DelveInsight’s, “HER2 Positive Breast Cancer Pipeline Insight 2024” report provides comprehensive insights about 60+ companies and 65+ pipeline drugs in HER2 Positive Breast Cancer pipeline landscape. It covers the HER2 Positive Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2 Positive Breast Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the HER2 Positive Breast Cancer Pipeline Report
- June 2024:- Latin American Cooperative Oncology Group– This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy.
- June 2024:- Seagen Inc.- This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
- June 2024:- Institut Curie– This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer (HER2+ MBC) after progression on tucatinib-capecitabine-trastuzumab or capecitabine-related toxicity.
- June 2024:- Ambrx, Inc.- A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd. A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
- June 2024:- Sichuan Baili Pharmaceutical Co., Ltd.- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer. This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
- DelveInsight’s HER2 Positive Breast Cancer pipeline report depicts a robust space with 60+ active players working to develop 65+ pipeline therapies for HER2 Positive Breast Cancer treatment.
- The leading HER2 Positive Breast Cancer Companies such as Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics, and others.
- Promising HER2 Positive Breast Cancer Therapies such as Zanidatamab, Letrozole, Tamoxifen, PTC+Pertuzumab, FEC-T+Pertuzumab, PHESGO, SHR-A1811, Pyrotinib, and others.
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HER2 Positive Breast Cancer Emerging Drugs Profile
- SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
SHR-A1811 is an innovative HER2-targeted antibody-drug conjugate with a topoisomerase I payload conjugated to an anti-HER-2 mAb by a cleavable linker. Once bound to HER2 expressing tumor cells, the ADC is internalized and the linker releases the toxin, leading to tumor cell death. It can bind to the cell membrane surface of HER2 expressing cells, and then enter the cells to reach the lysosome to release small Molecular toxins eventually induce tumor cell apoptosis, combining the high targeting of antibodies and the powerful killing power of cytotoxic drugs on target cells.
- HLX11: Shanghai Henlius Biotech
HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union (EU), which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients. HLX11 can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, HLX11 can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Currently, the drug is in the Phase III stage of its development for the treatment of HER2 Positive Breast Cancer.
- MCLA-128: Merus N.V.
MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC) -enhanced Biclonics® that utilizes Merus Dock & Block® mechanism and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors. MCLA-128 is believed to target the HER3 signaling pathway and to overcome the resistance of tumor cells to HER2-targeted therapies using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor. The therapeutic candidate is a full-length IgG bi-specific antibody that acts by targeting HER2 and HER3. It is an antibody-dependent cellular cytotoxicity (ADCC)-enhanced Biclonic, which is developed based on Biclonics ENGAGE platform. Currently the drug is in the Phase II stage of clinical trial evaluation for the treatment of HER2-positive metastatic breast cancer.
- GQ1001: GeneQuantum
GQ1001 is a novel HER2-targeted antibody-drug conjugate (ADC) that was developed using innovative conjugation technologies coined intelligent Ligase-Dependent Conjugation (iLDC), that can significantly improves homogeneity and biostability of ADC. In preclinical studies, GQ1001 showed a robust anti-tumor response in multiple HER2+ models alone or in combination with HER2 TKIs and chemotherapeutics, and excellent pharmacokinetics and safety profiles in rats and monkeys due to low level of payload release. GQ1001 has already received Clinical Trial approval from the Therapeutic Goods Administration (TGA) in Australia and IND from FDA in USA. Currently the drug is in the Phase I stage of clinical trial evaluation for the treatment of HER2-positive metastatic breast cancer.
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HER2 Positive Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
HER2 Positive Breast Cancer Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
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HER2 Positive Breast Cancer Companies and Therapies
- M.D. Anderson Cancer Center: Zanidatamab/Letrozole/Tamoxifen
- Seagen Inc.:- Tucatinibc/Trastuzumab/Pertuzumab
- Sichuan Baili Pharmaceutical Co., Ltd.:- BL-M07D1/T-DM1
- DualityBio Inc.:- DB-1303/BNT323/T-DM1
- Ambrx Inc.;- ARX788
Scope of the HER2 Positive Breast Cancer Pipeline Report
- Coverage- Global
- HER2 Positive Breast Cancer Companies- Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics, and others.
- HER2 Positive Breast Cancer Therapies- Zanidatamab, Letrozole, Tamoxifen, PTC+Pertuzumab, FEC-T+Pertuzumab, PHESGO, SHR-A1811, Pyrotinib, and others.
- HER2 Positive Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- HER2 Positive Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
For a detailed overview of our latest research findings and future plans, read the full details of HER2 Positive Breast Cancer Pipeline on our website @ HER2 Positive Breast Cancer Drugs and Companies
Table of Content
- Introduction
- Executive Summary
- HER2 Positive Breast Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- HER2 Positive Breast Cancer– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- MCLA-128: Merus N.V.
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- GQ1001: GeneQuantum
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- ES2B C001: ExpreS2ion Biotechnologies
- Drug profiles in the detailed report…..
- Inactive Products
- HER2 Positive Breast Cancer Key Companies
- HER2 Positive Breast Cancer Key Products
- HER2 Positive Breast Cancer- Unmet Needs
- HER2 Positive Breast Cancer- Market Drivers and Barriers
- HER2 Positive Breast Cancer- Future Perspectives and Conclusion
- HER2 Positive Breast Cancer Analyst Views
- HER2 Positive Breast Cancer Key Companies
- Appendix
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