本網站使用瀏覽器紀錄 (Cookies) 來提供您最好的使用體驗，我們使用的 Cookie 也包括了第三方 Cookie。相關資訊請訪問我們的隱私權與 Cookie 政策。如果您選擇繼續瀏覽或關閉這個提示，便表示您已接受我們的網站使用條款。 關閉
BANGKOK, June 6, 2023 /PRNewswire/ -- Psi Scott known as "Merman" to Thai locals, set a new open sea swim record and became the youngest person in Asia to swim unassisted across 50 kilometers, spanning three coastal provinces in southern Thailand: Krabi, Phang Nga, and Phuket. This extraordinary achievement establishes him as the first record holder in Asia under the SEA YOU STRONG project. Psi Scott's swim is verified by The Department of Marine Coastal Resources, in Thailand (DMCR). Thai “Merman” Psi Scott, Youngest Person in Asia Achieves Remarkable Record: Completes 50KM Open Sea Swim Across 3 Provinces in 21 Hours, Defending the Seas Leading a team of 36 Thai swimmers to swim across 3 provinces, Psi Scott became the first and only person in Southeast Asia to stand up as a marine preservationist to protect the sea and marine life threatened by humans through swimming. The journey commenced at Hat Yao Beach in Krabi, traversed through Phang Nga, and finished at Ao Por Pier in Phuket, covering an impressive total distance of 70 kilometers. Weather conditions were stormy with changing sea currents. The entire event was live-streamed on Facebook by PSI-Scott. Participants ranged from a 71-year-old swimming enthusiast to a one-legged swimmer and a 14-year-old youth. Psi Scott shared, "The purpose of this swim was crystal clear: to preserve the sea. When we have impeccable natural resources, it becomes our responsibility to protect it. Throughout the two-day journey of swimming across three provinces alongside my fellow volunteer swimmers, we remained wholeheartedly dedicated. We knew how important this would be for Thailand. Because I had 36 lives taking turns to accompany me, I wasn't afraid. We were like migrating dolphins. Despite our outward physical differences, we all shared an unwavering love for our country's natural resources.The diverse gender, body type and age of all the swimmers mirrors the diversity found in marine life. We all need a thriving ocean and a safe habitat." This volunteer-driven initiative originated in 2020 under the SEA YOU STRONG group to protect the seas. It represents Psi Scott's intention as a Thai individual in collaboration with other Thai swimmers to express their dedication as conservationists, actively caring for and safeguarding the seas. Throughout their swimming journey, each participant enthusiastically collected and removed debris and waste from the sea from Krabi through Phuket. Apart from open sea swims, they have continuously undertaken various initiatives to preserve the marine environment and raise awareness about the challenges facing our seas. Their ultimate aspiration is to restore the splendor of Thailand's seas. For those interested, the entire livestream can be revisited on Facebook at Psi Scott - Merman (www.facebook.com/PsiScott). Find and download more images from: https://1drv.ms/f/s!ArUHecj7GvSqjWHFsl6-q9mVuBeV
SINGAPORE, June 6, 2023 /PRNewswire/ -- Jun. 1st, 2023, Biosyngen Pte. Ltd. (hereinafter as "Biosyngen") announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) has granted to its application, for immune cell therapy BRG01for the treatment of nasopharyngeal cancer, the status of Orphan Drug Designation (ODD). The FDA Orphan Drug Designation program grants orphan status to promising investigation drugs or biological products designed to treat, prevent or diagnose rare diseases or conditions affecting fewer than 200,000 individuals in the U.S. Orphan drug designation qualifies sponsors for several incentives to the subsequent development, registration and commercialization including FDA support for clinical studies, tax credits for qualified clinical trials, exemption from user fees and potential seven years of market exclusivity after approval. Prior to this designation granted by U.S. FDA, Biosyngen's BRG01 IND application has been approved by U.S. FDA (Feb. 16th,2023) and China CDE (Dec. 14th, 2022) respectively. With this approval of ODD for BRG01, it reinforces Biosyngen's advances in technology and capability to develop first-in-class biological products addressing unmet needs for patients across the world. Moving forward, the company will continue to live up to its mission to address unmet clinical needs and bring superior treatments to patients. From this milestone, a follow-up application for Fast Tract Designation Request of BRG01 is being planned, together with other products in Biosyngen's portfolio projected to enter IIT/Phase I in 2023, across Singapore, China and the US. The indications targeted include hepatocellular cancer, gastric cancer and digestive