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TAIPEI, June 5, 2024 /PRNewswire/ – Asia Scientific Global (ASG), a leader in the research and development of novel inhaled drugs, has set up a laboratory in Taiwan, and plans to establish a second facility in Singapore later this year. This new lab will focus on developing 505(b)2 new dosage form drugs targeting four key areas: antibiotics, erectile dysfunction, respiratory health, and the central nervous system. ASG revealed today that Beta1, a novel drug currently under development, has successfully completed toxicology testing. The drug is slated to undergo a series of international multicenter clinical trials from 2024 to 2026. Additionally, the company intends to establish offices and local teams in China, Southeast Asia, and North America, integrating the planning processes for new product development, clinical trials, and market expansion. By leveraging Asia as its new R&D hub, ASG is expanding globally and expediting the clinical trial processes for its novel medicines. ASG's Core Strength: Advanced Technology Platform for Special Dosage Forms of Drugs ASG is advancing the development of 505(b)(2) new dosage form drugs, with a special focus on dry powder inhalers that deliver medication through the respiratory tract. The company's core strength lies in its special dosage form drug platform, based on the Aero-Particles Process Control Technology (APPC), advanced prescription process technology, and innovative medical device development technology. With its proprietary technologies, strategic product selection, and thorough market analysis, ASG is committed to addressing unmet medical needs. The company revolutionizes traditional drug delivery systems by utilizing specialized particle control technology combined with customized inhaler device designs. The approach ensures more effective lung penetration, enhanced absorption, and increased drug efficacy while significantly reducing side effects. ASG's innovative delivery system provides patients worldwide with faster, safer, and more convenient therapeutic options. This commitment aligns with the firm's mission to "make the world a better place with every breath". Precise Drug Development Strategy Helps to Expedite R&D Process CEO Hugues Hung said that ASG has leveraged its proprietary technology platform to develop breakthrough and improved drugs. Within just six months, the company has filed applications for multiple patents and rapidly advanced its products into toxicological trials. ASG's most rapidly progressing drugs are the Alpha and Beta series, targeting tuberculosis and erectile dysfunction. Mr. Hung highlighted the specific challenges with current tuberculosis treatments, which include drug resistance and poor patient compliance due to the excessive dosage for Tuberculosis treatment. The Alpha series aims to mitigate these issues by enhancing existing drug formulations through a specialized process that reduces the likelihood of drug resistance. Additionally, utilizing the special dosage form of the respiratory preparation, which is rapidly absorbed and easily used, Alpha can establish a superior delivery route that enhances the convenience of drug administration. Thanks to these features, the series is set to provide a breakthrough treatment solution in the field of antibiotic therapy, offering significant benefits to a larger patient population. For the treatment of erectile dysfunction, existing medications typically require between 40 minutes and two hours to reach their peak concentration. ASG's enhanced drug prescription design and inhalation delivery method not only speed up drug absorption but also improve ease of use through the company's specially designed portable and modern devices. ASG anticipates to submit a Pre-IND (Investigational New Drug) application in the United States and enter the clinical trial phase within this year. Comprehensive Drug Development Services ASG's drug development platform technology, along with its drug formulations and preparation methods, are currently pending U.S. patent approval. Additionally, the company has partnered with leading multinational medical research centers and Contract Development and Manufacturing Organizations (CDMOs) to facilitate comprehensive evaluation, analysis, and execution across all stages of drug development and production. This includes R&D, pilot production, preliminary testing, clinical trials, and even commercial production, offering one-stop drug development services. The approach ensures that ASG's products are well-positioned for successful market entry. With the strategic goal of licensing these products to international pharmaceutical companies, ASG is actively seeking partners to expedite the development and commercialization of its drugs.
