Avacta Group advances Phase 1 trial of oncology drug candidate AVA6000

Avacta Group plc (AIM: AVCT), a prominent life sciences company, has achieved a significant milestone in its Phase 1 clinical trial for AVA6000, a novel peptide drug conjugate. The trial, leveraging Avacta’s proprietary pre|CISION technology, has successfully completed the first cohort and initiated dosing for three patients in the second cohort. This advancement is part of the dose escalation study in Arm 2, following encouraging results from Arm 1.

Progress and Developments in the Trial

The ongoing Phase 1 trial aims to evaluate the safety, tolerability, and optimal dosing schedule of AVA6000. With the commencement of dosing in the second cohort, Avacta continues to explore the two-weekly dosing schedule (“Q2W”) to optimize efficacy for future studies. The trial also includes a sub-study that started in partnership with SOFIE, utilizing baseline [18F]FAPI-74 PET scanning. This sub-study aims to characterize the full burden of FAP-positive disease in patients, enhancing the understanding of the tumor expression and fibroblast activation protein (FAP) levels, which are commonly elevated in solid tumors.

Collaborative Efforts and Future Plans

Avacta’s collaboration with SOFIE for the [18F]FAPI-74 PET scanning in the AVA6000 Phase 1 trial underscores a commitment to integrating innovative diagnostic tools to refine treatment strategies. Christina Coughlin, MD, PhD, CEO of Avacta, expressed excitement about the integration of these advanced diagnostic approaches, which are anticipated to drive the program’s success through improved indication selection and dosing optimization.

Looking ahead, Avacta is set to begin the dose expansion Phase 1b efficacy study in the second half of 2024. The company also plans to present further data from the AVA6000 trial, which will inform the selection of a specific indication for a Phase 2 efficacy study.

Insights from Previous Trials

The Phase 1a Arm 1 of the trial consisted of seven dose cohorts with a total of 42 participants, employing a three-week dosing interval (“Q3W”). Results from this arm were presented at the American Association for Cancer Research (AACR) meeting in April, highlighting the significant antitumor activity of AVA6000 and its ability to deliver high concentrations of doxorubicin directly to the tumor microenvironment. Importantly, the study reported a notable reduction in the frequency and severity of known doxorubicin-related toxicities, without reaching a maximum tolerated dose even at 3.5 times the normal level of doxorubicin.

Avacta’s progress in the clinical development of AVA6000 reflects a robust approach to oncology drug development, utilizing targeted therapies that could potentially offer improved efficacy and safety profiles for patients with solid tumors. The integration of FAPI-PET scanning into the trial protocol represents a forward-thinking strategy to enhance diagnostic accuracy and therapeutic effectiveness.