
AI-generated summary
RigaChem Bioscience is developing various cancer treatment candidates based on the antibody-drug conjugate (ADC) platform technology 'Conjuol' and has been jointly developing SOT106 through technology transfer with its partner Sothio Biotech.
RigaChem Bioscience announced on the 28th that its partner Sothio Biotech's LRRC15 targeting antibody/drug conjugate (ADC) 'SOT106' has been additionally designated as an orphan drug/fast track by the U.S. Food and Drug Administration (FDA).
RigaChem's ADC platform technology 'Conjuol' was applied to SOT106. Rigachem signed an ADC platform technology transfer agreement with Sotio in November 2021, and SOT106 is the first ADC new drug candidate made by Sotio through this contract.
This time, the indications for which the FDA designated SOT106 as an orphan drug and fast track are soft tissue sarcoma and osteosarcoma, respectively.
Accordingly, Rigachem reported that SOT106 has been designated as an orphan drug and fast track by the FDA for both soft tissue sarcoma and osteosarcoma indications.
Orphan drugs and fast tracks are systems for developing treatments for rare diseases or areas with high unmet demand, and provide various benefits, including communication with regulatory authorities.
It is known that SOT106 has been confirmed to have strong anti-tumor effects and tolerability in preclinical trials.
SOTIO plans to begin clinical trials for SOT106 within the year.
Meanwhile, RigaChem announced that the American corporation AntibodyChem Bioscience (ACB) announced the results of preclinical research on the BCMA-targeted ADC being developed as a treatment for multiple myeloma at the International Myeloma Society conference held in Glasgow, England from the 23rd to the 26th.
RigaChem explained that its ADC new drug candidate 'LCB43' using Conjuol showed excellent anti-tumor effect and good tolerability in preclinical trials.
Rigachem added that ocular toxicity was pointed out as a problem with the existing product 'Blenrep', which proved the value of BCMA ADC, but LCB43 is expected to be able to improve this problem.
A RigaChem official said, โWe will proceed with the submission of the clinical trial plan (IND) for LCB43 without a hitch within the year and quickly enter global clinical trials.โ
AI outlook โ possibilities, not facts
RigaChem will submit an clinical trial plan (IND) for LCB43 within the year.
Very likely ยท Within months
SOTIO will begin clinical trials of SOT106 within the year.
Very likely ยท Within months

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