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GET BPOM APPROVAL, KALBE IMPLEMENT CLINICAL TRIAL COVID-19 VACCINE GX-19N

GET BPOM APPROVAL, KALBE IMPLEMENT CLINICAL TRIAL COVID-19 VACCINE GX-19N


Press Release No.  36/KFCP-DIR/PR/VII/21

Jakarta, July 9, 2021. PT Kalbe Farma Tbk (“Kalbe”) has received approval from the Food and Drug Supervisory Agency (“BPOM”) to conduct a phase 2b/3 clinical trial for the COVID-19 GX-19N vaccine in Indonesia. The clinical trial phase 2b/3 will start recruitment in July 2021 and is expected to have enough data to carry out an interim analysis for safety and efficacy (the ability of the vaccine to trigger immunity against COVID-19 infection) by end of 2021.

“Kalbe is grateful to the BPOM and the ethics committee for giving permission to carry out this clinical trial for the COVID-19 vaccine candidate - GX-19N. Currently, there are still unmet needs for COVID-19 vaccine in Indonesia. As an innovation-based healthcare company, we hope that Kalbe can contribute to the handling of COVID-19 in Indonesia," said Irawati Setiady, President Commissioner of PT Kalbe Farma Tbk,

"If the clinical trial phase 2b/3 is considered successful and gets approval for emergency use from BPOM, then the GX-19N vaccine can complement the currently available vaccines. For this reason, Genexine has made a commitment to supply 10 million doses of the GX19N vaccine as well as to provide technology transfer for local production," said Irawati again.

"BPOM supports all development and research of vaccines and medicine to overcome COVID-19 including for the vaccine candidate GX-19N. BPOM will continue to oversee, monitor and evaluate the implementation of the phase 2b/3 clinical trial of GX-19N. It is hoped that with the technology transfer we can be self-reliant for the needs and ease of access for long term COVID-19 vaccine in Indonesia.", said Penny K. Lukito, Head of BPOM. “This clinical trial is an important step in establishing the efficacy and safety of GX19N vaccine in support of its eventual registration and approval. We hope the implementation of this clinical trial will fulfill the highest scientific and ethical standards in accordance to GCP”, she further elaborated

"The Ministry of Health welcomes and supports the clinical trial of the COVID-19 GX-19N vaccine, which can later increase the fulfillment of vaccine needs in Indonesia. The Ministry of Health hopes that all stages of vaccine development can be followed properly, so that vaccines can be used safely," said dr. Maxi Rein Rondunuwu, DHSM, MARS, Acting Director General of Disease Prevention and Control of the Indonesian Ministry of Health.

"We have studied the DNA of the GX-19N vaccine from Genexine, and we believe that this vaccine has excellent potential to provide protection against various variants of the COVID-19 virus and also the possibility of a longer period of protection. The safety for the GX-19N vaccine also appears to be very good because as it does not contain any viral vectors or adjuvant, "said Prof.Dr.dr. Iris Rengganis Sp, PD-KAI, Head of the Research Team for the GX-19N COVID-19 vaccine clinical trial.

Prof Iris continued that in Indonesia, the clinical trial of the GX-19N vaccine will recruit 1000 volunteers with the research center located in FKUI, RSCM as a referral hospital and several satellites spread over Jakarta, Depok, Bekasi, Yogyakarta, Solo, and Klaten.

She explained that the clinical trial of the COVID-19 GX-19N vaccine phase 2b/3 was in collaboration with the Faculty of Medicine, University of Indonesia-National Central General Hospital Cipto Mangunkusumo, and also in collaboration with other medical faculties, namely the Faculty of Medicine and Health Sciences, Krida Wacana University, Faculty of Medicine. Medicine, Public Health, and Nursing Universitas Gadjah Mada and other partners.

Young-Chul Sung, Ph.D, CEO of Genexine, Inc. said that the clinical trials of the COVID-19 GX-19N vaccine stage 1 and stage 2a have been carried out in South Korea and stage 2b/3 clinical trials will also be carried out on a multinational basis involving many countries. . These countries are Turkey, India, UAE, Mexico, Peru, Colombia, Malawi, South Africa, Czechoslovakia, Poland including Indonesia and will recruit a total of 30,148 volunteers. The GX-19N vaccine was developed by a consortium of Genexine, Binex, the International Vaccine Institute (IVI), GenNBio, the Korea Advanced Institute of Science & Technology (KAIST), and Pohang University of Science & Technology (POSTECH).

Prof Iris explained further that the GX-19N COVID-19 vaccine is different from other COVID-19 vaccines, including:

- DNA-based GX-19N vaccine encodes more of the viral proteins so that it has the potential to produce higher   antibody titers t that last longer in the body, thus providing better protection against COVID-19

- The GX-19N vaccine also has the potential to provide protection against parts of the virus that have been   shown to rarely mutate, so the GX-19N vaccine is expected to provide protection against new variants of  COVID-19

- This GX-19N vaccine does not contain adjuvant (additives in the vaccine) so it has the potential to be given to people who have weak immune systems

- From the safety data for stage 1 and stage 2a, the GX-19N vaccine showed safe results with a description of mild and transient side effects

- This vaccine will be given into the muscle using a special device that will increase the delivery of the vaccine   directly into muscle cells.

About Kalbe Farma


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 brand portfolio; 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), the nutrition division (ChilKid, Prenagen, Diabetasol, Zee, etc.); and distribution division. Kalbe currently has more than 40 subsidiaries and 14 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).


About Genexine

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 employees, with more than 50% of researchers with an MSc, or Ph.D. Genexine is based in Pangyo Techno Valley, near Seoul, Korea.

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