Prostate Cancer - Competitive landscape, 2024

DelveInsight's, "Prostate Cancer - Competitive landscape, 2024," report provides comprehensive insights about 230+ companies and 265+ drugs in Prostate Cancer Competitive landscape. It covers the therapeutics assessment by product type, stage, and route of administration. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Prostate Cancer: Understanding

Prostate Cancer: Overview

Prostate is a part of male reproductive system located just below the bladder and in front of the rectum. It is about the size of a walnut and surrounds the urethra. Prostate cancer develops when the prostate cell become malignant in nature. It is the second most common malignancy in men worldwide after the lung cancer.

Prostate cancer can be categorized based on the type of cell linings where the cancer has developed. Among the many types of prostate cancer, one is by far the most common and is diagnosed in up to 99% of prostate cancers: prostate cancer. It develops in gland cells that produce prostatic fluid. Adenocarcinoma can occur almost anywhere in the body. They form in glandular epithelial cells that line the inside of organs and secrete mucus, digestive juices, or other fluids. In the prostate, adenocarcinoma is also called glandular prostate cancer.

The molecular pathology of prostate cancer is very complex. In addition to multiple genes, environmental factors such as diet and inflammation are also involved in the pathogenesis of prostate cancer. With the emergence of new investigational tools such as DNA microarray technology, and incorporation of application of application of the field of proteomics to the study of human cancers has made it possible to distinguish indolent from aggressive prostate tumors by molecular fingerprinting. Epidemiologically prostate cancer can be divided into hereditary and sporadic forms. Most of the prostate cancer are sporadic in nature. Polymorphisms associated with increased prostate cancer risk, somatic genetic changes, and factors involved in the progression of prostate cancer, such as the androgen receptor, growth factors, and invasion and metastasis genes can contribute to the development of prostate cancer.

For prostate cancer, radical prostatectomy remains the gold standard for surgical management. Radical prostatectomy (RP) has been demonstrated to improve survival among the patients with an intermediate risk of cancer-specific mortality and healthy life expectancy. During the conventional open prostatectomy, the surgeon operates through a single long skin incision (cut) to remove the prostate and nearby tissues. However, this type of surgery is done less often.

Radical prostatectomy can be done in two ways: Radical retropubic prostatectomy (the surgeon makes an incision in the lower abdomen, from the belly button down to the pubic bone) and Radical perineal prostatectomy (the surgeon makes the incision in the skin between the anus and scrotum the perineum).

Report Highlights:

• In July 2024, Ubix Therapeutics, Inc., announced that it had entered into an exclusive license agreement with Yuhan to develop and commercialize preclinical androgen receptor (AR) degrader program, UBX-103. Under the terms of the agreement, Yuhan will have exclusive, worldwide rights for the preclinical and clinical development and commercialization of UBX-103. Ubix will receive an upfront payment of more than 3.6 million US dollars (5 billion Korean won).
• In June 2024, AstraZeneca announced the successful completion of the acquisition of Fusion Pharmaceuticals Inc. The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments.
• In June 2024, Ensem Therapeutics had partnered with BeiGene to advance ETX-197, now known as BG-68501, into clinical trials. BG-68501 is a potent inhibitor of the cyclin-dependent kinase 2 (CDK2), an enzyme involved in the uncontrolled growth of solid tumors.
• In April 2024, Arvinas announced it had entered into an exclusive strategic license agreement with Novartis for the worldwide development and commercialization of ARV-766, Arvinas' second generation PROTAC androgen receptor (AR) degrader for patients with prostate cancer. The transaction also includes an asset purchase agreement for the sale of Arvinas' AR-V7 program to Novartis.
• In February 2024, Novartis announced that it had entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys. The acquisition, which is subject to customary closing conditions, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer and regulatory approvals, further expands and complements Novartis pipeline in oncology, one of its priority therapeutic areas, while also enhancing Novartis global footprint in hematology.
• In February 2024, AbbVie announced that it had completed acquisition of ImmunoGen. With the completion of the acquisition, ImmunoGen is now part of AbbVie. ImmunoGen's follow-on pipeline of ADCs further builds on AbbVie's existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies.
• In January 2024, LAVA Therapeutics N.V. entered into a clinical trial collaboration and supply agreement with Merck to evaluate its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with LAVA-1207, a Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in metastatic castration-resistant prostate cancer (mCRPC).

Prostate Cancer: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Luye Pharma Group Ltd.