SUZHOU, China and ROCKVILLE, Md., June 5, 2024 /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 updated clinical data of olverembatinib (HQP1351), a third-generation tyrosine kinase inhibitor (TKI), in patients with TKI-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST), in an oral report at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL. This is the third consecutive year in which clinical data from this study of olverembatinib were selected for presentations at the ASCO Annual Meeting. The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community. Presenting clinical development progress at the ASCO Annual Meeting for the seventh consecutive year, Ascentage had four clinical studies of three of the company's proprietary drug candidates selected for presentations, including an oral report, at ASCO 2024. The oral report features the latest data that further validated the promising efficacy and manageable safety of olverembatinib in SDH-deficient GIST. The Phase I study enrolled a total of 26 patients with SDH-deficient GIST. Among these patients, 6 achieved partial responses (PR), 18 achieved stable diseases (SD) that lasted longer than four treatment cycles, with a clinical benefit rate (CBR) of 92.3% (24/26) and a median progression-free survival (PFS) of 25.7 months. Olverembatinib, an orally-available novel TKI developed by Ascentage Pharma, is the first third-generation BCR-ABL inhibitor approved in China. At present, the drug is approved in China in two indications, including adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. While being clinically developed and adopted for the treatment of hematologic malignancies, olverembatinib is also being clinically evaluated in patients with GIST. To date, olverembatinib has been granted a Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with SDH-deficient GIST who had received first-line treatment. "SDH-deficient GIST represents a treatment gap that urgently needs new treatment options," said Prof. Haibo Qiu, of Sun Yat-Sen University Cancer Center, and the presenter of the report. "In the study, olverembatinib has shown impressive clinical benefits in SDH-deficient GIST, including a median PFS of 25.7 months, as well as favorable safety and tolerability profiles. Moving forward, we will continue to evaluate the drug's efficacy and safety in SDH-deficient GIST." "Building on data released at the ASCO Annual Meeting in the past two years, results presented in the oral report this year continued to demonstrate promising clinical benefits and manageable safety of olverembatinib in SDH-deficient GIST," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are very encouraged by these results, as they signal a potential breakthrough in addressing another indication with an urgent unmet clinical need. Remaining committed to the mission of addressing unmet clinical needs in China and around the world, we will press forward with this clinical development program in order to bring a safe and effective new treatment option to patients as soon as possible." Highlights of these data presented at ASCO 2024 are as follows: Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) Abstract#: 11502 Session Title: Sarcoma Date and Time: June 3, 2024, Monday, 3:00 PM – 6:00 PM (Central Time) First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China. Highlights: Background: SDH-deficient GIST is a subset of wild-type GIST that constitutes approximately 10% of GISTs. In the National Comprehensive Cancer Network (NCCN) guidelines, there is no preferred regimen for SDH-deficient GIST, thus indicating an urgent unmet medical need. Olverembatinib, approved in China for the treatment of patients with chronic myeloid leukemia, has shown promising clinical efficacy in SDH-deficient GIST. In this abstract, the study reports updated efficacy data of olverembatinib in SDH-deficient GIST. Introduction: The aim of this study was to evaluate the safety and efficacy (per RECIST v1.1) of olverembatinib in patients with SDH-deficient GIST and other solid tumors. Olverembatinib was administered orally once every other day (QOD) in 28-day cycles. Patient enrollment and methods: As of December 27, 2023, 26 patients with SDH-deficient GIST (confirmed by immunohistochemistry [IHC] assay) had received ≥1 dose of olverembatinib (median [range] age, 30 [13-56] years), and 25 of them had received 1-4 tyrosine kinase inhibitors (TKIs; 50.0%% [13/26] of patients received ≥3 TKIs). Olverembatinib was administered OQD in doses ranging from 30 to 50 mg (30 mg [n = 6]; 40 mg [n = 14]; 50 mg [n = 6]). Efficacy Results: In the 26 patients with SDH-deficient GIST, the median (range) duration of treatment was 15.6 (1.8-42.3) months. 