Kangstem Biotech Co., Ltd.’s Post

MRI imaging from the high-dose group in the Phase 1 clinical trial of Kangstem Biotech’s osteoarthritis treatment, OSCA, demonstrated significant pain reduction and cartilage regeneration. The evaluation was conducted independently by RadMD, a U.S.-based radiology company with extensive experience working with the FDA, ensuring both objectivity and data reliability.   In the high-dose group, as with the mid-dose group, pain reduction and joint function improvement were rapidly observed from the onset of treatment. In addition to quick symptomatic relief, structural improvements were also noted through WORMS (a osteoarthritis remission assessment) and MOCART (a localized cartilage change evaluation). Notably, knee osteoarthritis pain is primarily caused by damage to cartilage or subchondral bone, and most patients in the high-dose group showed promising results in both cartilage regeneration and subchondral bone structure improvement. This represents a major milestone for Kangstem Biotech, which is focused on developing a DMOAD(Disease-Modifying Osteoarthritis Drug), as it shows the potential for treating arthritis with a simple injection, without the need for surgery.   “The clear correlation between pain relief, functional improvement, and structural regeneration like cartilage and subchondral bone repair in the early stages of treatment is an extremely encouraging result—one that has not been seen with currently marketed or in-development drugs,” said Head of Clinical Development at Kangstem Biotech. “In particular, the pain reduction and therapeutic effects have lasted for more than six months after the first dose, with continued improvements in joint function over time. If successful, OSCA could be a game changer in the global arthritis treatment market.”   Regarding the recent domestic technology transfer agreement with Yuyoung Pharmaceutical, the company is a well-established mid-sized pharmaceutical firm with more than 40 years of experience in the osteoarthritis and musculoskeletal drug market. The positive clinical data from OSCA, along with favorable opinions from advisory experts regarding its clinical success and therapeutic potential, formed the basis of this agreement.   This domestic partnership is expected to accelerate Kangstem Biotech's global expansion, and it will also play a key role in the company’s international licensing efforts.   Kangstem Biotech expects to receive the full analysis report of the OSCA Phase 1 clinical trial in November. Based on these results, the company plans to present MRI images and clinical outcome data at international arthritis-related conferences and pursue global technology licensing opportunities. #kangstembiotech #stemcell #cell #stemcelltherapy #celltreatment #OSCA #osteoarthritis #DMOAD https://lnkd.in/gmxbf_3v

Kangstem Biotech will participate in Bio Europe 2024, taking place from November 4 to 6 in Stockholm, Sweden. Leveraging domestic Phase I clinical data for its osteoarthritis treatment, OSCA, the company aims to initiate global commercialization efforts, including technology transfers with major international pharmaceutical firms.   We have already received requests for one-on-one partnering meetings from global pharmaceutical companies in various regions such as the United States, Japan, and China, including Big Pharma in Germany, France, and Switzerland, and have confirmed the schedule. Notably, with large pharmaceutical company specializing in regenerative medicine such as cartilage, tissue, and bone, we will hold specific business discussions based on the pain, function, and activity improvement and MRI image evaluation data of the OSCA Phase 1 clinical trial separately at the Swiss headquarters.   Business Development Headquarters of Kangstem Biotech said “Prior to the event, we held a preliminary meeting to enhance the understanding of OSCA, our advanced biofusion drug. We will continue these discussions to strengthen local partnerships and facilitate our entry into the global market," and “A key focus of this meeting will be to demonstrate to European pharmaceutical companies that previously viewed cartilage improvement and regeneration as unattainable. We will present the promising results from OSCA’s Phase I clinical trial, which include cartilage regeneration and enhancement of soft bone. We believe this will significantly impact our global business performance, including technology exports.”   As the world enters a super-aging era, the prevalence of osteoarthritis is rising rapidly, and the market is expanding accordingly. However, there is currently no DMOAD(disease-modifying osteoarthritis drug) available. In response, OSCA has garnered significant attention in the industry and market, as it aims to treat osteoarthritis through an intra-articular injection in the knee joint, eliminating the need for surgery.   In Phase I clinical trials, OSCA demonstrated a differentiated pain reduction effect and sustained results compared to existing drugs. The outcomes, which include cyst reduction, cartilage regeneration, and improvements in subchondral bone structure—linked to pain alleviation through MRI evaluations—are anticipated to position OSCA as a global innovative new drug.   The analysis of the Phase I clinical trial results is expected to be finalized in November. We plan to present these findings at the OARSI(International Osteoarthritis Society) conference in Songdo next April and at the ISAKOS(International Society for Arthroscopic Sports Knee Surgery) conference in Munich in June. Additionally, the Phase 2a clinical trial in Korea is accelerating with the approval of the IND change from the Ministry of Food and Drug Safety on the 24th.   https://lnkd.in/gfUj_NjF #kangstembiotech

