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Rznomics registered a U.S. patent for its original ‘circular RNA' source technology
Rznomics announced
on the 26th that it has registered a U.S. patent for its foundational
technology platform, the ‘self-circularization RNA structure’ which enables efficient
and simple production of circular RNA, overcoming the limitations of the
existing technologies.
Rznomics has also completed applications in
Europe, Japan, China, Australia, Canada, Singapore, Israel and Brazil.
Circular RNA (circular RNA or circRNA), unlike
linear RNA used in mRNA vaccines, has a closed structure, providing superior
stability against nucleases.
Rznomics has developed a new technology fundamentally
different from the existing ‘PIE(Permuted Intron-Exon) method’ based on the
conventional ‘Group I Intron ribozyme’ for RNA circularization. While the PIE
method leaves unwanted nucleotide sequences in the final product, Rznomics’ RNA
circularization technology ensures that specific nucleotide sequences are
completely absent from the circular RNA after the self-circularization reaction.
Dr. Kyung-hyun
Lee, a senior researcher at Rznomics, stated, "Due to the unique
characteristics of our self-circularization mechanism, various designs can
enhance self-circularization efficiency compared to the PIE method, resulting
in significantly higher self-circularization and purifications yields."
Seong-wook Lee, CEO of Rznomics, stated,
"In the finally registered patent, we have been granted broad rights by
describing the components of the self-circularization RNA structure based on
their functions, without limiting them to specific sequences in the examples.”
He continued, “With the registration of the U.S. patent, we are actively
engaged in research on various applications and indications using circular RNA,
in addition to establishing mass production processes through advanced self-circularization
and purification efficiency improvements for rapid commercialization."2024-03-27 -
Promising Anticancer Gene Therapy Makes Headway
Promising Anticancer Gene Therapy Makes HeadwayFDA designations underscore the potential clinical impact of a pioneering RNA-based gene therapyRznomics, a South Korea-based biopharma, recently announced two significant advancements on their pathway to develop a novel anticancer therapy. Their lead clinical candidate, RZ-001, a viral vector engineered to deliver a proprietary RNA-based trans-splicing ribozyme, is produced leveraging Charles River’s adenoviral vector contract development and manufacturing (CDMO) experience.RZ-001 has the potential to treat several cancer types due to its multi-faceted mechanism of action. The expressed ribozyme is directly cytotoxic against cancer cells by downregulating expression of hTERT and replacing it with an HSV-TK sequence. Additionally, Rznomics has preclinical data indicating that treatment with RZ-001 can provoke an antitumor immune response in animal models.Both the master virus bank and RZ-001 clinical product have been manufactured at Charles River’s viral vector production site in Rockville, MD. “The needs of the program have changed over time, but we’ve been able to adapt the manufacturing process accordingly,” notes James Cody, PhD, Associate Director, Technical Sales and Evaluations. “We will continue to adapt as needed in order to meet the increased clinical need in the future”.Previously approved for Phase I/IIa clinical trials for hepatocellular carcinoma (HCC) in both the US and South Korea, RZ-001 was granted Orphan Drug designation by the FDA, providing access to regulatory assistance from the Office of Orphan Products Development, and has also shown promise against other cancer types.On the Fast TrackRZ-001 was also recently granted FDA Fast Track designation for the treatment of a type of brain tumor known as glioblastoma multiforme (GBM), the most common malignant brain and central nervous system (CNS) tumors accounting for around half of all cases.The gene therapy has been approved for Phase I/IIa trials for GBM treatment in both the U.S. and South Korea, and this significant designation allows for an expedited review process to improve access to patients in critical need."We are proud to receive Fast Track designation from the FDA. This signifies an important milestone in developing a safe and effective treatment for patients with GBM who require new therapeutic options," commented Dr. Seong-Wook Lee, Chief Executive Officer, Rznomics.This latest announcement highlights the opportunity for RZ-001 to make a clinical impact for patients with HCC, GBM, and potentially other types of cancer in the future. For more information on our advanced therapy development and manufacturing services, visit Cell and Gene Therapy CDMO Solutions.