6 of these patients achieved partial responses (PR); and another 18 patients achieved stable diseases (SD) lasting > 4 cycles. The clinical benefit rate (CBR, complete response [CR] + PR + SD > 4 cycles) was 92.3% (24/26), the longest treatment duration was 40 months, and the median (range) PFS was 25.7 months (12.9-not reached [NR]). Safety results: The adverse event profile was the same as previously reported (Qiu H, et al, J Clin Oncol 41:11540), with no newly emergent safety issues observed. Conclusions: Olverembatinib was well tolerated. In patients with SDH-deficient GIST, olverembatinib demonstrated a CBR exceeding 90% and significantly prolonged the estimated median PFS, indicating the potential benefit of this treatment and providing a benchmark for future studies in this rare subtype of GIST. *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland. Appendix: The four clinical studies of Ascentage Pharma's three drug candidates, including lisaftoclax, presented at this year's ASCO Annual Meeting. Drug Candidates Abstract Title Abstract# Format Olverembatinib (HQP1351) Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma. #11502 Oral Report Lisaftoclax （APG-2575） Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia. #6541 Poster Presentation Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). #7078 Poster Presentation APG-2449 Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors. #3124 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, including 5 global registrational phase III studies, 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 in China, has been granted Priority Review Designations and Breakthrough Therapy Designations 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 5, 2024 /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 updated results from a global, multicenter Phase Ib/II study of the Bcl-2 inhibitor lisaftoclax (APG-2575) alone or in combinations for the treatment of patients with Waldenström macroglobulinemia (WM), in a poster presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL. This is the second consecutive year in which this study of lisaftoclax, a key drug candidate in the company's apoptosis-targeted pipeline, was selected for presentations at the ASCO Annual Meeting. The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community. Presenting clinical development progress at the ASCO Annual Meeting for the seventh consecutive year, Ascentage had four clinical studies of three of the company's proprietary drug candidates selected for presentations, including an oral report, at ASCO 2024. The latest results from this clinical study validated the favorable safety and efficacy of lisaftoclax monotherapy and in combinations in WM. According to the data, lisaftoclax combined with ibrutinib showed an objective response rate (ORR) of 90.9% in treatment-naïve patients with WM (responses that were unaffected by the CXCR4 mutation), manageable adverse events (AEs), and a low risk of tumor lysis syndrome (TLS). In addition, no potential drug-drug interactions (DDIs) with ibrutinib were observed in the study. "Lisaftoclax is a novel Bcl-2 selective inhibitor developed to treat malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells," said Dr. Sikander Ailawadhi, the Principal Investigator of the Study from Mayo Clinic. "In this global Phase Ib/II study in patients with relapsed/refractory (R/R) WM, lisaftoclax both as a monotherapy and in combination with ibrutinib or rituximab has shown favorable efficacy that was not negatively affected by the presence of the CXCR4 mutation. In addition, lisaftoclax showed a manageable safety profile with low risk of TLS during daily dose ramp-up. We look forward to seeing more data from this trial." "Lisaftoclax is the first pivotal-stage Bcl-2 inhibitor in China and the second globally that has demonstrated promising efficacy," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "The updated clinical data of lisaftoclax in WM presented at this year's ASCO Annual Meeting underscore the