DelveInsight’s “Triple Negative Breast Cancer Pipeline Insight” presents a comprehensive assessment of more than 165 companies and over 170 drug candidates currently progressing through the TNBC development pipeline. The report delivers detailed therapeutic profiles spanning clinical and preclinical stages and evaluates assets based on product classification, development phase, route of administration, and molecular design. It also identifies discontinued and dormant programs within the TNBC landscape.
According to DelveInsight’s analysis, the TNBC therapeutics market is poised for notable expansion in the coming years. Key growth drivers include increasing disease incidence, advances in diagnostic technologies, heightened disease awareness, rising healthcare spending worldwide, and the expected launch of novel therapeutic options.
The prevalence of triple-negative breast cancer has shown a consistent upward trend, intensifying the demand for more effective treatment strategies. This expanding patient population, coupled with escalating R&D investments in next-generation therapies, is anticipated to accelerate market momentum. Several companies, including Jiangsu HengRui Medicine, G1 Therapeutics, Infinity Pharmaceuticals, and others, are advancing late-stage assets within the TNBC pipeline.
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Key Highlights From the Triple Negative Breast Cancer Pipeline Report
- January 2026, Kazia Therapeutics (NASDAQ: KZIA), today provided a clinical update from its ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy in patients with late-stage (Stage IV), metastatic triple-negative breast cancer (TNBC).
- November 2025: Akeso (9926.HK) announced that its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy for first-line TNBC treatment, received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).
- November 2025: Kazia Therapeutics Limited (Nasdaq: KZIA) reported that a patient with stage IV TNBC treated under an FDA-approved expanded access protocol – combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy – achieved an initial immune-complete response (iCR) as per iRECIST criteria, indicating a strong radiologic response in aggressive metastatic disease.
- June 2025: Cardiff Oncology, Inc. (Nasdaq: CRDF) shared positive findings from an investigator-initiated Phase 1b trial evaluating onvansertib combined with paclitaxel in metastatic TNBC patients, presented at the 2025 ASCO Annual Meeting in Chicago.
- June 2025: Cellectar Biosciences, Inc. (Nasdaq: CLRB) submitted a Phase 1b dose-escalation protocol to the U.S. FDA for CLR 125, an iodine-125 Auger-emitting radiopharmaceutical, for relapsed TNBC and other solid tumors.
- May 2025: AstraZeneca initiated a Phase III trial evaluating capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for patients with locally advanced or metastatic TNBC.
- May 2025: MedSIR launched a Phase II trial aimed at improving the tolerability of sacituzumab govitecan in patients with advanced or metastatic TNBC refractory to prior chemotherapy regimens.
- May 2025: Merck Sharp & Dohme LLC conducted a comparative study assessing adjuvant sacituzumab tirumotecan (MK-2870) plus pembrolizumab versus physician’s choice therapy in TNBC patients who did not achieve pathological complete response after neoadjuvant treatment.
- DelveInsight’s Triple Negative Breast Cancer Pipeline analysis depicts a robust space with 165+ active players working to develop 170+ pipeline treatment therapies.
