New York, USA, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Rich Insights Into The Robust Metastatic Melanoma Clinical Trials Pipeline Analysis Featuring 75+ Companies DelveInsight
The prevalence of skin cancer has been rising since the past few years, which prompts at the growing demand for treatment options. The emergence of effective immunotherapies is boosting the market. The companies developing the potential therapies in late-stage of development include HUYABIO International, LLC., IO Biotech, Nektar Therapeutics, Checkmate Pharmaceuticals, and several others.
DelveInsight’s 'Metastatic Melanoma Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline Metastatic Melanoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Metastatic Melanoma pipeline domain.
Key Takeaways from the Metastatic Melanoma Pipeline Report
- DelveInsight’s metastatic melanoma pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for metastatic melanoma treatment.
- Key metastatic melanoma companies such as Evaxion Biotech, InxMed, AiVita Biomedical, Iovance Biotherapeutics, Viralytics, Merck & Co., Neon Therapeutics, BioNTech, Bristol-Myers Squibb, Ono Pharmaceuticals, Cytovation AS, Biocad, Apexigen, Checkmate Pharmaceutical, Nektar therapeutics, HUYABIO International, LLC., IO Biotech, Bristol Myers Squibb, Karyopharm Therapeutics, Zucero Therapeutics, GlaxoSmithKline, Tesaro, Inc., Ultimovacs ASA, Eucure (Beijing) Biopharma Co., Ltd, Incyte Corporation, Philogen S.p.A., Ascentage Pharma, Exelixis/Ipsen, NovoCure Ltd., Hoffman-La-Roche, Provectus Biopharmaceuticals, BerGenBio ASA, Idera Pharmaceuticals, Celgene Corporation, Novartis, Taizhou Hanzhong biomedical co. LTD, Scancell Ltd, BioMed Valley Discoveries, Inc., Nykode Therapeutics, Sapience Therapeutics, BeiGene, Immunocore, Achilles Therapeutics UK Limited, Vanquish Oncology, Syntrix Biosystems, Inc., TILT Biotherapeutics, PrimeVax Immuno-Oncology Inc., Celldex Therapeutics, Taiga Biotechnologies, Inc., Galectin Therapeutics Inc, Foghorn Therapeutics Inc., TriSalus Life Sciences, Inc., Miltenyi Biomedicine GmbH, CytomX Therapeutics, Inc., Seagen Inc., Immutep, Regeneron pharmaceuticals, Adaptimmune, IDEAYA Biosciences, PokeAcell, Ultimovacs ASA, Verastem, Inc., PACT Pharma, Actuate Therapeutics, Inc., and others are evaluating new drugs for metastatic melanoma to improve the treatment landscape.
- Promising metastatic melanoma pipeline therapies in various stages of development include EVX 01, IN 10018, AV MEL 1, Lifileucel, V937, NEO-PTC-01, Relatlimab, CyPep-1, HBI-8000, NKTR-214,CMP-001, IO102-IO103, EVX-01, APX005M, BCD-217, Dostarlimab, LXH254, Niraparib, BNT111, UV1, YH003, Retifanlimab, L19IL2+L19TNF, Pexa-Vec, APG-115, Cabozantinib, RO7247669, PV-10, BGB324, VB10.NEO, IMO-2125, ABI-007, HX008, BVD-523, IOV-4001, ST101, BGB-10188, DYP688, ATL001, PAC-1, IN10018, SX-682, TILT-123, PV-001-DC, CDX-301, TBX-3400, GR-MD-02, FHD-286, SD-101, MB-CART20.1, BMS-986249, SEA-CD40, LAG525, Fianlimab, ADP-TILIL7, Poke-101, and others.
- In July 2022, Obsidian Therapeutics, Inc. announced that the US FDA cleared an Investigational New Drug application for an MD Anderson-sponsored Phase I clinical study of OBX-115, Obsidian's lead engineered tumor infiltrating lymphocyte (TIL) therapy candidate. OBX-115 has been developed in collaboration with MD Anderson as part of an agreement announced in 2020. The planned first-in-human single-arm, open-label, Phase I study will evaluate the safety and preliminary efficacy of OBX-115 as monotherapy in adult patients with metastatic melanoma who are relapsed or refractory to prior therapeutic regimens containing anti-PD-1 antibodies.
- In July 2022, Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of nivolumab and relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.
- Iovance held a successful pre-BLA meeting with the US FDA in late July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel in metastatic melanoma this month and complete the submission during the fourth quarter.
