Yonsei University

SEOUL, South Korea--( BUSINESS WIRE )--The South Korean biotech company GI Innovation announced today that it has signed a clinical trial collaboration and supply agreement with MSD (a tradename of Merck& Co., Inc., Rahway, NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma. This agreement marks GI Innovation’s second clinical trial collaboration with MSD, following a previous collaboration for GI-101A. The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options. GI Innovation is focused on three indications with significant market potential and potential likelihood of success: metastatic liver cancer, melanoma, and renal cell carcinoma. The company has already demonstrated strong anti-cancer efficacy with a 42.9% overall response rate (ORR) in a monotherapy trial of GI-102 in melanoma patients who failed to respond to standard-of-care treatment (3 partial responses out of 7 patients). Complete tumor regression was previously observed in 60% of mice treated with GI-102 monotherapy in a preclinical liver cancer model. Fourteen hospitals in South Korea and world-renowned sites in the U.S. have agreed to join the trial, including the Mayo Clinic (campuses in Rochester, Florida, and Arizona), Cleveland Clinic and Memorial Sloan Kettering Cancer Center. In South Korea, the trial will take place at leading hospitals including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital. "We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy”, said Dr Myung-Ho Jang, GI Innovation’s Chief Scientific Officer. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.

BUSAN, South Korea I July 16, 2024 I NexThera Co., Ltd. (CEO SaeGwang Park) announced that it has submitted a Phase 1/2a Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NT-101, a non-invasive eye drop treatment for wet age-related macular degeneration (wet AMD). NT-101 is NexThera’s first new drug candidate developed using its proprietary eye drop delivery platform. This innovative technology enables the safe and convenient administration of substances to the retinal tissue, eliminating the need for invasive injections into the eye. Wet AMD is a leading cause of blindness in the elderly. Current treatments primarily rely on antibody-based therapies targeting vascular endothelial growth factor (VEGF). However, these treatments require intraocular injections, which can be uncomfortable for patients and carry risks of infection, bleeding, and retinal detachment. Long-term administration can also lead to complications such as retinal atrophy and fibrosis. Consequently, there has been a persistent demand for a safe and convenient eye drop treatment to address this unmet medical need. NT-101 contains an endogenous peptide as an active drug substance and a carrier protein, and it has shown comparable or superior efficacy to existing antibody treatments. Notably, the carrier’s action enhances ocular surface retention and improves drug delivery to the retinal tissue, surpassing the efficacy of active ingredient alone. While conventional treatments primarily target VEGF inhibition, which can lead to side effects, NT-101 offers dual benefits by not only suppressing angiogenesis but also protecting optic nerve cells through balanced regulation of angiogenic and anti-angiogenic factors. A NexThera representative stated, “The phase 1/2a clinical trial for NT-101 is designed to evaluate the safety and tolerability of the investigational drug in patients with wet AMD. The trial will administer low or high doses of the drug to a cohort of 30 patients twice daily (morning and evening) for 28 days. Secondary objectives include monitoring changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA) following drug administration.” SaeGwang Park, CEO of NexThera, said, “We are confident that the NT-101 clinical trial will establish it as a groundbreaking treatment for wet AMD, paving the way for further development. We’re also exploring its potential application to other retinal neovascular diseases, such as diabetic retinopathy.” NexThera, a biopharmaceutical research and development company founded in February 2020 utilizing platform technology, has established itself through partnerships and strategic investments. The company has forged joint development agreements with EyeGene Inc. and BMI Korea Co., Ltd., and secured a total of KRW 16.3 billion (about USD 11.8 million) in funding through various channels, including seed funding, Series A investment, and bridge round investment. For the NT-101 clinical trial, CorestemChemon Inc. conducted the toxicity assessment, with non-clinical consulting provided by QuBEST BIO Co., Ltd. And, KCRN Research, Inc. in the United States served as the clinical contract research organization (CRO). The clinical trial drug product (DP) was manufactured by BMI Korea Co., Ltd. NexThera was co-founded by two medical school professors in Busan, South Korea. Leading the company is CEO SaeGwang Park, a physician-scientist (MD, PhD) and professor at College of Medicine, Inje University. Dr. Park graduated from College of Medicine, Inje University with a specialization in basic medicine and holds master’s and doctoral degrees from Seoul National University Graduate School of Medicine. He also has research experience at the University of Chicago in the United States. Jee-Yeong Jeong (PhD), NexThera’s co-founder and CTO, boasts an impressive background in biotechnology. After earning bachelor’s and master’s degrees in biochemistry from Yonsei University, he began his career at LG Chem’s renowned Biotech Research Institute, a breeding ground for Korean biotech startups. Dr. Jeong then went on to complete his doctorate at Purdue University in the United States. He has also served as an instructor at Harvard Medical School and currently holds a professorship at Kosin University College of Medicine. NexThera is dedicated to developing advanced treatments and platforms that leverage the unique strengths of its co-founders, drawing on their combined experience and achievements in biomedical research spanning over 20 years. In addition to NT-101, ongoing projects include advancing a biobetter development platform and cancer cell-selective protein synthesis inhibition technology. The biobetter development platform, which utilizes the properties of self-assembling proteins, is a versatile system applicable to the development of various protein drugs and biobetters, including peptides, enzymes, and antibody fragments. This platform is currently undergoing optimization following the completion of patent applications and the selection of application candidates. Additionally, the technology for selectively inhibiting protein synthesis in cancer cells has been chosen by the 2023 Korea Drug Development Fund to receive government subsidies for research due to its innovation and practicality. Research and development efforts are currently focused on successfully identifying lead compounds. To optimize its research and development activities, NexThera has established a dedicated R&D center staffed with a team of highly qualified researchers. The company recently bolstered its team with clinical development experts and biopharmaceutical manufacturing process specialists, all boasting extensive IND experience. This strategic expansion will accelerate NexThera’s development and commercialization efforts. Learn more about NexThera and its pipeline at https://nexthera.org/en/ . SOURCE: NexThera