drug's strong therapeutic potential, both as a monotherapy and in combinations, for the treatment of hematologic malignancies. We will continue to advance the clinical development of lisaftoclax with the hope to allow more patients to benefit from the drug as soon as possible." Highlights of these data presented at ASCO 2024 are as follows: Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM) Abstract#: 7078 Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Date and Time: June 3, 2024, Monday, 9:00 AM– 12:00 PM (Central Time) First Author: Masa Lasica, MBBS, FRACP, FRCPA, St Vincent's Hospital, Melbourne, Victoria, Australia. Highlights: Background: Lisaftoclax is a novel, oral, highly selective, potent Bcl-2 inhibitor. In an ibrutinib-resistant patient-derived WM xenograft/preclinical model, lisaftoclax combined with ibrutinib has a strong synergistic effect. Introduction: This was an open-label, multicenter, global Phase Ib/II study designed to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of lisaftoclax monotherapy or in combinations with agents such as ibrutinib/rituximab in patients with WM. Patient enrollment and methods: In this study, patients with WM were enrolled in 3 arms, including Arm A: lisaftoclax monotherapy in patients resistant to or intolerant of prior treatment with Bruton's tyrosine kinase inhibitors (BTKis); Arm B: lisaftoclax combined with ibrutinib in treatment-naïve patients with WM; and Arm C: lisaftoclax combined with rituximab in BTKi-naïve patients with relapsed/refractory WM. Lisaftoclax was orally administered once daily in 28-day cycles. Lisaftoclax was gradually escalated from the starting dose of 400 mg to 1,200 mg. As of January 25, 2024, a total of 46 patients were enrolled in the study (Arm A [n=14] at doses of up to 1,000 mg; Arm B [n=24] at doses of up to 1,200 mg; Arm C [n=8] at doses of up to 800 mg). Efficacy results: The median (range) durations of treatment were 11 (1-28), 23.5 (1-34), and 11.5 (5-33) months for Arms A, B, and C, respectively. The ORRs (PR, very good partial response [VGPR], CR) were 41.7%, 90.9%, and 37.5% for Arms A, B, and C, respectively. In Arm A, patients with wild-type CXCR4 (n =7) had better overall responses to lisaftoclax than the CXCR4 mutation group (n = 3). In Arms B and C, no significant differences between patients with/without CXCR4 mutation were observed. Safety results: In Arm B, 1 dose-limiting toxicity (DLT, grade 3 clinical TLS), in the setting of anticipated renal impairment, occurred at 1,200 mg; and 1 grade 3 laboratory TLS, primarily attributed to dehydration and concomitant symptomatic therapies, occurred at 1,000 mg. Abnormal electrolytes was resolved without recurrence after 1 day of drug interruption. Grade ≥ 3 lisaftoclax-related AEs included neutropenia (15.2%), thrombocytopenia (4.3%), decreased leukocytes (4.3%), TLS (4.3%), anemia (2.2%), weight loss (2.2%), and septic shock (2.2% in the setting of neutropenia). Ventricular arrhythmia was not observed. One patient required dose reduction because of neutropenia. The maximum-tolerated dose (MTD) was not reached. Lisaftoclax combined with ibrutinib showed a PK exposure comparable to lisaftoclax or ibrutinib alone, indicating no potential DDIs. Conclusions: Lisaftoclax alone or combined with ibrutinib or rituximab was well tolerated and demonstrated measurable effects in patients with treatment-naïve or BTKi-treatment-failed WM. *Lisaftoclax is an investigational drug that has not been approved in any country and region. Appendix: The four clinical studies of Ascentage Pharma's three drug candidates, including lisaftoclax, presented at this year's ASCO Annual Meeting. Drug Candidates Abstract Title Abstract# Format Olverembatinib(HQP1351) Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma. #11502 Oral Report Lisaftoclax (APG-2575) Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia. #6541 Poster Presentation Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). #7078 Poster Presentation APG-2449 Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors. #3124 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, including 5 global registrational phase III studies, 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 in China, has been granted Priority Review Designations and Breakthrough Therapy Designations 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.
