Her2 Positive Breast Cancer Pipeline Insight

DelveInsight’s, “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. 

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 by DelveInsight 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.

Further product details are provided in the report……..

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

DelveInsight’s 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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

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?

Introduction

Executive Summary

HER2 Positive Breast Cancer: Overview

  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics

  • Comparative Analysis

Therapeutic Assessment

  • 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

HER2 Positive Breast Cancer– DelveInsight’s Analytical Perspective

Late Stage Products (Phase II/III)

  • Comparative Analysis

ARX 788: Ambrx

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

  • Comparative Analysis

Inavolisib: Genentech

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

  • Comparative Analysis

ALT P7: Alteogen

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

  • Comparative Analysis

Drug Name: Company Name

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

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

List of Table

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 Products

List 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

• 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.

 

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