SEOUL, South Korea I July 09, 2024 I S.BIOMEDICS (KOSDAQ: 304360) announced positive one-year assessment data from the first 3 participants (first low dose cohort) of Phase I/IIa clinical trial for Parkinson’s disease with TED-A9, hESC (human embryonic stem cell)-derived midbrain dopaminergic progenitors. The data demonstrates that 3 participants showed safety and efficacy of TED-A9 in a one-year follow-up. The clinical trial was conducted at Severance Hospital of Yonsei University in South Korea led by Prof. Jin-Woo Chang, a neurosurgeon and Prof. Phil Hyu Lee, a neurologist. For the 3 participants who received initial low dose (3.15 million cells), MRI and CT scans after one year revealed no adverse effects related to the cell transplantation or surgery. Moreover, the MDS-UPDRS Part III (off) evaluation, which objectively measures motor functions, showed a mean decrease of 12.7 points, from baseline 61.7 to 49.0 one-year post treatment. The MDS-UPDRS Part III (off) evaluation indicated significant improvement in their motor abilities. Improvement was also observed in symptoms such as wearing off and freezing of gait. DAT brain imaging (FP-CIT-PET), conducted one-year post transplantation, revealed an increase in dopamine transporters (DAT), suggesting the potential engraftment of dopamine neurons, which correlated with improvements in the patients’ Parkinson’s symptoms. “Although this clinical evaluation only targets the first 3 low-dose patients, but not all 12 subjects, no adverse issues related to transplant surgery or cell safety were observed in one-year post transplantation. Importantly, the clinical results demonstrated very promising efficacy,” said Prof. Dong-Wook Kim at Yonsei University College of Medicine and CTO of S.BIOMEDICS. “The results are believed to align closely with the findings from our preclinical in vitro and in vivo studies. We are excited that TED-A9 could be a fundamental treatment that directly replaces dopaminergic neurons lost in patients with Parkinson’s disease.” Assessment data of further participants (first high dose cohort) will be announced in September or October of 2024 after a one-year follow-up. About TED-A9 and Phase I/IIa clinical trial TED-A9 is an investigational cell therapy designed to replace ventral midbrain-specific dopaminergic cells lost in patients with Parkinson’s disease. These ventral midbrain-specific dopaminergic cells are derived from hESCs by exclusively utilizing small molecules only. TED-A9 represents a significant advancement in the field, offering highly purified dopamine cells derived from hESCs. Through surgical procedure, these hESC-derived dopaminergic progenitor (precursor) cells (TED-A9) are transplanted to three segments of the putamen; the anterior, middle, and posterior sections, with three tracks per each putamen. Bilateral putamina received cell transplantation in a single surgical procedure, with cells injected at three points within each track. After transplantation, the expectation is that the transplanted dopaminergic progenitor cells will mature into dopaminergic neurons which will supply the dopamine that Parkinson’s patients are lacking, restoring the motor function of patients. The Phase I/IIa clinical trial is conducted on 12 participants who have been diagnosed with Parkinson’s disease for more than 5 years and exhibited motor complications such as wearing-off, freezing of gait or dyskinesia. The participant’s age was between 50 and 75 years old. TED-A9 were administered to 6 participants in the low-dose group (3.15 million cells) and to another 6 participants in the high-dose group (6.30 million cells). An initial cohort of three patients was enrolled at a low dose to assess initial safety, including dose-limiting toxicity (DLT) evaluation, over a period of up to 3 months post-transplantation. There were no safety concerns within this timeframe. Thus, an additional 3 patients were enrolled at a high dose for evaluation over another 3-month period post-transplantation. As no safety issues arose during this extended period, the clinical trial continued by adding three further patients to each of the low-dose and high-dose groups, totaling 12 patients. The final participant was administered with TED-A9 on February 2024. The primary objective of the Phase I/IIa trial is to assess the safety and exploratory efficacy of TED-A9 transplantation over two years post-transplant. Safety will be monitored for additional 3 years, making it a total 5 years. About S.BIOMEDICS Established in 2005, S.BIOMEDICS is at the forefront of stem cell therapy, focusing on regenerative medicine powered by data-driven biology. Based on two core platform technologies, S.BIOMEDICS currently develops seven cell therapy programs, targeting non-curable diseases. Its leading programs are under clinical stage accelerating the journey of cell medicine as shown below: For more information about S.BIOMEDICS, visit www.sbiomedics.com . S.BIOMEDICS is listed on the Korea Exchange (KOSDAQ: 304360) and is also the founder and controller of S.THEPHARM ( www.sthepharm.com ), a corporation specializing in anti-aging products such as HA-Filler. More Information about the Phase 1/2a clinical trial for Parkinson’s disease is available at ClinicalTrials.gov (NCT05887466) . SOURCE: S.Biomedics