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Kalbe Gets Phase-2 Clinical Trial Approval on COVID-19 Drug - GX17

Kalbe Gets Phase-2 Clinical Trial Approval on COVID-19 Drug - GX17

Press Release No. 057/KFCP-DIR/PR/XII/20

Jakarta, 30 December 2020 - PT Kalbe Farma Tbk (Kalbe) through its subsidiary PT Kalbe-Genexine Biologics (KGBio) today has received approval for a clinical trial (PPUK) from the Food and Drug Administration of the Republic of Indonesia (BPOM) to carry out Phase 2 clinical trials of the drug GX-17, which is an immunotherapeutic drug that will be developed as a treatment for COVID-19 patients. BPOM has issued approval to KGBio to conduct a phase-2 clinical trial based on safety and effectiveness data from a previous study conducted by Genexine with IMAB in South Korea. GX-17 is the only long-acting interleukin-7 drug under development in the world that can increase the absolute lymphocyte count. This increase in the number of lymphocytes by GX-17 can prevent the worsening of the condition of mild or asymptomatic COVID-19 patients, especially in vulnerable populations such as the elderly by activating T-cells and the immune system in the early stages of COVID-19 infection.

“Kalbe is committed to continue contribute in handling the COVID-19 pandemic. After working with Genexine in the development of the GX-19 vaccine, now Kalbe and Genexine are working together in developing the COVID-19 drug GX-17," said Sie Djohan, Director of PT Kalbe Farma Tbk who is also the President Director of PT. Kalbe Genexine Biologics. "We hope that the development of GX-17 can help protect the society, especially the elderly who are vulnerable to the effects of COVID-19," he continued.

As of December 29, 2020, there were 727,122 confirmed cases of COVID-19 with the addition of 7,903 new patients. Unlike other viral infections, SARS-CoV-2 can quickly damage the immune system and progress from mild disease to more serious and even cause death. This is especially so in susceptible patients such as the elderly where their T-cell count is lower.

Djohan further stated that if this study is successful, the GX-17 has the potential to save many people and can also help reduce the burden on our health system, especially in facing the COVID-19 pandemic.

This approved phase 2 clinical trial will recruit 210 subjects with mild and asymptomatic COVID-19 patients over the age of 50 to analyze the safety and effectiveness of GX-17 compared to placebo. GX-17 will be given as a single injection along with standard therapy within 7 days of symptom discovery and will be monitored for a total of 9 weeks, including 1 week for selection, 4 weeks of treatment and 4 weeks of follow-up. This phase 2 clinical trial is estimated to take 6 months.

Overview of Kalbe Genexine Biologics (KG Bio)
KG Bio is a joint venture company between PT. Kalbe Farma, Tbk from Indonesia and Genexine, Inc of Korea. KG Bio focuses on the clinical development and commercialization of new biologics and monoconal antibodies in ASEAN, Asia Pacific and MENA. Through an innovative technology platform that ensures affordable and high quality products, KG Bio aims to provide innovative biological and immuno-oncology products, and better solutions to treat human diseases.

Kalbe at a glance
PT Kalbe Farma Tbk (“Kalbe”) was founded in 1966 and is one of the largest publicly listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a reliable and diverse portfolio of brands; prescription drugs division); health product division that handles over-the-counter drugs (Promag, Mixagrip, Komix, Woods, Fatigon, etc.), multivitamins (Fatigon, H2, XonCe, Hevit-C, JossC1000 etc.), and supplement and ready-to-drink drinks (Hydro Coco, Extra Joss), nutrition division (ChilKid, Prenagen, Diabetasol, Zee, etc.); and distribution division. Kalbe currently has more than 40 subsidiaries and 16 production facilities with international standards, and employs approximately 16,000 employees, spread across 76 branches throughout Indonesia. Since 1991, Kalbe's shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).

Genexine at a glance
Genexine, Inc., registered with KOSDAQ (095700) since 2009, is a company engaged in biotherapeutics with a focus on immuno-oncology and rare diseases. Genexine already has a strong product portfolio with a number of products at the clinical stage, e.g. Hyleukin-7 ™, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on the “long-acting Fc fusion technology” platform and therapeutic DNA vaccine technology. Genexine has successfully completed its Phase II clinical trials and is preparing Phase III of HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is currently in phase II in Europe and Korea for cervical cancer (CIN) II / III. Founded in 1999, Genexine employs approximately 180 people, with more than 50% researchers with an MSc, or Ph.D. Genexine is based in Pangyo Techno Valley, near Seoul, Korea.



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