Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023 JCN Newswire

Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023

TOKYO, Jan 18, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21.Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386(1), a CREB-binding protein (CBP) / beta-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (NCT03833700; Abstract: #106). Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.Research from the LEAP (LEnvatinib And Pembrolizumab) clinical program includes a poster presentation featuring a health-related quality of life analysis from the Phase 3 LEAP-002 trial investigating the lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA(2)) combination versus lenvatinib plus placebo as a first- line treatment for patients with unresectable hepatocellular carcinoma (NCT03713593; Abstract: #506). Additional presentations on Eisai's oncology pipeline showcase Eisai's investigational compound, E7389- LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors. Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort (NCT04078295; Abstract: #337) and a gastric cancer cohort (NCT04078295; Abstract: #339)."We are eager to share new data at the annual symposium where specialists in gastrointestinal cancers gather from all over the world, including findings from a Phase 1 study evaluating the novel investigational anticancer agent, E7386, in advanced solid tumors including colorectal cancer," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our findings across colorectal, esophageal, gastric and liver cancer illustrate Eisai's commitment to further oncology research for people living with gastrointestinal cancers, who account for over one quarter of the global cancer incidence(1)."In March 2018, Eisai and Merck (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck's anti-PD-1 therapy pembrolizumab. To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.(1) E7386 is created through collaboration research between Eisai and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa)(2) KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.For more information, visit www.eisai.com/news/2023/pdf/enews202308pdf.pdf.Media Inquiries:Public Relations Department, Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
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Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors ACN Newswire

Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors

LONDON AND HONG KONG, Jan 11, 2023 - (ACN Newswire via SEAPRWire.com) - Prenetics Global Limited (NASDAQ: PRE) a leader in genomic and diagnostic testing, today announced that ACT Genomics, a company which Prenetics recently acquired a majority stake in, has received clearance from the U.S. Food and Drug Administration (FDA) for ACTOnco, the company's comprehensive genomic profiling test for solid tumors. ACTOnco is intended for use by healthcare professionals to help them inform clinical management decisions in accordance with professional guidelines for cancer patients with solid tumors. This is the first and only Asia-based company to receive FDA clearance for a comprehensive genomic profiling test. ACTOnco is a diagnostic test which:-- provides a comprehensive genomic profiling test that looks at 440 cancer-associated genes;-- provides information to help guide clinical management decisions on the use of targeted oncology therapies, including immunotherapies;-- is intended as a pan-cancer test including breast, colon, endometrial, lung, and other cancers;-- is an FDA-cleared platform for comprehensive genomic profiling assay development for biopharma companies developing precision therapeutics.The ability to perform a comprehensive genomic profiling test on an individual tumor helps open the door for personalized medicine, and a future where a person is matched with a treatment that targets the specific weaknesses in his or her cancer."Today's landmark clearance by the FDA represents a significant advancement in personalized cancer care in Asia and may lead to reimbursement and coverage by private insurers and healthcare systems. The clearance by the FDA further validates our status as a pioneer in the industry and we will continue to invest further in R&D efforts, especially related to early detection of cancer in healthy populations." Said Danny Yeung, Chairman of ACT Genomics and Chief Executive Officer of Prenetics. Dr. Hua Chien Chen, Chief Executive Officer of ACT Genomics, said "It was a tremendous team and scientific effort to develop ACTOnco. Asia contributes 48% of the new cancer cases and 55 % of the cancer deaths in the world. The disease imposes a serious burden on Asia. While precision medicine provides an advantage in disease diagnosis and treatment planning and has become a routine clinical practice in the west, it is not the case in Asia. ACT Genomics is the first biotech company in Asia that received market authorization for a cancer comprehensive genomic profiling assay. Unlike most of the currently marketed tests developed by US companies using mainly clinical samples from Western countries, the ACTOnco assay was developed and validated using half of the Western clinical samples and half of the Asia clinical samples. ACTOnco enables physicians to gain better insights into the genetic underpinnings of each patient's illness and helps them to formulate the best treatment decisions. Having ACTOnco cleared by the FDA will open new opportunities for patients to get the best cancer care. With this incredible milestone achieved, we will continuously promote precision medicine in Asia and our company mission to turn genomics into action." About ACT GenomicsACT Genomics is an innovation-driven cancer solution provider with offices in Taipei, Hong Kong, Singapore, Tokyo, Bangkok, and the United Kingdom. With its Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team, and proprietary AI algorithms, ACT Genomics provides optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Its mission is to "Turn Genomics into Action". To learn more about ACT Genomics, visit www.actgenomics.com.About PreneticsFounded in 2014, Prenetics is a major global diagnostic and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars - Consumer Health, Clinical Care and Medical & Cancer Genomics - comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across nine locations, including the United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening and provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. Prenetics is listed on NASDAQ with the ticker PRE. To learn more about Prenetics, visit www.prenetics.com.Investor Relations Contact:investors@prenetics.comICR Westwicke:Caroline Corner +415 202 5678 Email: caroline.corner@westwicke.comForward-Looking Statements In addition to historical information, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These statements are based on estimates and forecasts and reflect the views, assumptions, expectations, and opinions of Prenetics and ACT Genomics. Any such estimates and assumptions, expectations, forecasts, views or opinions, whether or not identified in this press release, should be regarded as indicative, preliminary and for illustrative purposes only and should not be relied upon as being necessarily indicative of future results. These statements include, but are not limited to, statements by our management or the board regarding expectations for the closing of the acquisition, statements of plans, objectives, and expectations of synergy between Prenetics and ACT by our management or the board or by ACT or ACT's management or board. Our expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Because of these uncertainties, you should not make any investment decisions based on our estimates or forward-looking statements. All information provided in this press release is as of the date of this press release. Prenetics does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required under applicable law. Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Alercell Is All Set to Launch a Leukemia Diagnostic Test Lena Q51(R)

