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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
RZNOMICS Inc. Announces Clinical Trial Collaboration and Supply Agreement to Evaluate RZ-001 in Combination with anti-PDL1 in liver cancer patients

SEONGNAM, 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 entered into a clinical collaboration agreement with F. Hoffmann-La Roche Ltd (Roche) to study RZ-001, a gene therapy approach utilizing the company's proprietary trans-splicing ribozyme-based RNA reprogramming and editing technology, in combination with Roche's atezolizumab, in patients with hepatocellular carcinoma (HCC). Under the terms of the agreement, Roche will provide atezolizumab to be used in combination with RZ-001 for the planned Phase 1b/2a study.RZ-001, the RNA replacement enzyme based cancer gene therapy, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. Specifically, RZ-001 induces anti-HCC activity by suppressing hTERT expression selectively in cancer cells, which express hTERT, and simultaneously inducing a cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. It also induces effective immune cell infiltration into treated tumors and reduces VEGF expression in the tumors, which leads to the anti-cancer efficacy and transformation of tumor microenvironment to be more responsive to immunotherapy.RZ-001 has demonstrated therapeutic activity in preclinical studies and significant improvement in anti-cancer efficacy in a dose dependent manner in combination with atezolizumab. The clinical study will evaluate the safety and efficacy in liver cancer patients and it is anticipated that the combination of RZ-001 with atezolizumab may enhance response rate and anti-cancer efficacy that could benefit patients with HCC."We are excited to initiate collaboration with longstanding oncology leader, Roche, to further explore the potential benefits of combining checkpoint blockade with RZ-001," said Dr. Seong-Wook Lee, Chief Executive Officer of RZNOMICS. "We look forward to having this collaboration, evaluating combination therapy and continuing our mission to offer innovative therapies for patients in need."About RZ-001RZ-001 is the first Group I intron based trans-splicing ribozyme-based RNA reprogramming approach approved by the FDA for evaluation in patients. The treatment was developed utilizing Rznomics' proprietary RNA reprogramming and editing technology and takes the form of an adenoviral vector that expresses an hTERT targeting trans-splicing ribozyme to treat hepatocellular carcinoma (HCC) patients. HCC is the most common type of primary liver cancer, accounting for 80 percent of cases worldwide.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 HCC and Glioblastoma as well.About Rznomics Inc.Rznomics Inc., is a biotech company specialized in the development of RNA-based gene therapies for cancers and intractable diseases. Founded in 2017, its RNA replacement enzyme platform is being developed for numerous indications such as hepatocellular carcinoma, glioblastoma, retinitis pigmentosa, rett syndrome and alzheimer's disease.For more information, please visit https://www.rznomics.com/ Media Contact:rznomics_bd@rznomics.com SOURCE Rznomics Inc.

2023-11-13
Rznomics selected as one of the 50 Best Companies in excellent Technology Development for Small and Medium-sized Businesses

Rznomics announced on the 18th that it has been selected as ‘Top 50 Companies in excellent Technology Development for SMEs’ by Korean ‘Ministry of SMEs and Startups.’

The 50 Best Technology Development for SMEs is
in its first year to promote innovation, quality advancement, and
commercialization of excellent technology development for SMEs.

The 50 Best
Technology Development for SMEs evaluates and selects 30 companies with
excellent commercialization performance, including cumulative sales of
technology development projects, ▲ 6 companies that achieved world-class
technology in the national strategic technology field ▲ 7 companies that
succeeded overcoming technology takeover and management crisis ▲ 7 innovative
product companies that contributed to improving public services such as
industrial safety over the past five years (2018-2023).

For its selected grant projects by the
Ministry of SMEs and Startups, Rznomics has developed RNA replacement enzymes
that can be used as selective and specific treatments as a new way to replace
genes at the mRNA level. Based on the aforementioned development, Rznomics is
selected as one of the final six companies in the national strategic technology
sector in recognition of its excellence and differentiation of technology
development performances, with performances such approval of the clinical trial
plan (IND) of development of liver cancer gene therapy by Ministry of Food and
Drug Safety and U.S. Food and Drug Administration, domestic and international
patent registration, and verification of anticancer efficacy by independent
administration.
Based on the same platform technology recognized, mentioned above, Rznomics has also obtained IND approval from the Ministry of Food and Drug Safety and the FDA for glioblastoma (malignant brain tumor) treatments. And Rznomics is preparing to conduct clinical trials within this year.

In addition,
IND applications for the treatment of autosomal dominant formulation hereditary
retinopathy, which is first pipeline of Rznomics to treat genetic rare disease
currently without treatment, is also being prepared to be submitted in early
2024.

Seong-wook Lee, CEO of Rznomics, said, "I
am pleased to be able to recognize Rznomics' technology for its excellence and
selection as a top 50 company. We will use this opportunity to promote our
technology more widely and do our best to implement Rznomics’ technology as an
innovative treatment that can solve the unmet demand for rare and intractable
diseases.”

2023-10-18

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