UK life sciences company Avacta Group plc (AIM:AVCT) announced on Tuesday that it has successfully completed the sixth dose escalation cohort in the ALS-6000-101 Phase 1 clinical trial of AVA6000.
Designed to assess AVA6000's safety and tolerability, the trial has also shown encouraging results in terms of efficacy. One patient with soft tissue sarcoma demonstrated a significant reduction in tumour volume in response to the drug, with further signs of activity observed in patients with cancers not limited to soft tissue sarcoma.
AVA6000 is a tumour targeted form of doxorubicin that has been chemically modified with Avacta's pre|CISION platform, designed to reduce systemic side effects by targeting the release of the active chemotherapy to tumour tissue.
The Safety Data Monitoring Committee has recommended continuation to the seventh dose cohort at 385 mg/m2, which is equivalent to approximately 3.5 times the standard dose of doxorubicin. This will be the final dose escalation cohort in the ALS-6000-101 Phase 1a safety study for three weekly dosing.
Avacta also said that the favourable safety profile of AVA6000 supports its potential for higher dosing and increased cycles compared to standard doxorubicin. A short study exploring fortnightly dosing of AVA6000 as a first-line treatment in soft tissue sarcoma patients is planned for Q4 2023, pending FDA protocol amendment approval.
In light of the positive data emerging from the ALS-6000-101 study, the company has adapted its clinical development strategy with the aim of bringing forward the start of a potentially pivotal phase 2 study in soft tissue sarcoma, subject to regulatory approval.
Detailed Phase 1a data from the ALS-6000-101 clinical study, encompassing clinical and pharmacokinetic data, is anticipated for release in Q4 2023.
Pykus Therapeutics' PYK-2101 achieves positive interim clinical trial results
FDA accepts Novo Nordisk's filing application for oral semaglutide 25 mg
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
Armata Pharmaceuticals' AP-SA02 clinical trial receives additional US DoD funding
BioArctic receives SEK101.7m in royalties from Q1 Leqembi sales
SKNV launches Kefunova Cream for actinic keratosis and superficial basal cell carcinoma
Ingenium Therapeutics' Gengleucel to enter Phase 2 trial in MRD+ AML following FDA feedback
Nuformix receives positive EMA opinion for orphan drug designation of NXP002 in IPF
MHRA to review monthly maintenance dosing for Leqembi in early Alzheimer's treatment
Ro integrates with NovoCare Pharmacy to offer access to all doses of Wegovy at lowest price
Myosin Therapeutics receives grant to advance MT-110 clinical trial in methamphetamine use disorder
CSL Vifor and Travere Therapeutics gain full EU approval for FILSPARI in IgA nephropathy