Bozeman, MT, December 29, 2022 – (SEAPRWire) – Alercell is all set to launch LENA Q51(R) in January 2023. A leukemia diagnostic test based on sequencing DNA will detect up to 51 Genes mutations in Leukemia patients. Alercell is on a mission of making a significant difference in the fight against cancer by offering unique and precise diagnostic solutions that enhance patient outcomes. Alercell is a young and dynamic firm. To better fulfill the demands of the clients, they are continually working to improve their products and services. They have an active research and development program to create new goods for even more precise testing, and their products are based on the most recent technology. Alercell, Inc. seeks to provide innovative in-vitro testability for cancer testing while streamlining the process of detecting infectious diseases. In their ideal world, early disease detection is achieved by testing, allowing prompt implementation of preventative measures. Alercell is based in the United States, but they also have manufacturing and storage facilities in Europe and Asia, extending its accessibility and reach around the globe. In July 2020, the first Alercell COVID-19 fast test arrived in the USA. Since then, Alercell has created a stir in the sector by creating new, creative methods for conducting tests that are more precise, effective, and easily accessible. Being a molecular diagnostics startup, Alercell, Inc. also offers quick testing for leukemia and cancer to detect life-threatening conditions as soon as possible. The company was established to give cancer patients worldwide better precise and rapid diagnostic tools. By offering unique and accurate diagnostic solutions that enhance patient outcomes, Alercell aims to contribute to the fight against cancer. “Stopping it before it starts” is the cornerstone of the Alercell mission. Our genetic testing is the first defense against cancer, leukemia, and infectious diseases. Bozeman, Montana-based Alercell is a biotechnology business with a R&D branch in New York City. Alercell will soon introduce a new test and brand. The first leukemia diagnostic test, LENA Q51®, was based on DNA sequencing and could identify up to 51 gene alterations in leukemia patients. An intriguing development is this test. Until recently, a series of blood tests and a bone marrow biopsy were required when someone was “suspected” to have leukemia. It costs thousands of dollars and takes somewhere between 6 and 9 weeks. With LENA Q51®, all of this is avoided, and in just three hours using a qPCR machine, clinicians will be able to identify any gene mutations among 51 different genes. By doing this, we can determine in 3 hours via computer, eliminating the need for human interpretation; the information gathered will also enable us to tailor the patient’s treatment—all of this for a much lower price. Moreover, the fight against the most lethal cancer, lung cancer in the US is a first. The first methylation-based molecular diagnostic test for lung cancer, LENA S1®, will be made available by Alercell later in the first quarter of 2023. As an epigenetic regulator of gene expression, DNA methylation enables early diagnosis of lung cancer and very accurate localization of the disease, if present. Alercell Neuroscience will make a formal announcement in early 2023. Alercell Neuroscience aims to create a nanoparticle neural interface for recording and controlling brain activity. Prof. Gleb Sukhorukov, Ph.D., Chair in Biopolymers at the School of Engineering and Materials Science, Queen Mary University of London (QMUL), will spearhead our efforts. Professor Sukhorukov is a renowned scientist around the globe. Alercell plays a significant role in preventative medicine, particularly in the detection and treatment of cancer. The CEO and the CMO of the company, Dr. Alexandre Scheer MD, are leveraging genetic research to develop novel drugs and testing procedures. Scheer thinks that genetic science holds the answer to improving early diagnosis and eventually identifying severe illnesses before they manifest inside the body. By employing such techniques, the healthcare system may save a large sum of money, and patients may receive excellent care before grueling chemotherapy treatments. Scheer is particularly sensitive to this subject since he is undergoing all these challenging therapies while battling severe cancer. Frederic Scheer stated, “I want to let people know well in advance to avoid what I am going through”. Alercell, Inc. co-founder Frederic Scheer successfully floated multiple start-up firms on stock-exchanges including NASDAQ and NYSE. For the past 25 years, he has worked in the chemical business and alternative technology. Scheer holds 15 US biotechnology patents including three on nanoparticles. As the co-founder of Alercell Inc. “I am thrilled that via the application of our knowledge of the genome, we are now able to produce very performing tests that will help people in finally avoiding the unpleasant traditional treatment,” he says regarding the company’s goods. The business focuses on collaborating with reputed pharmaceutical firms and other healthcare organizations to benefit its patients and ensure that the public always has access to the quickest diagnostic procedures and most affordable medications.” Media Contact Brand: ALERCELL, INC. Contact: Frederic Scheer E-Mail: fscheer@alercell.com Website: https://alercell.com SOURCE: ALERCELL The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)
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Prenetics Acquires ACT Genomics; First M&A Deal since IPO, Set to Expand Footprint in Cancer Genomics ACN Newswire

