Triple Negative Breast Cancer FDA Approvals, Emerging Therapies, Pipeline Insights and Companies

Globe and Mail

05-02-2025

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 therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Discover the latest drugs and treatment options in the Triple Negative Breast Cancer Pipeline. Dive into DelveInsight's comprehensive report today! @ Triple Negative Breast Cancer Pipeline Outlook
Key Takeaways from the Triple Negative Breast Cancer Pipeline Report
In January 2025:- Merck Sharp & Dohme LLC- The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
In January 2025:- AstraZeneca:- This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.
In January 2025: Mabwell (Shanghai) Bioscience Co., Ltd.- This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
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® (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others.
Stay ahead with the most recent pipeline outlook for Triple Negative Breast Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Triple Negative Breast Cancer Treatment Drugs
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 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 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
Unveil the future of Triple Negative Breast Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Triple Negative Breast Cancer Market Drivers and Barriers
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® (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
Get the latest on Triple Negative Breast Cancer Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Triple Negative Breast Cancer Companies, Key Products and Unmet Needs
Table of Content
Introduction
Executive Summary
Triple Negative Breast Cancer: Overview
Pipeline Therapeutics
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 Key Companies
Triple Negative Breast Cancer Key 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
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