2024-03-18 -
Rznomics Gene Therapy-Based Anti-Cancer Candidate Approved by FDA for New Manufacturing Process
Rznomics has changed the
manufacturing method of its anti-cancer candidate ‘RZ-001’, which is currently
in clinical trials. It has become possible to produce a sufficient amount of
clinical drug for high-concentration administration cost-effectively.
Rznomics announced on the 6th that it has
received approval from the U.S. Food and Drug Administration (FDA) to use the
newly manufactured RZ-001 in clinical trials.
Changes in the manufacturing method for drugs
that have already entered clinical trials under the approval of the IND require
approval from regulatory authorities. An Rznomics official said, "By implementing
the new manufacturing method, we can obtain a greater quantity of finished pharmaceutical
drugs at the same cost, allowing for more efficient conduct of clinical trials
for safety and efficacy validation." They added, "The development of
the new process was led by Rznomics rather than CDMO."
Rznomics' RZ-001 is currently undergoing
clinical trials for hepatocellular carcinoma (HCC) and glioblastoma (GBM). Last
month, it received Orphan Drug Designation(ODD) from the FDA for the treatment of
hepatocellular carcinoma and was granted Fast Track status for glioblastoma.
Bo-mi Kim, head of Rznomics’ RA team, said,
"From a regulatory perspective, the establishment of the new manufacturing
method’s CMC(Chemistry, Manufacturing and Controls) will likely be
significantly beneficial when considering Biologics License Application(BLA)
submissions."
Seong-wook Lee, CEO of Rznomics, also emphasized,
"The CMC(Chemistry, Manufacturing and Controls) is a crucial aspect to
confirm during discussions with global partners for licensing agreements and it
will serve as a highly positive factor from a business perspective."2024-02-06 -
Rznomics Gene Therapy-Based Anti-Cancer Candidate Approved by FDA for New Manufacturing Process
Rznomics has changed the
manufacturing method of its anti-cancer candidate ‘RZ-001’, which is currently
in clinical trials. It has become possible to produce a sufficient amount of
clinical drug for high-concentration administration cost-effectively.
Rznomics announced on the 6th that it has
received approval from the U.S. Food and Drug Administration (FDA) to use the
newly manufactured RZ-001 in clinical trials.
Changes in the manufacturing method for drugs
that have already entered clinical trials under the approval of the IND require
approval from regulatory authorities. An Rznomics official said, "By implementing
the new manufacturing method, we can obtain a greater quantity of finished pharmaceutical
drugs at the same cost, allowing for more efficient conduct of clinical trials
for safety and efficacy validation." They added, "The development of
the new process was led by Rznomics rather than CDMO."
Rznomics' RZ-001 is currently undergoing
clinical trials for hepatocellular carcinoma (HCC) and glioblastoma (GBM). Last
month, it received Orphan Drug Designation(ODD) from the FDA for the treatment of
hepatocellular carcinoma and was granted Fast Track status for glioblastoma.
Bo-mi Kim, head of Rznomics’ RA team, said,
"From a regulatory perspective, the establishment of the new manufacturing
method’s CMC(Chemistry, Manufacturing and Controls) will likely be
significantly beneficial when considering Biologics License Application(BLA)
submissions."
Seong-wook Lee, CEO of Rznomics, also emphasized,
"The CMC(Chemistry, Manufacturing and Controls) is a crucial aspect to
confirm during discussions with global partners for licensing agreements and it
will serve as a highly positive factor from a business perspective."2024-02-06 -
Rznomics "Hepatocellular Carcinoma Drug ‘RZ-001’ Designated as an Orphan Drug by FDA"
Phase 1/2a
clinical trial in patients with liver cancer that does not respond to transarterial
chemoembolization
Rznomics (CEO Seong-wook Lee) announced on the
22nd that its developmental cancer treatment, “RZ-001(developmental code name),
targeting hepatocellular carcinoma, has received Orphan Drug Designation from
the U.S. Food and Drug Administration (FDA).
