EOC Pharma (Thaizhou) Co., Ltd.

One of the most frequently diagnosed cancers worldwide accounts for breast cancer with respect to its high prevalence and fatalities gaits. Hitherto, the management of breast cancer remains a hassle to healthcare professionals. Breast Cancer, a heterogeneous and complex disease, demands innovative treatment strategies to confront its varied manifestations. In recent years, the spotlight has turned towards a promising field the synergy of combining different types of antibodies, which will aid to offer a potential breakthrough in the battle against the formidable adversary, breast cancer. The realm of combinational antibodies has emerged as an innovative treatment regimens in which by harnessing the potential of different types of antibodies with therapeutic agents aid to treat breast cancer. Conventionally, traditional therapies like hormone therapy, chemotherapy or immunotherapy were utilized which exhibited good efficacy and tolerability to breast cancer. However, there exist numerous patients who don’t respond to conventional treatment, creating a major room for improvement. As a result, there is an urgent need of combinational antibodies for the treatment of multiple patients suffering from breast cancer malignancies. Download Antibodies Combinations Therapy Research Insight: The notion of combining antibodies with other therapeutic agents clenches long chronicle which can be backtracked to the late 1990s in which the first monoclonal antibody, Trastuzumab, sold under the brand name Herceptin, was approved by FDA in 1998. Since then, numerous researches for combining different types of monoclonal antibodies like Trastuzumab are being ongoing in the domain with the key objective of developing advanced and innovative antibody combination in order to provide treatment for breast cancer indications. Following that, antibody combinations such as pertuzumab (Perjeta) in conjugation with trastuzumab (Herceptin) and Phesgo (combination of Herceptin, Perjeta along with enzyme Hyaluronidase) are being approved in the year 2012 and 2020 for the management of breast cancer malignancies. Apart from that, numerous combination of antibodies with chemotherapy are enduring that evaluates the role of antibodies with immune checkpoint inhibitors, like PD-1, and HER2 which have already been approved for the management of breast cancer. For instance, Trastuzumab in combination with Pyrotinib, dual inhibitor of EGFR/HER2, is currently in the clinical research for the treatment of breast cancer. The treatment regimen is lately in the phase III stage of development which is sponsored by Shengjing Hospital. With ceaseless advancement and progress in antibody combinations along with molecular biology techniques, helps in managing breast cancer. Preliminary data exhibits remarkable heterogeneity of breast cancer at the molecular level. Utilizing the realm of antibody combinations offers multifaceted approaches, addressing diverse molecular pathways and subtypes. This strategy seeks to overcome the limitations of the single agent therapies by comprehensively targeting different aspects of the disease. The clinical pipeline in the sphere of antibody combination consists of multitudinous combinations of antibodies with chemotherapies, immunomodulatory drugs, vaccines, together with immune checkpoint inhibitors, such as CTLA-4, PD-1 and PD-L1, PARP inhibitors, CDK4/6 inhibitors, bispecific antibodies, CAR T cell therapies, antibody drug conjugates, and others. Besides, the market for antibody combinations also includes the presences of Herceptin bio similar in the clinical pipeline. The aim of these studies is to increase the efficiency and safety of treatment regimen. For instance, Institut fuer Frauengesundheit and Samsung Bioepis initiated a clinical investigation in which a combination of Pertuzumab with Herceptin bio similar medication, Ontruzant that is lately in the phase IV clinical studies for the treatment of HER2 positive breast cancer. Furthermore, due to the presence of the key players along with rising clinical trials will help to launch novel antibody combinations in the commercial market. Giant pharmaceutical companies such as Pfizer, Bristol-Myers Squibb, AstraZeneca, Daiichi Sankyo, Taizhou EOC Pharma, Agenus, Novartis, Celldex Therapeutics and Merck are currently shepherding the clinical trials and studies in order to launch an innovative antibody combination for breast cancer. It is expected that the sphere of antibody combinations will expand in the forthcoming years on account of aspects like agreement, rise in clinical research along with collaborations. For instance, in March 2023, acquisition agreement was settled amongst Pfizer and Seagen with the purpose of combining Seagen’s antibody-drug conjugate (ADC) candidates with Pfizer's antibody candidates to develop a novel antibody combination treatment for breast cancer. This will further provide thrust to the market growth of combination antibodies. As breast cancer incidences, advancement in technology along with research and development expands; the market of antibody combination for the treatment of breast cancer will multiply further in the imminent years.

