HER2 Negative Breast Cancer- Pipeline Insight, 2025

DelveInsight’s, “HER2 Negative Breast Cancer- Pipeline Insight, 2025” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in 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

HER2 Negative Breast Cancer: Understanding

HER2 Negative Breast Cancer: Overview

Breast cancer is the world’s most common disease in women, and is also a major factor that leads to death. It is reported that 5% of patients with breast cancer have distant metastasis at a diagnosis, and 30% of patients with early cancer subsequently experience the distant metastasis. Metastatic breast cancer cannot be completely cured; however, significant improvement in the survival period was observed consistent with the emergence of novel therapy. The purpose of the treatment for metastatic breast cancer is to prolong the survival period and improve the cancer patients’ quality of life (QOL) by managing cancer-related symptoms. To that end, not the same strategy for all patients but individual approach for each patient should be used. When a breast cancer is HER2-negative, it means that the cancerous cells do not contain high levels of the protein HER2.

There are many treatment options available for this type of breast cancer, but the outlook can vary. “HER2” stands for human epidermal growth factor receptor 2. It may refer to the HER2 gene or to the protein HER2, which the gene makes.HER2 proteins are receptors that sit on the surface of breast cells. They usually help control the growth and repair of healthy breast tissue. Most studies divide HER2-negative breast cancer into two types. Based on the presence or absence of hormone receptors on the surface of cancer cells: hormone receptor-positive (HR-positive) breast cancer, triple-negative breast cancer. When person have HER2-negative advanced (metastatic) breast cancer, treatment usually focuses on managing the disease, not curing the cancer. The goal is to help a person live longer and have a better quality of life. This type of cancer is most often treated with systemic therapy. These drugs go into the bloodstream to send treatment to cells and organs throughout the body. Hormonal therapy is often the first treatment doctor’s use for women with HER2-negative advanced breast cancer that's """"hormone receptor positive."""" Some 50%-70% of breast cancers are hormone receptor positive. That means that the hormones, like estrogen or progesterone, help the cancer grow. Hormonal or endocrine therapies help to block this process. Some drugs lower your levels of estrogen. Others stop estrogen from connecting to cancer cells so they can’t multiply. Hormonal therapies have a lower risk of serious side effects than chemotherapy. Many different chemotherapy drugs are used, either alone or in combination, to treat HER2-negative breast cancer. Targeted therapies block certain proteins or molecules that drive the growth and spread of cancer cells. Those molecules are the """"targets"""" of the drugs. There’s a lot of research into targeted therapies for cancer.

These drugs are also called precision medicine. Once diagnosed with HER2-negative advanced breast cancer, patient may also consider starting palliative care. Palliative therapies treat pain, anxiety, and other issues that can come along with cancer.

""HER2 Negative Breast Cancer- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth 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, 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 HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HER2 Negative Breast Cancer.

HER2 Negative Breast Cancer Emerging Drugs Chapters

This segment of the 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.

HER2 Negative Breast Cancer Emerging Drugs

• Giredestrant : Genentech

Giredestrant is a novel investigative small molecule that works as selective estrogen receptor degrader (SERD) by targeting the estrogen receptor (ER). The drug candidate is a new molecular entity (NME) which is administered through oral route. Preclinical studies suggest that Giredestrant is orally bioavailable and competitively inhibits the binding of estrogen to the ER. In preclinical models, Giredestrant has been shown to restrain the normally dynamic behavior of both wild-type and mutant ER, immobilizing the ER and attenuating the expression of its target genes. Currently, the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

• Inavolisib : Genentech

Inavolisib is an investigational small molecule designed to selectively inhibit mutant PI3Kα. In preclinical models, the molecule showed potent selective inhibition of PI3Kα and has increased potency to mutant PI3K cells over wild type. It is less sensitive for the other three PI3K isoforms. Inavolisib binds to the ATP-binding site of PI3Kα, thereby blocking phosphorylation of PIP2 to PIP3 and preventing downstream signaling as shown in preclinical models. Moreover, inavolisib specifically degrades the mutant form of PI3Kα, resulting in reduction of pathway activity. Currently the drug is in Phase III stage of its development for the treatment of HER2 negative breast cancer.

• CX-2009 : CytomX Therapeutics

CX-2009 (Praluzatamab ravtansine) is a conditionally activated antibody-drug conjugate (ADC) comprised of a CD166-directed humanized monoclonal antibody conjugated to the maytansinoid DM4, a tubulin inhibitor. Praluzatamab ravtansine utilizes CytomX Probody® platform technology, which incorporates a masking peptide to cover and block the cellular binding region of the antibody. Tethered to the antibody via a protease-cleavable linker, currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

• H3B 6545 : H3 Biomedicine

H3B-6545 is an oral, selective estrogen receptor covalent antagonist (SERCA) for the research of metastatic ER-positive, HER2-negative breast cancer. H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα.4 H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies. Currently, the drug is in Phase II stage of its development for the treatment of HER2 negative breast cancer.

• RGT-419B : Regor Therapeutics

RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. Results from non-clinical studies showed that RGT-419B demonstrated full suppression of ER+ breast cancer cell proliferation with acquired resistance to CDK4/6 inhibitors. Additionally, RGT-419B's tumor cell suppression was further augmented when combined with a selective estrogen receptor down-regulator or a PI3K signaling pathway inhibitor. Currently, the drug is in Phase I stage of its development for the treatment of HER2 negative breast cancer.

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

HER2 Negative Breast Cancer: Therapeutic Assessment

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

• Major Players in HER2 Negative Breast Cancer
• There are approx. 70+ key companies which are developing the therapies for HER2 Negative Breast Cancer. The companies which have their HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, Genentech.
• 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 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

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 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 HER2 Negative Breast Cancer drugs.

HER2 Negative Breast Cancer Report Insights

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

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

Key Players

• Genentech
• CytomX Therapeutics
• H3 Biomedicine
• Regor Therapeutics
• Immutep Limited
• Merck & Co
• Klus Pharma
• Olema Pharmaceuticals
• BeiGene
• AstraZeneca
• Janssen/Merck/GSK
• Ono Pharmaceutical
• Laekna Therapeutics
• NanoMab
• InSilico Medicine
• TYK Medicine
• Shanghai Pharmaceutical Group
• Verastem Oncology
• Allarity Therapeutics
• Shenzhen Yangli Pharmaceutical Technology
• Phoenix Molecular Designs

Key Products

• Giredestrant
• Inavolisib
• CX-2009
• H3B 6545
• RGT-419B
• Runimotamab
• Eftilagimod alpha
• Ladiratuzumab vedotin
• SKB 264
• Palazestrant
• Pamiparib
• Olaparib
• Niraparib
• Ipatasertib
• ONO 4578
• Afuresertib
• NM 03 theranostic
• ISM 5043
• TY-0540
• I 022
• Tremelimumab
• Avutometinib
• Dovitinib
• TFX 06
• PMD-026

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