- In June 2022, Immunocore Holdings Plc entered into a clinical trial collaboration and supply agreement with Sanofi. Under the agreement, Sanofi will evaluate its precisely PEGylated, engineered version of IL-2, SAR444245, in combination with KIMMTRAK, Immunocore’s novel bispecific protein targeting gp100, in HLA-A*02:01 positive patients with advanced unresectable or metastatic skin cancers as part of Sanofi’s ongoing Phase I/II study.
- In March 2022, US FDA granted Fast Track designation to 7HP349, 7Hill Pharma’s lead clinical-stage immunostimulant, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.
- In March 2022, FDA approved Bristol-Myers Squibb Company’s Opdualag (nivolumab and relatlimab-rmbw) for use in adults and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The drug is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
- In January 2022, Immunocore announced approval from the United States Food and Drug Administration of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021.The approval was granted four weeks ahead of the assigned PDUFA date of February 23, 2022.
Request a sample and discover the recent advances in metastatic melanoma treatment drugs @ Metastatic Melanoma Clinical Trial Outlook
The metastatic melanoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage metastatic melanoma products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the metastatic melanoma pipeline landscape.
Metastatic Melanoma Overview
Melanoma is the third most frequent cutaneous cancer, following basal cell carcinoma and squamous cell carcinoma. Melanoma is the fifth most prevalent cancer in men and the sixth most common malignancy in women. According to the American Cancer Society, the five-year metastatic melanoma survival rate for persons diagnosed with melanoma that has spread to adjacent lymph nodes is 66%.
The radiation from the UV rays is among the major metastatic melanoma causes. Fatigue, swollen or painful lymph nodes, weight loss, lack of appetite, difficulty breathing or a persistent cough, bone pain, migraines, seizures, and liver swelling are all metastatic melanoma symptoms. The doctor will perform a skin inspection during the melanoma diagnosis process. A biopsy would be required if they suspect the patient has skin cancer, a biopsy would be required.
Find out more about metastatic melanoma treatment drugs @ Chemo Drugs for Metastatic Melanoma
A snapshot of the Metastatic Melanoma Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| HBI-8000 | HUYABIO International, LLC. | Phase III | 1 Phosphatidylinositol 3 kinase inhibitor | Oral |
| IO102-IO103 | IO Biotech | Phase III | Cytotoxic T lymphocyte stimulants | Subcutaneous |
| CMP-001 | Checkmate Pharmaceuticals | Phase II/III | Immunostimulants; Toll-like receptor 9 agonists | Intratumoral |
| EVX-01 | Evaxion Biosciences | Phase II | Immunostimulants | Intramuscular |
| APX005M | Apexigen, Inc. | Phase II | Antibody-dependent cell cytotoxicity; Apoptosis stimulants; CD40 antigen stimulants; Immunostimulants | Intravenous |
| BCD-217 | Biocad | Phase II | Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; Programmed cell death-1 receptor antagonists; T lymphocyte stimulants | Intravenous |
| Pixatimod | Zucero Therapeutics | Phase II | Dendritic cell stimulants | Intravenous |
| Selinexor | Karyopharm Therapeutics | Phase II | Exportin-1 protein inhibitors | Oral |
| Relatlimab | Bristol-Myers Squibb | Phase II | Antibody-dependent cell cytotoxicity; CD223 antigen inhibitors; T lymphocyte stimulants | Intravenous |
| V937 | Viralytics | Phase II | CD55 antigen inhibitors; Cell death stimulants; Intercellular adhesion molecule 1 antagonists | |
| VB10.NEO | Nykode Therapeutics | Phase I/II | Immunostimulants | Intramuscular |
| RO7247669 | Hoffmann-La Roche | Phase I/II | Antibody-dependent cell cytotoxicity; CD223 antigen inhibitors; Programmed cell death-1 receptor antagonists; T lymphocyte stimulants | Intravenous |
| NEO-PTC-01 | BioNTech | Phase I | Immunologic cytotoxicity; Immunostimulants; T lymphocyte replacements | Intravenous |