With Orphan Drug Designation, the company
becomes eligible for benefits such as tax credits for research and development
expenses, exemption from approval application fees, and a seven-year market
exclusivity period starting from the approval date. The designation is expected
to provide favorable conditions during the priority and accelerated review
decisions.
RZ-001 is currently undergoing Phase 1/2a
clinical trials, having received approval for its clinical trial plan from the Ministry
of Food and Drug Safety in Korea and the FDA. The trial focuses on patients
with hepatocellular carcinoma who do not respond to transarterial
chemoembolization(TACE) and aims to develop a treatment option that can be
prioritized before using systemic therapies.
Seong-wook Lee, CEO of Rznomics, said, "Effective
treatments for hepatocellular carcinoma are urgently needed at various stages,
and we will do our best to make RZ-001 a new therapeutic option."
In addition to the ongoing clinical
development, Rznomics has expanded the application of RZ-001 to include glioblastoma,
receiving Fast Track designation from the FDA in November last year. The company is actively
engaged in global clinical development through collaborations with
pharmaceutical companies, including a clinical partnership with Roche.2024-01-23 -
Rznomics Launches Clinical Trials in Australia for Genetic Retinal Disease Treatment
'RZ-004' Approved by OGTR in
Australia... Plans to expand clinical development countries in the future
Rznomics (CEO Seong-wook Lee) has announced on
January 16th that it has received approval for the review of the phase 1
clinical trial for ‘RZ-004’ in Australia, a therapeutic candidate for genetic
retinal diseases, including Retinitis Pigmentosa. The review is being conducted
by the Office of the Gene Technology Regulator (OGTR) in Australia.
Retinitis Pigmentosa is a rare and incurable
genetic retinal disorder where visual cells progressively deteriorate, leading
to a narrowing field of vision and eventual vision loss. It occurs globally at
a rate of approximately 1 out of every 3,500 to 4000 people.
‘RZ-004’
aims to eliminate mutated Rhodopsin RNA by using ‘Trans-splcing ribozyme’, a
RNA correction platform technology owned by Rznomics. Notably, Rznomics
explains that its technology can correct over 150 different known mutations
with a single therapeutic agent.
Sung-woo Hong, the Head of
Development at Rznomics, stated, “Australia possesses elements conducive to the
early clinical development of genetic ocular diseases, such as an excellent
healthcare system, medical expertise, patient numbers, patient compliance and
regulatory support.” He further mentioned plans to expand clinical development
to the United States and Europe, with Australia as the starting point.
Seong-wook Lee, the CEO of
Rznomics, emphasized the significance of ‘RZ-004’ by highlighting the lack of
approved treatments and the scarcity of ongoing therapeutic developments for
the targeted condition. He expressed the company’s commitment to providing
treatment opportunities for patients suffering from diseases and enhancing
their quality of life through swift development efforts.2024-01-17 -
Rznomics’s Liver Cancer Treatment, Clinical trials in combination with immuno-oncology drugs
Rznomics, a gene therapy development company, announced that its Phase 1b/2a clinical trial plan (IND) for the administration of liver cancer drug candidate “RZ-001” along with immune-oncology drugs has been recently approved by the Ministry of Food and Drug Safety.Rznomics plans to evaluate the efficacy and safety of “RZ-001” as a first-line treatment in about 50 patients diagnosed with hepatocellular carcinoma along with the immune-oncology drug ‘Ticentric’ and the targeted therapy ‘Avastin’. ‘Ticentric’ and ‘Avastin’ are Roche’s most widely used anti-cancer drugs for the first-line treatment of hepatocellular carcinoma. Roche will provide Rznomics for the ‘Ticentric’ to be used in this clinical trial.RZ-001 received MFDS and FDA clinical trial approval for HCC and GBM as a single administration therapy.Rznomics is conducting an independent clinical trial of RZ-001 in patients with hepatocellular carcinoma.
