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LONDON & WETHERBY, England--(BUSINESS WIRE)--Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, today announces that the fifth dose escalation cohort in the ALS-6000-101 dose escalation Phase 1 clinical trial to evaluate the safety and tolerability of AVA6000 has been completed successfully. The data continue to show a very favourable safety profile for the tumour targeted chemotherapy and several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed.
Avacta Group plc, a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announced that the first patient has been dosed in the fifth cohort of the first-in-human phase I trial (ALS-6000-101) of AVA6000. This follows the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA) to allow for higher levels of dosing. nnAvacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has recommended that the phase Ia dose escalation clinical trial continues to a fifth dose cohort at 250mg/m2, following the favourable safety profile of AVA6000 generated in the study to date. Escalation to this level of dosing falls outside of the original clinical trial protocol, and therefore the protocol required amendment and approval by the MHRA, which has now been completed. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies. nnDr Alastair Smith, chief executive officer of Avacta Group, commented: “We are very much encouraged by the positive safety and tolerability data emerging from the dose escalation phase 1a study of AVA6000. Following the recommendation from the SDMC, and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial. nnThe recent confirmation of release of active chemotherapy in the tumour tissue and the safety data being generated in the ALS-6000-101 study are providing detailed insights into the preCISION platform which add significant value to the technology and confirm the tumour targeting potential of the preCISION platform. nnThis announcement has been approved for release by Alastair Smith, chief executive officer of Avacta Group plc. nnAVA6000 is a novel form of doxorubicin that has been modified with Avacta’s preCISION FAP-activated delivery platform to improve its safety and therapeutic index. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein a (FAPa) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression. nnAnthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a market size that is expected to grow to $1.38 billion by 2024, are widely used as part of standard of care in several tumour types, but its use is limited by cumulative dose toxicity associated with cardiomyopathy. nnThe preCISION tumour targeting platform can be used to modify a chemotherapy in order to selectively release the active drug in tumour tissue thereby reducing the systemic exposure that causes damage to healthy tissues. preCISION modified chemotherapies are designed to reduce the side effects and improve the overall safety and therapeutic potential of these powerful anti-cancer treatments.
LONDON & WETHERBY, England--(BUSINESS WIRE)--Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announces the opening on 5 April 2023 of the first two clinical investigator sites for the phase 1 clinical trial of AVA6000 under its US Investigational New Drug (IND) Application.The two sites, Memorial Sloan Kettering Cancer Center (MSK) in New York and Fred Hutch Cancer Center in Seattle, are now open for patient enrolment to ALS-6000-101. This is the first-in-human trial of AVA6000, Avacta’s lead pre|CISION™ drug candidate for the treatment of soft tissue sarcoma. nnActive enrolment has now begun for soft tissue sarcoma patients to the phase 1 clinical trial in the US, led by Dr William D. Tap, Chief of the Sarcoma Medical Oncology Service at MSK, and Dr Lee D. Cranmer, Professor at the Clinical Research Division of Fred Hutch Cancer Center. nnThe opening of the US phase 1 trial sites for recruitment marks a significant milestone in Avacta’s plan to expand AVA6000 clinical studies. A phase 1a dose escalation study is currently underway in the UK and recently begun dosing patients in the fifth cohort at 250 mg/m2 as announced on 5 April 2023, following the favourable safety profile of AVA6000 generated in the study to date. The US trial sites will initially contribute patients to the dose escalation phase, while being uniquely positioned to lead the enrolment of soft tissue sarcoma patients in the phase 1b dose expansion stage of the AVA6000 study when this begins. Patients will receive the same doses at each stage of the trial as in the UK.
LONDON & WETHERBY, England--(BUSINESS WIRE)--Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announces that the first patient has been dosed in the fifth cohort of the first-in-human phase I trial (ALS-6000-101) of AVA6000. This follows the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA) to allow for higher levels of dosing. nnAvacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has recommended that the phase Ia dose escalation clinical trial continues to a fifth dose cohort at 250mg/m2, following the favourable safety profile of AVA6000 generated in the study to date. Escalation to this level of dosing falls outside of the original clinical trial protocol, and therefore the protocol required amendment and approval by the MHRA, which has now been completed. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies.
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