DUBLIN--( BUSINESS WIRE )--The "HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage HR Positive/ HER2 Negative Breast Cancer: Overview Three common tests employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal. The present goal of therapy for early HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments. Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence HR Positive/ HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HR Positive/ HER2 Negative Breast Cancer. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Chapters This segment of the HR Positive/ HER2 Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Camizestrant: AstraZeneca Camizestrant is a potent, next-generation oral SERD and pure ER? antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same. Dato-DXd: Daiichi Sankyo, Inc. Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers. CX-2009: CytomX Therapeutics CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer. RGT-419B: Regor Therapeutics RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer. HR Positive/ HER2 Negative Breast Cancer: Therapeutic Assessment This segment of the report provides insights about the different HR Positive/ HER2 Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as: Major Players in HR Positive/ HER2 Negative Breast Cancer There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases The report covers around 53+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. HR Positive/ HER2 Negative Breast Cancer: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HR Positive/ HER2 Negative Breast Cancer therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HR Positive/ HER2 Negative Breast Cancer drugs. HR Positive/ HER2 Negative Breast Cancer Report Insights HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs HR Positive/ HER2 Negative Breast Cancer Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing HR Positive/ HER2 Negative Breast Cancer drugs? How many HR Positive/ HER2 Negative Breast Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HR Positive/ HER2 Negative Breast Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HR Positive/ HER2 Negative Breast Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for HR Positive/ HER2 Negative Breast Cancer and their status? What are the key designations that have been granted to the emerging drugs? Key Players Regor Therapeuics Seagen Inc. CytomX Therapeutics Taizhou EOC Pharma Chia Tai Tianqing Pharmaceutical Group AstraZeneca Daiichi Sankyo, Inc. Tyme, Inc. Seagen Inc. Context Therapeutics Eisai Inc. Shanghai Hengrui Pharmaceutical Co., Ltd. Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals Merus N.V. Atossa Therapeutics Roche Ellipses Pharma Key Products RGT-419B SGN-B7H4V CX-2009 EOC202 TQB3616 Camizestrant Dato-DXd SM-88 SGN-B7H4V Onapristone Giredestrant H3B-6545 Z-endoxifen MCLA-128 EP0062 HRS8807 SCR-6852 AND019 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/g7co1l About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Highlights Sydney, AUSTRALIA, April 19, 2021 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, provides an update on the ongoing development of its product candidates, eftilagimod alpha (“efti” or “IMP321”) and IMP761, and the activities of its partners for the quarter ended March 31, 2021. “We continue to lead the world in the development of different LAG-3 related therapies, with a robust pipeline of exciting clinical stage programs and promising data. Throughout the quarter ended 31 March 2021, we have been extremely active advancing and expanding upon these clinical programs, building upon our data generated last year” said Marc Voigt, CEO of Immutep. “We are well-positioned for long-term success, as we have a steady stream of positive data advancing our clinical studies, and decades of experience across our clinical team, which includes the discoverer of the LAG-3 immune control mechanism, as well as a strengthened balance sheet.” “There has recently been broad industry coverage of positive Phase II/III data from another company’s LAG-3 program to treat melanoma, which we’re pleased to say further validates targeting the LAG-3 pathway to enhance the immune response. While they have additional data to announce, what has been discussed to-date further supports our knowledge of the LAG-3 mechanism and is in line with our MSD collaboration to develop a combination of KEYTRUDA® with efti. This year is shaping up to be an exciting period for the clinical development of LAG-3 therapies,” added Dr. Frederic Triebel, CSO/CMO of Immutep. Efti Development Program Updates Intellectual PropertyImmutep recently further strengthened its IP profile for lead active immunotherapy candidate efti, which is a soluble LAG-3 fusion protein (LAG-3Ig). In particular, in March 2021, the United States Patent & Trademark Office granted a new patent number 10,940,181, which is entitled “Combined Preparations for the Treatment of Cancer or Infection”. The patent was filed as a divisional application and follows the grant of the parent patent announced on 30 December 2020. The claims of this new patent build on the protection provided by the parent patent and are patent protecting Immutep’s methods of treating cancer by administering efti and a PD-1 pathway inhibitor: either pembrolizumab (KEYTRUDA®) or nivolumab. The expiry date of the patent is 20 January 2036 (including a patent term adjustment of 12 days). TACTI-002 (Two Active Immunotherapies, also designated KEYNOTE-798) - Phase II clinical trial The TACTI-002 study is evaluating the combination of efti with KEYTRUDA® (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada), in first and second line non-small cell lung cancer (NSCLC) and second line head and neck squamous cell carcinoma (HNSCC). This