Tumor vaccine and PD1, melanoma patients with complete remission rate of 45%! Obtained fda breakthrough therapy

On December 15, IO Biotech announced that the FDA has awarded its development of a breakthrough therapy for tumor vaccines IO102 and IO103 in combination with anti-PD-1 monoantial therapy for non-removable/metastasis melanoma.
phase I/II clinical study code-named MM1636 included 30 patients with metastasis melanoma who received the Navuliyu single anti-combined tumor vaccine IO102 and IO103 as first-line treatment.
patients received Narvulyu monotherapy every 2 weeks, IO102 and IO103 were injected every 2 weeks, and after 6 injections of IO102 and IO103, they were given 4 weeks until one year.
the safety of the combination therapy, the immune response in blood and biopsies, and its efficacy.
the medium follow-up time was 15 months, 1 patient was awaiting evaluation, 29 patients were assessed for efficacy, the overall remission rate (ORR) was 79%, and the ORR in PD-L1-positive and negative patients was 94% and 62%, respectively.
data cut-off period, 45 percent of patients were fully relieved and 34 percent were partially relieved, significantly higher than the PD-1 single-drug standard therapy control data extracted from the Danish metastasis melanoma database.
-progress-free lifetime (mPFS) was 25.6 months.
, in addition to local reactions at the vaccination site, the toxicity of the combination therapy was comparable to that of Narvulyu monotherapy.
vaccine-specific T-cells for IDO and/or PD-L1 can be detected in all patients treated with periterymic blood monocytes (PBMC) and tumor sites.
IO102 and IO103 are IO companies based on their T-win? The first-in-class immunomodulation vaccine developed by the technology platform is capable of participating in and activating IDO and PD-L1-specific human T-cells, thus having a dual mechanism of action that can target and directly kill immunosuppressive cells and tumor cells, while indirectly activating other T-effect cells to produce strong anti-tumor activity.
melanoma is a highly malignant tumor of melanin cell origin, which occurs mostly in the skin and can also be seen in the mucous membranes, internal organs, under the eyes, or the original lesions are unknown.
about 200,000 people worldwide are diagnosed with melanoma each year, with 90 percent of white melanomas being non-limb skin types and Chinese groups dominated by mucous membranes and limb skin types.
than other solid tumors, melanoma, with the exception of early surgical cut, lacks special treatment, poor prognosis, and lower age of death.
Most melanomas have MAPK signaling path factor activation, such as BRAF, NRAS, NF1 mutations, of which NRAS activation mutation accounted for 15% to 25%, BRAF activation mutation accounted for 40%-60%, Dalafinib and Cymotinib, Vimofinib and other drugs approved for melanoma to provide an oral targeted combination therapy.
In addition, melanoma is generally considered to be the most immunogenic solid tumor, so highly sensitive to immunotherapy, keytruda, Opdivo and other PD1 monoantigens were first approved for the adaptation of melanoma, providing BRAF inhibitor resistance patients with a new option for second-line treatment.
but when patients with advanced melanoma are also resistant to PD1 drugs, they face a drug-free situation.
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