This “HER2 Positive Breast Cancer- Pipeline Insight, 2022” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in HER2 Positive 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.
HER2-positive breast cancer is when breast cancer cells have a protein receptor called HER2 (human epidermal growth factor receptor 2). Normally, this protein helps breast cells grow, divide, and repair themselves. But sometimes, something goes wrong in the gene that controls the HER2 protein and the body makes too many of these receptors. This causes the breast cells to grow and divide uncontrollably. About 1 of 5 breast cancers are HER2-positive.While HER2 is more aggressive than other types of breast cancer, there are treatments that can help. A lump in the breast that feels different from the area around it is the most common symptom of breast cancer. Other symptoms of HER2-positive breast cancer can include: Breast swelling, a change in its shape, skin irritation or dimpling, pain in the breast or nipple, redness or thickness of the nipple or breast skin and discharge from the nipple (not breast milk). Doctors don't know the exact causes of breast cancer. Experts think it may be a combination of things, including genes, environment, and lifestyle. If patient is diagnosed with breast cancer, the doctor will check to see if it is HER2-positive. They'll probably give patient one or more of these tests: The IHC test uses certain antibodies that identify the HER2 protein in a sample of breast cancer tissue, the FISH test uses fluorescent pieces of DNA that stick to the HER2 gene in cells, which can then be counted under a microscope and the Inform Dual ISH test uses stains that color HER2 genes in a tissue sample so they can be counted under a microscope. HER2-positive (HER2+) breast cancers constitute an aggressive type of breast cancer and tend to grow faster and are more likely to spread. However, therapies that specifically target HER2, such as Herceptin® (traztuzumab), are very effective. HER2 targeted therapies, has significantly improved the therapeutic outcome for patients with HER2 positive breast cancer.
"HER2 Positive Breast Cancer- Pipeline Insight, 2022" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HER2 Positive Breast Cancer pipeline landscape is provided which includes the disease overview and HER2 Positive Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HER2 Positive Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, HER2 Positive Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
This segment of the HER2 Positive 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.
Alteogen is using NexMab™ ADC technology to develop ALT-P7, a targeted breast / gastric cancer drug. ALT-P7 is an anti-HER2 targeting ADC utilizing NexMab™ ADC technology. ALT-P7's payload drugs are site specifically conjugated to the HER2 targeted antibody, whereas Kadcyla has drug payloads conjugated, on a non-site specific manner, to the HER2 targeted antibody. Because of the site-specific conjugation, ALT-P7 can be developed as safer and better alternative anti-cancer drug than Kadcyla. A phase I clinical trial is being completed and phase II clinical trial will soon be held.
ARX788, is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials. The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2+ metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer. ARX788 is a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the payloads to the antibody. Currently the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
Inavolisib (GDC-0077, RG6114) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
This segment of the report provides insights about the different HER2 Positive Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:
There are approx. 75+ 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 II /III include, Ambrx.
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HER2 Positive Breast Cancer therapeutic drugs key players involved in developing key drugs.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HER2 Positive Breast Cancer drugs.
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Geography Covered
- Global coverage
HER2 Positive Breast Cancer: Understanding
HER2 Positive Breast Cancer: Overview
HER2-positive breast cancer is when breast cancer cells have a protein receptor called HER2 (human epidermal growth factor receptor 2). Normally, this protein helps breast cells grow, divide, and repair themselves. But sometimes, something goes wrong in the gene that controls the HER2 protein and the body makes too many of these receptors. This causes the breast cells to grow and divide uncontrollably. About 1 of 5 breast cancers are HER2-positive.While HER2 is more aggressive than other types of breast cancer, there are treatments that can help. A lump in the breast that feels different from the area around it is the most common symptom of breast cancer. Other symptoms of HER2-positive breast cancer can include: Breast swelling, a change in its shape, skin irritation or dimpling, pain in the breast or nipple, redness or thickness of the nipple or breast skin and discharge from the nipple (not breast milk). Doctors don't know the exact causes of breast cancer. Experts think it may be a combination of things, including genes, environment, and lifestyle. If patient is diagnosed with breast cancer, the doctor will check to see if it is HER2-positive. They'll probably give patient one or more of these tests: The IHC test uses certain antibodies that identify the HER2 protein in a sample of breast cancer tissue, the FISH test uses fluorescent pieces of DNA that stick to the HER2 gene in cells, which can then be counted under a microscope and the Inform Dual ISH test uses stains that color HER2 genes in a tissue sample so they can be counted under a microscope. HER2-positive (HER2+) breast cancers constitute an aggressive type of breast cancer and tend to grow faster and are more likely to spread. However, therapies that specifically target HER2, such as Herceptin® (traztuzumab), are very effective. HER2 targeted therapies, has significantly improved the therapeutic outcome for patients with HER2 positive breast cancer.