Prenetics Acquires ACT Genomics; First M&A Deal since IPO, Set to Expand Footprint in Cancer Genomics

HONG KONG, Dec 16, 2022 - (ACN Newswire via SEAPRWire.com) - Prenetics Global Limited (NASDAQ: PRE) ("Prenetics" or the "Company"), a global leader in genomic and diagnostic testing, is acquiring a majority stake of ACT, an Asia based genomics company specializing in precision oncology with operations in Hong Kong, Taiwan, Japan, Singapore, Thailand and the UK, for an upfront consideration consisting of 19.9 million shares of Prenetics common stock and US $20 million cash (the "transaction"). That is the first M&A deal Prenetics is to make since its listing, which will expand its footprint in the cancer genomics space, bringing it closer to realizing the vision of building an end-to-end health ecosystem. With the acquisition well underway, effective from January 1, 2023, Professor Tony Mok, Chairman of ACT, will join Prenetics Scientific Advisory Board.Boasting cutting-edge technologies in cancer genomics and bioinformatics, ACT has a multi-diagnostic technology platform and offers a comprehensive range of products in clinical services with high pan-Asia coverage. In November 2021, ACT merged with Sanomics Holdings Limited ("Sanomics"), both of which were awarded the Elite Program funding by Hong Kong Science and Technology Parks Corporation ("HKSTP"), where the strongest technical ecosystem is provided locally to its park companies to grow and thrive. HKSTP is home to over 200 health tech related start-ups and several international research clusters in healthcare.With the continuous support from HKSTP and the government, Prenetics will have an extended reach to the healthcare technology market in the Greater Bay Area and beyond. Financially, ACT's revenue is expected to grow at a CAGR of 60% between FY2022 and FY2026. Prenetics expects ACT to contribute revenues of approximately US$25-30 million in 2023. When the acquisition is completed, leveraging ACT's R&D engines which specializes in next-generation sequencing and bioinformatics in both tissue and liquid biopsy, Prenetics will have the scientific rigor to offer tests to patients throughout their cancer journey. This will also position Prenetics solidly within the US$80+ billion global precision oncology market.Danny Yeung, Chief Executive Officer and Co-founder of Prenetics, said, "This is a significant move for Prenetics, as it is our first M&A deal since listing and is set to enlarge our footprint in the cancer genomics space. It is our goal to democratize testing and make cancer genomics accessible to all. With Professor Mok and the ACT team on board, we believe Prenetics can deliver the information needed to enable best-in-class personalized cancer care and make new heights. Lastly, we are actively n close discussions on additional M&A opportunities which we believe will be in the interest to Prenetics and our shareholders."Professor Tony Mok, Chairman of ACT Genomics, said, "We are very pleased to join forces with Prenetics. ACT has pioneered and made breakthroughs in cancer prevention and diagnostics since it was founded in 2014. Our flagship ACTOnco+ has provided oncologists and cancer patients with valuable biomarker information for therapy selection. I believe this transaction will give both companies enhanced financial strength and commercial and R&D capabilities to drive significant growth." Mr. Albert Wong, Chief Executive Officer of Hong Kong Science and Technology Parks Corporation, said, "We are thrilled to witness this milestone, which is a clear vote of confidence in Hong Kong's ambition to become a biomedical technology center of excellence. It was only last year when we saw the merger of two health tech pioneers from the Hong Kong Science Park, ACT Genomics and Sanomics. The acquisition by Science Park incubatee, Prenetics, is a testament to the high-quality innovation ecosystem and translational research infrastructure that have been established at the Park over the past 20 years. Backed by government support and its unique advantages, Hong Kong is open to innovators from around the world who want to come and accelerate their future success." Under the terms of the transaction agreement, Prenetics has agreed to issue 19.9 million shares of Prenetics' class A ordinary shares and pay $20 million in cash. Upon closing, Prenetics will hold a majority stake in ACT. More details about the transaction can be found under link: https://prenetics.gcs-web.com/static-files/fd50a409-45b7-4827-96e0-1c207ccca5aa About PreneticsFounded in 2014, Prenetics is a major global diagnostics and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars - Consumer Health, Clinical Care and Medical & Cancer Genomics - comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across nine locations, including United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening; and provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. Prenetics is listed on NASDAQ with the ticker PRE. To learn more about Prenetics, visit www.prenetics.com.About ACT Genomics / SanomicsACT Genomics is an innovation-driven cancer solution provider with offices in Taipei, Hong Kong, Singapore, Tokyo, Bangkok and UK. With our Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team, and proprietary AI algorithms, we provide optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Together, we "Turn Genomics into Action". To learn more about ACT Genomics, visit www.actgenomics.com.Investor Relations contact:investors@prenetics.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Eisai to Present Preclinical and Clinical Research on Eribulin at the 2022 San Antonio Breast Cancer Symposium JCN Newswire