Finding cancer cells is easy with PET-CT scanner

The Phase 1 clinical trial of FURESTEM-OA Kit., which targets the DMOAD(disease-modifying osteoarthritis drug) of osteoarthritis without surgery, is on track.   The low-dose group, which has entered the fifth month of treatment, will undergo an MRI-based imaging evaluation in February to confirm cartilage regeneration and subchondral bone structure improvement. Patients who have completed treatment are being monitored regularly, and to date, there have been no adverse events related to the drug. Significant improvements are also being seen in pain or overall assessment of joint function using pain scales(VAS), osteoarthritis scales(WOMAC), and knee function and activity scales(IKDC).   The mid-dose group, which completed dosing in November, also reported no significant safety-related adverse events at the one-month dose-limiting toxicity(DLT) study in January, and significant improvements in post-dose pain and joint function assessments are being observed in a much shorter period of time than in the low-dose group.   Patients in the FURESTEM-OA Kit trial are reporting significant pain reduction and functional improvements that have led to increased ease of daily living, and the mid-dose group in particular is showing greater improvement in a number of assessments and real-world activities, which is encouraging.   Kangstem Biotech plans to start dosing patients in the last clinical group, the high-dose group, this month and complete the safety evaluation and imaging evaluation of the low-dose group in February. After that, the mid-dose and high-dose groups will be conducted and completed sequentially according to the clinical trial procedure, and the Phase I clinical trial will be completed in August and the overall results will be disclosed in the second half of the year.   Meanwhile, FURESTEM-OA Kit a new drug aimed at the DMOAD of osteoarthritis with a single intra-articular injection without surgery, is currently undergoing a Phase 1 clinical trial to evaluate the safety and tolerability of low, medium, and high doses of stem cell doses and to identify the optimal recommended dose and exploratory efficacy. Dosing is designed at 2-month intervals per group, and clinical results will be presented after 6 months of observation for each cohort(group). #kangstembiotech #stemcell #cell #stemcelltherapy #celltreatment #osteoarthritis #DMOAD https://lnkd.in/g7TuchqZ

Radiopharmaceuticals (RPT) are gaining increasing attention worldwide, particularly after the success of Novartis' Pluvicto. This market, though in its early stages, is showing significant potential despite mixed evaluations. On one hand, the market has attracted substantial investments, such as $90 million in a Series A round for Artbio in 2023, even in a challenging investment environment. On the other hand, the high technical barriers make it a difficult field for new entrants. RPTs use radioactive isotopes for diagnosis and treatment, targeting cancer cells directly for improved efficacy and safety. Isotopes are categorized as either diagnostic or therapeutic, with key factors including how well they target tumors and their duration at the site. RPT uses photons for imaging, electrons for longer-range tumor treatment, and alpha particles for short-range, high-energy DNA damage, making it effective against cancers such as thyroid and metastatic prostate cancer. FDA-approved RPTs, like I-131, Lu-177, and Ra-223, have already demonstrated improved patient outcomes. Additionally, newer isotopes like Ac-225 and Pb-212 are being researched to target small tumors and metastases, offering potential breakthroughs in personalized cancer therapy. Challenges still remain in areas such as dosimetry complexity, logistical hurdles, and public concerns about radioactivity. However, RPT's ability to simultaneously diagnose and treat cancer with minimal radiation exposure enhances its clinical utility, making it a promising personalized cancer care. In South Korea, companies like SK Biopharm and FutureChem are positioning RPT as a core growth area. SK Biopharm, in partnership with TerraPower, holds exclusive rights to Ac-225 in Asia for treating cancers like prostate and pancreatic. FutureChem is developing both diagnostic and therapeutic radiopharmaceuticals, with its FC705 showing superior efficacy at lower doses compared to Novartis’ Pluvicto. These efforts position South Korea as a growing player in the global RPT market. Globally, the RPT market is projected to reach $8.9 billion by 2026, driven by innovations in targeting cancer-specific proteins. Companies like Novartis, Eli Lilly, and BMS are leading the market with acquisitions and new therapies for prostate and neuroendocrine cancers. references: https://lnkd.in/gh3k9xAS Sgouros, G., Bodei, L., McDevitt, M.R. et al. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nat Rev Drug Discov 19, 589–608 (2020). https://lnkd.in/gbQYJHDC https://lnkd.in/ga5kZy46 #RPT

We're thrilled to share a recent article featuring our very own Professor Kim Dong-wook, highlighting advancements in oral cancer surgery and reconstruction. Titled "I Want to Find Hope Through Oral Cancer Surgery'", this insightful piece sheds light on the innovative approaches and technologies transforming patient care in this field. The article underscores the importance of early detection and emphasizes the role of advanced techniques in improving patient outcomes. We're proud to be part of an industry that continues to push boundaries and prioritize patient care above all else. This article serves as a testament to our ongoing dedication to excellence in oral cancer surgery and reconstruction. Read the full article here to learn more about the remarkable advancements shaping the future of oral cancer treatment. https://lnkd.in/g6nAmvmG #OralCancer #SurgicalInnovation #PatientCare #MedicalAdvancements #medicaldevice #Innovation #TiMandible #3dprinting #cubelabs

