New York, USA, July 11, 2022 (GLOBE NEWSWIRE) -- Metastatic Castration-Resistant Prostate Cancer Clinical Trial Pipeline Insights | DelveInsight
Metastatic castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. The cancer in CRPC no longer responds to hormonal therapy, which includes testosterone-lowering treatments. The clinical trials for the treatment of metastatic castration-resistant prostate cancer are continuously increasing. The major companies involved in the development of potential treatments include AstraZeneca, Janssen, Veru Inc., Hinova Pharmaceuticals, Zenith Epigenetics, Cardiff Oncology, Regeneron Pharmaceuticals, and several others.
DelveInsight’s 'Metastatic Castration-Resistant Prostate Cancer Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline metastatic castration-resistant prostate cancer therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, and future growth potential of the metastatic castration-resistant prostate cancer pipeline domain.
Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report
- DelveInsight’s metastatic castration-resistant prostate cancer pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for metastatic castration-resistant prostate cancer treatment.
- The leading metastatic castration-resistant prostate cancer companies include AstraZeneca, Hinova pharmaceuticals, POINT Biopharma, Exelixis, Tavanta Therapeutics, Pfizer, Zenith Epigenetics, Surface Oncology, Opna-IO LLC, Taiho oncology, Arvinas, Forma therapeutics, ESSA Pharma, Oncternal, Janux Therapeutics, Blue Earth Therapeutics, Arcus Biosciences, Fortis therapeutics, Amgen, Regeneron Pharmaceuticals, Veru Inc, Constellation Pharmaceuticals, Noxopharm Limited, Immunic AG, Accutar Biotechnology Inc, Hinova pharmaceuticals, Novartis, Nuvation Bio, Bayer, Cardiff Oncology, Astellas Pharma, Hoffman-La-Roche, Modra Pharmaceuticals, Bristol Myers Squibb, Bellicum Pharmaceuticals and others are developing novel drug candidates to improve the metastatic castration-resistant prostate cancer treatment landscape.
- Key metastatic castration-resistant prostate cancer therapies in the pipeline and are in various stages of development include Capivasertib, TAVT-45, HC-1119, PNT2002, Cabozantinib, TAVT-45, ZEN-3694, SRF 617, PLX2853, REGN5678, VERU-100, CPI-1205, NOX66, IMU-935, AC176, HP518, NZV930, NIR178, NUV 422, XL092, VERU-111, BAY2315497, Onvansertib, Enfortumab vedotin, Talazoparib, and others.
- In January 2022, Hinova Pharmaceuticals announced that the first patient with metastatic castration-resistant prostate cancer (mCRPC) had been successfully dosed in Phase I clinical trial of HP518, a highly selective and orally bioavailable chimeric degrader targeting androgen receptor (AR). The ongoing open-label Phase I study in Australia will evaluate the safety, pharmacokinetics, and anti-tumor activity of HP518 in patients with mCRPC.
- In December 2021, Accutar Biotechnology announced the FDA clearance of the IND application for Phase I Trial of AC0176 in prostate cancer. Accutar expects to begin enrollment in Phase 1 clinical trial for AC0176 in the first quarter of 2022.
- In April 2022, Janssen announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet plus prednisone, based on the results of the Phase III MAGNITUDE study for the treatment of patients with prostate cancer who have progressed to metastatic castration-resistant prostate cancer (mCRPC) and are positive for homologous recombination repair (HRR) gene alterations. In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2018), for exclusive rights to niraparib in prostate cancer.
- In May 2022, Janux Therapeutics announced that the US Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). JANX007 is the Company’s lead novel T cell engager (TCE) therapeutic from its TRACTr platform. Janux plans to initiate a Phase I clinical trial for JANX007 in the second half of 2022.
- In June 2022, Blue Earth Therapeutics announced results from a series of preclinical analyses designed to evaluate the biodistribution and potential therapeutic efficacy of 177Lu-rhPSMA-10.1 and 177Lu-PSMA-I&T in the treatment of prostate cancer preclinical models. In April 2022, the FDA cleared an investigational new drug application for 177Lu-rhPSMA-10.1 as a potential therapeutic option for patients with metastatic castration-resistant prostate cancer (mCRPC).
- Oncternal is supporting an investigator-sponsored study being conducted at the UC San Diego School of Medicine, a Phase Ib clinical trial of zilovertamab in combination with docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC). In addition, it is also developing ONCT-534, a dual-action androgen receptor inhibitor (DAARI), that is in preclinical development as a potential treatment for castration-resistant prostate cancers, including those with clinically important resistance to approved androgen receptor inhibitors.
