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Rznomics applies for phase 1 and 2 clinical trials in Korea for malignant glioblastoma
Attempt to extend RZ-001 indication Rznomics announced on January 4 that it applied to the Ministry of Food and Drug Safety for phase 1 and 2 clinical trials for malignant glioblastoma (brain cancer) of "RZ-001", a new anticancer drug candidate.RZ-001 was approved by the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) last year and is undergoing clinical trials. Malignant glioblastoma is an incurable disease with a 5-year survival rate of less than 3 percent and no clear treatment yet. Immuno-cancer drugs also showed no therapeutic effect, so a new mechanism of treatment is urgently needed.Rznomics has a technology that removes target RNA based on RNA trans-splicing ribozyme and expresses the desired gene. RZ-001 is an adenovirus that carries ribonucleic acid substituent. It targets telomerase (hTERT) RNA that is specific to cancer cells and expresses genes that induce anticancer action. It is said that telomerase targeted by RZ-001 can be applied to various carcinomas because it is expressed in most cancer cells.Rznomics is pushing to expand its indications to other intractable cancers, starting with hepatocellular carcinoma undergoing clinical trials and this malignant glioblastoma. It is also developing treatments in various fields using platform technologies such as Alzheimer's, hereditary retinal pigmentation, and retinal syndrome as well as anticancer drugs.Seong-wook Lee, CEO of Rznomics, said, "The candidate materials under development are entering clinical trials as planned. We will do our best to speed up the progress of clinical trials and quickly provide new treatment opportunities to patients suffering from incurable diseases."
2023-01-05 -
[Technical Commercialization University] Rznomics Cancer Treatment Development
The company's cumulative investment attraction, which aims to develop innovative bio-new drugs for cancer and incurable diseases, amounts to 60.9 billion. The reason why investors value Rznomics highly is the "Trans-Splicing Ribozyme" platform technology. This technology removes the bad-tempered RNA sequence that causes incurable diseases in the body and injects enzymes (ribozyme) into the area so that good-tempered RNA can be produced. Professor Lee has been studying a technology that induces the activity of therapeutic genes in cells by editing targeted RNA, which is a treatment target, into therapeutic RNA for 20 years. In particular, through research to increase the safety of enzymes, enzymes with therapeutic functions were developed for the first time in vivo.Rznomics is challenging the development of liver cancer treatments using this technology. Following the announcement of the results of research on liver cancer cell death using the RNA substitution enzyme platform in the official journal of the U.S. Genetic Cell Therapy Association, the domestic Ministry of Food and Drug Safety and the U.S. Food and Drug Administration approved phase 1 and 2a clinical trials for "RZ-001", a candidate for liver cancer treatment.It is also studying glioblastoma of malignant brain tumors and a treatment for hereditary retinal pigmentation. And It is also considering the possibility of developing treatments for neurological and cognitive diseases such as Alzheimer's and Ret syndrome.Professor Lee had been considering starting a business early on thanks to his advisor's teaching at the time of his Ph.D. ‘s saying that "he should not be satisfied with leaving research results and names on a few pages of paper.""I believe that the technology developed through sweat with researchers with the support of taxpayers' money should not be replaced," he said. "Our goal is to grow into a global company based on unique platform technology and pipelines that prove the value of this technology."
2023-01-04 -
Rznomics, Signining MOU for joint research with the University of Missouri in the United States
Rznomics announced on the 14th that they signed an MOU for joint research with the University of Missouri in the United States.Under the agreement, two sides will cooperate in all areas of research for the development of gene therapy products, including ribonucleic acid (RNA) editing, establishment of human gene transduction animal models, preclinical trials and clinical research.The MOU is expected to promote mutual exchange of human and material resources and technological development.The University of Missouri, established in 1839, is a state university that is prominent in the fields of agriculture, veterinary medicine, medicine, and pharmacy. Which recently, they shared their interest in gene therapy research.Seongwook Lee, CEO of Rznomics, stated, "By combining the RNA editing platform technology possessed by Rznomics and the research infrastructure of the University of Missouri, we will be able to strengthen our competitiveness in the field of RNA-based gene therapy research. We will leap forward as a global gene therapy company.”