track cancers. About BRG01 EBV, the first oncovirus identified, is a human herpesvirus and has infected ~95% of global population. It has been listed as Group 1 carcinogen ("Carcinogenic to humans") by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer, EBV-positive gastric cancers, lymphoma and lymphoproliferative diseases. As one of the most common head and neck tumors, nasopharyngeal cancer - an epithelial carcinoma arising from the nasopharyngeal mucosal lining, is closely related to EBV infection. According to WHO, an estimated number of 133,000 new cases of nasopharyngeal cancer worldwide was reported in 2020; 50% of which was diagnosed in China. South China provinces such as Guangdong and Guangxi provinces make up for more than 60% of nasopharyngeal cancer patient population in China. Though existing practice such as immune checkpoint inhibitor has been applied in second-line treatment of nasopharyngeal cancer, overall response rates were generally below 30%. In another words, more than 70% patients did not benefit from existing therapy. Therefore, it is imperative to explore new approaches to improve efficacy and satisfy unmet medical needs. BRG01 developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for nasopharyngeal cancer treatment. Patients' T cells were isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials. About Biosyngen Biosyngen is a cell and gene therapy biotechnology company, focusing on R&D in immunotherapy and drug development; to achieve the best outcome for cancer patients. The company's R&D team consists of multinationals from Singapore, China, Germany, Australia, France and the USA, many of whom received their Phd. from renowned universities. Biosyngen's strategy of dual R&D centres and dual GMP facilities in Singapore and China, firmly anchors it as an Asian company towards a global ambition. The company's product pipeline potentially addresses an estimated value of 50 billion USD in the global oncology market. Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, gastrointestinal cancer and EBV-positive hematological malignancies. The company's first-in-class product BRG01 was granted IND approval by US FDA and CN NMPA for Phase I/II clinical trial. Biosyngen is also one of a few biopharmaceutical companies that possess a portfolio consisting of CAR-T, TCR-T, TIL and multi-specific antibodies. Based in Singapore and Guangzhou, Biosyngen collaborate closely with the world's leading biomedical research and clinical institutes including A*STAR, Helmholtz Zentrum München, Hannover Medical School, Sun Yat-Sen University Cancer Center and a network of hospitals to advance R&D, develop products and conduct clinical trials in Singapore, Australia and China. Through our R&D capability and translational medicine platform, Biosyngen have been able to engage the end-to-end cycle in drug development from lead identification, preclinical studies, cell production, quality control, regulatory filing, to clinical studies - integrating the entire chain of R&D, clinical trial, GMP manufacturing and commercialization.
SUZHOU, China and ROCKVILLE, Md., June 6, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that for the second consecutive year, it has released updated data of APG-2449, a novel FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma, in patients with non-small cell lung cancer (NSCLC), in a Poster Discussion session at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting. Showcasing progress in clinical development at the ASCO Annual Meeting for six consecutive years, Ascentage Pharma had clinical results from four clinical studies of four of the company's lead drug candidates selected for presentations in 2023. Among these results, the updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK. These data indicated efficacy and safety of APG-2449 in patients with NSCLC, with 8 partial responses (PRs) in the 28 patients who had failed treatment with the second-generation ALK TKIs. Developed by Ascentage Pharma, APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development. "APG-2449 is an effective multi-targeted inhibitor targeting FAK/ALK/ROS1. Compared to data released at the ASCO Annual Meeting last year, the updated results reported this year continuously indicated favourable safety and promising antitumor activity in patients with NSCLC, and the preliminary efficacy observed in patients who were resistant to second-generation ALK inhibitors was particularly encouraging," said Prof. Li Zhang, the Principal Investigator of this study from Sun Yat-Sen University Cancer Center. "We believe that FAK inhibition could be a new treatment strategy for patients with NSCLC resistant to second-generation ALK