Prostate Cancer – Pipeline Insight, 2020

DelveInsight’s, “Prostate Cancer – Pipeline Insight, 2020,” report provides comprehensive insights about 900+ companies and 900+ pipeline drugs in Prostate 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
Prostate Cancer Understanding
Prostate Cancer: Overview
The prostate is a small walnut shaped gland in the pelvis of men. It is located next to the bladder and can be examined by getting a digital rectal exam. Prostate cancer is a form of cancer that develops in the prostate gland. It is the second-leading cause of cancer deaths for men in the U.S. About 1 in 9 men will be diagnosed with prostate cancer in their lifetime. This year, nearly 191,000 men will be diagnosed with prostate cancer. Growths in the prostate can be benign (not cancer) or malignant (cancer).
Benign growths (like benign prostatic hyperplasia (BPH):
• Are rarely a threat to life
• Don't invade the tissues around them
• Don't spread to other parts of the body
• Can be removed and can grow back very slowly (but usually don't grow back)
Malignant growths (prostate cancer):
• May sometimes be a threat to life
• Can spread to nearby organs and tissues (such as the bladder or rectum)
• Can spread (metastasize) to other parts of the body (like lymph nodes or bone)
• Often can be removed but sometimes grow back
Prostate cancer cells can spread by breaking away from a prostate tumor. They can travel through blood vessels or lymph nodes to reach other parts of the body. After spreading, cancer cells may attach to other tissues and grow to form new tumors, causing damage where they land.
Treatment
Primarily, surgery, radiation therapy, and proton beam therapy are the current treatment options of prostate cancer. However, chemotherapy, hormonal therapy, cryosurgery, and high intensity focused ultrasound (HIFU) are also belonging to the treatment strategies, depending on clinical conditions, and outcomes. Also, the choice of treatment depends on the stages of the disease progression, the level of prostate specific antigen (PSA), the Gleason score among others.
Prostate Cancer Emerging Drugs Chapters
This segment of the Prostate Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.
Prostate Cancer Emerging Drugs
• Relugolix: Myovant
Relugolix is the Myovant’s lead product candidate and is an orally available small molecule, non-peptide gonadotropin-releasing hormone (GnRH or luteinizing hormone-releasing hormone (LHRH)) antagonist, with potential antineoplastic activity. Relugolix competitively binds to and blocks the GnRH receptor in the anterior pituitary gland, which both prevents GnRH binding to the GnRH receptor and inhibits the secretion and release of both luteinizing hormone (LH) and follicle stimulating hormone (FSH). In males, the inhibition of LH secretion prevents the release of testosterone from Leydig cells in the testes. Since testosterone is required to sustain prostate growth, reducing testosterone levels may inhibit hormone-dependent prostate cancer cell proliferation. Relugolix is similar to the approved GnRH antagonist Firmagon (degarelix; Ferring/Astellas), as both drugs deplete androgen levels without an accompanying flare of testosterone that occurs with GnRH agonist treatment.
• FP-001: Foresee Pharmaceuticals
FP-001 is a long-acting gonadotropin releasing hormone (GnRH) agonist being developed as Leuprolide Mesylate for Injectable Suspension. It is under development by Foresee Pharmaceuticals and ScinoPharm Joint Venture and is currently in Phase III stage for the treatment of Prostate Cancer. The drug candidate is being developed in different dosage formulations and depending on them, they are in different stages of development:-
• LMIS 50 mg: Pre-registration stage (Foresee Pharmaceuticals submitted NDA for FDA approval of LMIS 50 mg)
• LMIS 25 mg: Phase III Stage
• LMIS 8.3 mg: Research Stage
• GX301: Mediolanum
GX301 is being developed by Mediolanum for the treatment of Prostate cancer. It is currently in phase II stage of development.

• TAS3681: Taiho Oncology
TAS3681, a pure AR antagonist, is specifically designed to address the unmet medical need in CRPC patients by combining known mechanisms of action with novel ones:
• A selective AR antagonist suppressing transactivation of both wild-type and mutated (including F876L) cell lines and inhibiting AR translocation to the nucleus
• Downregulating AR expression in prostate cancer cells in vitro and in vivo and effectively suppressing androgen independent AR transactivation by outlaw pathways
• Driving AR downregulation of full-length androgen receptor (FL-AR) and AR splice variants (eg, AR-v7) in vitro and in vivo, and suppressing AR dependent and AR-v7 dependent cell growth

Further product details are provided in the report……..
Prostate Cancer: Therapeutic Assessment
This segment of the report provides insights about the different Prostate Cancer drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Prostate Cancer
There are approx. 900+ key companies which are developing the therapies for Prostate Cancer. The companies which have their Prostate Cancer drug candidates in the most advanced stage, i.e. phase III include Myovant and others
• Phases
DelveInsight’s report covers around 900+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage products (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

• Route of Administration
Prostate 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
• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Oral
• Parenteral
• Subcutaneous
• Topical.
• Molecule Type
Products have been categorized under various Molecule types such as
• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

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

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

Report Highlights
• The companies and academics are working to assess challenges and seek opportunities that could influence Prostate Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Prostate Cancer.
• A New Drug Application (NDA) has been submitted to the FDA for once-daily, oral relugolix (RRVT-601, Relumina) at a dose of 120 mg as treatment of male patients with advanced prostate cancer by the company.
• Takeda has granted Myovant an exclusive, worldwide license (excluding Japan and certain other Asian countries) to relugolix (TAK-385). Takeda will retain commercial rights for relugolix in Asian countries, including Japan, where is actively conducting two phase 3 registration studies for the treatment of uterine fibroids.
• March 2019: Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
Prostate Cancer Report Insights
• Prostate Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs
Prostate 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 Prostate Cancer drugs?
• How many Prostate Cancer drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Prostate Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Prostate 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 Prostate Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?
Key Players
• AstraZeneca
• Daiichi Sankyo
• Abgenix
• Orion Corporation
• Pfizer
• Bayer
• Medivation LLC
• Clovis Oncology
• Laekna Limited
• FutureChem
• Foresee Pharmaceuticals
• Mediolanum
• Myovant
• Taiho Oncology

Key Products
• Capivasertib
• PLX3397
• ABX-EGF
• ODM-201
• Enzalutamide
• BAY1841788
• MDV3100
• Rucaparib
• LAE001
• Ludotadipep
• FP-001
• GX301
• Relugolix
• TAS3681