Eisai to Present Preclinical and Clinical Research on Eribulin at the 2022 San Antonio Breast Cancer Symposium

TOKYO, Dec 1, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN, "eribulin") will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10. Eisai will present five eribulin-related abstracts, including a post hoc subgroup analysis from two pivotal Phase 3 studies (EMBRACE and Study 301), as well as:- Real world use of eribulin following treatment with a P13K inhibitor, mostly in people with Hormone Receptor (HR)-positive/HER2-negative metastatic breast cancer.- Preclinical data exploring a liposomal formulation of eribulin, in a Phase 1 expansion cohort for breast cancer, versus eribulin at the same dose, in patient-derived breast cancer xenografts. "We continue to relentlessly pursue research that provides useful insights for people living with breast cancer," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "A big part of this commitment is the ongoing sharing of our preclinical and clinical data with eribulin." This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.For more information, visit www.eisai.com/news/2022/news202286.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)
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Claudin18.2, a shining star in gastric cancer, Transcenta’s TST001 stands at the global forefront

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 treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned. 1. Claudin18.2 is expected to be the most shining star target in gastric cancer The European Society for Medical Oncology (ESMO) Congress 2022 was held in person in Paris and virtually between 9-13 September 2022. Around 2000 abstracts and late-breaking abstracts were presented during the congress days. Transcenta's poster with the dose expansion cohort interim data from the TST001 in combination with chemotherapy in first line treatment of locally advanced or metastatic G/GEJ cancer patients with Claudin18.2 expression was presented on Sept 12, 2022.Data shows that as of August 4, 2022, 51 patients were enrolled and dosed including 36 patients treated with TST001 plus CAPOX at 6mg/kg Q3W in the expansion phase. Among the 15 patients with measurable disease and at least one post-treatment tumor assessment, 11 (73.3%) achieved partial response and four (26.7%) achieved stable disease. All 51 enrolled patients were evaluated for safety and tolerability. Treatment-emergent adverse events regardless of causality were mostly grade 1-2. Twelve (23.5%) patients experienced dose delay, five (9.8%) experienced dose reduction and no patient experienced discontinuation due to treatment related adverse events. In this study, TST001 also demonstrated a clear dose proportional pharmacokinetic profile, is consistent with those observed with TST001 monotherapy and in US patients. These data suggest that TST001 combined CAPOX is well tolerated and with promising efficacy in a broad gastric cancer patient population with tumors expressing Claudin18.2, including medium and high expressors. Furthermore, Transcenta has also developed a proprietary IHC assay to select patients with Claudin18.2 expressing tumors for registration enabling studies. Despite progresses in the treatment of advanced gastric cancer with HER2, VEGF, VEGFR, or PD-1/PD-L1 targeted therapies, outcomes remain poor for 1st line patients with median overall survival of around 14 months. Claudin18.2 expression is observed at various levels in 50%-70% of gastric cancer patients, and at relatively high percentage in a variety of tumors including pancreatic, cholangiocarcinoma, ovarian and lung cancer. It is one of the hottest targets in cancer treatment. A few Claudin18.2 directed targeted drugs have entered the clinical stage, including monoclonal antibodies, bispecific antibodies, CAR-T and antibody-drug couples (ADCs). TST001, a humanized anti-Claudin18.2 monoclonal antibody, with higher target binding affinity and enhanced ADCC activity than other antibodies, has demonstrated very encouraging preliminary signs of activity in 1st L gastric / GEJ cancers with various levels of CLDN18.2 expression, and