inhibitors." "We are excited by the results presented at this year's ASCO Annual Meeting as they demonstrated APG-2449's therapeutic option in advanced NSCLC and the drug's potential in offering a safe and effective novel therapy to this underserved patient population," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "Moving forward, we will expedite this clinical development program, which hopefully can yield a safe and effective new treatment option to patients, fulfilling our mission of addressing unmet clinical needs in China and around the world." * APG-2449 is an investigational drug that has not been approved in any country and region. Highlights of the poster on APG-2449 presented at this year's ASCO Annual Meeting: FAK inhibition with novel FAK/ALK inhibitor APG-2449 could overcome resistance in NSCLC patients who are resistant to second-generation ALK inhibitors Abstract#: 9015 Poster Board#: 3 Session Title: Lung Cancer—Non-Small Cell metastatic Key Results:This open-label, multicenter, Phase I dose-escalation and dose-expansion study was designed to evaluate the safety/tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of APG-2449 in patients with ALK/ROS1+ NSCLC or other solid tumors. As of December 9, 2022, 136 patients were enrolled and treated with APG-2449 at dose levels from 900 to 1,500 mg. The median (range) age of these patients was 53 (21-78) years, and 54.4% of them were female. After 1,200 mg daily (QD) was determined as the recommended Phase II dose (RP2D), patients with NSCLC were enrolled into 2 dose-expansion cohorts. Among them, Cohort 1 included patients who were resistant to second-generation ALK/ROS1+ TKIs, while Cohort 2 included those who were ALK/ROS1+ TKI-naïve. Efficacy Results: In the subgroup of patients with TKI-naïve NSCLC (n = 33; 31 were efficacy evaluable), the overall response rate (ORR) and disease control rate (DCR = complete response [CR] rate + partial response [PR] rate + stable diseases [SD] rate) were 70.6% (12/17) and 88.2% (15/17), respectively, in ROS1+ treatment-naïve patients; and were 78.6% (11/14) and 100% (14/14) in ALK+ treatment-naïve patients. Among the 28 patients with ALK+ NSCLC that was resistant to second-generation ALK inhibitors, 8 achieved PR (8/28; 28.6%) when treated with APG-2449 at the RP2D. Analysis of FAK Expression: Among the 48 patients with ALK+ NSCLC who were previously treated with second-generation ALK inhibitors, compared to baseline, those who experienced PR showed greater reduction in phosphorylated FAK (pFAK) levels in peripheral blood mononuclear cells (PBMCs) by Day 28 than patients who experienced SD and progressive disease (PD), thus suggesting that patients with higher FAK expression at baseline were likely to achieve deeper clinical responses to APG-2449. Safety Results: A total of 123 (90.4%) patients experienced treatment-related adverse events (TRAEs), with the most frequent TRAEs (>20%) being elevated blood creatinine (46.3%), elevated alanine aminotransferase (ALT) (40.4%), and elevated aspartate aminotransferase (AST) (33.1%), as well as gastrointestinal disorders that included nausea (27.2%), vomiting (22.8%), and diarrhea (21.3%). A total of 19 (14%) patients experienced grade ≥ 3 TRAEs. Conclusions: APG-2449 showed a favourable preliminary safety profile and antitumor efficacy in patients with NSCLC. Preliminary efficacy was observed in patients who were TKI naïve and resistant to second-generation ALK inhibitors. FAK inhibition could be a novel approach to overcome ALK resistance in patients with NSCLC that is resistant to second-generation ALK inhibitors. Appendix: The four posters on Ascentage Pharma's four lead drug candidates, including APG-2449, presented at this year's ASCO Annual Meeting. Drug Candidates Abstract Title Abstract# Format APG-2449 FAK inhibition with novel FAK/ALK inhibitor APG-2449 could overcome resistance in NSCLC patients who are resistant to second-generation ALK inhibitors. #9015 Poster Discussion Olverembatinib (HQP1351) Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)- resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST). #11540 Poster Presentation Lisaftoclax (APG-2575) Preliminary data of a phase 1b/2 study of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). #7569 Poster Presentation APG-115 (Alrizomadlin) A phase 2 study of alrizomadlin (APG-115) in combination with pembrolizumab in patients with unresectable or metastatic cutaneous melanoma that has failed immuno-oncologic (IO) drugs. #9559 Poster Presentation About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted two Priority Review Designations and two Breakthrough Therapy Designations (BTDs) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.