2022-11-14 -
Rznomics Inc. shared its platform technology and program development progress
Rznomics Inc. shared its platform technology and program development progressRznomics revealed its platform technology and program development progressSeongwoo Hong, vice president & head of development department made a presentation on '2022 LOG IN IR EXPO 100' held at the FKI Hall in Yeouido.Rznomics develops RNA-targeting drugs using an RNA replacement enzyme platform.Rznomics' platform uses a ribozyme that causes trans-splicing and a therapeutic transgene that encodes a therapeutic effect inducer.It is a method in which DNA linked to a ribozyme and a therapeutic gene is delivered into the cell using a vector such as adenovirus, and drug RNA transcribed from the cell targets the target RNA.A ribozyme specifically binds to a target RNA and then replaces a portion of the target RNA with a therapeutic gene RNA by trans-splicing method. The function of the target disease RNA is lost and the protein encoded by the therapeutic gene is expressed.Global drug development based on trans-splicing is still in its infancy, and Ascidian Therapeutics, which develops RNA-targeted therapeutics using trans-splicing, announced its $50 million Series A funding last month.
2022-11-04 -
[Journal publish]Pros and Cons of In Vitro Methods for Circular RNA Preparation
'Pros and Cons of In Vitro Methods for Circular RNA Preparation' by Ph.D. Kyung Hyun Lee, Researcher Seongcheol Kim, Ph.D. Seong-wook Lee, of Rznomicshas been published in the 'International Journal of Molecular Sciences.'
2022-10-31 -
[CEO Interview] Rznomics aims to serve two ends via RNA replacement
[CEO Interview] Rznomics aims to serve two ends via RNA replacementOriginal article: hankyung BIO Insight October 2022
2022-10-26 -
RZNOMICS Inc. received FDA approval to initiate clinical development of trans-splicing ribozyme-based RNA editing technology in liver cancer patients
SEONGNAM, South Korea, Oct. 25, 2022 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, recently received Phase 1/2a IND approval from the U.S FDA in October 10th for its hepatocellular carcinoma (HCC) treatment called RZ-001 and thus has achieved an important milestone for the company and the RNA editing field. Being the first U.S. FDA-approved ribozyme-based RNA reprogramming approach to be evaluated in patients, RZ-001, a gene therapy approach utilizing the company's proprietary trans-splicing ribozyme-based RNA reprogramming and editing technology, is a replication-incompetent adenoviral vector that expresses an hTERT targeting ribozyme with multiple additional MoA to treat HCC patients. Rznomics also received IND approval of RZ-001 from the South Korean Ministry of Food and Drug Safety this June and already initiated a phase 1/2a clinical trial in Korea. Therefore, U.S. FDA approval allows Rznomics to start an international clinical study in HCC patients treating them with RZ-001 and therapeutic RNA editing. The trans-splicing ribozyme is derived from the self-splicing Tetrahymena group I intron, which both recognizes and reprograms the target RNA into the therapeutic transcript of interest. Ribozyme-based RNA editing technology developed by Rznomics has unique features, differentiating it from other nucleic acid-based editing approaches, as follows: (1) A single RNA molecule is capable of both suppressing target RNA expression and simultaneously expressing a therapeutic RNA. Thus, no potentially antigenic proteins or cofactors are required. (2) Safety can be improved by selectively inducing therapeutic RNA expression only in cells/tissues where the target gene is expressed. (3) Therapeutic gene expression can be regulated proportionally to endogenous cellular target RNA levels. (4) Editing occurs at the RNA level, not the genomic level, thus eliminating concerns about genomic toxicity and eternal genome changes. (5) Indications with multiple mutation sites scattered throughout a target RNA can be edited with a single RNA designed to react upstream of all mutations and by replacing and editing large stretches of RNA. (6) Additional safety can be conferred by building control mechanisms into the ribozyme itself, without the need to modulate intrinsic cellular mechanisms or external proteins. More specifically, RZ-001 engenders effective anti-HCC activity by suppressing hTERT expression selectively in cancer cells, which over-express hTERT, and simultaneously inducing a cytotoxic effect by trans ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. Moreover, the result of such editing efficiently induces immune cell infiltrations into HCC tumors in preclinical animal models. (http://www.rznomics.com/pipeline/RZ-001.php). The Phase 1/2a clinical trial will be a dose escalation/expansion study to assess the safety and tolerability of RZ-001 and to determine the most effective dose with the least toxicities of RZ-001 in