Metastatic Castration-Resistant Prostate Cancer - Pipeline Insight, 2024

This “Metastatic Castration-Resistant Prostate Cancer - Pipeline Insight, 2024” report provides comprehensive insights about 90+ companies and 95+ pipeline drugs in Metastatic Castration-Resistant 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 Castration-Resistant Prostate Cancer: Understanding

Metastatic Castration-Resistant Prostate Cancer: Overview

Prostate cancer is a type of malignancy that occurs in the prostate gland, which is a part of male reproductive system. Castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. With CRPC, the cancer no longer completely responds to treatments that lower testosterone. It shows signs of growth, like a rising PSA (prostate-specific antigen), even with low levels of testosterone. With Metastatic CRPC (mCRPC), the cancer stops responding to hormone treatment, and it is found in other parts of the body. It can spread to nearby lymph nodes, bones, the bladder, rectum, liver, lungs, and maybe the brain. Although metastatic castration-resistant prostate cancer (MCRPC) patients currently benefit from a wealth of effective treatment options, MCRPC remains incurable, and the prognosis of these patients is quite poor. There may be no signs or symptoms at all. If there are symptoms from mCRPC, they depend on the size of the tumors and where the cancer has spread.

Signs of mCRPC include - Trouble urinating,Pain while passing urine or blood in the urine,Feeling more tired or weaker than normal, Weight loss, Shortness of breath and Bone pain. The prostate is roughly 3 centimeters long, about the size of a walnut, and weighs approximately 20 grams. Its function is to produce about a third of the total seminal fluid. The prostate is primarily glandular tissue, which produces fluid that constitutes about 30% to 35% of the semen. This prostatic portion of the semen nourishes the sperm and provides alkalinity, which helps maintain a high pH. (The seminal vesicles produce the rest of the seminal fluid.) The prostate gland requires androgen (testosterone) to function optimally. This is why hormonal therapy (testosterone deprivation) is so effective. Castrate-resistant tumors are thought to generate intracellular androgens. Cancer begins with a mutation in normal prostate glandular cells, usually beginning with the peripheral basal cells.

Most of the time men suffering from prostate cancer remains asymptomatic until the prostate cancer advances, screening test with PSA test may be important for early detection of disease. Diagnosis is primarily based on a detailed medical history, taking particular note of underlying diseases and medications. Clinical examination and laboratory tests complete the diagnosis. Imaging procedures (i.e., transrectal ultrasonography, and magnetic resonance imaging scans) can provide helpful supporting information. A prostate biopsy can be ordered to confirm the diagnosis. The main goal for treating mCRPC is to control symptoms and slow progress. Even though androgen deprivation therapy (ADT) or hormone therapy may no longer work completely to stop prostate cancer from growing, most men with mCRPC remain on ADT because some prostate cancer cells will continue to respond to it. Other cells need additional treatment to keep the cells from forming. More treatments are added, like: Chemotherapy like docetaxel and cabazitaxel, Cabazitaxel is given with the steroid prednisone, Immunotherapy like sipuleucel-T, Second-line hormone therapies like abiraterone and enzalutamide, and radioactive material like Xofigo.

"Metastatic Castration-Resistant Prostate Cancer - Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Metastatic Castration-Resistant Prostate Cancer pipeline landscape is provided which includes the disease overview and Metastatic Castration-Resistant Prostate Cancer treatment guidelines. The assessment part of the report embraces, in depth Metastatic Castration-Resistant Prostate 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, Metastatic Castration-Resistant Prostate 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 Metastatic Castration-Resistant Prostate Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Castration-Resistant Prostate Cancer.

Metastatic Castration-Resistant Prostate Cancer Emerging Drugs Chapters

This segment of the Metastatic Castration-Resistant Prostate Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

Metastatic Castration-Resistant Prostate Cancer Emerging Drugs

Deutenzalutamide (HC-1119): Hinova Pharmaceuticals

Deutenzalutamide (HC-1119) is a Class 1 new drug independently developed by Hinova for the treatment of metastatic castration-resistant prostate cancer (mCRPC), which is a deuterated agent of enzalutamide, a second-generation androgen receptor (AR) antagonist, and has been awarded by Ministry of Science and Technology of the People’s Republic of China as one of National Major Projects of “Significant New Drugs Creation”. Deutenzalutamide (HC-1119), as an AR inhibitor, competitively inhibits the binding of androgens to AR, blocks the AR signaling pathway, inhibits the proliferation of prostate cancer cells and induces apoptosis in prostate cancer cells. Previous clinical and preclinical results had shown that deutenzalutamide (HC-1119) has the potential for higher efficacy, better safety profile and stronger patient adherence than its counterparts on the market, and that its compound patent will last until 2032 with a longer validity period.