Luye Pharma Group Ltd. is a global pharmaceutical company headquartered in China, specializing in the development, production, and commercialization of innovative and generic drugs. The company has a strong focus on central nervous system (CNS) disorders, oncology, and cardiovascular diseases, with a diverse portfolio that includes both oral and injectable medications. Luye Pharma is known for its research and development capabilities, supported by multiple R&D centers across China, the US, and Europe. The company actively pursues international expansion through strategic acquisitions, partnerships, and a growing presence in key global markets, particularly in Asia and North America.

Product Description: BAITUOWEI

It is a long-acting, extended-release microsphere formulation of the acetate form of goserelin, a synthetic decapeptide analog of luteinizing hormone-releasing hormone (LHRH), with potential antineoplastic activity. Upon administration, goserelin binds to and activates pituitary gonadotropin-releasing hormone (GnRH) receptors. Prolonged administration of goserelin inhibits the secretion of pituitary gonadotropin, thereby decreasing levels of testosterone (in males) and estradiol (in females). Administration of this agent in an extended-release formulation may result in the regression of sex hormone-sensitive tumors and a reduction in sex organ size and function. It was approved by the National Medical Products Administration (NMPA) of the People's Republic of China for the treatment of prostate cancer for patients requiring androgen deprivation therapy (ADT).

2. Company Overview: Dendreon Corporation

Dendreon Corporation is a biotechnology company focused on the development and commercialization of immunotherapy treatments for cancer. The company is best known for Provenge (sipuleucel-T), an autologous cellular immunotherapy for advanced prostate cancer, which was one of the first FDA-approved cancer immunotherapies. Dendreon's innovative approach involves harnessing the patient's own immune system to target and attack cancer cells. The company continues to explore new applications of immunotherapy across different cancer types. Dendreon operates as a subsidiary of Sanpower Group and remains a leader in personalized cancer treatments.

Product Description: PROVENGE

Sipuleucel-T is a therapeutic vaccine that is formulated to stimulate an immune response to prostate cancer cells by targeting prostate acid phosphatase (PAP), a tissue antigen expressed by prostate cancer cells. The therapeutic intent is to generate PAP-specific T cells capable of recognizing and killing prostate cancer cells that express PAP. After radical prostatectomy, the major remaining source of PAP in the body is the cancerous prostate tissue. It is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

3. Company Overview: Pharmaand GmbH

Pharmaand GmbH is a German-based pharmaceutical company specializing in the development and commercialization of high-quality, innovative healthcare solutions. The company focuses on producing generic and specialty medicines, aiming to improve accessibility and affordability for patients. Pharmaand GmbH operates across multiple therapeutic areas and is committed to meeting unmet medical needs through its diverse product portfolio. With a strong emphasis on research, development, and quality manufacturing, the company works to provide effective treatments while maintaining regulatory compliance.

Product Description: RUBRACA

Rucaparib is a PARP (poly ADP-ribose polymerase) inhibitor used in the treatment of prostate cancer, particularly for patients with mutations in DNA repair genes like BRCA1 and BRCA2. PARP enzymes play a critical role in repairing single-strand DNA breaks. In prostate cancer cells with BRCA mutations, DNA repair mechanisms are already compromised, so inhibiting PARP leads to an accumulation of DNA damage, ultimately causing cancer cell death. By blocking the repair of damaged DNA, Rucaparib exploits the vulnerability of these cancer cells, a concept known as "synthetic lethality." This targeted mechanism makes Rucaparib particularly effective for patients with metastatic castration-resistant prostate cancer (mCRPC) who have BRCA mutations or other homologous recombination repair deficiencies.

4. Company Overview: ImPact Biotech

ImPact Biotech is a biotechnology company specializing in the development of innovative cancer therapies. The company is particularly focused on its flagship product, TOOKAD VTP (Vascular Targeted Photodynamic) therapy, which is designed for selective tumor ablation. This therapy aims to provide a non-invasive treatment option that can achieve surgery-like efficacy, making it suitable for patients who may not be eligible for traditional surgical interventions due to various health concerns.

ImPact Biotech is headquartered in Israel, with additional divisions located in the US and France. The company operates a GMP-certified facility and research center in Israel, ensuring compliance with high manufacturing standards.