- The leading Triple Negative Breast Cancer Companies such as G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Escugen Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Sichuan Baili Pharmaceutical, Novartis Pharmaceuticals, Akeso Biopharma, OBI Pharma, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Merck & Co, BeBetter Med, Tasly Biopharmaceuticals Co., Ltd., Ambrx, Eli Lilly and Company, Rhizen Pharmaceuticals, Roche, TJ Biopharma Co., Ltd., Prolynx, Merck Sharp & Dohme LLC, ES-102; Hexavalent OX40 agonist antibody, INBRX-106, Processa Pharmaceuticals, Oncolytics Biotech, OncoSec Medical Incorporated, PharmAbcine, JenKem Technology, MedSIR, Zenith Epigenetics, Astellas Pharma Inc, Intensity Therapeutics, Inc., NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., NeoImmuneTech, Scancell Ltd, Lantern Pharma Inc., Medicenna Therapeutics, Inc., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Salubris Biotherapeutics Inc, Pfizer/Merck, Celcuity Inc., Jacobio Pharmaceuticals Co., Ltd., Immunitas Therapeutics, Innolake Biopharm, Hummingbird Bioscience, Hutchmed/BeiGene, Adagene Inc, Genmab, ProDa BioTech, Rapa Therapeutics LLC, Amgen, Strand Therapeutics Inc., Simcha Therapeutics, UCB, Sumitomo Pharma America, Inc., Shanghai Junshi Biosciences, Abbisko Therapeutics, Cytovation AS, CytosinLab Therapeutics Co., Ltd., Cantargia AB, BioAtla, Inc., BicycleTx Limited, Transgene, Bristol-Myers Squibb, BioLite, Inc., Bolt Biotherapeutics, Inc., Avenzo Therapeutics, Inc., Apollo Therapeutics Ltd, A2 Biotherapeutics Inc., Fusion Pharmaceuticals Inc., Volastra Therapeutics, Inc., Teon Therapeutics, Inc., TransThera Sciences (Nanjing), Inc., TCR2 Therapeutics, NeoTX Therapeutics Ltd., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Xencor, Inc., Janux Therapeutics, Memgen, Inc., ModernaTX, Inc., Myeloid Therapeutics, Nanobiotix, NiKang Therapeutics, Inc., Numab Therapeutics AG, NextPoint Therapeutics, Inc., Nurix Therapeutics, Inc., Imugene Limited, OncoNano Medicine, Inc., Tizona Therapeutics, Inc, Theratechnologies, Exelixis, MBrace Therapeutics, LIGACHEM BIOSCIENCES Inc., Bellicum Pharmaceuticals, Compass Therapeutics, Circle Pharma, AbbVie, Adcentrx Therapeutics, Angiex, Inc., Precigen, Inc, Novartis, Laekna Limited, Light Chain Bioscience – Novimmune SA, BeiGene, SillaJen, Inc., Genentech, Inc., Accent Therapeutics, Arcus Biosciences, Inc., A2A Pharmaceuticals Inc., Adlai Nortye Biopharma Co., Ltd., Sichuan Baili Pharmaceutical Co., Ltd., Compugen Ltd, BioEclipse Therapeutics, Innate Pharma, ImmunoGenesis, Tubulis GmbH, Hinova pharmaceuticals, Repertoire Immune Medicines, VEANA THERAPEUTICS, Pharos iBio Co., Ltd., GeneQuantum Healthcare, Trio Pharmaceuticals, Cellectis, Rakovina Therapeutics, Pan Cancer T, Pinotbio, Starlight Therapeutics, Primevax, ARCE therapeutics, HC Biopharma, Casinvent, Speer Medical Technologies, Shengjing Hospital, others.
- Promising Triple Negative Breast Cancer Pipeline Therapies such as Trilaciclib, Sacituzumab Govitecan + Pembrolizumab, PM8002, Niraparib, Ipatasertib, FDA018-ADC, ESG401, Dato-DXd, Capivasertib, Camrelizumab, BL-B01D1, Alpelisib, AK112, Adagloxad Simolenin, Olaparib, B013+Nab-Paclitaxel, CBP-1008, Patritumab deruxtecan, Evexomostat, CFI-400945 + Durvalumab, Ceralasertib + Durvalumab/Nab-Paclitaxel, Carboplatin + Everolimus, Pembrolizumab and Carboplatin + Docetaxel, BEBT-209, B1962, ARX788, Bicalutamide + Abemaciclib, 9MW2821, Tenalisib, Tiragolumab, TJ107 + Pembrolizumab, Tobemstomig + Nab-Paclitaxel, PLX038, Pembrolizumab + Lenvatinib, INBRX-106 + Pembrolizumab, Vibostolimab + pembrolizumab, PCS6422 + Capecitabine, Alisertib + Paclitaxel, Pelareorep, Tavokinogene telseplasmid, Olinvacimab, JK-1201I, MEN1611, ZEN-3694, Enfortumab vedotin, INT230-6, NECVAX-NEO1, Onvansertib, OC-001, NUV-868, NT-I7, Modi-1, LP-184, MDNA11, KN046, JK08, ladiratuzumab