SUZHOU, China and ROCKVILLE, Md,, June 6, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has released preliminary results from a Phase Ib/II study of the Bcl-2 inhibitor, lisaftoclax (APG-2575), as a monotherapy or combined with ibrutinib or rituximab in patients with Waldenström macroglobulinemia (WM), in a Poster Presentation at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting that marked the first data readout from a multicenter global study of lisaftoclax in WM. Showcasing progress in clinical development at the ASCO Annual Meeting for six consecutive years, Ascentage Pharma had clinical results from four clinical studies of four of the company's lead drug candidates selected for presentations in 2023. Among these results, the clinical data of lisaftoclax showed safety and efficacy of the drug candidate as a monotherapy and in combinations, including an overall response rate (ORR) of 100% in treatment-naïve patients,and low risk of tumor lysis syndrome (TLS) with the daily-dose ramp-up (3 days at fixed doses) with lisaftoclax plus ibrutinib. In addition, only negligible drug-drug interaction (DDI) was observed in the study. WM is a rare, indolent, and incurable type of B lymphoplasmacytic cancer that is mostly treated with Bruton tyrosine kinase inhibitor (BTKi)- or rituximab-based regimens. However, there is currently no standard of care treatment for patients who are resistant or intolerant to first-line therapies and those who relapsed following responses to initial treatment. There is no Bcl-2 inhibitor has yet been approved for the treatment of WM. "Lisaftoclax is a highly selective Bcl-2 inhibitor that is capable of inducing apoptosis and suppressing cell growth," said Sikander Ailamadhi, MD, the Principal Investigator of the Study from Mayo Clinic. "In this global Phase Ib/II study, lisaftoclax monotherapy showed encouraging antitumor activity and satisfactory safety profile in patients with relapsed/refractory (R/R) WM who had received prior treatment with BTKis. In addition, a response rate of 100% was achieved when in combination with BTKi for patients with treatment-naïve WM. This drug's other attributes include the patient friendly daily dose ramp-up schedule which allows for faster attainment of target therapeutic doses. We look forward to further exploring the efficacy and safety of lisaftoclax as a monotherapy and in combinations." "The clinical results of lisaftoclax in patients with WM presented at this year's ASCO Annual Meeting highlighted the promising therapeutic utility of the drug candidate as a monotherapy or in combination in hematologic malignancies," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In particular, the lisaftoclax plus BTKi regimen has demonstrated an impressive ORR that signalled exciting clinical potential. Looking ahead, we will accelerate this clinical development program and expedite the drug's journey to market to allow patients to benefit from this novel therapeutic as soon as possible." * Lisaftoclax is an investigational drug that has not been approved in any country and region. Highlights of the poster on lisaftoclax presented at this year's ASCO Annual Meeting: Preliminary data of a phase 1b/2 study of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). Abstract#: 7569 Poster Board#: 120 Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Highlights: This open-label, multicenter, global Phase Ib/II study was designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of the orally administered highly selective novel Bcl-2 inhibitor lisaftoclax (APG-2575) as monotherapy or in combination with ibrutinib or rituximab in patients with WM. As of April 12, 2023, a total of 46 patients were enrolled in the study and later enrolled into 3 arms as follows: Arm A: lisaftoclax monotherapy in patients with WM resistant/intolerant to BTKis (n=14) Arm B: lisaftoclax plus ibrutinib in treatment-naïve patients (n=24) Arm C: lisaftoclax plus rituximab in ibrutinib and other BTKi-naïve relapsed/refractory patients (n=8) The dose of lisaftoclax was escalated from 400 to 1,200 mg using a modified toxicity probability interval-2 (mTPI-2) design. Doses in Arms A, B, and C were escalated to up to 1,000 mg, 1,200 mg, and 800 mg, respectively. Efficacy Results: The ORR (minor or deeper responses) and median time (range) to response (MTTR) for Arms A, B, and C were 50%, 100%, and 62.5%; 4.6 (1-9), 1 (1-5), and 4.4 (1-10) months, respectively. 