The drug is currently being investigated in the Registration stage of development for the treatment of Metastatic Castration-Resistant Prostate Cancer.

PNT2002: Lantheus

A radioconjugate composed of PNT2002, is a human prostate-specific membrane antigen (PSMA)-targeting ligand, conjugated to the beta-emitting radioisotope lutetium Lu 177 (177Lu), with potential antineoplastic activity. Upon administration of lutetium Lu-177 PNT2002, the PNT2002 moiety targets and binds to PSMA-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of beta particle radiation. PSMA, a tumor-associated antigen (TAA) and type II transmembrane protein, is expressed on the membrane of prostatic epithelial cells and overexpressed on the majority of prostate tumor cells. Currently, the drug is in the Phase III stage of its development for the treatment of Metastatic Castration Resistant Prostate Cancer.

FPI-2265: AstraZeneca

FPI-2265 a small molecule targeting PSMA expressed in prostate cancers and is an actinium-225 based PSMA-targeting RC for mCRPC. Actinium-225 emits alpha particles and holds the promise of being a next-generation radioisotope in cancer treatment. By delivering a greater radiation dose over a shorter distance, alpha particles such as actinium-225 have the potential for more potent cancer cell killing, and targeted delivery, thereby minimizing damage to surrounding healthy tissue. The drug is currently being evaluated in Phase II/III clinical trials to treat Prostate Cancer.

JANX 007: Janux Therapeutics

JANX007 is lead novel Tumor Activated T Cell Engager (TRACTr). JANX007 is designed to target PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors and is in the clinic for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The company designed PSMA-TRACTr drug candidate as a single-masked TRACTr in which the PSMA-binding domain is unmasked. The T cell-specific binding domain (CD3e) is masked to help minimize CRS. The drug is currently in Phase I stage of its development for the treatment of Prostate cancer.

TGW101: Tagworks Pharmaceuticals

TGW101 is a preclinical asset which targets TAG72, a clinically validated, non-internalizing, pan-carcinoma target that is widely expressed in a range of epithelial-derived human cancers such as breast, colorectal, stomach, lung, pancreatic, prostate, and ovarian cancers. As it is relatively stable on the extracellular cell membrane, it has so far not been effectively addressed with current ADC technologies. TGW101-ADC consists of a TAG72-binding diabody conjugated with TCO-linked monomethyl auristatin E (MMAE) toxin. MMAE has a well understood and manageable safety profile, and a well-documented bystander effect. In TGW101 therapy, the ADCis administered first and allowed to bind the tumor and clear from circulation, after which the trigger molecule is injected systemically, resulting in cleavage of the tumor-bound ADC and passive distribution of MMAE into the surrounding tumor cells. The drug is currently in Preclinical stage of its development for the treatment of Prostate cancer.

Metastatic Castration-Resistant Prostate Cancer: Therapeutic Assessment

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

Major Players in Metastatic Castration-Resistant Prostate Cancer

There are approx. 90+ key companies which are developing the therapies for Metastatic Castration-Resistant Prostate Cancer. The companies which have their Metastatic Castration-Resistant Prostate Cancer drug candidates in the most advanced stage, i.e. Registration include, Hinova Pharmaceuticals.

Phases

The report covers around 95+ 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

Metastatic Castration-Resistant 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
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as:

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

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

Metastatic Castration-Resistant Prostate Cancer: Pipeline Development Activities

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

Metastatic Castration-Resistant Prostate Cancer Report Insights

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

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

Key Players

• Hinova Pharmaceuticals
• Lantheus
• Janux Therapeutics
• Tagworks Pharmaceuticals
• AstraZeneca
• Xencor
• Cardiff Oncology
• Madison Vaccines
• Bayer
• Olema Oncology
• Eli Lilly and Company
• Curium
• Pfizer
• Regeneron Pharmaceuticals
• PendreaBio
• Momotaro-Gene
• Norroy Bioscience
• Orion Corporation
• Epizyme
• Barinthus Biotherapeutics
• Twinpig Biolab
• Oxford Vacmedix
• Roche
• ImaginAb
• Halda THERAPEUTICS
• Novartis
• Kyinno Biotechnology

Key Products

• Deutenzalutamide (HC-1119)
• PNT2002
• FPI-2265
• JANX 007
• TGW101
• Capivasertib
• Vudalimab
• Onvansertib
• MVI 816
• BAY2315497
• HC-XO29
• OP-3136
• Abemaciclib
• 177Lu-PSMA-I&T
• Mevrometostat
• REGN5678
• PB1002
• Ad5-SGE-REIC/Dkk3
• 177Lu-NYM032
• ODM-209
• Tazemetostat
• VTP-850
• TB511
• OVM-200
• RO7656594
• IAB2MA
• HLD-0915
• AR-V7
• KA-3001

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