Genexine Announces Encouraging Topline Results from Phase 1b/2 Clinical Trial with GX-I7 (efineptakine alfa) in Refractory or Recurrent Triple Negative (R/R) Metastatic Breast Cancer

Seoul, South Korea–(BUSINESS WIRE)–Genexin (KOSDAQ: 095700), a publicly listed, clinical-stage biopharmaceutical company engaged in the discovery and development of novel biologics for the treatment of unmet medical needs, today announced initial results from the Phase 1b/2 clinical study of KEYNOTE-899 trial of GX-I7 (efineptakine 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 metastatic R/R TNBC. Genexine presented these data in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 3-7, 2022.

Early data showed that GX-17 in combination with pembrolizumab was safe and well tolerated across the entire Phase 1b/2 trial. For the Phase 2 expansion cohort, GX-I7 was administered at a dose of 1200 mcg/kg at nine-week intervals in combination with pembrolizumab 200 mg administered every three weeks.

The ORRs observed with GX-17 in combination with 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 specimen, 40.0% (10/25) were PD-L1 positive (CPS≥10). Notably, the ORR in PD-L1 positive patients was 60% (6/10). Absolute lymphocyte count and CD4 count+ and CD8+ T cells were significantly increased, while NLRs and the proportion of Treg in CD4+ T cells were significantly decreased in patients receiving GX-I7 720 µg/kg or more.

“The results of this study are quite encouraging and indicate that GX-I7 (efineptakine alfa) in combination with a checkpoint inhibitor could become an important therapy for patients with metastatic r/r TNBC.” said Professor Sohn Ju-hyuk, principal investigator of the trial and professor of medical oncology at Yonsei Severance Hospital. “GX-I7 represents a potential new class of 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 ORR of 60% in PD-L1 positive patients, especially since there was no response in the PD-L1 group. L1 negative with previous study. I think further trials with PD-L1 positive TNBC patients are warranted.

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

GX-I7 (efineptakin alfa), discovered and developed by Genexine, is an Fc-fused hybrid long-acting recombinant human IL-7 that plays a critical role in T cell development and homeostasis. play an important role in the fight against cancer by recognizing cancer cells and killing them directly or indirectly by communicating with other immune cells. As a T-cell enhancer, GX-I7 can stimulate the immune system and help eradicate tumor cells more effectively. GX-I7 can modulate several steps in the cancer immunity cycle to overcome resistance to current immunotherapy. By working in synergy with cutting-edge and emerging immuno-oncology therapies, GX-I7 can broaden, deepen and prolong anti-tumor responses in cancer patients.

About Genexin

Genexine, Inc. is a publicly traded clinical-stage biotechnology company focused on the development and commercialization of next-generation immunotherapies and long-acting biologics. Its main technology platforms are therapeutic DNA vaccine technology and hyFcMT fusion technology. The Company has several products in clinical development, several of which are in Phase 3 registration trials. The Company’s proprietary pipeline includes, among others, GX-188 for cervical cancer, GX-I7 (efineptakine alfa) for several cancers, GX-H9 (eftansomatropin alfa) for pediatric growth hormone deficiency and GX-E4 for CKD-induced anemia. Genexine has established multiple partnerships with global companies to accelerate product development and commercialization and create significant value. Genexine is listed on the Korean Stock 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 goals, expectations, financial or other projections, intentions or beliefs, development plans and commercial potential for Genexin’s drug development pipeline, including without limitation GX-I7 (efineptakine 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, in particular the challenges inherent in the process of discovering, developing and commercializing safe and effective new drug products for human therapeutic use, and in the effort to create a company around these drugs.

Genexine’s forward-looking statements also involve assumptions which, if they never materialize or prove to be incorrect, 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, such statements are based solely on facts and factors currently known to Genexine. Accordingly, you are cautioned not to rely on these forward-looking statements. These and other risks relating to Genexine’s programs are further described in Genexine’s annual reports on the Data Analysis, Retrieval and Transfer System (DART) website (https://dart.fss.or.kr/) of the Korea Financial Services Commission. Genexine undertakes no obligation to update any 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.

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