Verismo Therapeutics’ SynKIR-110 receives fast track designation from FDA
SynKIR-110 is an investigational drug to treat mesothelin-expressing mesothelioma, ovarian cancer and cholangiocarcinoma.
Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110.
The investigational drug has been developed for treating patients with mesothelioma, a rare type of cancer that impacts abdominal cavities or the chest lining.
Fast-track designation is intended to help accelerate the review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs.
Clinical programs which are granted this designation may also apply for accelerated approval and priority review, subject to meeting relevant criteria.
Verismo Therapeutics CEO, DMD and co-founder Dr Bryan Kim said: “We are thrilled to receive Fast Track designation from the FDA.
“This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment options.”
SynKIR-110 is an investigational drug to treat serious diseases and life-threatening conditions, specifically mesothelin-expressing mesothelioma, ovarian cancer and cholangiocarcinoma.
The new designation has been awarded to Verismo Therapeutics around seven months after it received orphan drug designation (ODD) from the US FDA for SynKIR-110 cell therapy.
Currently, Verismo Therapeutics is carrying out a Phase I multi-centre clinical trial to assess the anti-tumour activity, safety and feasibility of this investigational new drug.
The company is leveraging its novel KIR-CAR technology, a dual-chain CAR-T cell therapy, to develop new treatments for life-threatening medical conditions.
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