DelveInsight’s, “HER2 Positive Breast Cancer Pipeline Insight 2023” report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in the HER2 Positive Breast Cancer pipeline landscape. It covers the HER2 Positive Breast Cancer pipeline drug profiles, including HER2 Positive Breast Cancer clinical trials and nonclinical stage products. It also covers the HER2 Positive 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.
Key Takeaways from the HER2 Positive Breast Cancer Pipeline Report
- DelveInsight’s HER2-positive breast cancer pipeline report depicts a robust space with 75+ active players working to develop 75+ pipeline therapies for HER2-positive breast cancer treatment.
- The leading HER2-positive breast cancer Companies include Ambrx, Alteogen, Genentech, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, Roche Pharma AG, GeneQuantum Healthcare (Suzhou) Co. Ltd., Klus Pharma Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, DualityBio Inc., Seagen Inc., and others
- Promising HER2 Positive Breast Cancer Pipeline Therapies include ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002, Monalizumab, PTC-Pz, DZD1516, ZW25, PRS-343, ORM-5029, RC48-ADC, XMT-2056, BL-M07D1, Hemay 022, CAM-H2, Zanidatamab, MEN1611, ZRC-3277, MCLA-128, Ipatasertib, CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others.
- The HER2 Positive Breast Cancer companies and academics are working to assess challenges and seek opportunities that could influence HER2 Positive Breast Cancer R&D. The HER2 Positive Breast Cancer pipeline therapies under development are focused on novel approaches to treat/improve HER2 Positive Breast Cancer.
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HER2-Positive Breast Cancer Overview
HER2-positive breast cancer is when breast cancer cells have a protein receptor called HER2 (human epidermal growth factor receptor 2). Normally, this protein helps breast cells grow, divide, and repair themselves. But sometimes, something goes wrong in the gene that controls the HER2 protein and the body makes too many of these receptors. This causes the breast cells to grow and divide uncontrollably.
Recent Developmental Activities in the HER2 Positive Breast Cancer Pipeline Landscape
- In September 2022, Celltrion agreed to jointly develop Abpro’s cancer molecule ABP-102 in a deal that could be worth as much as $1.75 billion.Massachusetts-based Abpro is developing ABP-102 as an antibody aimed at T-cell activity for patients with HER2-positive breast cancer. Celltrion will take over complete control, development, and marketing of the pre-clinical molecule. If ABP-102 is approved, Abpro will receive as much as $1.75 billion in sales and $10 million in milestone payments.
- In September 2022, Artiva Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had cleared the company’s investigational new drug (IND) application for AB-201.AB-201 is the first systemically administered CAR-NK cell therapy candidate targeting the most prevalent HER2-positive cancer indications, including breast and gastric carcinomas.
- In August 2022, ALX Oncology Holdings Inc. and Quantum Leap Healthcare Collaborative™ (“Quantum Leap”) announced that ALX Oncology’s next generation CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. Sponsored by Quantum Leap, this Phase 1 (open-label), multi-center study arm will investigate evorpacept in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody-drug conjugate (“ADC”), to determine the safety, tolerability and efficacy of this drug combination.
- In August 2022, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki (Enhertu) for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.
- In July 2022, Byondis B.V., announced that the U.S. Food & Drug Administration (FDA) accepted the company’s submission of a Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The company has been given a Prescription Drug User Fee Act (PDUFA) action date of May 12, 2023.
- In June 2022, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of fam-trastuzumab deruxtecan-nxki (Enhertu) monotherapy for patients with metastatic HER2-positive breast cancer who have received at least 1 prior anti–HER2-based regimen.
- In February 2022, Alphamab Oncology announced Clinical Cancer Research, published the data from a phase I clinical study of the company’s proprietary HER2 bispecific antibody KN026 for the treatment of HER2-positive metastatic breast cancer (“First-in-human HER2-targeted Bispecific Antibody KN026 for the Treatment of Patients with HER2-positive Metastatic Breast Cancer.The updated data of this China Phase I clinical study from this publication demonstrated that KN026 was well tolerated, showed encouraging preliminary antitumor activity and achieved promising efficacy in patients with HER2-positive metastatic breast cancer (MBC) who had progressed on at least 1 prior line of anti-HER2 therapies.
