Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, announces that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the third dose cohort following a positive review of the safety data from the dosing of the second cohort.
Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the second cohort dosed with AVA6000 at 120mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 160mg/m2.
AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ 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 (FAP) 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. Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a market size that is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but doxorubicin’s use is limited by cumulative toxicity associated with cardiomyopathy.
Dr Alastair Smith, Chief Executive Officer of Avacta, commented: “AVA6000, and the pre|CISION platform more broadly, have the potential to deliver safer and affordable oncology drugs that could significantly improve cancer patients’ lives. We are very pleased with the progress being made with ALS-6000-101 study and look forward to seeing more data as it emerges from the trial.”
Neil Bell, Chief Development Officer of Avacta, commented: “The recommendation from the Safety Data Monitoring Committee to initiate dosing in Cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date. We look forward to providing additional updates as the dose escalation phase of the trial progresses.”