Triple Negative Breast Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Triple Negative Breast Cancer Pipeline Insight" report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Triple Negative Breast Cancer pipeline landscape. It covers the Triple Negative Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Triple Negative Breast Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Triple Negative Breast Cancer Pipeline Report

* In March 2025: Novartis Pharmaceuticals conducted a study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2).
* In March 2025:- Providence Health & Services conducted a study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.
* In March 2025:- Rhizen Pharmaceuticals SA announced a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.
* DelveInsight's Triple Negative Breast Cancer Pipeline analysis depicts a robust space with 75+ active players working to develop 80+ pipeline treatment therapies.
* The leading Triple Negative Breast Cancer Companies such as 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 , and others.
* Promising Triple Negative Breast Cancer Pipeline Therapies such as Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere Registered (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others.

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Triple Negative Breast Cancer Emerging Drugs Profile

* Camrelizumab: Jiangsu HengRui Medicine

Camrelizumab (Airuika) is a humanized monoclonal antibody acts as immunomodulatory agent. It is formulated as solution for intravenous route. Camrelizumab is indicated as third-line treatment for recurrent or refractory classical hodgkin's lymphoma, advanced hepatocellular carcinoma patients with oxaliplatin system chemotherapy, combined with pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, non-resectable locally advanced or metastatic first-line treatment of non-squamous non-small cell lung cancer (NSCLC), locally advanced or metastatic esophageal squamous cell carcinoma patients who have previously received first-line chemotherapy and whose disease has progressed or become intolerable and for the treatment of patients with advanced nasopharyngeal carcinoma who had disease progression after previous second-line and above chemotherapy or intolerable treatment. 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 SIRP, 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.

The Triple Negative Breast Cancer Pipeline report provides insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Triple Negative Breast Cancer with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Triple Negative Breast Cancer Treatment.
* Triple Negative Breast Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Triple Negative Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Triple Negative Breast Cancer market

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Triple Negative Breast Cancer Companies

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, and others.

Triple Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

* Oral
* Parenteral
* intravenous
* Subcutaneous
* Topical

Triple Negative Breast Cancer Products have been categorized under various Molecule types such as

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

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Scope of the Triple Negative Breast Cancer Pipeline Report

* Coverage- Global
* Triple Negative Breast Cancer Companies- 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, and others.
* Triple Negative Breast Cancer Pipeline Therapies- Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere Registered (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others.
* Triple Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Triple Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Triple Negative Breast Cancer Executive Summary
* Triple Negative Breast Cancer: Overview
* Triple Negative Breast Cancer Pipeline Therapeutics
* Triple Negative Breast Cancer Therapeutic Assessment
* Triple Negative Breast Cancer - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Camrelizumab: Jiangsu HengRui Medicine
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* AK117: Akeso Biopharma
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* PMD-026: Phoenix Molecular Designs
* Drug profiles in the detailed report.....
* Inactive Products
* Triple Negative Breast Cancer Companies
* Triple Negative Breast Cancer Products
* Triple Negative Breast Cancer Unmet Needs
* Triple Negative Breast Cancer Market Drivers and Barriers
* Triple Negative Breast Cancer Future Perspectives and Conclusion
* Triple Negative Breast Cancer Analyst Views
* Triple Negative Breast Cancer Key Companies
* Appendix

About Us

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