Immunomodulation vaccine! FDA grants IO102/IO103 breakthrough drug eligibility: 79% overall remission rate for first-line treatment of melanoma with combined O drug

December 16, 2020 // -- IO Biotech is a clinical biotech company dedicated to the development of breakthrough immunotherapy for cancer.
the company's first immunomodulated anti-cancer therapy pipeline, developed by the unique technology platform T-win® to activate immunosuppressive molecularly specific T cells.
, the company announced that the U.S. Food and Drug Administration (FDA) has granted IO102 and IO103 combined anti-PD-1 monoantial combination therapy to treat non-removable/metastasis melanoma patients with breakthrough drug eligibility (BTD).
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug has significantly improved one or more clinically significant endpoints compared to existing drugs.
access to BTD drugs and closer guidance at the time of development, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
IO102 and IO103 are leading immuno-oncology candidates for IO Biotech.
Both compounds are based on IO Biotech's patented T-win® technology platform, which identifies compounds with dual mechanisms that target and directly kill immunosuppressive and tumor cells, while indirectly activating other T-effectors to produce powerful anti-tumor responses without adding additional security.
specifically, IO102 and IO103 are a class of pioneering (first-in-class) immunomodulation vaccines, IO102 contains a segment of IDO (pyridine 2,3-double oxygenase) derived peptide sequence, IO103 contains a PD-L1 derived peptide sequence, designed to activate IDO and PD-L1 specific human regulatory T cells.
T-win immunomodulation vaccine - mechanism of action (Photo: IO Biotech) - Click on the image to view the graph of this BTD qualification, based on data from the MM1636 Phase 1/2 clinical trial.
the trial evaluated IO102, IO103, and anti-PD-1 therapies in 30 patients with metastasis melanoma.
Phase 2, the patient received the multi-antigen vaccine IO102-IO103 combined anti-PD-1 monoantiopdivo (Odivo, generic name: nivolumab, Navuliyu monoanti) as a first-line treatment.
study, IO102-IO103 was given every 2 weeks for up to 12 weeks, followed by every 4 weeks for up to 1 year.
the trial was designed to assess safety, immune response to blood and biopsies, and efficacy.
Based on the latest summary data recently presented at the 2020 Virtual Congress of the European Society of Medical Oncology (ESMO), the combination of IO102 vaccine and IO103 vaccine plus Opdivo has been shown to be safe, and the early efficacy data are encouraging: 79% of patients have remission (total remission rate (ORR) 79%), and 45% of patients have complete remission or complete tumor disappearance (complete remission rate (CR) 45%).
-specific T-cells were found in individual nuclear cells (PBMCs) and tumor sites in the outer blood.
, about 290,000 new cases of melanoma (the most invasive skin cancer) are diagnosed each year and more than 60,000 deaths are reported.
incidence of skin melanoma is increasing, and advanced melanoma (non-removable or metastasis) can have fatal consequences if left untreated.
total medium survival (OS) in patients with stage melanoma (untreated or treated with BRAF inhibitors and MEK inhibitors) was between 22 and 25 months, with a survival rate of about 40% over 3-5 years.
, there is a significant unseeded medical need for improved combination therapies that improve anti-PD-1 efficacy without significantly increasing toxicity. Dr Mai Britt Zocca, CEO and Founder of
IO Biotech, said: "A breakthrough designation is a rapid plan in which the FDA will work closely with IO Biotechnology to develop the synthetic peptide vaccine (IO103) that encodes human PD-L1 (9-27) and (IO102), Providing guidance for the treatment of non-excisive/metastasis melanomas for IDO, pyridine 2, 3-double oxygenase and anti-PD-1", "including providing recommendations to support the evidence required to support drug approval in an effective and potentially expedited manner," said IO Biotech' clinical program, which we are committed to bringing to patients as quickly as possible.
"s original origin: The Food and Drug Administration (FDA) grants IO Biotech profile therapy designation for IO102 and IO103 in composition with anti-PD-1 in unresectable/metastatic melanoma