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HER2-Negative Breast Cancer Pipeline, FDA Approvals, Unmet Needs, Preclinical and Discovery Stage Product, and Companies 2024 (Updated)

05-19-2024 07:48 PM CET | Health & Medicine

Press release from: DelveInsight Business Research LLP

HER2-Negative Breast Cancer Pipeline

HER2-Negative Breast Cancer Pipeline

DelveInsight's, "HER2-Negative Breast Cancer Pipeline Insight 2024" 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.

Key Takeaways from the HER2-Negative Breast Cancer Pipeline Report
• DelveInsight's HER2-Negative Breast Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for HER2-Negative Breast Cancer treatment.
• The leading HER2-Negative Breast Cancer Companies working in the market include 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, and others.
• Promising HER2-Negative Breast Cancer Therapies in the various stages of development include Paclitaxel, Trastuzumab, Doxorubicin, Cyclophosphamide, AZD9833, Eribulin, Cyclophosphamide, and others.
• May 2024:- Seagen Inc.- A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors. This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.
• May 2024:- Olema Pharmaceuticals Inc.- A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01). This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
• May 2024:- Hoffmann-La Roche- A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy.

Request a sample and discover the recent advances in HER2-Negative Breast Cancer @ HER2-Negative Breast Cancer Pipeline Outlook Report- https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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.

HER2-Negative Breast Cancer Emerging Drugs Profile

• 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.

Learn more about HER2-Negative Breast Cancer in clinical trials @ HER2-Negative Breast Cancer Drugs- https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

HER2-Negative Breast Cancer Therapeutics Assessment
There are approx. 70+ key HER2-Negative Breast Cancer 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.

DelveInsight's HER2-Negative Breast Cancer Pipeline 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

Discover more about HER2-Negative Breast Cancer in development @ HER2-Negative Breast Cancer Clinical Trials- https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

HER2-Negative Breast Cancer Companies
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, and others.

HER2-Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
• Oral
• Parenteral
• Intravitreal
• Subretinal
• Topical

HER2-Negative Breast Cancer Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

To know more about HER2-Negative Breast Cancer, visit @ HER2-Negative Breast Cancer Segmentation- https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the HER2-Negative Breast Cancer Pipeline Report
• Coverage- Global
• HER2-Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• HER2-Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• HER2-Negative Breast Cancer Companies- 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, and others.
• HER2-Negative Breast Cancer Therapies- Paclitaxel, Trastuzumab, Doxorubicin, Cyclophosphamide, AZD9833, Eribulin, Cyclophosphamide, and others.

For further information on the HER2-Negative Breast Cancer Pipeline Therapeutics, reach out @ HER2-Negative Breast Cancer Products Development- https://www.delveinsight.com/sample-request/her2-negative-breast-cancer-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. HER2 Negative Breast Cancer: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. HER2 Negative Breast Cancer- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Giredestrant : Genentech
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. CX-2009 : CytomX Therapeutics
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. RGT-419B : Regor Therapeutics
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug Name: Company Name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. HER2 Negative Breast Cancer Key Companies
21. HER2 Negative Breast Cancer Key Products
22. HER2 Negative Breast Cancer- Unmet Needs
23. HER2 Negative Breast Cancer- Market Drivers and Barriers
24. HER2 Negative Breast Cancer- Future Perspectives and Conclusion
25. HER2 Negative Breast Cancer Analyst Views
26. HER2 Negative Breast Cancer Key Companies
27. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
Email: info@delveinsight.com
Phone: 9650213330
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

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