| TILT-123 | TILT Biotherapeutics | Phase I | Cell death stimulants; Immunologic cytotoxicity; Interleukin-2 expression stimulants; Tumour necrosis factor alpha stimulants | Intratumoural |
| AV MEL 1 | AiVita Biomedical | Phase I | Immunostimulants | Parenteral |
Learn more about the novel and emerging metastatic melanoma pipeline therapies @ Metastatic Melanoma Clinical Trials
Metastatic Melanoma Therapeutics Assessment
The metastatic melanoma pipeline report proffers an integral view of the metastatic melanoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Metastatic Melanoma 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: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: Immunostimulants, Focal adhesion protein-tyrosine kinase inhibitors, PTK2 protein inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, CD55 antigen inhibitors, Cell death stimulants, Intercellular adhesion molecule 1 antagonists, CXCR4 receptor antagonists, Mitogen activated protein kinase 3 inhibitors; Mitogen-activated protein kinase 1 inhibitors
- Key Metastatic Melanoma Companies: Evaxion Biotech, InxMed, AiVita Biomedical, Iovance Biotherapeutics, Viralytics, Merck & Co., Neon Therapeutics, BioNTech, Bristol-Myers Squibb, Ono Pharmaceuticals, Cytovation AS, Biocad, Apexigen, Checkmate Pharmaceutical, Nektar therapeutics, HUYABIO International, LLC., IO Biotech, Bristol Myers Squibb, Karyopharm Therapeutics, Zucero Therapeutics, GlaxoSmithKline, Tesaro, Inc., Ultimovacs ASA, Eucure (Beijing) Biopharma Co., Ltd, Incyte Corporation, Philogen S.p.A., Ascentage Pharma, Exelixis/Ipsen, NovoCure Ltd., Hoffman-La-Roche, Provectus Biopharmaceuticals, BerGenBio ASA, Idera Pharmaceuticals, Celgene Corporation, Novartis, Taizhou Hanzhong biomedical co. LTD, Scancell Ltd, BioMed Valley Discoveries, Inc., Nykode Therapeutics, Sapience Therapeutics, BeiGene, Immunocore, Achilles Therapeutics UK Limited, Vanquish Oncology, Syntrix Biosystems, Inc., TILT Biotherapeutics, PrimeVax Immuno-Oncology Inc., Celldex Therapeutics, Taiga Biotechnologies, Inc., Galectin Therapeutics Inc, Foghorn Therapeutics Inc., TriSalus Life Sciences, Inc., Miltenyi Biomedicine GmbH, CytomX Therapeutics, Inc., Seagen Inc., Immutep, Regeneron pharmaceuticals, Adaptimmune, IDEAYA Biosciences, PokeAcell, Ultimovacs ASA, Verastem, Inc., PACT Pharma, Actuate Therapeutics, Inc., and others
- Key Metastatic Melanoma Pipeline Therapies: EVX 01, IN 10018, AV MEL 1, Lifileucel, V937, NEO-PTC-01, Relatlimab, CyPep-1, HBI-8000, NKTR-214,CMP-001, IO102-IO103, EVX-01, APX005M, BCD-217, Dostarlimab, LXH254, Niraparib, BNT111, UV1, YH003, Retifanlimab, L19IL2+L19TNF, Pexa-Vec, APG-115, Cabozantinib, RO7247669, PV-10, BGB324, VB10.NEO, IMO-2125, ABI-007, HX008, BVD-523, IOV-4001, ST101, BGB-10188, DYP688, ATL001, PAC-1, IN10018, SX-682, TILT-123, PV-001-DC, CDX-301, TBX-3400, GR-MD-02, FHD-286, SD-101, MB-CART20.1, BMS-986249, SEA-CD40, LAG525, Fianlimab, ADP-TILIL7, Poke-101, and others.
Dive deep into rich insights for new drugs for metastatic melanoma treatment, visit @ Metastatic Melanoma Treatment Drugs
Table of Contents
| 1. | Metastatic Melanoma Pipeline Report Introduction |
| 2. | Metastatic Melanoma Pipeline Report Executive Summary |
| 3. | Metastatic Melanoma Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Metastatic Melanoma Pipeline Therapeutics |
| 6. | Metastatic Melanoma Pipeline: Late Stage Products (Pre-registration) |
| 7. | Metastatic Melanoma Pipeline: Late Stage Products (Phase III) |
| 7.1 | IO102-IO103: IO Biotech |
| 8. | Metastatic Melanoma Pipeline: Mid Stage Products (Phase II) |
| 8.1 | Pixatimod: Zucero Therapeutics |
| 9. | Metastatic Melanoma Pipeline: Early Stage Products (Phase I) |
| 9.1 | TILT-123: TILT Biotherapeutics |
| 10. | Metastatic Melanoma Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Metastatic Melanoma Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Metastatic Melanoma 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 melanoma pipeline therapeutics, reach out @ New Drugs for Metastatic Melanoma Treatment
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