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Metastatic Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 100+ Companies and 100+ Drugs

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Metastatic Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 100+ Companies and 100+ Drugs

January 19
21:09 2023
Metastatic Breast Cancer Pipeline, Clinical Trial Analysis and NDA Approvals | 100+ Companies and 100+ Drugs

DelveInsight’s, “Metastatic Breast Cancer Pipeline Insight, 2022,” report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in the Metastatic 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.

 

In the Metastatic Breast Cancer pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, Metastatic Breast Cancer NDA approvals (if any), and product development activities comprising the technology, Metastatic Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Key takeaways from the Metastatic Breast Cancer Pipeline Report

  • DelveInsight’s Metastatic Breast Cancer Pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for Metastatic Breast Cancer treatment.
  • The leading Metastatic Breast Cancer companies with various Metastatic Breast Cancer medications include RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, Kind Pharmaceuticals LLC, Dantari, Inc., Veru Inc., Taiho Oncology, Eli Lilly and Company, Sermonix Pharmaceuticals, Merus N.V., Minerva Biotechnologies Corporation, Kintara Therapeutics, Inc., Sichuan Baili Pharmaceutical Co., Ltd.,  Regor Pharmaceuticals Inc., Tianjin Hemay Biotech, Jiangsu Simcere Pharmaceutical Co., Ltd., and others.
  • Key Metastatic Breast Cancer pipeline therapies in various stages of development include Disitamab Vedotin, EndoTAG®-1 (SB05), Stenoparib (2X-121), U3-1402, KN026, trastuzumab duocarmazine, HS-10342, MRG002, ARX788, DHP107, PMD-026, PVX-410, HX008, Tenalisib, MEN1611, SM-88, HMPL-013, ODM-209, HC-5404-FU, RP12146, PU-H71, NOV120101, SC10914, Eftilagimod Alpha, ARV-471, E7090, DZD1516, G1T38, Sitravatinib, TQ-B211, B003, PF-06873600, OTS167PO, AND019, DAN-222, Enobosarm, Futibatinib, LY3484356, Lasofoxifene, MCLA-128, huMNC2-CAR44 CAR T cells, REM-001, GNC-035, RGT-419B, Hemay022, SCR-6852, and others.
  • The Metastatic Breast Cancer Companies and academics are working to assess challenges and seek opportunities that could influence Metastatic Breast Cancer R&D. The Metastatic Breast Cancer pipeline therapies under development are focused on novel approaches to treat/improve Metastatic Breast Cancer.

 

To explore more information on the latest breakthroughs in the Metastatic Breast Cancer Pipeline treatment landscape of the report, click here @ Metastatic Breast Cancer Pipeline Outlook

 

Metastatic Breast Cancer Overview

Metastatic breast cancer (also called stage IV) is breast cancer that has spread to another part of the body, most commonly the liver, brain, bones, or lungs. The symptoms of metastatic breast cancer can vary greatly depending on the location of the cancer. This section covers the symptoms of breast cancer that has spread to the bone, lung, brain, and liver, and the tests used to diagnose metastatic breast cancer.

 

Recent Developmental Activities of Metastatic Breast Cancer Treatment Landscape   

  • On May 04, 2022, Rhizen Pharmaceuticals AG announced the presentation of promising interim data from an ongoing Ph2 trial of Tenalisib in locally advanced or metastatic breast cancer patients, at the ESMO Breast Cancer Meeting, in Berlin, Germany from May 3-5, 2022. Tenalisib was well tolerated and showed encouraging preliminary efficacy as a single agent in both primary and secondary resistant mBC; Data supports further development of Tenalisib in patients with HR+ and HER2- MBC.
  • In April 2022, Alphamab Oncology announced that data from the phase II clinical study of the chemo-free regimen of KN026 in combination with KN046 (KN026-203) were presented as an E-poster at the AACR Annual Meeting 2022 (AACR 2022). As of August 10, 2021, 24 patients with HER2-positive other solid tumors (non-breast cancer/gastric cancer ) who received ≥1L prior systemic therapy were enrolled, 20 patients were evaluable for overall response: the ORR was 55.0%, the DCR was 85.0%, the 6-month PFS rate was 84.1%; Out of 11 evaluable CRC patients, the ORR and DCR was 45.5% and 90.9% respectively.
  • In April 2022, Quantum Leap Healthcare Collaborative™ (Quantum Leap)  and Ambrx Biopharma Inc., announced the selection of Ambrx’s antibody-drug conjugate (ADC) ARX788 for a new investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting. Sponsored by Quantum Leap, the I-SPY 2.2 TRIAL is a continuation of the I-SPY 2 TRIAL that seeks to create personalized treatments by adapting therapies for each patient to optimize the clinical outcome.
  • In March 2022, TYME Technologies, Inc. announced the availability of the poster abstract, “SM-88, D/L-alpha-metyrosine, is a novel anti-cancer agent in estrogen receptor-positive breast cancer,” which was submitted by researchers from Georgetown University. The abstract was presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans, LA.  In September 2021, TYME Technologies, Inc. announced that the first patient had been dosed in the Phase II OASIS trial in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2 negative (“HR+/HER2-“) breast cancer who previously received a CDK4/6 inhibitor regimen being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner.)
  • In February 2022, Phoenix Molecular Designs (PhoenixMD), announced the completion of patient enrollment and dosing of PMD-026 in their Phase 1b monotherapy clinical trial. The successful completion of patient enrollment in this Phase 1/1b trial is an important step forward for PhoenixMD as they advance PMD-026 into Phase 2 combination trials for triple-negative breast cancer (TNBC) and hormone-positive breast cancer.
  • In December 2021, Arvinas, Inc. and Pfizer Inc. announced an update on Phase 1 dose-escalation data of ARV-471, a novel PROTAC® estrogen receptor (ER) degrader, which is being co-developed for the treatment of patients with locally advanced or metastatic ER-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER+/HER2-).
  • In August 2021, Seagen Inc. and RemeGen Co., Ltd. announced that the two companies had entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC.

