DelveInsight’s, “HER2 Positive Breast Cancer Pipeline Insight 2024” report provides comprehensive insights about 60+ companies and 65+ pipeline drugs in HER2 Positive Breast Cancer pipeline landscape. It covers the HER2 Positive Breast Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the HER2 Positive Breast Cancer 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 HER2 Positive Breast Cancer Pipeline Report
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HER2 Positive Breast Cancer Emerging Drugs Profile
SHR-A1811 is an innovative HER2-targeted antibody-drug conjugate with a topoisomerase I payload conjugated to an anti-HER-2 mAb by a cleavable linker. Once bound to HER2 expressing tumor cells, the ADC is internalized and the linker releases the toxin, leading to tumor cell death. It can bind to the cell membrane surface of HER2 expressing cells, and then enter the cells to reach the lysosome to release small Molecular toxins eventually induce tumor cell apoptosis, combining the high targeting of antibodies and the powerful killing power of cytotoxic drugs on target cells.
HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union (EU), which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients. HLX11 can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, HLX11 can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Currently, the drug is in the Phase III stage of its development for the treatment of HER2 Positive Breast Cancer.
MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC) -enhanced Biclonics® that utilizes Merus Dock & Block® mechanism and inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors. MCLA-128 is believed to target the HER3 signaling pathway and to overcome the resistance of tumor cells to HER2-targeted therapies using two mechanisms: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor. The therapeutic candidate is a full-length IgG bi-specific antibody that acts by targeting HER2 and HER3. It is an antibody-dependent cellular cytotoxicity (ADCC)-enhanced Biclonic, which is developed based on Biclonics ENGAGE platform. Currently the drug is in the Phase II stage of clinical trial evaluation for the treatment of HER2-positive metastatic breast cancer.
GQ1001 is a novel HER2-targeted antibody-drug conjugate (ADC) that was developed using innovative conjugation technologies coined intelligent Ligase-Dependent Conjugation (iLDC), that can significantly improves homogeneity and biostability of ADC. In preclinical studies, GQ1001 showed a robust anti-tumor response in multiple HER2+ models alone or in combination with HER2 TKIs and chemotherapeutics, and excellent pharmacokinetics and safety profiles in rats and monkeys due to low level of payload release. GQ1001 has already received Clinical Trial approval from the Therapeutic Goods Administration (TGA) in Australia and IND from FDA in USA. Currently the drug is in the Phase I stage of clinical trial evaluation for the treatment of HER2-positive metastatic breast cancer.
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HER2 Positive Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
HER2 Positive Breast Cancer Products have been categorized under various Molecule types such as
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HER2 Positive Breast Cancer Companies and Therapies
Scope of the HER2 Positive Breast Cancer Pipeline Report
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