Metastatic Prostate Cancer - Pipeline Insight, 2024

This “Metastatic Prostate Cancer (MPC) - Pipeline Insight, 2024” report provides comprehensive insights about 90+ companies and 110+ pipeline drugs in metastatic 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

Metastatic Prostate Cancer Understanding

Metastatic Prostate Cancer: Overview

Metastatic Prostate Cancer is a type of prostate cancer which spreads to the other parts of body, i.e., cancer has metastasized. Most often, prostate cancer spreads to the bones or lymph nodes. It's also common for it to spread to the liver or lungs. It's rarer for it to move to other organs, such as the brain. Metastatic prostate cancer is an advanced form of cancer. There's no cure, but it can treat it and control it. Most men with advanced prostate cancer live a normal life for many years.

Symptoms of Metastatic Prostate Cancer
In the majority of the cases, the symptoms of prostate cancer are not apparent in the early stages of the disease. The symptoms of prostate cancer may be different for each man, and other conditions may cause some of these symptoms described below. The symptoms of Metastatic/Advanced Prostate Cancer include the following::

• difficulty in urinating
• bloody urine or semen
• erectile dysfunction
• painful ejaculation
• swelling in pelvic area or legs
• fatigue
• unexplained weight loss

Stages of Metastatic Prostate Cancer
Advanced prostate cancer has several stages to get through before it can be considered advanced. Prostate cancer occurs when cells in the prostate gland mutate and start to develop abnormally. They will multiply at an uncontrolled rate. In some instances, the cells can spread to other body parts. Cancerous cells can spread through tissue, the blood, or the lymphatic system. The stages of prostate cancer range from stage I to stage IV. Stage IV is the most advanced cancer form and the topic of this article. Stage IV prostate cancer is advanced prostate cancer that has spread to pelvic lymph nodes or is blocking the ureters. The ureters are the tubes that connect the kidneys to the bladder.

There are two types of stage IV prostate cancer:
Stage IV D1: Prostate cancer has spread to the pelvis, lymph nodes, or surrounding organs. However, the cancer has not spread further- Stage IV D2: Cancers have spread to more distant organs, such as the spine, pelvis, ribs, or other bones. Unfortunately, stage IV D2 prostate cancer is the hardest to cure but is still treatable
Treatment of Metastatic prostate cancer
Metastatic prostate cancer includes stage 4 and recurrent disease when the cancer has spread beyond the tissues surrounding the prostate to other parts of the body. The healthcare team will suggest treatments based on needs of the patient. Hormonal therapy is the main treatment for metastatic prostate cancer. It may be given along with radiation therapy or chemotherapy. Hormonal therapy is the main treatment for metastatic prostate cancer. It may be given along with radiation therapy or chemotherapy. Systemic radiation therapy with radium-223 (Xofigo) may be offered to men who have castrate-resistant prostate cancer that has spread to the bones. Castrate-resistant prostate cancer means that it comes back or doesn’t go away after treatment with hormonal therapy. A transurethral resection may be done to help relieve urinary problems caused by an enlarged prostate pressing on the urethra. Chemotherapy may be offered for metastatic prostate cancer with or without hormonal therapy. Docetaxel (Taxotere) and prednisone are most often used to treat metastatic prostate cancer. These drugs can be used to treat men with either castrate-sensitive or castrate-resistant prostate cancer.

Metastatic Prostate Cancer Emerging Drugs Chapters

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

Metastatic Prostate Cancer Emerging Drugs

FP-001: Foresee PharmaceuticalsFP-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.

Relugolix: Myovant BiosciencesRelugolix (Pre-registration) 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).

Atezolizumab: GenentechAtezolizumab (Tecentriq, Phase III) is a novel, anti-PDL1 targeted prescription cancer immunotherapy. It is monoclonal antibody derived from the Chinese hamster ovary cells by recombinant DNA technology. Atezolizumab works by binding to PD-L1 receptor expressed on tumor cells and tumor-in?ltrating immune cells and thereby leads to the prevention of binding of PD-L1 receptor to other proteins namely as B7.1 and PD-1. This process leads to the release of PD-1/ PD-L1 mediated inhibition of the immune response, and also causes the activation of anti-tumor immune response without inducing the antibody dependent cellular cytotoxicity (ADCC). As stated by the company, this mode of action may eliminate the stop sign that gives the signals to inactivate T-cells. Tecentriq may also affect normal cells.

Darolutamide: BayerDarolutamide (Phase III) is an orally administered second generation androgen receptor (AR) antagonist that has a unique chemical structure designed to block the growth of cancer cells through binding to the AR with high affinity and inhibiting the receptor function. In preclinical studies, darolutamide and its main circulating metabolite are active also in known AR mutants (ex W742L, F877L), and have been found to have negligible blood-brain barrier penetration.

DCVAC/PCa: SotioDCVAC is an autologous immunotherapy manufactured from a patient’s white blood cells. It is composed of autologous Polyinosinic-Polycytidylic activated dendritic cells pulsed with killed LNCaP prostate cancer cell line. Sotio is currently leading following trials for the treatment of Metastatic prostate cancer:
o Phase III: Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy
o Phase I/II: Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men with Advanced Metastatic Castration-resistant Prostate Cancer
Ipatasertib: RocheIpatasertib is an orally administered small molecule, potent, novel, selective ATP-competitive, selective AKT inhibitor which is designed to target and bind to the adenosine triphosphate (ATP)-binding pocket of the 3 activated isoforms of AKT, potentially inhibiting downstream signaling. Ipatasertib is being investigated in combination with various treatment modalities (e.g., anti-hormonal therapy, chemotherapy). It acts as serine/threonine protein kinase Akt (protein kinase B) with potential antineoplastic activity. Currently, Roche is investigating ipatasertib as part of a combination with Zytiga (abiraterone acetate; Johnson & Johnson/AstraZeneca) in asymptomatic or mildly symptomatic, previously untreated metastatic castration-resistant prostate cancer patients.

