Osteosarcoma - Pipeline Insight, 2020

DelveInsight’s, “Osteosarcoma – Pipeline Insight, 2020,” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Osteosarcoma 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
Osteosarcoma Understanding
Osteosarcoma: Overview
Osteosarcoma is a type of cancer that produces immature bone. It is the most common type of cancer that arises in bones, and it is usually found at the end of long bones, often around the knee. Most people diagnosed with osteosarcoma are under the age of 25, and it is thought to occur more often in males than females. Osteosarcomas range from low grade tumors that only require surgery to high grade tumors that require an aggressive treatment regimen. Patients with osteosarcoma are best treated at a cancer center where an expert sarcoma team and resources are available to provide specialized and responsive care.
Symptoms
Most people with osteosarcoma do not feel sick. Patients may have a history of pain in the affected area and may have developed a limp. Often the pain is thought to be related to muscle soreness or growing pains, but it does not go away with rest. Many patients only see a doctor when there is some sort of injury to the area or when the tumor weakens a bone so much that it breaks (this is called a pathological fracture).
Diagnosis
An x-ray is often the first diagnostic test that osteosarcoma patients receive, and an experienced radiologist may recognize immediately that bone cancer is the likely diagnosis. There are several additional tests that are a critical part of osteosarcoma diagnosis and staging:
• An MRI of the entire bone where the primary tumor is located. This test can rule out skip metastases (spread of the tumor to other areas of the bone).
• A chest x-ray and CT scan of the chest to detect lung metastases
• A bone scan of the body to rule out distant spread of the disease
• A biopsy of the tumor, which provides a definite diagnosis based on the characteristics of tumor tissue seen under a microscope. The biopsy will also show whether the tumor is high grade (highly malignant, which is the case for most osteosarcomas) or low grade.
Treatment
Osteosarcoma is often treated with a combination of therapies that can include surgery, chemotherapy and radiation therapy. Most patients with high grade tumors receive about three months of chemotherapy, known as neo-adjuvant therapy, before surgery. A surgeon will then remove the tumor, along with a wide margin of healthy tissue around the tumor, with the goal of leaving the area free of all disease. Most tumors at the bones and joints can be removed safely while sparing the involved limb.
Osteosarcoma Emerging Drugs Chapters
This segment of the Osteosarcoma 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.
Osteosarcoma Emerging Drugs
• ZKAB 001: Sorrento Therapeutics
ZKAB 001 is a human monoclonal antibody directed against the immunosuppressive ligand programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274), with potential immune checkpoint inhibitory and antineoplastic activities. Upon intravenous administration, anti-PD-L1 monoclonal antibody ZKAB001 specifically targets and binds to PD-L1, blocking its binding to and activation of its receptor programmed cell death 1 (PD-1; cluster of differentiation 279; CD279). This reverses T-cell inactivation caused by PD-1/PD-L1 signaling and enhances the cytotoxic T-lymphocyte (CTL)-mediated anti-tumor immune response against PD-L1-expressing tumor cells.
• Humanized anti-GD2 antibody: Y-mAbs Therapeutics
Y-mAbs Therapeutics is conducting a phase II study of humanized monoclonal antibody 3F8 (Hu3F8) with granulocyte-macrophage colony stimulating factor (GM-CSF) in the treatment of recurrent osteosarcoma. The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease. Safety data from the Phase II osteosarcoma trial, Study 15-096, for the 25 patients enrolled in the study at MSK was presented. Patients who had recurrent disease and two (2) or more complete remissions were treated with naxitamab and GM-CSF, administered to the patients in an outpatient setting. The Company plans to initiate a multi-center trial in 2020.
• IVT-8086: Innova Therapeutics
IVT-8086 is a humanized monoclonal antibody, designed to decrease tumor cell angiogenesis and cell migration, increase tumor cell apoptosis and rescue T cell exhaustion, according to a company press release. It has a high affinity to SFRP2, a novel anticancer therapeutic target in osteosarcoma tumor cells.
Further product details are provided in the report……..
Osteosarcoma: Therapeutic Assessment
This segment of the report provides insights about the different Osteosarcoma drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Osteosarcoma
There are approx. 50+ key companies which are developing the therapies for Osteosarcoma. The companies which have their Osteosarcoma drug candidates in the mid to advanced stage, i.e. phase III and Phase II include, Eisai, Lee's Pharmaceutical Limited, Jiangsu HengRui Medicine, AstraZeneca, Iovance Biotherapeutics etc.
Phases
DelveInsight’s report covers around 50+ products under different phases of clinical development like
• Mid-stage products (Phase II and Phase I/II)
• Early-stage products (Phase I/II and Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

• Route of Administration
Osteosarcoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Subcutaneous
• Intravenous
• Oral
• Intravenous
• Intratumoral

• Molecule Type
Products have been categorized under various Molecule types such as
• Immunoglobulin Fc fragments
• Small molecules
• Monoclonal antibodies
• Immunoglobulins
• Immunoproteins
• Serum globulins

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

Osteosarcoma: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Osteosarcoma 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 Osteosarcoma drugs.

Report Highlights
• The companies and academics are working to assess challenges and seek opportunities that could influence Osteosarcoma R&D. The therapies under development are focused on novel approaches to treat/improve Osteosarcoma.
• September 2020: Innova Therapeutics receives rare pediatric disease designation for osteosarcoma treatment
• Innova Therapeutics Inc. has been granted rare pediatric disease designation by the FDA for its IVT-8086 osteosarcoma treatment.
Osteosarcoma Report Insights
• Osteosarcoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs
Osteosarcoma 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 Osteosarcoma drugs?
• How many Osteosarcoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Osteosarcoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Osteosarcoma 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 Osteosarcoma and their status?
• What are the key designations that have been granted to the emerging drugs?
Key Players
• Eisai
• Lee's Pharmaceutical Limited
• Jiangsu HengRui Medicine
• AstraZeneca
• Iovance Biotherapeutics
Key Products
• ZKAB001
• Camrelizumab in Combination With Neoadjuvant Chemotherapy
• Avelumab
• Y-ESO-1（TCR Affinity Enhancing Specific T cell Therapy
• humanized anti-GD2 antibody
• CLR 131
• CRX100