HER2-positive Gastric Cancer - Pipeline Insight, 2024

This “HER2-positive Gastric Cancer- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in HER2-positive Gastric 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.

Geography Covered

• Global coverage

HER2-positive Gastric Cancer: Understanding

HER2-positive Gastric Cancer: Overview

Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world. Early gastric cancer has no associated symptoms; however, some patients with incidental complaints are diagnosed with early gastric cancer. Most symptoms of gastric cancer reflect advanced disease. All physical signs in gastric cancer are late events. In some people with stomach cancer, the cancer cells have too much of a growth-promoting protein called HER2 on their surface. Cancers with increased levels of HER2 are called HER2-positive. Drugs that target the HER2 protein can often be helpful in treating these cancers. Unfortunately, only a minority of patients with gastric cancer who undergo surgical resection will be cured of their disease. Most patients have a recurrence. HER2, also known as ErbB2/Neu, belongs to the EGFR family and is located on human chromosome 17 (17q21); this gene encodes a 185 kDa transmembrane glycoprotein (p185). EGFR family members include HER1, HER2, HER3, and HER4, which are composed of three parts: an extracellular ligand-binding domain, a transmembrane domain, and an intracellular tyrosine kinase domain.

Stomach cancer doesn’t typically cause symptoms during the early stages. Even the most common early signs of stomach cancer - often unexplained weight loss and stomach pain - don’t usually show up until the cancer is more advanced. Symptoms of stomach cancer include, loss of appetite, trouble swallowing, fatigue or weakness, nausea and vomiting, unexplained weight loss, heartburn and indigestion. Stomach cancer forms when there’s a genetic mutation (change) in the DNA of your stomach cells. DNA is the code that tells cells when to grow and when to die. Because of the mutation, the cells grow rapidly and eventually form a tumor instead of dying.

The doctor will review the medical history, ask about the symptoms and perform a physical exam that may involve feeling for a mass in stomach. They may order several tests to diagnose and stage stomach cancer. Staging allows doctor to assess how much the cancer has spread with stomach cancer, staging ranges from 0 (zero) to IV (four). Stage 0 means the cancer hasn’t spread beyond stomach lining. Stage IV means that it’s spread to other organs. The other diagnostic tests include upper endoscopy, endoscopic ultrasound, radiologic tests, blood tests and laparoscopy.

Treatment depends on how far the cancer’s spread, health and treatment preferences. It often involves a care team that includes primary care provider, a cancer specialist (oncologist) and a gastrointestinal specialist (gastroenterologist). They can advise on treatment options. The treatment plans also include surgery upper endoscopy, gastrectomy, chemotherapy, radiation, targeted drug therapy, immunotherapy.

HER2-positive Gastric Cancer- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HER2-positive Gastric Cancer pipeline landscape is provided which includes the disease overview and HER2-positive Gastric Cancer treatment guidelines. The assessment part of the report embraces, in depth HER2-positive Gastric Cancer commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, HER2-positive Gastric Cancer collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence HER2-positive Gastric Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HER2-positive Gastric Cancer.

HER2-positive Gastric Cancer Emerging Drugs Chapters

This segment of the HER2-positive Gastric Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

HER2-positive Gastric Cancer Emerging Drugs

SHR-A1811: Jiangsu HengRui Medicine Co., Ltd.SHR-A1811 is a novel anti-HER2 antibody-drug conjugate (ADC) that features an optimized molecular design to enhance plasma stability and bystander effect. Hengrui Pharma is currently conducting more than 10 clinical studies of SHR-A1811 from phase 1 to phase 3 to evaluate its safety and efficacy as single agent or combination therapy in a wide variety of cancer indications. Currently, the drug is in Phase III stage of its development for the treatment of HER2-positive Gastric Cancer.

Cinrebafusp alfa: Pieris Pharmaceuticals Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising 4-1BB-targeting Anticalin proteins and a HER2-targeting antibody. The drug candidate is currently in phase 2 development for the treatment of HER2-expressing solid tumors. In phase 1 studies, cinrebafusp alfa has shown an acceptable safety profile at all doses tested with no dose-limiting toxicities. The bispecific also showed a dose response and a 4-1BB-driven mechanism of action based on clinical benefit and pharmacodynamic correlates. Currently, the drug is in Phase II stage of its development for the treatment of HER2-positive Gastric Cancer.

BI-1607: Bio Invent International BI-1607 is an Fc?RIIB-blocking antibody that differs from BI-1206 (BioInvent’s clinical-stage Fc?RIIB antibody) in that it has been engineered for reduced Fc-binding to Fc?Rs. Preclinical proof-of-concept data indicate that combined treatment with BI-1607 may both enhance efficacy of current anti-HER2 regimens and increase response rates in patients no longer responding to anti-HER2-directed therapies such as trastuzumab. Currently, the drug is in Phase I/II stage of its development for the treatment of HER2-positiveGastricCancer.

HER2-positive Gastric Cancer: Therapeutic Assessment

This segment of the report provides insights about the different HER2-positive Gastric Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in HER2-positive Gastric Cancer

• There are approx. 20+ key companies which are developing the therapies for HER2-positive Gastric Cancer. The companies which have their HER2-positive Gastric Cancer drug candidates in the most advanced stage, i.e. phase III include, Jiangsu HengRui Medicine Co., Ltd.

Phases

This report covers around 20+ 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

Route of Administration

HER2-positive Gastric Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

HER2-positive Gastric Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HER2-positive Gastric Cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HER2-positive Gastric Cancer drugs.

HER2-positive Gastric Cancer Report Insights

• HER2-positive Gastric Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

HER2-positive Gastric Cancer Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing HER2-positive Gastric Cancer drugs?
• How many HER2-positive Gastric Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HER2-positive Gastric Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HER2-positive Gastric Cancer therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for HER2-positive Gastric Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Jiangsu HengRui Medicine Co., Ltd.
• Pieris Pharmaceuticals
• Bio InventInternational
• Daiichi Sankyo|AstraZeneca
• Shanghai JMT-Bio Inc.
• Acepodia Biotech, Inc.
• Klus Pharma Inc.
• Carisma Therapeutics Inc
• Novartis Pharmaceuticals
• Celularity Incorporated
• Hoffmann-La Roche
• DualityBio Inc.
• Shanghai Miracogen Inc.
• Bavarian Nordic

Key Products

• SHR-A1811
• Cinrebafusp alfa
• BI-1607
• Trastuzumab deruxtecan
• KN026
• ACE1702
• A166
• CT-0508
• LJM716
• CYNK-101
• Atezolizumab
• DB-1303
• MRG002
• TAEK-VAC-HerBy

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