2024-01-04 -
Ministry of SMEs and Startups(MSS), Open Innovation Performance Sharing Meeting
The Ministry of
SMEs and Startups held the 2023 Public-Private Cooperation Open Innovation
Performance Sharing Meeting at JW Marriott Dongdaemun Square in Jung-gu, Seoul
on the 7th to spread the results of open innovation (open innovation)
performance.
The public-private partnership open innovation
project is a project that discovers and links the demand for collaboration
between large companies and startups, and to activate open innovation with
follow-up support from the government. This year, it supported the
collaboration of 87 startups. Selected startups received up to 100 million won
in funds for commercialization of collaboration, mentoring, and R&D
support.
At the event, 37 companies, including
outstanding collaborative start-ups and large companies, were awarded. Eight
people, including Jae-hwan Park, manager of SK Telecom, Lee Jung-joong, head of
Lotte World at Hotel Lotte, and Kim Sung-sung, manager of the Seoul Creative
Economy Innovation Center, received the MSME Minister’s Commendation. Lotte
World, May Eye, Moorim P&P, and YooSeung In Nature Nature were introduced
as outstanding examples of collaboration
.
Five companies, including Thoth, CA Lab,
Rznomics, The Wave Talk, and MANGOSLAB, were selected as support companies for
the Super Gap Startup Open Innovation Challenge. The Ministry of SMEs and
Startups selected 5 start-ups with high potential through cooperation with
large companies in the 10 Super-gap fields and provide them up to 50 million
won in collaboration funds and preferential benefits when applying for next
year's Super-gap project.
Lim Jeong-Wook, head of the Startup and
Venture Innovation Office at MSME, said, "Open innovation has now
established itself as one of the pillars of mutual growth between large
companies and startups," and added, "We will continue to create a
win-win collaboration ecosystem where large companies and startups can grow
together as a team."2023-12-11 -
Rznomics Inc. Secures Fast Track Designation from the U.S. FDA for RZ-001
SEONGNAM-SI, South Korea , Nov. 10, 2023 /PRNewswire/ -- Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, announced today that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, for the treatment of patients with Glioblastoma (GBM).Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs, thus enabling drugs to reach patients sooner. If relevant criteria are met, the drug with Fast Track Designation may also be eligible for Accelerated Approval and Priority Review.GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. RZ-001, the RNA replacement enzyme-based cancer gene therapy for the treatment of GBM, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. RZ-001 has demonstrated very promising responses in preclinical studies in which an enhanced anti-cancer efficacy and a higher survival rate was observed."We are proud to receive Fast Track Designation from the FDA," said Dr. Seong-Wook Lee, Chief Executive Officer of Rznomics. "This designation signifies an important milestone in developing a safe and effective treatment for patients with GBM who are in need of new therapeutic options."Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial will investigate the safety, tolerability, and efficacy of RZ-001 in patients with GBM. Subjects will be treated with RZ-001 according to the planned dose escalation design.About RZNOMICSAs a biopharmaceutical company founded in the laboratory of Professor Seong-Wook Lee, Dankook University Department of Bioconvergence Engineering, Rznomics is researching with the goal of developing new RNA-based gene therapeutic bio-drugs for cancer and incurable diseases. Rznomics' core platform technology is based on an RNA replacement enzyme, known as trans-splicing ribozyme, which can edit target RNA through simultaneous destruction and repair (and/or reprogramming) to yield the desired therapeutic RNA, thus, selectively inducing therapeutic gene activity in cells expressing the target RNA.Rznomics' lead candidate (RZ-001) is a treatment for Hepatocellular Carcinoma & Glioblastoma (Phase 1/2a IND approval from both in South Korea and in the U.S.), with other treatments for Alzheimer's disease and hereditary retinal dystrophy (RD)For more information, please visit https://www.rznomics.com/SOURCE Rznomics Inc.
2023-11-13
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