Pusan National University Hospital

Apollo Hospitals is now using a new health insurance claim solution by insurance tech provider ClaimBuddy. A senior manager of the group shared that ClaimBuddy will help "expedite claim approvals, reduce paperwork, and enhance the overall efficiency of our insurance desk operations." The insurtech solution is also being used in more than 250 hospitals across India. The National Rehabilitation Center in South Korea is opening up its clinical rehabilitation test bed to help manufacturers of rehabilitation medical devices get their products approved. It is said that most local manufacturers of medical devices for rehabilitation are unaware of standards – both local and international – and face difficulties recruiting testers and accessing platforms for usability testing. The NRC will provide them with the space, equipment, and manpower to conduct usability testing for software-as-a-medical devices, which is necessary for securing regulatory licenses . These include devices for cognitive therapy, treatment for mental disorders, electromyogram analysis, as well as cardiopulmonary, respiratory and musculoskeletal rehabilitation. Pusan National University Hospital is now using three da Vinci surgery equipment from US-based manufacturer Intuitive Surgical, after adding da Vinci SP, which is used for single port surgery. This comes as the hospital is expanding its scope of robotic surgery applications, which were initially for cancer surgeries involving the pelvic region such as the kidney and prostate; now it is being applied to surgeries for gastric and colon cancers, the hospital shared in a blog post. PNUH got its first robotic surgery equipment, the da Vinci SI, in 2013. The Hong Kong Polytechnic University is collaborating with the Mongolian National University of Medical Sciences (MNUMS) to set up an advanced assistive technology training centre. A first for Mongolia, the Assistive Technology Rehabilitation and Education Centre at MNUMS will be equipped with various equipment, including 3D scanning and printing equipment and eye-tracking systems for augmentative and alternative communication. Based on a statement, the training centre will help advance the training of local rehabilitation professionals. This is the universities' first project together after signing a memorandum of understanding, which intends to contribute to the Belt and Road Initiative.

Anbal-cel argeting DLBCL completes phase 2 trial Anticipation growing over Korea's first CAR-T therapy ahead of regulatory review Commercial manufacturing scheduled in 2025 at Korea's only CAR-T GMP facility DAEJEON, South Korea, Nov. 1, 2023 /PRNewswire/ -- Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy "Anbal-cel" that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma). This announcement is a significant milestone and is paving the way towards the launch and approval of Korea's first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea. The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital. "Anbal-cel" is a next-generation CAR-T therapy based on Curocell's OVIS™ technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis. Curocell made international headlines during the company's oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market. Curocell plans to officially announce the final results of its Phase 2 clinical trial for "Anbal-cel" in the first half of next year and submit an BLA application to Korea's Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea's only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment. CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea's first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business." The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653) Corporate Overview "Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies" Curocell is Korea's first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world's most promising new drugs to emerge in recent years. Curocell's technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types. Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaboaring with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea's first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country's leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products. "CAR-T cell therapy, a next generation cancer immunotherapy" CAR-T (Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves genetically modifying a patient's immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer. Through the process of separating the patient's immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single administration where no other treatment options are available. SOURCE Crucocell Inc.

STOCKHOLM, Aug. 7, 2023 /PRNewswire/ -- Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today the formation of a Scientific Advisory Council as the company intensifies its plans for next phase of development. In February, Medivir announced positive, preliminary results from the dose escalation cohorts of its candidate drug fostrox, in combination with Lenvima® and initiated the phase 2a expansion cohort. Fostrox, designed to selectively treat liver cancers while minimizing systemic side effects, has the potential to become the first liver-targeted and orally administered drug for patients with hepatocellular carcinoma (HCC). The Scientific Advisory Council will work closely with Medivir to design the next phase of clinical development. - "I am truly honored that we have been able to attract some of the world's leading experts in liver cancer to our Scientific Advisory Council. As underlined by the outcome of the dose escalation cohorts and the swift recruitment in the ongoing dose expansion, it is an exciting time in the development of fostrox. The Scientific Advisory Council, with its expertise and deep clinical experience will be critical in moving the clinical development of fostrox forward," says Dr. Pia Baumann, CMO at Medivir. - "Despite recent advancements in the treatment of HCC, a significant unmet medical need remains. Patients with advanced HCC have an underlying liver disease that can negatively impact their ability to benefit from systemic, medical treatments. Fostrox, with its unique, liver-targeted mechanism has the potential to minimize the tumor burden locally in the liver and provide synergistic activity with existing medical treatments and improve the anti-tumor activity" says Dr. Richard Finn, Professor of Medicine at the Geffen School of Medicine at UCLA. The members of Medivir's Scientific Advisory Council; Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program. Dr. Richard Finn is a Professor of Medicine at the Geffen School of Medicine at UCLA Department of Medicine, Division of Hematology/Oncology. Dr. Finn splits his time between patient care and directing the Translational Research Laboratory in the Division of Hematology/Oncology. His research interests are focused on the development of targeted therapeutics for solid tumors across histologies. Dr Finn has been the primary investigator of several, ground-breaking studies in HCC, including the ground-breaking ImBrave 150 study. Dr. Jeong Heo is a Professor of Internal Medicine at Pusan National University School of Medicine and Director of Gastroenterology and Hepatology at Pusan National University Hospital. During his career, Professor Heo has held a number of academic positions, university and hospital appointments and has been principal investigator in many clinical trials for phase I-IV of hepatitis B, C and hepatocellular carcinoma. He is an investigator in the fostrox clinical program. Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program. Dr. Arndt Vogel is managing senior consultant and Professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. He is also head of the GI-Cancer Center and of the Center for Personalized Medicine at Medical School Hannover. His scientific focus is the translational and clinical research in gastrointestinal cancer. Professor Vogel is member and chairman of Hepatobiliary Cancer Study Group of the AIO, a collaborative group in clinical oncology in Germany. Within ESMO, he is member of the ESMO Guidelines Steering Committee. Furthermore, Professor Vogel has responsibilities in the establishment of the national guideline and is the coordinator of the ESMO clinical practice guideline on the management of hepatocellular carcinoma and biliary tract cancer. For additional information, please contact; Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100 E-mail: [email protected].com About fostrox Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing. About primary liver cancer Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . The following files are available for download: SOURCE Medivir