a manageable safety and tolerability profile.Since entering into the clinical stage, Transcenta has attracted the attention of many multinational corporations. It established a global clinical collaboration with Bristol-Myers Squibb to evaluate the combination of TST001 with Opdivo(R) (Bristol-Myers Squibb's anti-PD-1 therapy) for the treatment of patients with unresectable locally advanced or metastatic G/GEJ cancer earlier in March this year. These TST001 data have also generated a lot of excitement from GI cancers investigators who see TST001 as an effective new treatment option to cover the high unmet need of Claudin18.2 medium and high expressors cancers, providing a broader treatment option than other players in the same class. As TST001 data continue to mature, Transcenta progresses TST001 towards phase III trial and has initiated Health authority consultations. 2. Dr. Caroline Germa, former AstraZeneca Oncology's Vice President, is now Transcenta's Chief Medical Officer as the Company accelerates its expansion internationallyIn August 2022, Transcenta announced the appointment of Dr. Caroline Germa as the Executive Vice President, Global Medicine Development and Chief Medical Officer. Dr. Caroline Germa was formerly Vice President of AstraZeneca Oncology and has extensive oncology development experience. Prior to joining AstraZeneca, she also worked for a number of world-renowned companies including Pfizer and Bristol-Myers Squibb, and led the late-stage clinical development of a number of key oncology assets, in particular the global registration strategy and approval of blockbuster drugs including Ribociclib (CDK4/6 inhibitor - Kisqali) and Neratinib. She has a deep understanding of the industry and, with her pharmaceutical industry contacts and unique ideas on the business development of the Company, international clinical development and regulatory approvals, the Company is confident that Dr Caroline Germa will be able to lead Transcenta to better global expansion and make a significant contribution to enhancing the Company's shareholder value.3. TST001 is ranked among the top two most advanced clinical programs for Claudin18.2 worldwide, and the first in ChinaZolbetuximab is the first clinical stage anti-claudin18.2 monoclonal antibody. In a phase II, randomized study evaluating Zolbetuximab + epirubicin + oxaliplatin + capecitabine (EOX) for the first-line treatment of CLDN18.2 positive advanced G/GEJ cancer or esophageal adenocarcinoma, zolbetuximab plus EOX chemotherapy showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone in the overall population, padding the Claudin18.2 target's potential for druggability. TST001 of Transcenta is a second generation anti-Claudin18.2 antibody with a differentiated profile relative to Zolbetuximab. It not only has 10-folds higher affinity binding to Claudin18.2, but also has a reduced fucose profile in the Fc of the humanized antibody. Combining these features, the ADCC activity of TST001 is 30-100 folds higher compared to Zolbetuximab analogue in tumor cells expressing various levels of Claudin18.2, which translated into much more potent in vivo anti-tumor activity, in particular, for those tumors expressing medium or low levels Claudin18.2. TST001 is being developed in parallel in China and the US and is currently in Phase II clinical studies. It is expected to start the global pivotal trial for TST001 during the Mid-2023. In the meantime, Transcenta will continue to evaluate other combination therapies as well as other indications. As the Company continues to accelerate its clinical development and commercialization, Transcenta will eventually better realize more of its potential with its outstanding platform, increase the shareholder value and develop innovative drugs that will benefit patients worldwide. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Eisai Presents Results of Post Hoc Analysis of Eribulin Mesylate (HALAVEN) at the European Society for Medical Oncology (ESMO) Congress 2022 JCN Newswire

Eisai Presents Results of Post Hoc Analysis of Eribulin Mesylate (HALAVEN) at the European Society for Medical Oncology (ESMO) Congress 2022

