FDA Grants Orphan Drug Designation to IMCgp100 for Uveal Melanoma

“The FDA granted orphan drug designation to IMCgp100 for the treatment of uveal melanoma.

“IMCgp100 (Immunocore) is part of a class of bispecific biologic reagents known as ImmTACs, or immune-mobilizing monoclonal T-cell receptors against cancer.

“The agents combine a T-cell receptor-based targeting system with an anti-CD3 effector function designed to activate a specific and potent T-cell response to recognize and destroy cancer cells, according to Immunocore.”


New Collaboration Leads to Combo Experimental Therapy for Metastatic Melanoma

“Pharmaceutical companies are teaming up to combine experimental therapies that may help combat metastatic cutaneous and uveal melanomas in a whole new way. The novel international collaboration may bring new combined targeted therapies to the market much sooner.

“Eli Lilly and Immunocore Limited are collaborating in immunotherapy-based clinical trials to evaluate the utility of Immunocore’s lead T-cell receptor-based investigational drug IMCgp100. This agent will be combined with Lilly’s galunisertib (LY2157299) and merestinib (LY2801653) for melanoma treatment. The investigators will explore the durability and efficacy of potential combined regimens in patients with metastatic cutaneous and uveal melanomas.

“ ‘Combining our ImmTAC, IMCgp100 with Lilly’s galunisertib and merestinib has the potential to transform the treatment of metastatic cutaneous and uveal melanoma. Immunocore is committed to the development of IMCgp100 in metastatic uveal and cutaneous melanoma where there is such great unmet medical need,’ said Eliot Forster, who is chief executive officer of Immunocore, Oxford, England.”


New Immunotherapy Yields Long-Lasting Responses in Some Patients with Advanced Melanoma

“A first-in-class immunotherapy called IMCgp100 yielded durable responses in patients with advanced cutaneous melanoma and those with advanced ocular melanoma, according to data from a phase I/IIa clinical trial presented here at the AACR Annual Meeting 2015, April 18-22.

” ‘IMCgp100 is a new type of immunotherapy that has two functional ends,’ said Mark R. Middleton, MD, PhD, professor of experimental cancer medicine at the University of Oxford in the United Kingdom. ‘The targeting end attaches to melanoma cells and the effector end locks on to any neighboring killer T cell [a type of immune cell], resulting in directed destruction of the tumor. One can think of IMCgp100 as a molecular bridge connecting melanoma cells with killer T cells, encouraging the killer T cells to destroy the melanoma cells.

” ‘Last year at the AACR Annual Meeting, we reported the results of the phase I dose-escalation portion of the clinical trial, which showed that IMCgp100 was well tolerated and had efficacy in some patients with advanced melanoma,’ continued Middleton. ‘This year, we are reporting data from 17 patients treated with the maximum tolerated dose of 600 nanograms of IMCgp100 per kilogram or an absolute dose of 50 micrograms of IMCgp100 as part of the phase I and phase IIa portions of the trial.’ “


Melanoma Treatment 2014: Emerging News


Immunotherapy may be patients’ biggest hope for transforming cancer treatment. This approach boosts a patient’s own immune system to fight cancer. More and more immunotherapy treatments are showing promise for more and more patients, and Science magazine named immunotherapies 2013’s Breakthrough of the Year. Continue reading…


Experimental Drug Shows Early Promise for Some Cases of Advanced Melanoma

“An experimental cancer drug that activates the immune system has shown early promise for advanced cases of melanoma skin cancer, researchers report.

“The findings come from an early stage trial of just 31 patients. But experts were cautiously optimistic about what the study showed: The drug’s side effects were manageable, and four patients saw their tumors shrink.

“That’s a small number, but a trial like this is largely aimed at seeing whether a drug is safe and finding a tolerable dose.”

Editor’s note: This story is about a new melanoma drug called IMCgp100 that is being tested in patients. Learn more about immunotherapy drugs and clinical trials for melanoma here.


New Melanoma Immunotherapy Advances in Early Trials

On the strength of a promising phase I clinical trial, evaluations are continuing for an experimental immunotherapy that targets and selectively kills melanoma cells. Called IMCgp100, the drug has two parts that are fused together. One part is an immune system protein that has been engineered to recognize a protein called gp100, which is on the surface of melanoma cells. The other part of the new drug is a protein fragment that boosts the immune response against the tumor. The phase II trial of IMCgp100 is currently recruiting new participants.