Product Description: TOOKAD

TOOKAD, developed by ImPact Biotech (formerly Steba Laboratories), is a vascular-targeted photosensitizer used primarily for the treatment of low-risk localized prostate cancer. Its mechanism involves a novel approach known as vascular-targeted photodynamic therapy (VTP), which selectively destroys cancerous tissue while preserving surrounding healthy structures. Once activated, the active substance in Tookad, TOOKAD, triggers the production of high levels of substances known as oxygen radicals, which cause the destruction of the vessels supplying blood to the cancer followed by rapid death of the cancer cells.

TOOKAD operates by being administered intravenously and activated using non-thermal laser light. Upon activation, it induces immediate occlusion of the tumor's blood supply, leading to tumor necrosis and triggering an immune response against the cancer cells. This targeted approach minimizes damage to adjacent healthy tissues, making it a promising option for patients with localized prostate cancer.

Prostate Cancer: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Tavanta Therapeutics

Tavanta Therapeutics (Tavanta), headquartered in King of Prussia Pa., is a clinical stage specialty pharmaceutical company developing a diverse pipeline of specialty drugs designed to bring clinically meaningful benefits to patients with serious or debilitating diseases. Tavanta has developed a risk-balanced approach to discovery and product development by both enhancing the clinical performance of established molecules and synthesizing novel small molecules and therapeutic peptides. Conditions represented in the Tavanta pipeline include metastatic prostate cancer, anal fissures, and cystic fibrosis.

Product Description: TAVT-45

TAVT-45 is an enhanced formulation of abiraterone acetate for the treatment of prostate cancer. TAVT-45 Granules was designed to be an improved formulation of the commercially available Zytiga (abiraterone acetate) tablets and developed using the High Throughput (HT) Matrix Screening Platform at Tavanta. TAVT-45 was also developed to address some of the limitations of current abiraterone treatment, including low bioavailability, high variability in systemic exposure, and large food effect. The drug is currently being evaluated in Phase III clinical trials to treat patients with metastatic castration-resistant prostate cancer (mCRPC).

2. Company Overview: Lantheus

Lantheus is a leading US based company specializing in diagnostic imaging and therapeutic products, primarily serving the oncology, cardiology, and endocrinology markets. Known for its expertise in radiopharmaceuticals and precision diagnostics, Lantheus offers a range of products, including radiotracers, contrast agents, and biomarkers, which are used to detect and monitor diseases at the molecular level. The company's portfolio includes key products like DEFINITY (an ultrasound enhancing agent) and PYLARIFY (a PSMA PET imaging agent for prostate cancer). Lantheus is committed to advancing precision medicine through innovation, with a focus on improving patient outcomes by enabling earlier and more accurate diagnosis and treatment.

Product Description: PNT2002

A radioconjugate composed of PNT2002, 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. The drug is currently being evaluated in Phase III clinical trials to treat patients with metastatic castration-resistant prostate cancer (mCRPC).

3. Company Overview: Madison Vaccines

Madison Vaccines Incorporated (MVI) is a biotechnology firm based in Madison, Wisconsin, focused on developing innovative DNA plasmid immune stimulants specifically for prostate cancer treatment. Founded by Dr. Douglas McNeel and Dr. Richard Lesniewski, MVI aims to address the growing unmet medical need as prostate cancer rates rise among aging populations, particularly affecting African American men disproportionately.

MVI's therapeutic approach involves creating vaccines that activate T-cells to enhance the body's immune response against prostate tumors, aiming to prevent metastases and improve patient quality of life. Their therapies are designed to complement existing treatments, including checkpoint inhibitors and androgen deprivation therapies, thereby maximizing clinical efficacy.

Product Description: MVI-816

MVI-816, also known as pTVG-HP, is a plasmid DNA vaccine developed by Madison Vaccines targeting prostatic acid phosphatase (PAP), a clinically validated antigen for prostate cancer. This vaccine is designed to stimulate the immune system to recognize and attack prostate cancer cells, potentially delaying the onset of bone metastases and improving patient outcomes. The drug is currently being evaluated in Phase II clinical trials to treat patients with Prostate Cancer.

4. Company Overview: Johnson & Johnson Innovative Medicine

Johnson & Johnson Innovative Medicine is a division of Johnson & Johnson focused on discovering and delivering transformative medicines. The division encompasses therapeutic areas such as oncology, immunology, cardiovascular, pulmonary hypertension, and neuroscience. It combines scientific expertise with innovative technologies, leveraging its global research and development network to address unmet medical needs. With a strong commitment to advancing precision medicine, J&J's innovative medicine portfolio includes leading products like Darzalex for multiple myeloma and Tremfya for plaque psoriasis. The division plays a critical role in the company's strategy of bringing innovative therapies to market through strategic partnerships and in-house development.