TOKYO, Sep 12, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today results from a post hoc analysis of three randomized, pivotal, Phase 3 studies (EMBRACE trial/Study 305, Study 301 and Study304) evaluating the efficacy of eribulin mesylate (marketed as HALAVEN) versus other chemotherapies (Treatment of Physician's Choice [TPC], capecitabine, and vinorelbine, respectively) in patients living with metastatic breast cancer (mBC) whose tumors have low or no HER2 expression. These data were presented as a poster (Presentation: #259P) at the European Society for Medical Oncology (ESMO) Annual Meeting (#ESMO22), held virtually and in-person in Paris, France from September 9-13, 2022.The HER2-low breast cancer subtype is a newly defined subset consisting of tumors that would have previously been considered HER2-negative based on an immunohistochemistry (IHC) assay and an in situ hybridization (ISH) assay. HER2-low tumors express low amounts of the HER2 protein, but not enough to be considered HER2-positive. HER2-low is defined as an IHC of 1+ or 2 with a negative ISH. Of the approximate 288,000 new cases of female breast cancer expected to be diagnosed in the U.S. in 2022,(1) it is estimated that approximately 80-85% of patients would previously have been considered to have the HER2-negative subtype. Of those patients, about 60% would now be considered to have the HER2-low subtype.(2)"In this post-hoc analysis, the outcomes seen in mBC patients whose tumors are considered HER2-low are consistent with the results of the three pivotal Phase 3 clinical trials," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "As the oncology community's understanding of mBC continues to evolve, it's important that we continue to evaluate the role of existing therapies in new contexts to contribute to the body of knowledge that is available to health care professionals."(1) National Institutes of Health, National Cancer Institute website, "Cancer Stat Facts: Female Breast Cancer": https://seer.cancer.gov/statfacts/html/breast.html(2) U.S. FOOD & DRUG ADMINISTRATION website, "FDA Approves First Targeted Therapy for HER2-Low Breast Cancer": bit.ly/3xc0N7qFor more information, visit www.eisai.com/news/2022/pdf/enews202266pdf.pdf.Media Inquiries:Public Relations DepartmentEisai Co., Ltd. +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)
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Potential New Therapeutic Approach for Pancreatic Cancer is proposed at 2022 Keystone Meeting: Blocking Obesity or Fatty Acid Oxidation SeaPRwire

Potential New Therapeutic Approach for Pancreatic Cancer is proposed at 2022 Keystone Meeting: Blocking Obesity or Fatty Acid Oxidation

Seoul, Korea, September 08, 2022 – (SEAPRWire) – In “the immunometabolism at the crossroads of obesity and cancer, Keystone Symposia (Sept. 5-9, 2022, Keystone, Co, USA)”, Dr. Soo-Youl Kim, Principal Scientist of the National Cancer Center of South Korea, showed that cancer obtains energy absolutely by burning fatty acids from blood as well as that obesity causes cancer to grow explosively by burning fat. Therefore, calorie balanced carbohydrate diet reduced tumor growth 1/5 to compare to high fat diet in mouse cancer model. It is proposed as ‘Kim effect’ in the latest Seminars in Cancer Biology journal that cancer energy metabolism absolutely depends on fatty acids (https://doi.org/10.1016/j.semcancer.2022.07.005). This announcement is expected to make great strides in cancer metabolism treatment and immunotherapy and foreshadows the emergence of new anticancer drugs that control obesity and fat catabolism. Dr. Kim announced that anti-cancer drug targeting fatty acid oxidation will be in clinical trial in South Korea. Know more, please contact Dr. Soo-Youl Kim, Principal Scientist of National Cancer Center, Korea. E: tgase@ncc.re.kr W: www.ncc.re.kr The article is provided by a third-party content provider. SEAPRWire ( https://www.seaprwire.com/ ) makes no warranties or representations in connection therewith. Any questions, please contact cs/at/SEAPRWire.com Sectors: Top Story, Daily News SEA PRWire: PR distribution in Southeast Asia (Hong Kong: AsiaExcite, EastMud; AsiaEase; Singapore: SEAChronicle, VOASG; NetDace; Thailand: SEAsiabiz, AccessTH; Indonesia: SEATribune, DailyBerita; Philippines: SEATickers, PHNotes; Malaysia: SEANewswire, KULPR; Vietnam: SEANewsDesk, PostVN)
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New Horizon Health Announced 2022 Interim Report: Revenue Up 414% YoY, Gross Margin Climbs to 82% ACN Newswire

New Horizon Health Announced 2022 Interim Report: Revenue Up 414% YoY, Gross Margin Climbs to 82%

