Triple Negative Breast Cancer - Pipeline Insight, 2025

This “Triple Negative Breast Cancer - Pipeline Insight, 2025,” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Triple 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.

Triple Negative Breast Cancer Understanding

Triple Negative Breast Cancer: Overview

Triple Negative Breast Cancer (TNBC) is defined as a tumor where the estrogen and progesterone (ER/PR) are negative, as assessed by immunohistochemistry (IHC), and there is a lack of overexpression of HER2, as assessed by immunohistochemistry (IHC), or the absence of its gene amplification, as assessed by fluorescence in situ hybridization technique. The epidemiological risk factor profiles also vary between TNBC (ER-PR-HER2-) and other breast cancers. TNBCs are frequently identified as hyper dense masses without associated calcifications. The majority of TNBCs are histologically classified as high-grade, invasive, ductal carcinomas of no special type with basal-like features. Central necrosis, pushing tumor borders, a conspicuous lymphocytic infiltrate, and fibrosis are common histologic features. The most common symptom of breast cancer is a new lump or mass (although most breast lumps are not cancer). A painless, hard mass that has irregular edges is more likely to be cancer, but breast cancers can be also soft, round, tender, or even painful. Other possible symptoms of breast cancer include: Swelling of all or part of a breast (even if no lump is felt), Skin dimpling (sometimes looking like an orange peel), Breast or nipple pain, Nipple retraction (turning inward), Nipple or breast skin that is red, dry, flaking, or thickened, Nipple discharge (other than breast milk) and Swollen lymph nodes under the arm or near the collar bone. Once a breast cancer diagnosis has been made using imaging tests and a biopsy, the cancer cells will be checked for certain proteins. If the cells do not have estrogen or progesterone receptors (ER or PR), and also do not make any or too much of the HER2 protein, the cancer is considered to be triple-negative breast cancer. Triple-negative breast cancer has fewer treatment options than other types of invasive breast cancer. This is because the cancer cells do not have the estrogen or progesterone receptors or enough of the HER2 protein to make hormone therapy or targeted HER2 drugs work. Because hormone therapy and anti-HER2 drugs are not choices for women with triple-negative breast cancer, chemotherapy is often used. If the cancer has not spread to distant sites, surgery is an option. Chemotherapy might be given first to shrink a large tumor, followed by surgery. Chemotherapy is often recommended after surgery to reduce the chances of the cancer coming back. Radiation might also be an option depending on certain features of the tumor and the type of surgery patient had. In cases where the cancer has spread to other parts of the body (stage IV), platinum chemotherapy, targeted drugs like a PARP inhibitor or antibody-drug conjugate, or immunotherapy with chemotherapy might be considered.

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

Triple Negative Breast Cancer Emerging Drugs Chapters

This segment of the Triple 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.

Triple Negative Breast Cancer Emerging Drugs

Camrelizumab: Jiangsu HengRui Medicine

Camrelizumab is a humanized monoclonal antibody that specifically binds to PD-1 and blocks its interaction with PD-L1, thereby restoring T-cell activation and reversing tumor immune evasion. In a multicenter Phase II trial, camrelizumab combined with apatinib and eribulin was found to be effective and tolerable in patients with heavily pretreated advanced TNBC. The objective response rate (ORR) was 37.0%, and the disease control rate (DCR) was 87.0%. The median progression-free survival (PFS) was 8.1 months, and grade 3/4 treatment-related adverse events occurred in 41.3% of patients. This combination regimen showed promising efficacy and a manageable toxicity profile in patients with advanced TNBC, including those with PD-L1-negative tumors or those who had progressed after prior checkpoint inhibitors. It is formulated as solution for intravenous route. Currently, the drug is in Phase III stage of clinical trial evaluation for the treatment of Triple Negative Breast Cancer.

SKB264: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors). SKB264 has received Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer.

AK117: Akeso Biopharma

AK117, independently developed by Akeso, is a next generation of humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Triple Negative Breast Cancer.

PLX038: ProLynx

PLX038 is a long-acting prodrug of the topoisomerase 1 (Top1) inhibitor, SN-38, which is also the active component of anti-cancer agents irinotecan and the ADC SC. Top1 inhibitors cause DNA breaks and kill tumors that are unable to repair the damage. Previously, Curie researchers showed that about one-third of TNBC patients have defects in DNA damage repair, and should respond to an effective SN-38-based therapy (Coussy et al., 2020). In PLX038, SN-38 is covalently bound to a circulating nanoparticle and is slowly released to provide free SN-38 with a long half-life, low Cmax, and high exposure - important facets for optimal safety and efficacy. Importantly, in preclinical studies PLX038 was shown to accumulate and be retained in solid tumors, where it slowly releases its SN-38. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Triple Negative Breast Cancer.

PMD-026: Phoenix Molecular Designs

PhoenixMD's lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. It is a pill that is convenient for patients as opposed to intravenous delivery, the mode most commonly used to deliver chemotherapy. PMD-026 was designed for TNBC because RSK2 was specifically identified as the key kinase that drives the growth of this breast cancer subtype5, 6. PMD-026 is well-tolerated in breast cancer patients and can stop tumor growth for up to 5 months based on Phase 1 data. PFS in women with TNBC is three times longer for patients that express high levels of RSK2 activation as compared to those with low RSK2 activation. Preclinical data shows PMD-026 has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of Triple Negative Breast Cancer.

Triple Negative Breast Cancer: Therapeutic Assessment

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

Major Players in Triple Negative Breast Cancer

There are approx. 75+ key companies which are developing the therapies for Triple Negative Breast Cancer. The companies which have their Triple Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, Jiangsu HengRui Medicine and others.

Phases

The report covers around 80+ 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

Triple 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
• Parenteral
• intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Product Type

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

Triple 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 Triple 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 Triple Negative Breast Cancer drugs.

Triple Negative Breast Cancer Report Insights

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

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

Key Players

• Shanghai Henlius Biotech
• Jiangsu HengRui Medicine Co., Ltd.

G1 Therapeutics, Inc.

Infinity Pharmaceuticals

• HiberCell, Inc.

Zenith Epigenetics

• BioLite, Inc.

Abbisko Therapeutics

• Phoenix Molecular Designs
• OncoTherapy Science
• ModernaTX, Inc

Key Products

• HLX10
• Camrelizumab
• Trilaciclib
• IPI-549
• Imprime PGG
• ZEN003694 +Talazoparib
• BLEX 404
• X4P-001
• PMD-026
• OTS167PO
• mRNA-2752

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