"HER2 Positive Breast Cancer- Pipeline Insight, 2022" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HER2 Positive Breast Cancer pipeline landscape is provided which includes the disease overview and HER2 Positive Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HER2 Positive Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, HER2 Positive Breast Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence HER2 Positive Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HER2 Positive Breast Cancer.
HER2 Positive Breast Cancer Emerging Drugs Chapters
This segment of the HER2 Positive 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.
HER2 Positive Breast Cancer Emerging Drugs
ALT P7: Alteogen
Alteogen is using NexMab™ ADC technology to develop ALT-P7, a targeted breast / gastric cancer drug. ALT-P7 is an anti-HER2 targeting ADC utilizing NexMab™ ADC technology. ALT-P7's payload drugs are site specifically conjugated to the HER2 targeted antibody, whereas Kadcyla has drug payloads conjugated, on a non-site specific manner, to the HER2 targeted antibody. Because of the site-specific conjugation, ALT-P7 can be developed as safer and better alternative anti-cancer drug than Kadcyla. A phase I clinical trial is being completed and phase II clinical trial will soon be held.
ARX 788: Ambrx
ARX788, is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials. The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2+ metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer. ARX788 is a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the payloads to the antibody. Currently the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
Inavolisib: Genentech
Inavolisib (GDC-0077, RG6114) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
HER2 Positive Breast Cancer: Therapeutic Assessment
This segment of the report provides insights about the different HER2 Positive Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in HER2 Positive Breast Cancer
There are approx. 75+ 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 II /III include, Ambrx.
Phases
This report covers around 75+ 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
- Route of Administration
HER2 Positive 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
HER2 Positive Breast Cancer: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HER2 Positive 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 HER2 Positive Breast Cancer drugs.
HER2 Positive Breast Cancer Report Insights
- HER2 Positive Breast Cancer Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
HER2 Positive Breast Cancer Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing HER2 Positive Breast Cancer drugs?
- How many HER2 Positive 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 HER2 Positive Breast Cancer?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HER2 Positive 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 HER2 Positive Breast Cancer and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Ambrx
- Alteogen
- Genentech
- Suzhou Zanrong Pharma Limited
- AstraZeneca
- Shanghai Henlius Biotech
- Roche Pharma AG
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Klus Pharma Inc.
- Carisma Therapeutics Inc
- Triumvira Immunologics, Inc.
- Precirix
- DualityBio Inc.
- Seagen Inc.
Key Products
- ALT P7
- ARX 788
- Inavolisib
- ZN-A-1041
- Monalizumab
- HLX11
- Pertuzumab
- GQ1001
- A166
- CT-0508
- SHR-A1811
- TAC01-HER2
- CAM-H2
- DB-1303
- ladiratuzumab vedotin
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Table of Contents
IntroductionExecutive Summary
HER2 Positive Breast Cancer: Overview
- Causes
- Mechanism of Action
- Signs and Symptoms
- Diagnosis
- Disease Management
- Comparative Analysis
- Assessment by Product Type
- Assessment by Stage and Product Type
- Assessment by Route of Administration
- Assessment by Stage and Route of Administration
- Assessment by Molecule Type
- Assessment by Stage and Molecule Type
Late Stage Products (Phase II/III)
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
- Comparative Analysis
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
AppendixList of Tables
Table 1 Total Products for HER2 Positive Breast Cancer
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive ProductsList of Figures
Figure 1 Total Products for HER2 Positive Breast Cancer
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
Companies Mentioned
A selection of companies mentioned in this report includes:
- Ambrx
- Alteogen
- Genentech
- Suzhou Zanrong Pharma Limited
- AstraZeneca
- Shanghai Henlius Biotech
- Roche Pharma AG
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Klus Pharma Inc.
- Carisma Therapeutics Inc
- Triumvira Immunologics, Inc.
- Precirix
- DualityBio Inc.
- Seagen Inc.