HANGZHOU, Aug 19, 2022 - (ACN Newswire via SEAPRWire.com) - New Horizon Health (6606.HK), China's leading biotechnology company for early cancer screening, announced its half-year results for the year ended June 30, 2022 today.Based on the financial information before the audit as of June 30, 2022, New Horizon Health achieved total revenue of RMB226 million in the first half of 2022, an increase of 414% over the same period in 2021; achieved a gross profit of RMB185 million, an increase of 650% over the same period in 2021; gross profit margin climbed to 82.0% from 56.2% in the first half of 2021. The Company's adjusted net loss for the half-year was RMB106 million and the adjusted net loss rate(1) narrowed significantly from 221% to 47%; the ratio of expenses to sales(1) dropped significantly from 161% to 86%, and the ratio of management expense to sales(1) dropped significantly from 80% to 23%. The Company's total cash, including time deposits, cash, and cash equivalents, amounted to RMB1.65 billion.The Company announced its cervical cancer screening product, CerviClear(TM), which had been launched in a large-scale prospective multi-center registered clinical trial in June 2022. CerviClear(TM) is the world's first HPV cervical cancer screening product that provides painless and non-invasive urine self-sampling at home, covering a comprehensive range of 14 high-risk HPV viruses. The clinical trial for LiverClear(TM) is progressing well and is expected to be launched in the fourth quarter of 2022 or the first quarter of 2023. As of June 30, 2022, the Company's R&D expenses(1) were RMB39.4 million, an increase of 111% over the same period in 2021."The results of the interim report were not easy to get. New Horizon Health's team is faithful to its promise that it is able to do what it says and do what it does. The Company's revenue in the first half of the year has exceeded last year's full-year revenue. The performance growth is mainly attributed to the increase in revenue and gross profit of ColoClear and Pupu Tube, as well as the listing of UU Tube. The underlying logic of the high growth and high gross profit of the three products is that more and more people with high risk are accelerating the change of concept, attaching importance to the risk prevention and control of high incidence cancer in personal and family health management, recognizing the important value of cancer early screening product compliance and willing to pay for it", the Chairman and CEO of New Horizon Health, YeQing ZHU, said, "Cancer early screening products are both serious medical and consumer products, and the huge market opportunity is backed by the high barrier of research and development and compliance as well as the high investment in market education. The necessary condition for the approval of cancer early screening products under New Horizon Health is solid prospective large-scale multi-center registration clinical validation, which is the strong barrier of our diversified business strategy and the foundation of user trust."Normalization of COVID-19 epidemic accelerates the market education process for early screening at home: ColoClear and Pupu Tube continue to see 3-digit revenue growthColoClear achieved revenue of RMB73.6 million in the first half of 2022, representing an increase of 419% over the same period in 2021. The shipment volume in the first half of the year was approximately 294,600 kits, representing an increase of 143% over the same period in 2021. The increase in revenue of ColoClear was mainly due to the increase in volume sold and recognized as revenue and the increase in average recognition unit price.China's first at-home self-testing FIT test product, Pupu Tube, achieved revenue of RMB68.5 million in the first half of 2022, an increase of 132% over the same period in 2021; and achieved shipment of 2,929,700 units, an increase of 54% over the same period in 2021. The increase in revenue recognized by Pupu Tube was mainly due to the increase in sales volume and the increase in the average unit price (including the increase in the unit price of direct-to-consumer pipeline and the increase in the unit price of health check centers).Other than New Horizon Health, no domestic player has yet announced the launch of a large-scale prospective multi-center registration clinical trial for colorectal cancer screening. ColoClear is the only product approved by the National Medical Products Administration of China for screening cancer. Pupu Tube is the only approved product for at-home self-testing of FIT in China. In February 2022, ColoClear's multi-target stool FIT-DNA technology was recommended by the latest version of the Cancer Foundation of China's "China Integrated Cancer Treatment Guidelines", making it the only molecular early screening technology in China to be included in all national guidelines for colorectal cancer prevention and treatment.In the first half of 2022, the policy of early screening of cancer at home was intensively favorable. The "14th Five-Year Medical Equipment Industry Development Plan ", the "14th Five-Year National Health Plan " and the "14th Five-Year Bio-economic Development Plan " all focus on "early screening and health management of key diseases" such as cancer and in vitro diagnosis in home scenes. The normalization of the detection of COVID-19 epidemic has accelerated the public's awareness of home screening and healthy "symptom-free" people.The only consumer self-test for H. pylori testing: $83.5 million in half-year sales revenue for UU TubeAs of June 30, 2022, the sales revenue of UU Tube since its listing on January 18, 2022, was RMB83.5 million.On December 31, 2021, UU Tube was approved for registration as a Class III medical device by the National Medical Products Administration of China and is the only product in China that is suitable for "consumer self-testing" for H. pylori detection, for which we have the exclusive patented design of the "pregnancy test stick" which is an integrated design for sampling and testing.Data show that more than half of the users of UU Tube are