The mid-dose arm of the Phase 1 clinical trial of Furestem-OA Kit Kangstem Biotech's osteoarthritis treatment, has entered the finalization phase. We plan to complete patient observation and begin MRI-based imaging analysis by the end of May.   In the mid-dose arm, where we have high expectations for a radical treatment, pain reduction was rapid in all patients early in the study and has been sustained since the single dose. In particular, as time passes, the clinical patients are showing clear therapeutic effects, such as significant improvement in joint function, which is expected to have a significant impact on the fundamental treatment of osteoarthritis.   In addition, the MRI-based imaging assessment of patients in the low-dose arm, announced in April, confirmed that all patients in the study showed localized cartilage regeneration, and all three patients showed improvement in synovial inflammation on the Osteoarthritis Overall Rating Scale (WORMS). In addition, two of the subjects demonstrated cartilage regeneration and improvement in the structure of the subchondral bone, and one patient demonstrated improvement in most subcategories, including WORMS total score.   The low-dose arm of the trial, which is the lowest dose of stem cells, has demonstrated pain control, cartilage regeneration, and positive imaging results that exceeded expectations. The mid-dose and high-dose trials, which are currently in their final stages, are showing significantly greater improvement than the low-dose trial, with the potential for even greater structural improvement and a breakthrough treatment.   In the mid-dose arm, which is expected to be completed by the end of May, a single injection has been shown to reduce pain and improve by more than 60-70% compared to pre-dose, resulting in structural improvements such as cartilage regeneration in the knee joint that are more pronounced than in the low-dose arm. In addition, all patients who completed the treatment from the low to high dose have not experienced any significant side effects, and as the injected cells differentiate into chondrocytes and directly contribute to the regeneration of cartilage tissue, we expect a fundamental treatment effect for osteoarthritis that is safe without surgery.   We expect to complete patient observation in the mid-dose arm within the month and will rapidly move forward with MRI image analysis to accelerate ongoing out-licensing discussions.   Based on the top-line data from the Phase 3 clinical trial for atopic dermatitis, which is expected in June, and the results of the MRI imaging evaluation of the mid-dose arm of the Phase 1 clinical trial for osteoarthritis, Kangstem Biotech will apply for a marketing authorization for atopic dermatitis and pursue early technology export for osteoarthritis. https://lnkd.in/g8BMQZBj #kangstembiotech #stemcell #cell #stemcelltherapy #celltreatment #osteoarthritis  

Kangstem Biotech today completed the dosing of six patients in the high-dose arm of its Phase 1 clinical trial of FURESTEM-OA Kit Inj. for osteoarthritis. This completes the full dosing of the Phase 1 clinical trial of FURESTEM-OA Kit, which aims to treat osteoarthritis through joint injections without knee surgery.   The Phase 1 study is divided into three groups based on stem cell dose: low, medium and high dose to evaluate the safety and tolerability of FURESTEM-OA Kit and to determine the recommended dose.   The low-dose group completed treatment at the end of August last year and is undergoing evaluation, including MRI, at six months post-treatment, and is expected to complete imaging evaluation by the end of this month. In addition, we plan to analyze the results by linking the level of change and validity of seven biomarkers related to cartilage production with the imaging evaluation.   In the mid-dose group, the dosing was completed in October, and patients were observed through pain assessment measures such as VAS, KOOS, IKDC, and daily life, and it was confirmed that osteoarthritis symptoms such as pain and knee function and activity improved by more than 60~70% compared to pre-dosing. This is an excellent improvement rate that has not been seen in any other drug developed to date, and is expected to lead to structural improvement of the knee joint.   Yo-han Bae, Head of Clinical Development at Kangstem Biotech said, "The speed and magnitude of improvement in the low- and mid-dose groups was faster and more dramatic than our initial expectations, confirming the safety and significant exploratory efficacy of FURESTEM-OA Kit in patients with moderate knee osteoarthritis," and "In particular, we are very excited about the development of the new drug, as some of the participants in the mid-dose group had suffered from osteoarthritis for a long time and showed significant improvements in activity with a single injection. Although it is only in Phase I, we will increase the business value of new drug development by securing high therapeutic effectiveness and MRI and biomarkers that can prove it." https://lnkd.in/gec4RQgW #kangstembiotech #stemcell #cell #stemcelltreatment #celltherapy #osteoarthritis

Changes in nails can be an early sign of cancer. Stay informed and read more in this enlightening article https://lnkd.in/gEJhHPBp #NailHealth #CancerAwareness #HealthCheck #CancerSigns #EarlyDetection #HealthTips #Oncology #SkinAndNails #CancerPrevention #MedicalNews #StayHealthy #CancerCare #KnowTheSigns #HealthyLiving #AwarenessMatters #HealthEducation #CancerInfo #WellnessTips #PatientEducation #HealthAlert