 

Request a sample and discover the recent advances in Metastatic Breast Cancer Ongoing Clinical Trial Analysis and Medications, click here @ Metastatic Breast Cancer Treatment Landscape

 

Metastatic Breast Cancer Emerging Drugs

 

Giredestrant: Roche

Giredestrant is a next generation investigational Selective estrogen receptor degrader (SERD), designed to fully block ER signalling with robust receptor occupancy. Oestrogen encourages HR-positive breast cancer cells to grow by attaching to the ER. Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).

 

Disitamab Vedotin: RemeGen

Disitamab Vedotin (RC48) is a novel anti-HER2 antibody-drug conjugate (ADC) which is currently across various solid tumor types. It was the first domestically-developed ADC in China approved by the CDE for clinical development in China. ADCs are a therapeutic modality consisting of an antibody molecule linked to a highly cytotoxic agent, and is typically designed to specifically deliver chemotherapies to tumor cells.

 

EndoTAG®-1 (SB05): SynCore Biotechnology

SB05 is an innovative composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Due to the positively charged lipids, SB05 interacts with newly developing, negatively charged endothelial cells, which are especially required for the growth of tumor blood vessels. The SB05 paclitaxel component attacks the activated endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the supply to not activated endothelial cells of healthy tissue. By doing this, SB05 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth.

 

Stenoparib (2X-121): Allarity Therapeutics

Stenoparib (2X-121) is a unique, small molecule dual targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and telomerase maintenance enzymes (Tankyrase 1 and 2). Allarity exclusively in-licensed it (globally) from Eisai. Given its novel mechanism of action and ability to cross the blood brain barrier (BBB), plus its associated DRP®, stenoparib is poised to yield improved efficacy, lower toxicity, and lower drug resistance compared the other late-stage or marketed PARP inhibitors.

 

Metastatic Breast Cancer Pipeline Therapeutics Assessment

There are approx. 100+ key companies which are developing the therapies for Metastatic Breast Cancer. The companies which have their Metastatic Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, Roche.

 

For further information, refer to the detailed Metastatic Breast Cancer Unmet Needs, Metastatic Breast Cancer Market Drivers, and Metastatic Breast Cancer Market Barriers, click here for Metastatic Breast Cancer Ongoing Clinical Trial Analysis

 

Metastatic Breast Cancer Phases

  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of
  • Metastatic Breast Cancer Pre-clinical and Discovery stage candidates
  • Metastatic Breast Cancer Discontinued & Inactive candidates
  • Metastatic Breast Cancer Route of Administration

 

Scope of the Metastatic Breast Cancer Pipeline Report

  • Coverage- Global
  • Metastatic Breast Cancer Companies- RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, Kind Pharmaceuticals LLC, Dantari, Inc., Veru Inc., Taiho Oncology, Eli Lilly and Company, Sermonix Pharmaceuticals, Merus N.V., Minerva Biotechnologies Corporation, Kintara Therapeutics, Inc., Sichuan Baili Pharmaceutical Co., Ltd.,  Regor Pharmaceuticals Inc., Tianjin Hemay Biotech, Jiangsu Simcere Pharmaceutical Co., Ltd., and others
  • Metastatic Breast Cancer Therapies- Disitamab Vedotin, EndoTAG®-1 (SB05), Stenoparib (2X-121), U3-1402, KN026, trastuzumab duocarmazine, HS-10342, MRG002, ARX788, DHP107, PMD-026, PVX-410, HX008, Tenalisib, MEN1611, SM-88, HMPL-013, ODM-209, HC-5404-FU, RP12146, PU-H71, NOV120101, SC10914, Eftilagimod Alpha, ARV-471, E7090, DZD1516, G1T38, Sitravatinib, TQ-B211, B003, PF-06873600, OTS167PO, AND019, DAN-222, Enobosarm, Futibatinib, LY3484356, Lasofoxifene, MCLA-128, huMNC2-CAR44 CAR T cells, REM-001, GNC-035, RGT-419B, Hemay022, SCR-6852, and others.
  • Metastatic Breast Cancer Pipeline Segmentation: Phases, Molecule Type, Product Type, Mechanism of action

 

Dive deep into rich insights for drugs for Metastatic Breast Cancer Market Drivers and Metastatic Breast Cancer Market Barriers, click here @ Metastatic Breast Cancer Unmet Needs and Analyst Views

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Metastatic Breast Cancer: Overview
  4. Metastatic Breast Cancer Pipeline Therapeutics
  5. Metastatic Breast Cancer Therapeutic Assessment
  6. Metastatic Breast Cancer – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Giredestrant: Roche
  9. Mid Stage Products (Phase II)
  10. Stenoparib – Allarity Therapeutics
  11. Early Stage Products (Phase I/II)
  12. ARV-471: Arvinas
  13. Preclinical and Discovery Stage Products
  14. Drug name: Company name
  15. Inactive Products
  16. Metastatic Breast Cancer Key Companies
  17. Metastatic Breast Cancer Key Products
  18. Metastatic Breast Cancer- Unmet Needs
  19. Metastatic Breast Cancer- Market Drivers and Barriers
  20. Metastatic Breast Cancer- Future Perspectives and Conclusion
  21. Metastatic Breast Cancer Analyst Views
  22. Metastatic Breast Cancer Key Companies
  23. Appendix

 

Got Queries? Find out the related information on Metastatic Breast Cancer Mergers and acquisitions, Metastatic Breast Cancer licensing activities @ Metastatic Breast Cancer Emerging Drugs and Recent Trends

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