SHANGHAI, June 4, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the final follow-up results of the investigator-initiated trial CT041-CG4006 (NCT03874897) of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) have been published in Nature Medicine on June 3, 2024. Data were presented as an oral presentation at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting on June 3, 2024, 12:30 pm-3:30 pm, Eastern Daylight Time. Further details have been posted on the corporate website https://www.carsgen.com. The article in Nature Medicine was titled "Claudin18.2-specific CAR T Cells in gastrointestinal cancers: phase 1 trial final results".[1] The 2024 ASCO Annual Meeting abstract was titled "Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Therapy for Patients with Gastrointestinal Cancers: Final Results of CT041-CG4006 Phase 1 Trial".[2] The leading PI of this study, Professor Lin Shen of Beijing Cancer Hospital, said, "Satri-cel has shown promising efficacy and manageable safety profiles in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly those with gastric cancer or gastroesophageal junction cancer. This study marks a significant advancement in the field of CAR T-cell therapy for solid tumors. It suggests that CAR T-cell therapy has the potential to transform existing treatment paradigms and provides important reference points for further innovative research. In the future, we anticipate that more clinical trials and studies will further validate and refine this innovative therapy, enabling it to benefit a broader patient population as soon as possible." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the final results of the CT041-CG4006 study have been simultaneously published in the prestigious journal Nature Medicine and reported as an oral presentation at the 2024 ASCO Annual Meeting. This study represents a significant milestone in the field of CAR T-cell therapy for solid tumors, demonstrating the encouraging safety and efficacy of satri-cel. We extend our heartfelt thanks to the investigators for their years of dedicated efforts, and to the patients and their families for their trust and support. It is our shared goal to provide better treatment options for patients, and we will continue to advance the global clinical development of satri-cel, ensuring this innovative CAR T-cell therapy benefits more patients with gastric, pancreatic, and other gastrointestinal cancers." About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that can potentially be the first-in-class globally. Satri-cel has been developed for the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. Satri-cel received an Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and an Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Reference [1] Qi, C., Liu, C., Gong, J. et al. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results. Nat Med (2024). https://doi.org/10.1038/s41591-024-03037-z[2] Qi C, et al. ASCO 2024. Abstract 2501
SUZHOU, China and ROCKVILLE, Md., June 4, 2024 /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 the latest results from a Phase Ib/II study of its Bcl-2 inhibitor lisaftoclax (APG-2575) in combination with azacitidine (AZA) in patients with treatment-naïve (TN) or relapsed/refractory (R/R) acute myeloid leukemia (AML), in a poster presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, IL. The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community. Presenting clinical development progress at the ASCO Annual Meeting for the seventh consecutive year, Ascentage had four clinical studies of three of the company's proprietary drug candidates selected for presentations, including an oral report, at ASCO 2024. The data of lisaftoclax combined with AZA in elderly/unfit TN patients with AML who were intolerant of standard induction chemotherapies and patients with R/R AML showed excellent therapeutic potential and a favorable safety profile in terms of tumor lysis syndrome (TLS), low incidence of neutropenic fever, and low early mortality. "As a proprietary novel Bcl-2 inhibitor, lisaftoclax has shown treatment responses comparable to the approved Bcl-2 inhibitor and a better safety profile," said Prof. Jie Jin, a principal investigator of the study from the First Affiliated Hospital, Zhejiang University School of Medicine. "The improved safety offered by lisaftoclax means lower treatment-related mortality, fewer dose adjustments, and earlier start of sequential chemotherapies that should contribute to patients' long-term survival." "The introduction of Bcl-2 inhibitors represents a major breakthrough for the treatment of AML. However, the hematologic safety issues associated with the approved Bcl-2 inhibitor have limited the clinical adoption and the long-term efficacy," said Dr. Huafeng Wang, PhD, from the First Affiliated Hospital, Zhejiang University School of Medicine, and the presenter of the poster. "As a novel drug, lisaftoclax was frequently presented and attracted broad interest. When combined with chemotherapies, lisaftoclax showed a rate of hematologic adverse events that was lower than that of the approved Bcl-2 inhibitor. More importantly, its hematologic adverse events were relatively mild and easy to manage. Its