confirm non-inferiority by administering and comparing with Roche's Mircera, a third-generation long-acting anemia treatment.

According to the interim results presented by KG Bio at the WCN, the response rate of GX-E4 administered every 2 weeks was 69.6% and the hemoglobin level was maintained at 91.2%, while Mircera maintained the response rate at 63.2% and the hemoglobin level at 87.2% during the same period. In addition, during the evaluation period, the hemoglobin level change value was 1.58 g/dL per month, which conformed to the recommended standard of 1.0 to 2.0 g/dL per month of the KDIGO (Kidney Disease: Improving Global Outcome) guideline of the International Society for Nephrology. Equivalent safety performance was also confirmed compared to Mircera.

“We are highly excited about the result KG Bio is sharing. This clinical trial is an opportunity to once again prove the global competitiveness of GX-E4, developed through Genexine's proprietary hyFc platform technology.” Genexine’s CEO Neil Warma said, “We will continue to challenge the global market by further expanding labels for dialysis patients as well as the non-dialysis market together with our partner KG Bio.”

Genexine and KG Bio are currently planning to complete multinational phase 3 clinical trials within the year and begin the official BLA application process starting with Indonesia, followed by applications in Korea and ASEAN markets.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutic and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc^R 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 for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4(Efepoetin alfa) 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.

Mr. Jongsoo Lee
Investor Relations, Genexine, Inc.
jongsoo.lee@genexine.com