Metastatic Prostate Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Metastatic Prostate Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Metastatic Prostate Cancer

There are approx. 90+ key companies which are developing the therapies for Metastatic Prostate Cancer. The companies which have their Metastatic Prostate Cancer drug candidates in the most advanced stage, i.e. Pre-registration phase include, Foresee Pharmaceuticals and Myovant Biosciences.

Phases

This report covers around 110+ products under different phases of clinical development like

• Late stage products (Pre-registration and Phase III)
• Mid-stage products (Phase II and Phase I/II) and
• Early-stage products (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Metastatic 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

• Intravenous
• Intradermal
• Intra-tumoral
• Oral
• Parenteral
• Subcutaneous etc.
• Mechanism of Action

Products have been categorized under various MOAs such as

• Luteinizing hormone-releasing hormone (LHRH) (GnRH) Agonists
• Luteinizing hormone-releasing hormone (LHRH) (GnRH) Agonists
• Poly (ADP-Ribose) Polymerase (PARP) Inhibitors
• Vascular endothelial growth factor inhibitors
• Androgen receptor antagonists
• Cytotoxic T-lymphocyte antigen 4 inhibitors
• Programmed cell ligand 1 (PD-L1) Inhibitors
• Programmed cell ligand 1 (PD-L1) Inhibitors
• AKT inhibitors
• Polo like Kinase 1 (PLK1) inhibitor
• Adenosine A2A receptor antagonists
• SSRP1 protein inhibitors
• Cyclin-dependent kinase 4 inhibitors
• Indoleamine-pyrrole 2,3-dioxygenase inhibitors
• Cytochrome P 450 enzyme system inhibitors
• Glutamate carboxypeptidase II inhibitors
• Fibroblast growth factor receptor antagonists
• Transforming growth factor beta type I receptor antagonists
• HSP70 heat shock protein inhibitors
• Wnt signalling pathway modulators
• Stem cell markers suppression
• CD46 protein Inhibitors
• CD3 antigen inhibitors
• Tubulin inhibitors
• Calcitriol receptor agonists
• ROS1 protein inhibitors
• Insulin-like growth factor I inhibitors
• Insulin-like growth factor II inhibitors etc.

Molecule Type

• Antibodies
• Cell Therapies Immunotherapies
• Liposome
• Microbiome
• Peptides
• Recombinant fusion proteins
• Small molecules
• Small interfering RNAs
• Vaccines
• Vitamin D analogues and others

Products have been categorized under various Molecule types such as

Product Type

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

Metastatic Prostate Cancer: Pipeline Development Activities

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

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Metastatic Prostate Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Prostate Cancer.
• In June 2020, Myovant Sciences announced Priority Review and FDA acceptance of New Drug Application for once-daily, oral relugolix for Advanced Prostate Cancer
• In February 2019, Foresee Pharmaceuticals entered into an exclusive license agreement with Accord Healthcare. An exclusive license agreement for the commercialization of Foresee Pharmaceutical's (6576.TWO) novel FP-001 program (leuprorelin depot), Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous depot formulations has been granted to Accord Healthcare.
• In January 2019, Sosei Group Corporation, announced that it has been notified by its strategic alliance partner AstraZeneca that it has reached a clinical development milestone with its partnered next generation immuno-oncology candidate AZD4635, triggering a US$15 million payment from AstraZeneca.
• In 2018, Novartis has completed the acquisition of Endocyte, a US-based biopharmaceutical company focused on developing radioligand and CAR-T therapies for cancer treatment.
• In January 2019, Telix Pharmaceuticals accelerated the Prostate Cancer therapy program and announced the strategy update for the TLX591 (prostate therapy) program. Under this acceleration, Telix is potentially able to accelerate its antibody-directed prostate cancer radiotherapy program by approximately two years.
• In 2019, the FDA granted Breakthrough Therapy designation for niraparib, an orally administered poly (ADP-ribose) polymerase inhibitor, for the treatment of patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer who have received prior taxane chemotherapy and androgen receptor-targeted therapy.
• In 2019, ARV-110, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after treatment with two or more systemic therapies.
• Foresee Pharmaceuticals is utilizing its proprietary Stabilized Injectable Formulation (SIF) platform technology for the development of FP-001 as a subcutaneous injection. Based on its differentiated profile, company is planning to penetrate the fast growing global prostate cancer market via key strategic collaborations such as a commercial partnership in the U.S. and out-licensing in other key territories such as Europe, Japan, China and emerging markets. This technology enables the development of tailor-made controlled release drug delivery systems for small molecules, peptides, and proteins and also satisfies an otherwise unmet need in drug delivery.
• Sotio utilizes active cellular immunotherapy (ACI) Technology platform, entitled DCVAC, for personalized treatment of prostate, ovarian and lung cancer. The Sotio DCVAC platform uses the patient’s own immune cells activated in vitro to reinforce the immune response to tumor cells.

Metastatic Prostate Cancer Report Insights

• Metastatic Prostate Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Metastatic 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 Metastatic Prostate Cancer drugs?
• How many Metastatic 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 Metastatic Prostate Cancer?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Metastatic 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 Metastatic Prostate Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?