Business
TMAC Programme Accelerates
TMAC Programme Accelerates.
About this update from Avacta Group Plc
[{"type":"text","content":"\n \nRNS Number : 8177A Avacta Group PLC 03 June 2019 \n\n \n3 June 2019\nAvacta Group plc\n(\"Avacta\", the \"Company\" or the \"Group\")\n \nTMAC Programme Accelerates: Clinical Trial Planned for Early 2020\n \nKey linker element of Avacta's novel TMACTM drug conjugate to be tested in humans within 12 months\n \nAvacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and research reagents, announces that it is planning to submit an IND/CTA application early in 2020 to test the TMACTM linker in a phase I study in patients with selected solid tumours. \nIn an acceleration of the TMAC programme, Avacta is now in a position to test this critical TMAC linker in humans, a major de-risking milestone for the programme, early in 2020 and well ahead of its original plans. \nAvacta's tumour microenvironment activated drug conjugates (TMAC) are a ground-breaking new form of cancer immunotherapy, co-invented with Tufts University Medical School, combining Affimers with chemotherapies in a single drug using a linker that is designed to only release the chemotherapy in the tumour microenvironment. This allows extremely potent chemotherapies, too potent to be given to patients systemically, to be combined with Affimer immune-checkpoint therapies.\nIn order to test the TMAC linker in humans for the first time, a standard-of-care chemotherapy called doxorubicin has been modified with the linker rendering it inactive and harmless until the linker is cleaved in the tumour releasing active doxorubicin. Doxorubicin has well documented safety issues limiting its dosing, and also limiting the patient sub-group that can be treated. Despite these issues, the global doxorubicin market is valued at $910m and is expected to reach $1.4bn by the end of 2025[1]. Avacta's TMAC linker has been shown to increase the maximum tolerated dose of doxorubicin by a factor of six in a pre-clinical study in mice. \nAvacta plans to submit an IND/CTA application for a phase I clinical study of the TMAC linker-doxorubicin early in 2020. The phase I trial will comprise a dose escalation study in patients with selected solid tumours including advanced and metastatic high-grade soft tissue sarcoma. Successful functioning of the TMAC linker will be reflected in tumour shrinkage as a result of t...