HCC patients with no extrahepatic metastasis. "The translation of the first trans-splicing-based RNA editing approach into an FDA-approved phase 1/2a clinical trial is an exciting achievement and a critical milestone for the RNA editing field. I am very excited about Rznomics' preclinical progress on ribozyme design and gene delivery optimization. The advances have allowed them to create and now translate a promising therapy, RZ-001, into the clinic. I and the entire editing field are eager to learn if RZ-001 and mRNA reprogramming is safe and able to combat hepatocellular carcinoma in patients. Rznomics is clearly a leader at bringing novel editing strategies to cancer patients that desperately need innovative, breakthrough therapies," said Dr. Bruce Sullenger, Joseph, and Dorothy Beard Professor of Surgery at Duke University. Dr. Sullenger is a scientific advisory board member of Rznomics and the initial pioneer developing approaches to therapeutically edit RNA and DNA using RNA guided endonucleases (RGENs) such as the group trans-splicing I ribozyme.. "It's a monumental achievement of Rznomics that RZ-001, the first trans-splicing ribozyme therapy at the front of our therapeutic pipeline, has successfully received the IND approval in both Korea and the United States. I am really grateful that RZ-001 earned the opportunity to potentially fulfill the unmet needs of HCC patients. Through the advanced development phase, I hope Rznomics can provide more new therapeutic options to patients suffering from intractable diseases. Rznomics will further expand our pipeline by targeting indications with highly unmet medical needs for which the unique characteristics of our platform technology may be the most competitively applied." said Dr. Seong-Wook Lee, CEO and founder of Rznomics.In addition to the HCC, Rznomics is expanding the indication of RZ-001 to glioblastoma multiforme and planning to submit the IND this year. Also under development are ribozyme-based RNA editing treatments for Alzheimer's disease (RZ-003) and inherited retinal dystrophies, called Retinitis pigmentosa (RZ-004).
2022-10-25 -
Rznomics, got US FDA approval of clinical trial plan for liver cancer treatment
Rznomics announced on october 11th,2022 that it had received approval for phase 1 and 2 clinical trial (IND) of 'RZ-001' from the US Food and Drug Administration (FDA).The clinical trial plan was approved by the Ministry of Food and Drug Safety in June,2022 and is an extension of the ongoing domestic clinical trial.Rznomics has the technology to express the desired gene while removing the target ribonucleic acid (RNA) based on RNA trans-splicing ribozyme.RZ-001 targets telomerase (hTERT) RNA specifically expressed in cancer cells by delivering a ribonucleic acid substitution enzyme to an adenovirus vector.At the same time, it is a mechanism for expressing genes that induce anticancer activity.Rznomics is pushing to expand indications to other carcinomas, and is planning a clinical trial for malignant glioblastoma within this year.In addition to the anticancer drug pipeline, Rznomics is developing therapeutics in various fields using platform technology, such as Alzheimer's treatment, hereditary retinopathy, and Rett's syndrome.Seongwook Lee, CEO of Rznomics, said, "The pipelines under development are scheduled to begin clinical trials in korea and abroad sequentially, and we will do our best to provide new treatment opportunities to patients."
2022-10-12 -
Rznomics, Wins Award for the most Promising Candidates for Genetic Therapy at International Events
Rznomics
announced on the 16th that it won the most promising pipeline award in the gene
therapy category at the "Asia-Pacific Cell & Gene Therapy Excellence
Awards" (ACGTEA) of the "Cell & Gene Therapy World Asia
2022" (CGTWA 2022) held in Singapore.
CGTWA
is an event to share representative technologies of cell and gene therapy.
At
the conference which is followed after the award, the "next-generation
cell gene therapy" session was announced.
In
the presentation, Rznomics explained the current status of candidate substances
(pipelines) including trans-splicing ribozyme based gene therapy platform
technology and liver cancer therapy currently undergoing clinical trials. As
a company with first-in-class platform technology, it presented technological
innovation and vision.
Rznomics
plans to apply for clinical trials for glioblastoma patients in the United
States and Korea in the first quarter of next year. In the second half of next
year, the U.S. is also planning to perform clinical trials on hereditary
retinitis pigmentosa.
Seong-wook,
Lee, CEO of Rznomics, said, "This award will be a great help to executives
and employees who have a desire to develop new drugs and those who supported
Rznomics," adding, "We will do our best to achieve better
results."2022-09-21
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