HER2 Positive Breast Cancer Pipeline, FDA Approvals, Unmet Needs, Preclinical and Discovery Stage Product, and Companies 2024 (Updated)

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 therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Key Takeaways from the HER2 Positive Breast Cancer Pipeline Report
• 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 working in the market include 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 in the various stages of development include ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002, Monalizumab, PTC-Pz, DZD1516, ZW25, PRS-343, ORM-5029, RC48-ADC, XMT-2056, BL-M07D1, Hemay 022, CAM-H2, Zanidatamab, MEN1611, ZRC-3277, MCLA-128, Ipatasertib, CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others.
• May 2024:- Seagen Inc.- A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05). 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.
• May 2024:- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.- A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer. A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer.
• May 2024:- The Netherlands Cancer Institute- The study will include patients with HER2-positive breast cancer and 1- 3 distant metastatic lesions, all amenable for curative intervention. Patients will be stratified by prior therapy and ER expression. Given the basket-design of this trial other baskets for oligo-metastatic breast cancer can be added, such as but not limited to other breast cancer subtypes or with other promising drugs.
• May 2024:- Baptist Health South Florida- This research study will evaluate how well brain metastases associated with HER-2 positive breast cancer can be controlled using a type of radiation known as stereotactic radiosurgery (SRS) when combined with three therapeutic agents, tucatinib, capecitabine, and trastuzumab.
• May 2024:- Fundacio Clinic Barcelona- This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab.
• May 2024:- Greenwich LifeSciences, Inc.- A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01).

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HER2 Positive Breast Cancer Overview
Breast cancer is not a single disease but a group of diseases. Scientists discovered human epidermal growth factor receptor 2 (HER2)-positive breast cancer when searching for genes that cause cancer. On the most basic level, cancer is the result of normal cells growing unchecked, an observation that led researchers to speculate that specific genes or gene mutations enable this to occur. Resistance to anti-HER2 therapies may occur via multiple mechanisms, some of which appear to be shared between different agents.

A common reason for trastuzumab treatment failure is incomplete inhibition of the HER family of receptors, which can be overcome by dual HER2-targeted therapy or ADCs with potent payloads that have activity even with lower HER2 expression. Effective inhibition of HER2 may also be thwarted by the emergence of HER2-activating mutations. Other resistance mechanisms include generation of p95HER2, a truncated form of HER2 that lacks the ECD that is recognized by anti-HER2 antibodies and Δ16HER2, a splice variant lacking the ECD encoded by exon 16, which leads to stabilization dimers and constitutive activation of downstream signaling.

HER2 Positive Breast Cancer Emerging Drugs

• 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.

• 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.

• DX126 262: Hangzhou DAC Biotech
DX-126262 is under development for the treatment of HER2-positive or HER2-mutated unresectable locally advanced or metastatic non-squamous NSCLC, HER2 positive breast cancer, breast cancer. The drug candidate is an antibody drug conjugate comprising recombinant humanized anti-Her2 monoclonal antibody conjugated to Tub-114. It is formulated as lyophilized powder and administered via intravenous route of administration. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.

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HER2 Positive Breast Cancer Therapeutics Assessment
There are approx. 60+ key companies which are developing the therapies for HER2 Positive Breast Cancer. The companies which have their HER2 Positive Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, Jiangsu HengRui Medicine Co., Ltd..

DelveInsight's HER2 Positive Breast Cancer pipeline report covers around 65+ products under different phases of clinical development like
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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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 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

To know more about HER2 Positive Breast Cancer, visit @ HER2 Positive Breast Cancer Segmentation- https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the HER2 Positive Breast Cancer Pipeline Report
• Coverage- Global
• 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
• 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- ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002, Monalizumab, PTC-Pz, DZD1516, ZW25, PRS-343, ORM-5029, RC48-ADC, XMT-2056, BL-M07D1, Hemay 022, CAM-H2, Zanidatamab, MEN1611, ZRC-3277, MCLA-128, Ipatasertib, CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others.

For further information on the HER2 Positive Breast Cancer Pipeline Therapeutics, reach out @ HER2 Positive Breast Cancer Products Development- https://www.delveinsight.com/sample-request/her2-positive-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. HER2 Positive Breast Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. HER2 Positive Breast Cancer- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. MCLA-128: Merus N.V.
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. DX126 262: Hangzhou DAC Biotech
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. ES2B C001: ExpreS2ion Biotechnologies
18. Drug profiles in the detailed report…..
19. Inactive Products
20. HER2 Positive Breast Cancer Key Companies
21. HER2 Positive Breast Cancer Key Products
22. HER2 Positive Breast Cancer- Unmet Needs
23. HER2 Positive Breast Cancer- Market Drivers and Barriers
24. HER2 Positive Breast Cancer- Future Perspectives and Conclusion
25. HER2 Positive Breast Cancer Analyst Views
26. HER2 Positive Breast Cancer Key Companies
27. Appendix

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