hematologic toxicity-related serious adverse events such as neutropenic fever and 30-/60-day mortalities were very low. This suggests that lisaftoclax-associated hematologic toxicities are transient, less serious, easier to manage, and therefore would have less negative impact on sequential chemotherapies. Overall, lisaftoclax has already shown a highly favorable clinical potential." "These efficacy and safety data of lisaftoclax combined with AZA in patients with AML are very encouraging because they reaffirmed the drug's global best-in-class potential as a hopeful new treatment option for patients with AML, a hematologic malignancy commonly associated with a poor prognosis," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "A global registrational Phase III study of lisaftoclax in AML is already underway. Remaining committed to the mission of addressing unmet clinical needs in China and around the world, we will accelerate the clinical development of lisaftoclax and bring this novel therapeutic to the broad population of patients with AML as soon as possible." Highlights of these data presented at ASCO 2024 are as follows: Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia Abstract#: 6541 Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Date and Time: June 3, 2024, Monday, 9:00 AM – 12:00 PM (Central Time) First Author: Huafeng Wang, MD, PhD, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. Highlights: Background and introduction: Early studies showed that lisaftoclax in combination with various agents can synergistically induce apoptosis in AML. This poster presents follow-up safety and efficacy data from a Phase Ib/II study of lisaftoclax combined with AZA in adults with AML. Patient enrollment and methods: This study enrolled elderly (≥75 years)/unfit TN patients with AML who were intolerant of standard induction chemotherapies and patients (≥18 years) with R/R AML. Lisaftoclax (400/600/800 mg) was administered orally once daily in 28-day cycles. In the first treatment cycle, a daily ramp up schedule was used to prevent TLS. AZA was administered once daily on D1-D7 at 75 mg/m2. As of January 25, 2024, 76 patients with AML were enrolled, including 37 patients with R/R AML and 39 elderly/unfit patients with TN AML who were intolerant of standard induction chemotherapies. The median (range) age was 66 (20-81) years. Efficacy results: In patients with R/R AML treated with lisaftoclax combined with AZA, the overall response rate ([ORR]=CR + CRi + morphologic leukemia-free state [MLFS] + PR) was 72.7%, and the composite complete remission rate (CRc = CR + CRi) was 45.5%. In the 600 mg cohort (n=30), the median duration of treatment was 3.8 months, the ORR was 76.7%, the CRc was 50.0%, the median time to CRc was 2.5 months, the median PFS was 10.2 months, and the median overall survival (OS) was 14.7 months. Among patients with TN AML treated with lisaftoclax combined with AZA, the ORR was 64.1%, and the CRc was 51.3%. In the 600 mg cohort (n=29), the median duration of treatment was 3.3 months, and the median time to CRc was 1.9 months. The median PFS and median OS were not reached. 600 mg lisaftoclax combined with AZA was established as the recommended Phase II dose (RP2D) Safety results: All patients treated with lisaftoclax combined with AZA reported treatment-emergent adverse events (TEAEs), with 89.5% experiencing grade 3/4 TEAEs and 43.4% experiencing serious adverse events (SAEs). Common Grade ≥ 3 TEAEs reported in ≥ 10% of patients included neutropenia (57.9%), thrombocytopenia (50.0%), anemia (27.6%), pneumonia (17.1%), and febrile neutropenia (10.5%). No TLS was reported. The 30-day mortality rate was 1.3%. Conclusions: These data support a promising role for the new Bcl-2 inhibitor lisaftoclax combined with AZA for the treatment of elderly/unfit TN patients with AML intolerant of standard induction chemotherapies and patients with R/R AML, especially given a potentially favorable safety profile in terms of TLS, the incidence of neutropenic fever, and low early mortality. A Phase III randomized, double-blind study is being conducted to determine whether lisaftoclax combined with AZA improves the survival of elderly/unfit TN patients with AML intolerant of standard induction chemotherapies. *Lisaftoclax is an investigational drug that has not been approved in any country and region. Appendix: The four clinical studies of Ascentage Pharma's three drug candidates, including lisaftoclax, presented at this year's ASCO Annual Meeting. Drug Candidates Abstract Title Abstract# Format Olverembatinib(HQP1351) Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma. #11502 Oral Report Lisaftoclax （APG-2575） Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia. #6541 Poster Presentation Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). #7078 Poster Presentation APG-2449 Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors. #3124 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, including 5 global registrational phase III studies, 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 in China, has been granted Priority Review Designations and Breakthrough Therapy Designations 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.
