The US Food and Drug Administration (FDA) has granted its approval to amend the protocol of AVM Biotechnology’s ongoing AVM0703-001 clinical trial of its drug, AVM0703, in non-Hodgkin’s lymphoma/leukaemia patients.
The initial protocol with a 3 x 3 design involved dose escalation of 3mg/kg for all the six cohorts, which varied from 6mg/kg to 21mg/kg.
Nearly three subjects were to be enrolled in each arm under an adaptive-design/expansion cohort trial.
The modified protocol removes three cohorts and reduces the interval between cohorts.
Removing the 9mg/kg, 12mg/kg and 15mg/kg dose cohorts and proceeding with the potentially efficient dose of 18mg/kg is vital for the trial, AVM noted.
According to the data from preclinical research and compassionate use, 18 to 21mg/kg dose of the drug could be effective for the expansion phase of the trial.
Eliminating intermediate dose levels is expected to expedite the completion of the dose-escalation part and facilitate the commencement of the efficacy part sooner than anticipated.
AVM Biotechnology chief regulatory officer Janet Rea said: “We are pleased that the FDA agreed with our proposal, which leveraged the safety data amassed from the ongoing study and expanded access (compassionate use) patient data obtained to date.
“This accelerates our clinical development programme and propels it toward an earlier NDA submission.”
The drug was well-tolerated clinically with mild and self-limiting side effects.
AVM noted that a single dose of AVM0703 induces the quick activation and mobilisation of novel gamma delta positive Natural Killer T (NKT) cells.
NKT cells show properties of innate and adaptive immunity. AVM-NKT cells could be utilised to address multiple serious conditions, including different cancers and autoimmune conditions such as type 1 diabetes.
In preclinical studies, AVM0703 showed a potential for synergistic activity with chemotherapy, facilitating a decrease in total chemotherapy cycles without compromising patient response.
Furthermore, AVM is developing AVM-NKT as an off-the-shelf cell therapy with extensive applications.
The company is also analysing AVM0703 for autoimmune diseases and various other indications. The plan is to directly launch the product in the market.