study is being conducted in collaboration with MSD, which refers to the study as “Keynote-798”. Patients participate in one of three parts: Part A - First Line NSCLC, PD-X naiveRecruitment of an additional 74 first line NSCLC patients was initiated in accordance with Part A of the TACTI-002 collaboration trial expansion plans announced on 19 November 2020, adding to the 36 patients already enrolled prior to the expansion. Immutep and MSD expanded Part A of the TACTI-002 study following the encouraging results presented at the Society for Immunotherapy of Cancer's (SITC) Congress in November 2020. Part B - Second Line NSCLC, PD-X refractoryImmutep decided to expand Part B of TACTI-002, under the study’s Simon’s two-stage clinical trial design. The Company recently commenced recruitment of an additional 13 second line NSCLC patients, forming Stage 2 of Part B. The decision follows a preliminary safety and efficacy review by the Data Monitoring Committee and its recommendation, based on the patients recruited in Stage 1 of Part B. Part C - Second Line HNSCCThe last patient was safely dosed for Stage 2 of Part C of TACTI-002. This completes recruitment for Part C of the study. The Company continues to be excited by this study, as it recently announced encouraging interim data from TACTI-002 at the SITC 2020 Congress. Specifically, the data from second line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this cancer type. Additional data from TACTI-002 is expected in H1 2021. TACTI-003 (Two Active Immunotherapies) - Phase IIb clinical trial - First Line HNSCCImmutep will also conduct a new randomised, controlled Phase IIb clinical study in approximately 160 first line HNSCC patients, which is a more commercially relevant indication than second line HNSCC. This study will evaluate the safety and efficacy of efti when given in combination with MSD’s KEYTRUDA®, compared to KEYTRUDA® alone. TACTI-003 will be executed in 20+ clinical sites in the United States, Australia and Europe, and study is expected to start in mid-2021. This is Immutep’s second collaboration with MSD for a combination of KEYTRUDA® and efti. EAT COVID - Phase II clinical trialThe investigator-initiated Phase II clinical trial being conducted by the University Hospital Pilsen in the Czech Republic advanced from the safety run and into the randomised portion of the study, which is evaluating efti in up to 110 hospitalised patients with COVID-19. In January 2021 Immutep reported that the independent Data Safety Monitoring Board (DSMB) had completed a safety run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID). Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women and 4 men) received the three planned 10 mg efti injections and were since discharged from hospital with no adverse events reported. Partner Updates GlaxoSmithKline As announced in January 2021, GSK stopped its Phase II clinical trial evaluating GSK2831781 (derived from Immutep’s IMP731 antibody) in ulcerative colitis based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. Immutep’s collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK. Other PartnersSelected for its in-depth LAG-3 expertise and knowledge, Immutep entered into a Licence and Collaboration Agreement with Laboratory Corporation of America Holdings, known as LabCorp, to support its development of immuno-oncology products or services in October 2020. LabCorp co-authored with Bristol Myers Squibb an abstract released in March 2021 on the distribution and prevalence of LAG-3 expression in samples of melanoma and gastric/gastroesophageal junction cancer for the American Association for Cancer Research Annual Meeting 2021. Immutep’s other licensing partnerships with Novartis, EOC Pharma and CYTLIMIC continue to progress well. Financial Summary - Q3 FY21 Cash receipts from customers for the quarter was $59k, compared to $336k in Q2 (i.e. the quarter ended 31 December 2020). The net cash used in G&A activities in the quarter was $242k compared to $1.82 million in Q2. The significant decrease compared with last quarter is mainly due to the prepayment of certain annual expenses in Q2. G&A costs for the quarter includes $125k in payment of Non-Executive Director’s fees and Executive Director’s remuneration. The net cash used in Research and Development activities in the quarter was $1.74 million, compared to $3.18 million in Q2. Year to date cash flow used in R&D activities for the 9 months from July 2020 to March 2021 was $7.0 million compared to $16.1 million for the 9 months from July 2019 to March 2020. The decline is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase. The cash used in R&D activities is expected to increase with the commencement of the new Phase IIb TACTI-003 clinical trial. Total net cash outflows used in operating activities in the quarter was $3.05 million. In comparison, total net cash outflows from operating activities in Q2 was $5.58 million. The cash and cash equivalent balance as at 31 March 2021 was $51.7 million compared to a balance of $54.9 million as at 31 December 2020. Immutep is in an excellent financial position with a cash runway into calendar year 2023 and beyond several significant data read-outs. About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer, infectious disease and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States. Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 protein, which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease. Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners. Further information can be found on the Company’s website or by contacting: Australian Investors/Media:Catherine Strong, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media:Tim McCarthy, LifeSci Advisors+1 (212) 915.2564; tim@lifesciadvisors.com