vedotin, Gedatolisib+Talazoparib, JAB-2485, IMT-009, ILB-2109, HMBD-001, Fruquintinib+Tislelizumab, ADG106, PRO1107, ProAgio, Zimberelimab, RAPA-201, Talimogene laherparepvec, STX-001, ST-067, UCB4594, SMP3124LP, JS108, ABSK-081, CyPep-1, CTS2190, Nadunolimab, CAB-ROR2-ADC, BT8009, BT5528, BT-001, BMS-986449, BMS-986340, BLEX 404, Bemarituzumab, BDC-3042, AVZO-021, APL-5125, A2B395, FPI-1434, VLS-1488, Rina-S, TT-702, TT-00420, TC-510, Naptumomab Estafenatox, PMD-026, PBA-0405, PBA-0111, XMT-1660, ZM008, XmAb®808, JANX008, LY4052031, LY4101174, LY4170156, MEM-288, mRNA-2752, MT-302, NBTXR3, NKT3447, NKT3964, NM32-2668, NPX267, NX-1607, CF33-hNIS-antiPDL1, ONM-501, TTX-080, TH1902, XB002, MBRC-101, CS5001, iC9-CAR.B7-H3 T Cell Therapy, HMBD-002, CTX-8371, CID-078, ABBV-400, ADRX-0706, AGX101, PRGN-3007, DKY709, LAE005, Boserolimab, NI-1801, BG-68501, BAL0891, Autogene Cevumeran, ATX-295, AB598, ABBV-927, AO-252, MK-5890, AN0025, [177Lu]Lu-NNS309, BL-M02D1, COM701, CRX100, IPH4502, IMGS-001, AZD8701, TUB-030, HP518, Tumor Associated Antigen, Dark Genome Antigen, VT101, PHI-501, PHI-101, CBP-8088, GQ1010, TROP2 TIE ADC, MUC1 CAR T-cells, KT-3000, PCT-1, PBX-001, STAR-001, PV001 DV, ARM 201, Research programme: ADC, Research programme: casein kinase 1 (CK1), KT-4000, DR-18621, SHR-1316, and others.
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Triple Negative Breast Cancer Emerging Therapies
- Trilaciclib (G1 Therapeutics): A short-acting IV CDK4/6 inhibitor designed to protect bone marrow and immune function during chemotherapy; currently in Phase III for TNBC.
- Olaparib (AstraZeneca): An oral PARP inhibitor approved for BRCA-mutated TNBC, demonstrating improved progression-free survival and ongoing evaluation in combination regimens.
- Patritumab Deruxtecan (Daiichi Sankyo/Merck): A HER3-targeted antibody–drug conjugate showing encouraging activity in HER3-expressing TNBC, now in Phase II development.
- NUV-868 (Nuvation Bio): A BET inhibitor under Phase I/II evaluation, with development strategies being reassessed for optimal combination approaches.
- TUB-030 (Tubulis): A next-generation 5T4-targeting ADC utilizing proprietary conjugation technology, currently in preclinical development.
Insights Provided in the TNBC Pipeline Report
- Comprehensive profiling of companies developing TNBC therapies and their respective portfolios
- Segmentation of pipeline assets by early, mid, and late clinical stages
- Evaluation of targeted therapies, including active and discontinued programs
- Detailed analysis by development phase, administration route, molecular class, mechanism of action, and combination strategy
- In-depth coverage of partnerships, licensing agreements, and funding activities supporting pipeline advancement
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Triple Negative Breast Cancer Route of Administration
- Intravenous
- Subcutaneous
- Oral
- Intramuscular
Triple Negative Breast Cancer Molecule Classification
- Monoclonal antibodies
- Small molecules
- Peptides
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Scope of the Triple Negative Breast Cancer Pipeline Report
- Geographic Coverage: Global
- Active Companies: 165+
- Pipeline Therapies: 170+
- Therapeutic Modalities: Monotherapy and combination regimens
- Clinical Stages Covered: Discovery through 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 DelveInsight
DelveInsight is a leading healthcare market research and consulting firm specializing in life sciences. The company delivers high-quality, data-driven insights and customized intelligence solutions to support strategic decision-making for pharmaceutical, biotech, and healthcare organizations worldwide.
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