ACN Newswire

Claudin18.2, a shining star in gastric cancer, Transcenta’s TST001 stands at the global forefront

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6 minutes

HONG KONG, Sep 28, 2022 - (ACN Newswire via SEAPRWire.com) - Transcenta Holding Limited (06628.HK), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announced that interim safety and efficacy data of dose expansion cohort from the phase I/II study of TST001 (Osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, in combination with Capecitabine and Oxaliplatin (CAPOX) as a first line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer was presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2022. In first line treatment of advanced or metastatic G/GEJ cancer, early interim data of the first 15 patients with measurable disease receiving the combination of TST001 with CAPOX demonstrated a partial response rate of 73.3% and a disease control rate of 100% per RECIST1.1. Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated. A global phase III clinical program of TST001 (Osemitamab) for the first line tre...

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Eisai Presents New Data From its Oncology Portfolio and Pipeline at ESMO Congress 2022

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3 minutes

TOKYO, Sep 6, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13. A late-breaking oral presentation of detailed results from the LEAP (LEnvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial will be featured in a Proffered Paper session (NCT03713593; Presentation: #LBA34). The study evaluated the combination of lenvatinib plus anti-PD-1 antibody pembrolizumab from Merck & Co., Inc., Rahway, NJ, USA versus lenvatinib monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma. Additionally, two mini-oral presentations will feature updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (NCT02811861; Presentation: #1449MO) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanc...

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Eisai Contributes to the Science of Cancer Medicine at ASCO 2022

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3 minutes

TOKYO, May 27, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7. Notable presentations include a poster discussion of safety and efficacy data (NCT03386942; Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942; Abstract: #3090)."Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai's first antibody drug conjugate combines our in-house developed anti-folate ...

ACN Newswire

Hua Medicine Announces 2021 Annual Results

indie
8 minutes

SHANGHAI, CHINA, Mar 17, 2022 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", Stock Code: 2552.HK) today announces the audited annual results of the Company and its subsidiaries for the year ended December 31, 2021 (the "Reporting Period"). The Reporting Period witnessed significant milestones in the commercialization process of dorzagliatin. The New Drug Application (NDA) of dorzagliatin for the treatment of Type 2 Diabetes was submitted to, and accepted by, the China National Medical Products Administration (the "NMPA"). The Company has also been actively advancing the full-life-cycle management plans of drugs. Total expenditures incurred by the Company in 2021 was approximately RMB327.2 million, of which approximately RMB186.8 million was research and development expenses. As of December 31, 2021, the Company's cash position was approximately RMB675.2 million.Hua Medicine has consistently focused on unmet clinical needs. After 10 years of breakthrough exploration, from the scientific theory of glucose homeostasis regulation to an innovative drug with a new and novel mechanism, the Company has successfully developed dorzagliatin, a first-in-class innovative gluc...

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LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma

ruth
7 minutes

TOKYO, Mar 7, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada)'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These results were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021, and published in the New England Journal of Medicine in January 2022.(1)In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p LENVIMA plus KEYTRUDA was previously approved under accelerated approval process in Taiwan, for the treatment of patients with advanced ...

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Eisai: Lenvima (Lenvatinib) in Combination with Keytruda (Pembrolizumab) Approved in Taiwan for the First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

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8 minutes

TOKYO, Jan 31, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) has been approved in Taiwan for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia.The approval is based on results from the CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination for the first-line treatment of patients with advanced RCC. These results were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.(1) In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the primary efficacy outcome measure of progression-free survival (PFS), as well as the key secondary efficacy outcome measures of overall survival (OS) and objective response rate (ORR) versus sunitinib. For PFS, LENVIMA plus KEYTRUDA reduced t...

