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

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 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.

Top-line data showed that GX-17 in combination with pembrolizumab was safe and well tolerated in the overall phase 1b/2 trial. For the phase 2 expansion cohort GX-I7 was administered at a dose of 1,200 µg/kg in nine-week intervals combined with pembrolizumab at 200 mg administered every three weeks.

Observed ORRs with GX-17 in combination pembrolizumab were 15.7% (8/51) for phase 1b and 21.2% (7/33) for phase 2. Of the 25 patients who had an evaluable PD-L1 from a biopsy sample, 40.0% (10/25) were PD-L1 positive (CPS≥10). Notably, the ORR in patients who were PD-L1 positive was 60% (6/10). Absolute lymphocyte count and the number of CD4⁺ and CD8⁺ T cells were significantly increased, while NLRs and proportion of Treg in CD4⁺ T cells were significantly decreased in patients receiving GX-I7 720 µg/kg or higher.

“The results from this study are quite encouraging and indicate that GX-I7 (efineptakin alfa) in combination with a check point inhibitor could become an important therapy for patients with r/r metastatic TNBC.” said Professor Sohn Ju-hyuk the primary investigator of the trial and professor of Medical Oncology at Yonsei Severance Hospital. “GX-I7 represents a new class of potential therapy for cancer patients and could become the first therapy to manage lymphopenia in cancer patients. Although this is a retrospective analysis, I am encouraged by the 60% ORR in PD-L1 positive patients especially considering there was no response in the PD-L1-negative group with previous study. I believe further trials with PD-L1 positive TNBC patients are warranted.”

“GX-I7 represents a potential first-in-class treatment for cancer patients. We are pleased with the observed safety and tolerability profile and are encouraged by the efficacy shown in these two trials,” said Neil Warma, CEO of Genexine. “We plan on carefully analyzing the complete data set but are highly encouraged by the CPS>10 cohort that showed a robust 60% ORR. Although this was observed in a modest sample size, we believe it warrants further review. GX-I7 is one of our flagship products and Genexine has embarked on a global development program in multiple cancers with our partners, NeoImmune Tech in the U.S. and I-Mab in China.”

GX-I7 (efineptakin alfa), discovered and developed by Genexine, is a hybrid Fc-fused long-acting recombinant human IL-7 which plays an essential role in the development and homeostasis of T-cells. T-cells play an important role in fighting cancer by recognizing cancer cells and killing them directly or indirectly by communicating with other immune cells. As a T-cell amplifier, GX-I7 may boost the immune system and help eradicate tumor cells more effectively. GX-I7 may modulate multiple steps in the cancer immunity cycle to overcome resistance to current immunotherapy. By working synergistically with leading and emerging immuno-oncology therapeutics, GX-I7 may broaden, deepen, and prolong anti-tumor responses in cancer patients.

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^TM fusion technology. The Company has multiple products clinical development including several undergoing Phase 3 registrational 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