HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2024

This “HR Positive/ HER2 Negative Breast Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative 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

HR Positive/ HER2 Negative Breast Cancer: Understanding

HR Positive/ HER2 Negative Breast Cancer: Overview

A breast cancer is classified as HR-positive if its cells have receptors for the hormones estrogen and progesterone, which suggests the cancer cells receive signals from these hormones that promote their growth. Cancer tissue is also tested for HER-2 proteins, or receptors, that help control the growth and repair of breast cells in which HER-2-negative breast cancers, have cells that contain little to no HER-2 protein, so they tend to grow more slowly and have a better outlook than HER-2-positive cancers The breast cancer subtype HR+/HER2- is the most common subtype with an age-adjusted rate of 87.4 new cases per 100,000 women, based on 2015-2019 cases. HER2 or ERBB2 gene is responsible for coding HER2 or ERBB2 proteins which are the receptors on the breast. A HER2-negative diagnosis also means that your cancer won't benefit from therapies that target the HER2 protein. Roughly half of metastatic breast cancers are both HR-positive and HER2-negative. Some of the common symptoms of Her2 negative breast cancer:

Swelling in the breasts
Notice change in the shape of the breasts
There would be an appearance of rashes or some irritation on the skin
Experience pain in the breast or nipples
Discharge from the nipple, not the breast milk
The appearance of prominent redness or thickness of the nipple or the breast skin
Three common test employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal.

The present goal of therapy for early HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments. Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse.

HR Positive/ HER2 Negative Breast Cancer- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative 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, HR Positive/ HER2 Negative 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 HR Positive/ HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HR Positive/ HER2 Negative Breast Cancer.

HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Chapters

This segment of the HR Positive/ HER2 Negative 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.

HR Positive/ HER2 Negative Breast Cancer Emerging Drugs

Camizestrant: Astra ZenecaCamizestrant is a potent, next-generation oral SERD and pure ERa antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activatingmutations.

The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same.

Dato-DXd: Daiichi Sankyo, Inc.Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in Astra Zeneca’s ADC scientificplatform.

Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.

CX-2009: CytomX Therapeutics CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types.

It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer.

RGT-419B: Regor Therapeutics RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer.

It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer.

HR Positive/ HER2 Negative Breast Cancer: Therapeutic Assessment

This segment of the report provides insights about the different HR Positive/ HER2 Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in HR Positive/ HER2 Negative Breast Cancer

There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca.

Phases

This report covers around 53+ 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

HR Positive/ HER2 Negative 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.

HR Positive/ HER2 Negative Breast Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HR Positive/ HER2 Negative 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 HR Positive/ HER2 Negative Breast Cancer drugs.

HR Positive/ HER2 Negative Breast Cancer Report Insights

• HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

HR Positive/ HER2 Negative 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 HR Positive/ HER2 Negative Breast Cancer drugs?
• How many HR Positive/ HER2 Negative 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 HR Positive/ HER2 Negative Breast Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HR Positive/ HER2 Negative 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 HR Positive/ HER2 Negative Breast Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Regor Therapeuics
• Seagen Inc.
• CytomX Therapeutics
• Taizhou EOC Pharma
• Chia Tai Tianqing Pharmaceutical Group
• AstraZeneca
• Daiichi Sankyo, Inc.
• Tyme, Inc.
• Seagen Inc.
• Context Therapeutics
• Eisai Inc.
• Shanghai Hengrui Pharmaceutical Co., Ltd.
• Jiangsu Simcere Pharmaceutical Co.,
• Kind Pharmaceuticals
• Merus N.V.
• Atossa Therapeutics
• Roche
• Ellipses Pharma

Key Products

• RGT-419B
• SGN-B7H4V
• CX-2009
• EOC202
• TQB3616
• Camizestrant
• Dato-DXd
• SM-88
• SGN-B7H4V
• Onapristone
• Giredestrant
• H3B-6545
• Z-endoxifen
• MCLA-128
• EP0062
• HRS8807
• SCR-6852
• AND019

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