2 very good partial responses (VGPRs) were observed in Arm B with a median time to VGPR of 3.1 (1.8-4.4) months. The study did not observe any significant difference between patients with and without the CXCR4 mutation. Safety Results: The dose-escalation of lisaftoclax did not meet the maximum-tolerated dose (MTD). At 1,200 mg, 1 grade 3 dose-limiting toxicity (DLT) (a grade 3 TLS) considered to be related to pre-existing renal impairment was observed in Arm B. Ventricular arrhythmias were not observed. 1 patient received dose reduction in lisaftoclax because of AEs, and 2 patients discontinued treatment because of AEs. Common lisaftoclax-related AEs (>10%) included neutropenia (36.9%), diarrhea (34.8%), leukocytopenia (21.7%), nausea (13.0%), anemia (13.0%), abdominal pain (10.9%), thrombocytopenia (10.9%), and decreased appetite (10.9%), with the most of these AEs being grade 1-2. The PK data indicated negligible drug- drug interaction (DDI) between lisaftoclax and ibrutinib. Conclusions: Lisaftoclax alone or combined with ibrutinib/rituximab demonstrated favorable safety and promising activity in patients with treatment-naïve or BTKi-refractory WM, with negligible risk of DDI between lisaftoclax and ibrutinib. Appendix: The four posters on Ascentage Pharma's four lead drug candidates, including lisaftoclax, presented at this year's ASCO Annual Meeting. Drug Candidates Abstract Title Abstract# Format APG-2449 FAK inhibition with novel FAK/ALKinhibitor APG-2449 could overcomeresistance in NSCLC patients who areresistant to second-generation ALKinhibitors. #9015 PosterDiscussion Olverembatinib (HQP1351) Antitumor activity of olverembatinib(HQP1351) in patients (pts) with tyrosinekinase inhibitor (TKI)- resistant succinatedehydrogenase (SDH)-deficientgastrointestinal stromal tumor (GIST). #11540 PosterPresentation Lisaftoclax (APG-2575) Preliminary data of a phase 1b/2 studyof BCL-2 inhibitor lisaftoclax (APG-2575)alone or combined with ibrutinib orrituximab in patients (pts) withWaldenström macroglobulinemia (WM). #7569 PosterPresentation Alrizomadlin (APG-115) A phase 2 study of alrizomadlin (APG-115) in combination withpembrolizumab in patients withunresectable or metastatic cutaneousmelanoma that has failed immuno-oncologic (IO) drugs. #9559 PosterPresentation About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted two Priority Review Designations and two Breakthrough Therapy Designations (BTDs) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.
As of November 10, 2022, 26 patients with HER2-positive unresectable or metastatic solid tumors (other than breast cancer and gastric/gastroesophageal junction cancer) were enrolled, 92.3% of whom had received ≥2L prior systemic therapy. The objective response rate (ORR) was 53.8% with 6.8 months median duration of response (mDOR), 5.6 months median progression survival (mPFS) and 80.4% 12-month overall survival (OS) rate. For 15 CRC patients, the ORR was 53.3% with mDOR 11.7 months, mPFS 12.2 months and 80.0% 12-month OS rate. SUZHOU, China, June 6, 2023 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that updated data from the phase II clinical study of the chemo-free regimen of KN026 in combination with KN046 (KN026-203) were presented at the 2023 American Society of Clinical Oncology (2023 ASCO) Annual Meeting. The e-poster can be accessed on the company's website at www.alphamabonc.com. KN026-203 is a single-arm, open-label, multi-cohort, multi-center phase II clinical study to evaluate the efficacy and safety of KN026 in combination with KN046 in the treatment of HER2-positive solid tumors. 102 patients were recruited including 3 cohorts: HER2-positive GC/GEJ, breast cancer as well as other solid tumors that have received ≥1L systemic treatment. The preliminary clinical results from other solid tumor cohort were first presented in April 2022 at the Annual Meeting of the American Association for Cancer Research (AACR). The data released at ASCO includes a larger population of patients for efficacy analysis and a longer follow-up period, compared with results of AACR poster. As of November 10, 2022, 26 patients with HER2-positive unresectable or metastatic solid tumors, including 15 CRC patients, 5 NSCLC patients, 4 biliary tract cancer patients, 1 renal pelvis cancer patient and 1 pancreatic cancer patient, were enrolled, 92.3% of whom had received ≥2L prior systemic therapy. Patients received KN046 (iv.5mg/kg