SHANGHAI, June 3, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company, announced today that the preliminary Phase 1/2 clinical data of MHB088C (B7-H3 ADC) was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral presentation. Abstract #: 3012 Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors In this Phase 1/2 study, the safety/tolerability, pharmacokinetics, and efficacy of MHB088C in patients (pts) with recurrent or metastatic solid tumors were evaluated. The study results were as follows: At data cutoff, MHB088C was well tolerated. The most common TRAEs were hematological toxicities. 4 mg/kg Q3W was the DLT dose and 3 mg/kg Q3W was defined as the MTD. 1.6 mg/kg Q2W, 2.0 mg/kg Q3W and 2.4 mg/kg Q3W demonstrated favorable safety profiles with low single-digit Grade ≥3 hematological AEs for the two lower doses. No interstitial lung disease (ILD) was reported as of the data cutoff. Of 98 efficacy evaluable pts with different tumor types at doses ranging from 0.8 mg/kg to 4.0mg/kg, ORR was 33.7% (33/98) and DCR was 83.7% (82/98), with DoR not reached yet. The majority of pts remain on the treatment. Of 31 efficacy evaluable pts with small cell lung cancer (SCLC), ORR was 61.3% (19/31) and DCR was 93.5% (29/31). 24 pts (77.4%) remain on the treatment, and 6 pts (19.4%) achieved 60% or more tumor reduction, with 2 CRs of target lesion at 3.0 mg/kg. Among 10 pts at 1.6 mg/kg Q2W, ORR was 80% and DCR was 90%. Of 7 efficacy evaluable pts with esophageal squamous cell carcinoma (ESCC), ORR was 42.9% and DCR was 85.7%. The median follow-up was over 3.0 months. Professor Lin Shen from the Beijing Cancer Hospital stated: "MHB088C represents an innovative advancement in cancer treatment as a novel B7-H3 ADC equipped with a potent DNA Topo I inhibitor. The preliminary data are highly encouraging, showcasing clinically meaningful and durable antitumor activities at very safe doses across multiple cancer types. We are optimistic about the ongoing study and anticipate further positive clinical outcomes." Dr. Guoqing Cao, CEO of Minghui Pharmaceutical, stated: "We are excited to share the results of Phase 1/2 study of MHB088C at the 2024 ASCO. MHB088C is a well-differentiated B7-H3 ADC, conjugating an optimal anti-human B7-H3 antibody with our Proprietary SuperTopoiTM payload. We are seeing robust efficacy at very safe doses without major hematological toxicity or ILD. Particularly, in SCLC, 9 out of 10 patients experienced tumor shrinkage at 1.6 mg/kg Q2W, with an ORR of 80%. The durability of responses was also notable in ESCC, with an ORR of 43% and median follow-up over 3 months. The safety profile of MHB088C is consistent with that of our other program MHB036C, a TROP-2 ADC, without major hematological toxicity or ILD either. Between the two clinical programs, with data from more than 250 patients, we are confident that we now have one of the best ADC platforms in the industry. Efficacy in other cancer types has also been observed and will be reported in future conferences. We look forward to initiating registrational trials of the monotherapy for selected tumor types by the end of 2024 and exploring the IO combination in earlier line settings for both ADC assets in the near future." About MHB088CMHB088C is a novel B7-H3 ADC generated through Minghui's SuperTopoiTM ADC platform. Minghui's proprietary payload is 5 to 10 times more potent than DXd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. Conjugated with Minghui's proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor's antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types. It was 3 to 10 times more potent in killing tumor cells than the competitor's compound in xenograft models. About Minghui PharmaceuticalMinghui Pharmaceutical, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates. For more information, please visit www.minghuipharma.com. Forward-Looking StatementsThis press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein.
Clinical Trials/Medical Discoveries
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