women, nearly 50% are aged 31-40, and people aged 24-30 and 40-50 are also the main users. Jiangsu, Guangdong and Zhejiang have ranked the top three provinces in terms of the number of UU Tube users, and household users are more concerned about the detection and prevention of H. pylori.The prevention and control of H. pylori is a major focus of the science of gastric cancer prevention and has been receiving widespread attention from the media and the public. Data show that in the first half of 2022, the epidemic prevention and control led to a significant decline in the measurement of H. pylori breath tests in hospitals and health checkups, while the number of online and offline gastroenterology consultations continued to rise during the same period, effectively boosting consumer demand for home testing of H. pylori and strongly supporting the rapid promotion of H. pylori.Diversification of 2C quality pipes in tandem: ColoClear, Pupu Tube and UU Tube have excellent profitability performanceIn the first half of 2022, all the three marketed products demonstrated excellent profitability, with the gross margins of ColoClear and Pupu Tube continuing to increase significantly compared to the same period in 2021. As of June 30, 2022, the gross margin of ColoClear reached 75.7%, the gross margin of Pupu Tube reached 80.0% and the gross margin of UU Tube reached 90.0%. Compared to the same period in 2021, the gross margins of ColoClear and Pupu Tube were 56.6% and 59.0%, respectively.The Company's sales volume of the core pipeline increased steadily in the first half of 2022, and the new pipeline continued to make efforts to take advantage of the favorable macro and micro home inspection policies in the first half of the year with "Resilient" marketing and firmly implementation. The high gross margin of the three products benefited from the Company's continuous and in-depth diversified business strategy, which optimized the pipeline mix for product sales, increased the revenue of single test for direct-to-consumer pipelines and brought about scale production through operational leverage benefits, which further reduced the operating cost of a single test.In the first half of the year, the Company has been making progress online and offline, both inside and outside the hospital. As of June 30, 2022, the Company has completed access and sales to over 800 hospitals in the first half of the year. During the "618" period, New Horizon Health continued to be the champion in sales of JD in three categories: medical devices, consumer medical and genetic testing. UU Tube won the top selling category of Tmall test paper. The Company's total sales in JD and Tmall exceeded RMB40 million, representing a 400% increase in total sales compared to the same period in 2021, and a 300% increase in sales of ColoClear YoY.Based on the mainland market, start international marketing: ColoClear debuted in Hong Kong and will advance to Southeast Asia in phases2022 is a milestone year for the internationalization of New Horizon Health. On May 23rd, the Company and Prenetics (Nasdaq: PRE) made a joint announcement that the two parties have launched in-depth cooperation to fully integrate the quality resources in market and pipeline development and product and service operation, and jointly promote the market coverage of ColoClear in Hong Kong, Macau and Taiwan, China, and explore the market opportunities in countries or regions in Southeast Asian at the same time. On June 8, ColoClear by Circle was officially launched in Hong Kong with an official price of HK$3,000. During the cooperation period, ColoClear is the colorectal cancer early screening product that Prenetics has exclusively partnered with.At the same time as ColoClear's debut in the Hong Kong market, New Horizon Health announced the establishment of the Company's first international R&D center in the Hong Kong Science and Technology Parks to attract global talent and focus on multi-omics cancer screening technology innovation and product development, including NGS, and to drive overseas commercialization and synchronized global clinical trials.About New Horizon HealthFounded in 2015, New Horizon Health is a pioneer and leader in China's cancer screening market, focusing on early home screening of high-incidence cancers, aiming to promote innovation in cancer screening technology and accelerate the popularity of cancer screening technology in China. On February 18, 2021, New Horizon Health was successfully listed on the SEHK with stock code 6606.HK, which became "the first listed Chinese cancer early screening company".New Horizon Health has three marketed products. ColoClear, Pupu Tube and UU Tube have all been approved by the National Medical Products Administration of China and are officially commercialized. ColoClear is the only cancer screening product approved by the National Medical Products Administration of China for people aged 40-74 who are at high risk of colorectal cancer. UU Tube is the only consumer self-test product for Helicobacter pylori approved by the National Medical Products Administration of China. Pupu Tube is the first FIT at-home self-test device approved in China. In addition, the Company has three pipelines of products in development for liver cancer (LiverClear), cervical cancer (CerviClear ) and nasopharyngeal cancer screening. The Company has global rights to all of its marketed and pipeline products. New Horizon Health works extensively with hundreds of hospitals, health check-ups, insurance companies, pharmacies and online channels. The Company has a class 100,000 clean production workshop that meets ISO13485 and ISO9001 international certification standards. The third parties medical testing laboratories in Beijing, Hangzhou and Guangzhou have been certified by international quality standards and the local health care commission and issued licenses to practice, with an annual testing capacity of 2 million people.(1) Excluding equity incentive-related expenses Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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