Q3W) combined with KN026 (iv.30mg/kg Q3W, with a loading dose on D8) treatment until progression, unacceptable toxicity or patient withdrawal. The primary endpoint was ORR and DOR assessed by the investigator Q6W according to RECIST 1.1. All 26 patients were included in the assessment of efficacy and safety. The objective response rate (ORR) was 53.8% (95% CI: 33.4, 73.4) with median duration of response (mDOR) 6.8 months (95% CI: 2.9, 15.3). The median progression free survival (mPFS) was 5.6 months (95% CI: 2.9, 16.5) and 12-month overall survival (OS) rate was 80.4% (95% CI: 59.1, 91.4). For 15 CRC pts, the ORR was 53.3% (95% CI: 26.6, 78.7) with mDOR 11.7 months (95% CI: 3.2, NE). The mPFS was 12.2 months (95% CI: 2.7, NE). 12-month OS rate was 80.0% (95% CI: 50.0, 93.1). As for safety, 25 of 26 patients (96.2%) had experienced treatment-related adverse event (TRAEs) of any grade, and total 9 of 26 patients (34.8%) had experienced ≥grade 3 TRAEs. The most common (≥20%) TRAEs were infusion related reaction (10,38.5%), AST increased (9,34.6%), conjugated bilirubin increased (7,26.9%), ALT increased (7,26.9%), anemia (7,26.9%), blood bilirubin increased (7,26.9%) and rash (7,26.9%). No treatment-related deaths were observed. About KN026 KN026 is an anti-HER2 bispecific antibody invented by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially superior efficacy to Trastuzumab and Pertuzumab in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. Alphamba already initiated multiple clinical trials for KN026 in China and the United States. KN026 showed good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer and gastric cancer. Currently, several phase III pivotal studies of KN026 are ongoing for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc. In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan). About KN046 KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism - CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function. There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September 2020. Several pivotal clinical trials are currently being conducted, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy as the first-line treatment of NSCLC successfully met the prespecified PFS endpoint. About Alphamab Oncology Alphamab Oncology is a leading biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of Hong Kong Stock Exchange, with the stock code:9966. We have converged a professional R&D team led by top scientists, and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production to clinical research. With multiple in-house proprietary platforms of bispecifics, protein engineering and antibody screening, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among them, 2 varieties were selected into the national special project of "New Drug Development", and 3 varieties were granted 4 orphan drug qualifications by FDA. The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration. More than 30 clinical studies have been carried out in 6 varieties in China, the United States and Australia, among which 8 studies of 3 varieties have entered the critical clinical stage in China and the United States. To make cancer manageable and curable,Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world.
Mediti700wireless和i700是全球牙醫的首選掃描儀 Medit的掃描儀屢獲殊榮，繼續推動牙科技術創新 韓國首爾和加州長灘2023年6月6日 /美通社/ -- Institute of Digital Dentistry(iDD)進行的一項最新全球問卷調查表明，Medit(Medit)i700 wireless和i700是牙科領域排名前兩位的口內掃描儀。此外，Mediti600也在該研究中排在前四。這項開創性的研究共有109個不同國家的1072名受訪者參加，範圍遍布全球四分之三以上的地區。 Medit 該研究旨在探討牙科行業口內掃描儀的用戶體驗。參與者被要求從速度、售後支持、可及性、價格和整體質量等幾個方面對不同的掃描儀進行評估。結果顯示，Mediti700 wireless和i700成為了全球牙科專業人士的首選，同時Mediti600也獲得了廣泛的認可。 Medit的全球KOL之一金東煥(Donghwan Kim)博士在評價Medit掃描儀的性能時表示："Mediti700 wireless和i700真正改變了我們臨床的操作方法。這些掃描儀不僅速度超快、易於使用、整體品質卓越，而且提供可靠的支持和有競爭力的價格。此外，Medit Link軟件平台提供的各種免費應用程序也能幫助提高效率並簡化工作流程。" Mediti700 wireless和i700採用先進的掃描技術，可實現精準而詳細的數字化印模。這些功能有助於準確診斷和簡化治療方案。 i700 wireless的無線功能和i700的有線連接為牙科專業人員提供了靈活性和便利性。 作為牙科技術的全球領導者，Medit繼續將創新和客戶滿意度放在首位。通過開發最前沿的解決方案，滿足了全球牙科專業人員不斷變化的需求。 Medit首席執行官GB Ko表示："我們的目標是為牙科醫生提供可靠、準確的用戶友好型掃描儀，以提升他們的工作流程並改善患者的治療效果。我們很高興我們的掃描儀在這項研究中獲得了認可，這也展示了我們追求卓越牙科技術的決心。" 欲了解有關Mediti700 wireless、Mediti700、Mediti600和Medit提供的其他先進牙科解決方案的更多信息，請訪問www.medit.com。 完整的調研報告可在此處獲取：[https://www.sciencedirect.com/science/article/pii/S0020653923000680?fbclid=PAAaYdwTWkajf4Yw_cHvdKuDt8Q37LxOF3Mz978BIyk9Ofavd5pTfgoGz_Ty8] Medit
A12 藝術空間
Type-C
請先登入後才能發佈新聞。
還不是會員嗎？立即 加入台灣產經新聞網會員 ，使用免費新聞發佈服務。 （服務項目） （投稿規範）