- In June 2022, ESSA Pharma Inc. presented clinical results from the Phase Ia dose-escalation study of EPI-7386, ESSA's first-in-class N-terminal domain androgen receptor inhibitor, as a monotherapy for the treatment of patients with metastatic castration-resistant prostate cancer resistant to current standard-of-care therapies. The initial data from 36 patients demonstrated that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily pretreated group of patients. ESSA expects to initiate the Phase Ib expansion study in Q3 2022.
- In May 2022, Arcus Biosciences reported that data analysis from the randomized cohort of ARC-6 evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in second-line metastatic castrate-resistant prostate cancer (CRPC) is anticipated in the second half of 2022 with a presentation of results expected in 2023.
- In February 2022, Arvinas reported that the novel androgen receptor (AR) PROTAC degrader, bavdegalutamide (ARV-110), was found to be clinically active and tolerable with manageable adverse effects (AEs) in Phase I/II clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) following 1 to 2 prior novel hormonal drugs.
- In March 2022, Forma therapeutics reported positive results from Phase I clinical trial evaluating FT-7051. It was well tolerated with signs of clinical activity and continues to enroll men with metastatic castration-resistant prostate cancer (mCRPC). The first evaluable patient completing 12 weeks of treatment demonstrated a >80% decline in prostate-specific antigen (PSA80) from baseline at 16 weeks with stable disease. As of May 2022, 25 patients were enrolled in the Phase I dose-escalation trial, assessing the predicted efficacious exposure range supported by target engagement. Future trial enrollment to include less heavily pre-treated patients and alternative dosing schedules to address adverse events, with updated results expected in the first half of 2023.
Request a sample and discover the recent breakthroughs and advances in metastatic castration-resistant prostate cancer drug treatment @ Metastatic Castration-Resistant Prostate Cancer Pipeline Outlook
The metastatic castration-resistant prostate cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage metastatic castration-resistant prostate cancer products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the metastatic castration-resistant prostate cancer pipeline landscape.
Metastatic Castration-Resistant Prostate Cancer Overview
Castrate-resistant prostate cancer (CRPC) is defined by disease progression despite androgen depletion therapy (ADT), which can manifest as a persistent rise in serum prostate-specific antigen (PSA) levels, progression of pre-existing disease, and the formation of new metastases. Over the years, advanced prostate cancer has been referred to variously as hormone-resistant prostate cancer (HRPC) and androgen-insensitive prostate cancer (AIPC) (AIPC). Recently, the designations CRPC and castration recurrent prostate cancer were coined to recognize the role that intracrine/paracrine androgen synthesis plays in the resistance of prostate cancer cells to testosterone suppression treatment.
While the average 5-year survival rate for prostate cancer is 98.2%, men with metastatic disease have a dismal 30% 5-year metastatic castration-resistant prostate cancer life expectancy.
Men with advanced prostate cancer may or may not have symptoms. Metastatic castration-resistant prostate cancer symptoms vary depending on where cancer develops in the body. With advanced disease, especially if the prostate has not been treated, people may have problems in passing pee or seeing blood in the urine. Some men may get tired, weak, or lose weight.
Find out more about metastatic castration-resistant prostate cancer treatment @ Metastatic Castration-Resistant Prostate Cancer Medication
A snapshot of the Metastatic Castration-Resistant Prostate Cancer Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| Capivasertib | AstraZeneca | Phase III | Proto oncogene protein c-akt inhibitors | Oral |
| TAVT-45 | Tavanta Therapeutics | Phase III | CYP17A1 protein inhibitors | Oral |
| VERU-111 | Veru Inc. | Phase III | Tubulin inhibitors; Tubulin polymerisation inhibitors | Oral |
| HC-1119 | Hinova Pharmaceuticals | Phase III | Androgen receptor antagonists | Oral |
| ZEN-3694 | Zenith Epigenetics | Phase II | Bromodomain and extraterminal domain protein inhibitors | Oral |
| SRF 617 | Surface Oncology | Phase II | Antibody-dependent cell cytotoxicity; CD39 antigen inhibitors; T lymphocyte stimulants | Parenteral |
| Vudalimab | Xencor | Phase II | Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants | Intravenous |
| Onvansertib | Cardiff Oncology | Phase II | Polo-like kinase 1 inhibitors | Oral |
| AZD4635 | AstraZeneca | Phase II | Adenosine A2A receptor antagonists | Oral |
| REGN4336 | Regeneron Pharmaceuticals | Phase I/II | Antibody-dependent cell cytotoxicity | Subcutaneous |
| TQB-3823 | Chia Tai Tianqing Pharmaceutical Group | Phase I/II | Poly(ADP-ribose) polymerase inhibitors | Oral |
| FOR46 | Fortis Therapeutics | Phase I/II | NA | Intravenous |
| AC0176 | Accutar Biotechnology | Phase I | Androgen receptor degradation enhancers | Oral |
| HP518 | Hinova | Phase I | Proteolysis | Oral |
| TAS3681 | Taiho Pharmaceuticals | Phase I | Androgen receptor antagonists | Oral |
Learn more about the novel and emerging metastatic castration-resistant prostate cancer therapies @ Metastatic Castration-Resistant Prostate Cancer Clinical Trials
Metastatic Castration-Resistant Prostate Cancer Therapeutics Assessment
The metastatic castration-resistant prostate cancer pipeline report proffers an integral view of the Metastatic Castration-Resistant Prostate Cancer emerging novel therapies segmented by Stage, Product Type, Molecule Type, Mechanism of Action, and Route of Administration.
Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous
- Therapeutics Assessment By Molecule Type: Small molecule, Monoclonal Antibody, Immunotherapy
- Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, CD39 antigen inhibitors, T lymphocyte stimulants, Bromodomain and extraterminal domain protein inhibitors, BRD4 protein inhibitors, Androgen receptor degradation enhancers, Proteolysis, Androgen receptor antagonists, Poly(ADP-ribose) polymerase inhibitors, Adenosine A2A receptor antagonists, Immunomodulators; T lymphocyte stimulants, Protein tyrosine kinase inhibitors, Proto-oncogene protein c met inhibitors, Vascular endothelial growth factor receptor antagonists
- Key Metastatic Castration-Resistant Prostate Cancer Companies: AstraZeneca, Hinova pharmaceuticals, POINT Biopharma, Exelixis, Tavanta Therapeutics, Pfizer, Zenith Epigenetics, Surface Oncology, Opna-IO LLC, Taiho oncology, Arvinas, Forma therapeutics, ESSA Pharma, Oncternal, Janux Therapeutics, Blue Earth Therapeutics, Arcus Biosciences, Fortis therapeutics, Amgen, Regeneron Pharmaceuticals, Veru Inc, Constellation Pharmaceuticals, Noxopharm Limited, Immunic AG, Accutar Biotechnology Inc, Hinova pharmaceuticals, Novartis, Nuvation Bio, Bayer, Cardiff Oncology, Astellas Pharma, Hoffman-La-Roche, Modra Pharmaceuticals, Bristol Myers Squibb, Bellicum Pharmaceuticals, and others
- Key Metastatic Castration-Resistant Prostate Cancer Pipeline Therapies: Capivasertib, TAVT-45, HC-1119, PNT2002, Cabozantinib, TAVT-45, ZEN-3694, SRF 617, PLX2853, REGN5678, VERU-100, CPI-1205, NOX66, IMU-935, AC176, HP518, NZV930, NIR178, NUV 422, XL092, VERU-111, BAY2315497, Onvansertib, Enfortumab vedotin, Talazoparib, and others
Dive deep into rich insights into new metastatic castration-resistant prostate cancer treatment drugs, visit @ Metastatic Castration-Resistant Prostate Cancer Drug Treatment Guidelines
Table of Contents
| 1. | Introduction |
| 2. | Executive Summary |
| 3. | Metastatic Castration-Resistant Prostate Cancer Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Metastatic Castration-Resistant Prostate Cancer Pipeline Therapeutics |
| 6. | Metastatic Castration-Resistant Prostate Cancer Pipeline: Late Stage Products (Phase III) |
| 6.1 | Capivasertib: AstraZeneca |
| 7. | Metastatic Castration-Resistant Prostate Cancer Pipeline: Mid Stage Products (Phase II) |
| 7.1 | ZEN-3694: Zenith Epigenetics |
| 8. | Metastatic Castration-Resistant Prostate Cancer Pipeline: Early Stage Products (Phase I) |
| 8.1 | AC0176: Accutar Biotechnology |
| 9. | Metastatic Castration-Resistant Prostate Cancer Pipeline: Preclinical Stage Products |
| 10. | Metastatic Castration-Resistant Prostate Cancer Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Metastatic Castration-Resistant Prostate Cancer Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies in the Metastatic Castration-Resistant Prostate Cancer Pipeline |
| 14. | Key Products in the Metastatic Castration-Resistant Prostate Cancer Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the metastatic castration-resistant prostate cancer pipeline therapeutics, reach out @ Metastatic Castration-Resistant Prostate Cancer Drugs
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