- In November 2021, Zymeworks Inc. announced the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody. Zanidatamab in combination with chemotherapy, was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive breast cancer.
For further information, refer to the detailed HER2-Positive Breast Cancer Drugs Launch, HER2-Positive Breast Cancer Developmental Activities, and HER2-Positive Breast Cancer News, click here for HER2-Positive Breast Cancer Ongoing Clinical Trial Analysis
HER2-Positive Breast Cancer Emerging Drugs Profile
- ALT P7: Alteogen
Alteogen is using NexMab™ ADC technology to develop ALT-P7, a targeted breast / gastric cancer drug. ALT-P7 is an anti-HER2 targeting ADC utilizing NexMab™ ADC technology. ALT-P7’s payload drugs are site specifically conjugated to the HER2 targeted antibody, whereas Kadcyla has drug payloads conjugated, on a non-site specific manner, to the HER2 targeted antibody. Because of the site-specific conjugation, ALT-P7 can be developed as safer and better alternative anti-cancer drug than Kadcyla. A phase I clinical trial is being completed and phase II clinical trial will soon be held.
- ARX 788: Ambrx
ARX788, is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials. The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2+ metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer. ARX788 is a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the payloads to the antibody. Currently the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
- Inavolisib: Genentech
Inavolisib (GDC-0077, RG6114) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of HER2-positive Breast Cancer.
HER2-Positive Breast Cancer Pipeline Therapeutics Assessment
There are approx. 75+ key companies which are developing the therapies for HER2 Positive Breast Cancer. The companies which have their HER2 Positive Breast Cancer drug candidates in the most advanced stage, i.e. phase II /III include, Ambrx.
Find out more about the HER2 Positive Breast Cancer Pipeline Segmentation, Therapeutics Assessment, and HER2 Positive Breast Cancer Emerging Drugs @ HER2 Positive Breast Cancer Treatment Landscape
Scope of the HER2 Positive Breast Cancer Pipeline Report
- Coverage- Global
- HER2-Positive Breast Cancer Companies- Ambrx, Alteogen, Genentech, Suzhou Zanrong Pharma Limited, AstraZeneca, Shanghai Henlius Biotech, Roche Pharma AG, GeneQuantum Healthcare (Suzhou) Co. Ltd., Klus Pharma Inc., Carisma Therapeutics Inc, Triumvira Immunologics, Inc., Precirix, DualityBio Inc., Seagen Inc., and others
- HER2-Positive Breast Cancer Pipeline Therapies- ALT P7, ARX 788, Inavolisib, ZN-A-1041, Monalizumab, HLX11, GQ1001, A166, CT-0508, SHR-A1811, TAC01-HER2, CAM-H2, ladiratuzumab vedotin, DP303c, KN026, MRG002, Monalizumab, PTC-Pz, DZD1516, ZW25, PRS-343, ORM-5029, RC48-ADC, XMT-2056, BL-M07D1, Hemay 022, CAM-H2, Zanidatamab, MEN1611, ZRC-3277, MCLA-128, Ipatasertib, CCT303 406, Evorpacept, SYD985, AB-201, ABP-102, and others
- HER2-Positive Breast Cancer Pipeline Segmentation: Product Type, Molecule Type, Route of Administration
Dive deep into rich insights for drugs for HER2-Positive Breast Cancer Pipeline Companies and Therapies, click here @ HER2-Positive Breast Cancer Unmet Needs and Analyst Views
Table of Content
- Introduction
- Executive Summary
- HER2 Positive Breast Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- HER2 Positive Breast Cancer– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase II/III)
- ARX 788: Ambrx
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Inavolisib: Genentech
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- ALT P7: Alteogen
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- HER2 Positive Breast Cancer Key Companies
- HER2 Positive Breast Cancer Key Products
- HER2 Positive Breast Cancer- Unmet Needs
- HER2 Positive Breast Cancer- Market Drivers and Barriers
- HER2 Positive Breast Cancer- Future Perspectives and Conclusion
- HER2 Positive Breast Cancer Analyst Views
- HER2 Positive Breast Cancer Key Companies
- Appendix
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