Arovella Therapeutics Ltd (ASX:ALA) is trading higher on releasing new data for lead product ALA-101 showing it has the potential to be a novel ‘off-the-shelf’ cell therapy to treat CD19-expressing leukemias and lymphomas as the company seeks to initiate first-in-human clinic trials.
The biotechnology company presented the latest data from cells manufactured using its new lentiviral vector at the recently-concluded American Association for Cancer Research (AACR) Annual Meeting.
The third-generation lentiviral vector, manufactured by Lentigen Technology Inc, a world-leading manufacturer of lentiviral vectors for cell and gene therapies, will be used in the firm's clinical trials as it is considered safer than previous lentiviral systems.
Shares higher
Investors have responded positively to this development with shares as much as 32.92% higher in the first hour of trading to A$0.105, a new high of almost four years.
Arovella, which is developing its invariant Natural Killer T (iNKT) cell platform to treat cancer, provided highlights of the new data including:
- iNKT cells could be well expanded (more than 5000-fold) during manufacture, and cryopreserved (frozen) for future use, without compromising the potency of the cells;
- ALA-101 effectively killed tumour cells that express CD19, including primary patient-derived tumour cells;
- ALA-101 significantly extended the lifespan of mice transplanted with aggressive human B-Cell Acute Lymphoblastic Leukemia (B-ALL) that does not produce CD1d, indicating the activity of ALA-101 through the engineered CD19 CAR;
- Following more than 5,000-fold increase in cell numbers during manufacture, CAR19-iNKT cells retained the ability to multiply further when exposed to tumour cells that express CD19; and
- The data confirmed that the proposed manufacturing process maintained the effectiveness of cryopreserved ALA-101 when used ‘off-the-shelf’ and after thawing.
Excellent data
Arovella chief executive officer and managing director Dr Michael Baker said: “We are delighted with the data we are generating for ALA-101 and pleased to have progressed to the point of having a vector suitable for clinical development.
“The fact that we see a statistically significant lifespan extension in an aggressive leukemia animal model provides excellent data to indicate our product's potency and support the ongoing development of ALA-101 and progression to human Phase 1 clinical trials in 2024.”
Arovella’s newly-appointed chairman Dr Tom Duthy added: “This is an exciting time for Arovella. The AACR Annual Meeting is one of the pre-eminent cancer meetings held each year, providing Arovella with significant exposure to clinicians and researchers alike.
“The data we have presented at AACR this year confirms my belief in the potential of our proprietary and highly differentiated iNKT cell platform with applicability to several haematological cancers utilising our off-the-shelf production methodology, which is expected to provide higher commercial returns with fewer logistical challenges than current autologous cell therapies.”
Public sharing session
The company will hold a webinar to share the data with the public at 11 am (AEST) this coming Wednesday. Questions can be submitted on the day or sent in advance to investor@arovella.com.
To register for the session, click here.
A recording of the webinar will also be available on the company’s website and social media channels after the event.