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Eisai to Present Abstracts on Lenvatinib at 2022 ASCO Gastrointestinal Cancers Symposium

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4 minutes

TOKYO, Jan 17, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022. At this symposium, the results of a primary analysis of a prospective clinical study evaluating transcatheter arterial chemoembolization (TACE) therapy in combination strategy with lenvatinib (TACTICS-L) in patients with unresectable hepatocellular carcinoma (uHCC) in Japan (Abstract No: 417), as well as research updates on the Phase IV Study (STELLAR) to evaluate safety and tolerability of lenvatinib in patients with advanced/unresectable hepatocellular carcinoma (Abstract No: TPS485) and results from a clinical study to evaluate the efficacy of lenvatinib for conversion surgery in patients with uHCC (investigator-initiated study in Japan, Abstract No: 458), will be presented. In addition, trial-in-p...

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The CREB-binding protein (CBP)/beta-catenin inhibitor E7386, co-created by Eisai and PRISM BioLab, achieved the clinical POC (Proof of Concept)

ruth
5 minutes

TOKYO, Nov 1, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and PRISM BioLab Co., Ltd. announced today that the CREB-binding protein (CBP) / beta-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept).Eisai is conducting a Phase I clinical study of E7386 monotherapy for solid tumors, and a Phase Ib clinical trial of E7386 plus lenvatinib mesylate (product name: LENVIMA, "lenvatinib"), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for solid tumors including hepatocellular carcinoma. The achievement of the POC, which is defined in a collaborative research agreement between Eisai and PRISM, was confirmed based on data such as antitumor activity and changes of biomarkers in these clinical trials.The E7386 targets, beta-catenin, is considered to be one of the undruggable targets that are particularly difficult to develop into drug discovery. beta-catenin, along with CBP, which is also the target of E7386, is located at the downstream of the Wnt signaling and regulates the Wnt signaling-dependent transcription activity. ...

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Adlai Nortye Announces First Patient Dosed in Phase Ia Clinical Trial of AN2025 and AN0025 in Combination with atezolizumab for Advanced Solid Tumors

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6 minutes

NEW JERSEY, the U.S. and HANGZHOU, China, Sep 8, 2021 - (ACN Newswire via SEAPRWire.com) - Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, today announced that the first patient has been dosed in the Phase Ia clinical trial in the U.S. to evaluate the triple combination of AN2025 (buparlisib, oral pan-PI3K inhibitor), AN0025 (oral EP4 antagonist) and atezolizumab (PD-L1 inhibitor) in patients with locally advanced/metastatic tumors.This trial (AN2025S0101) is an open-label, multicenter, Phase Ia study to evaluate the safety, tolerability, pharmacokinetics ("PK") and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with atezolizumab in patients with locally advanced/metastatic tumors. The study consists of three dose-limiting toxicity ("DLT") Observation Periods, Observation I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. Each Observation period will last 3 weeks. This study plans to recr...

ACN Newswire

Hua Medicine Announces 2020 Interim Results

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7 minutes

SHANGHAI, CHINA, Aug 19, 2021 - (ACN Newswire via SEAPRWire.com) - Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the consolidated results of the Company and its subsidiaries for the six months ended June 30, 2021 (the "Reporting Period"). During the Reporting Period, the New Drug Application (NDA) of the first glucokinase activator (GKA) dorzagliatin, has been accepted by The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and has become the first GKA globally to submit a NDA for the treatment of diabetes. During the Reporting Period, the Company incurred approximately RMB165.1 million in total expenditures, of which approximately RMB98 million was research and development expenses. As of June 30, 2021, the Company's cash position was approximately RMB846.9 million, to be used for the commercialization of dorzagliatin and innovative drug R&D.In the first half of 2021, Hua Medicine reached a breakthrough milestone in preparing for dorzagliatin's commercialization. The Company submitted the NDA for dorzagliatin, the first-in-class oral drug for the T2DM in March 2021 and was accepted by NMPA on April 23, 2021. To ...

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FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for First-Line Treatment of Adult Patients with Advanced Renal Cell Carcinoma (RCC)

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18 minutes

TOKYO and KENILWORTH, N.J., Aug 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).The approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR). For PFS, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 61% (HR=0.39 [95% CI: 0.32-0.49]; p Adverse reactions, some of which can be serious or fatal, may occur with LENVIMA, including hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or...

