Financial Status:
- Pro-forma cash and equivalents: $4.76 million as of December 31, 2023.
Q2 FY24 Achievements:
- Solid Tumor Strategy:
Manufacturing and Development:
- Signed an exclusive license with Sparx Group to develop a world-first CAR-iNKT cell therapy targeting Claudin 18.2 (CLDN18.2), expressed in gastric cancers (GC), gastroesophageal junction cancers (GEJC), and pancreatic cancer (PC).
Financial Strengthening:
- Completed GMP manufacturing and release of ALA-101 lentiviral vector for the lead CD-19-targeting iNKT cell product.
- Advanced manufacturing process development and scale-up.
Executive Appointment:
- Received a $1.92 million R&D Tax Incentive refund.
- Appointed Tim Luscombe as Chief Financial Officer (CFO) and Company Secretary.
Upcoming 12-Month Milestones:
- Proof-of-Concept Data:
Clinical Batches and IND Studies:
- Present initial proof-of-concept data for CLDN18.2-iNKT cells in H1 CY24.
Regulatory Approvals and Clinical Trials:
- Manufacture clinical batches of ALA-101 for phase I clinical trials (H1 CY24).
- Complete IND-enabling non-clinical safety and efficacy studies (H1 CY24).
Technology In-Licensing:
- Secure IND application with the FDA and/or regulatory filing with TGA for a phase I clinical trial in non-Hodgkin’s lymphoma (H2 CY24).
- Commence a phase I clinical trial in non-Hodgkin’s lymphoma (H2 CY24).
- In-license additional technologies to enhance the iNKT cell therapy platform.
Solid Tumor Targeting:
- Arovella's iNKT cell therapy platform aims to target solid tumors and has advantages over existing CAR-T treatments.
Specifics of iNKT Cells:
- Can be sourced from healthy donors without causing graft versus host disease (GvHD).
- Contain an invariant T cell receptor (iTCR) targeting lipid-bound CD1d on various tumor types.
- Can be modified to produce a chimeric antigen receptor (CAR) for dual-targeting of specific tumors.
- Can be expanded significantly from a single manufacturing batch.
- Exhibit natural efficacy against solid tumors, influencing the tumor microenvironment and targeting pro-tumor cells.
Novel Monoclonal Antibody (mAb) Sequence:
- Secured a global, exclusive license for a novel mAb sequence (SPX-101) targeting Claudin 18.2 (CLDN18.2) in cell therapies.
- SPX-101 has completed preclinical studies and is set for a phase I trial to treat gastric cancers.
Clinical Landscape:
- CLDN18.2 is a validated target, with products like zolbetuximab in clinical development. Zolbetuximab has Priority Review for treating GC and GEJC by the FDA, with an expected decision in 2024.
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