Product Description: Cetrelimab

Administered intravenously, cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied to treat bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens across the Janssen Oncology portfolio. The drug is currently in Phase II stage of clinical trial evaluation for the treatment of Prostate cancer.

5. Company Overview: Phanes Therapeutics

Phanes Therapeutics is a clinical-stage biotechnology company focused on developing innovative antibody-based therapies for cancer and autoimmune diseases. Founded in 2016 and headquartered in San Diego, California, Phanes leverages its proprietary technology platforms to discover and develop next-generation monoclonal antibodies and multispecific therapeutics. The company aims to target specific pathways in disease progression, thereby improving patient outcomes and addressing unmet medical needs. Their research includes both preclinical and clinical-stage programs, showcasing a commitment to advancing therapeutic options for complex conditions.

The company's lead candidates are designed to engage the immune system in more effective ways, with a strong emphasis on precision medicine. Phanes has established strategic collaborations with various academic institutions and pharmaceutical companies to enhance its research capabilities and accelerate the development of its pipeline. As it progresses through clinical trials, Phanes Therapeutics seeks to position itself as a key player in the biopharmaceutical landscape, focused on creating transformative therapies that can change the treatment paradigm for patients suffering from severe diseases.

Product Description: PT217

PT217 refers to a bispecific antibody that targets DLL3 (delta-like ligand 3) and CD47, currently under investigation for its potential in treating various neuroendocrine tumors. This drug is part of a broader category of therapies that aim to leverage the unique expression profiles of DLL3 in tumor cells for selective targeting, thereby minimizing effects on normal cells.

PT217 functions by binding to DLL3, which is overexpressed in certain tumors. This binding facilitates the internalization of the antibody-drug conjugate, leading to tumor cell death through mechanisms such as apoptosis. The drug's design aims to enhance therapeutic efficacy while reducing systemic toxicity. Currently, the drug is in the Phase I/II stage of its development for the treatment of Neuroendocrine Prostate Cancer.

6. Company Overview: ORCA Therapeutics

ORCA Therapeutics BV is a biopharmaceutical company based in the Netherlands, founded in 2005. The company specializes in developing innovative cancer treatments using oncolytic viruses, particularly through its proprietary Oncolytic Replication Competent Agents (ORCA) technology. This approach leverages highly engineered oncolytic adenoviruses that selectively target and kill cancer cells while stimulating an immune response against tumors.

The lead product of ORCA Therapeutics is ORCA-010, which is being developed for the treatment of prostate cancer. This oncolytic adenovirus has demonstrated significantly higher potency compared to existing therapies, with potential applications across various solid tumors.

Product Description: ORCA-010

The investigational new drug ORCA-010 is a novel and improved oncolytic adenovirus based on the adenovirus serotype 5 (Ad5) genome. ORCA-010 replicates specifically in cancer cells and not in normal tissue cells. Its replication has been shown in a wide variety of cancer cell types, and it is not limited to prostate cancer. ORCA-010 exhibits superior oncolytic potency across 14 different human cancer cell lines. A Phase I/II clinical trial is being evaluated for ORCA-010 to treat Prostate Cancer.

Prostate Cancer Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Prostate Cancer Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Prostate Cancer Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Prostate Cancer Report Assessment

• Company Analysis
• 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 and approved drugs?

Key Players

• Jiangsu HengRui Medicine
• SOTIO
• AB Science
• Bristol Myers Squibb
• Merck
• AstraZeneca
• Madison Vaccines
• Johnson & Johnson
• Antev Ltd.
• Elevation Oncology
• Laekna Therapeutics
• Exelixis
• Regeneron Pharmaceuticals
• Luye Pharma Group
• Dendreon Corporation
• pharmaand GmbH
• Tavanta Therapeutics
• Lantheus
• Phanes Therapeutics
• ORCA Therapeutics

Key Products

• Fluzoparib
• DCVAC/PCa
• Masitinib
• Nivolumab
• Pembrolizumab
• FPI-2265
• MVI 816
• Cetrelimab
• Teverelix-TFA
• Seribantumab
• LAE001
• XL092
• REGN5678
• BAITUOWEI
• PROVENGE
• RUBRACA
• TAVT-45
• PNT2002
• PT217
• ORCA-010