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Black Spade Acquisition Co Announces Pricing of $150 Million Initial Public Offering

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4 minutes

HONG KONG, Jul 16, 2021 - (ACN Newswire via SEAPRWire.com) - Black Spade Acquisition Co (the "Company") today announced the pricing of its initial public offering of 15,000,000 units at a price of $10.00 per unit. The units are expected to be listed for trading on the New York Stock Exchange (the "NYSE") under the ticker symbol "BSAQU" beginning July 16, 2021. Each unit consists of one of the Company's Class A ordinary shares and one-half of one redeemable warrant. Each whole warrant entitles the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Company expects that its Class A ordinary shares and warrants will be listed on the NYSE under the symbols "BSAQ" and "BSAQWS," respectively.The Company was formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or assets. Although the Company may pursue an initial business combination opportunity in any industry or any region, it is focused on identifying a business combination target that can benefit from the extensive c...

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Eisai to Present Data on Oncology Pipeline and Products at ASCO Annual Meeting

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3 minutes

TOKYO, May 20, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the latest data regarding its oncology pipeline and products including in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: LENVIMA, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: HALAVEN, "eribulin") will be presented at the American Society of Clinical Oncology (2021 ASCO Annual Meeting*), to be held virtually from June 4 to 8, 2021. At this meeting, there will be an oral presentation on the analysis of health-related quality-of-life (HRQoL) (Abstract No: 4502) of the pivotal Phase 3 CLEAR Study (Study 307/KEYNOTE-581) evaluating lenvatinib in combination with pembrolizumab (product name: KEYTRUDA, "pembrolizumab"), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma. Additionally, respective CLEAR poster presentations on analysis of depth of response and efficacy (Abstract No: 4560) and a post hoc analysis of ...

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Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan

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2 minutes

TOKYO, Mar 31, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and MSD K.K. a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) announced today that Eisai has submitted an application in Japan for the additional indication of its in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA (generic name: lenvatinib mesylate), in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.'s KEYTRUDA (generic name: pembrolizumab) as a treatment for patients with advanced renal cell carcinoma (RCC). This is the first application to be submitted in Japan for this combination therapy.This application is based on the results of the Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC, which were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU), and simultaneously published in the New England Journal of Medicine in February 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) as well as key secon...

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Eisai: European Medicines Agency Accepts the Marketing Authorisation Applications for Two Additional Indications of Anti Cancer Agent Lenvatinib in Combination with Pembrolizumab

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4 minutes

TOKYO, Mar 30, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that the European Medicines Agency (EMA) has confirmed it has accepted for review applications for the use of its in-house discovered multiple receptor tyrosine kinase inhibitor, lenvatinib mesylate (product name: LENVIMA / Kisplyx, "lenvatinib"), in combination with anti-PD-1 therapy pembrolizumab (brand name: KEYTRUDA), developed by Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) as a treatment for patients with advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC), respectively.The application requesting an indication of lenvatinib in combination with pembrolizumab for RCC is based on the results of the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC, which were presented at 2021 Genitourinary Cancers Symposium (ASCO GU), and simultaneously published in the New England Journal of Medicine in February 2021. In this trial, lenvatinib plus pembrolizumab demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of pr...

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APOLLOMICS, INC ANNOUNCES SUCCESSFUL ENROLLMENT OF FIRST PATIENT INTO PHASE 1 CLINICAL TRIAL OF APL-106 (UPROLESELAN INJECTION) IN CHINA

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3 minutes

FOSTER CITY, Calif. and HANGZHOU, ZHEJIANG, CHINA, Mar 4, 2021 - (ACN Newswire via SEAPRWire.com) - Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, today announced that the first patient has been successfully enrolled into a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) in China. In February of this year, the two Phase 1 study sites were initiated.The Phase 1 clinical trial is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML. Its principal investigator is Professor Jianxiang Wang of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The primary objective of the Phase 1 is to study the pharmacokinetic (PK) characteristics of APL-106 in Chinese subjects with relapsed or refractory AML and to evaluate the safety and tolerability of APL-106 in combination with chemotherapy.About APL-106 (uproleselan injection) APL-106 (uprole...