Cell therapy weekly: US$16 million for solid tumor cell therapy development
This week: OverT Bio (NY, USA) secured US$16 million in seed funding, Obsidian Therapeutics (MA, USA) appointed a new Chief Technology Officer and the US Food and Drug Administration (FDA; MD, USA) granted Fast Track designation to an in vivo gene insertion therapy for Ornithine Transcarbamylase deficiency.
The news highlights:
- US$16 million seed funding to advance cell therapies for solid tumors
- Obsidian Therapeutics appoints new Chief Technology Officer
- In vivo gene insertion therapy receives FDA Fast Track designation
US$16 million seed funding to advance cell therapies for solid tumors
OverT Bio, a data-driven biotech company developing cell therapies for solid tumors, has secured US$16 million in seed funding co-led by ARTIS Ventures (CA, USA) and Wing Venture Capital (CA, USA). The investment will support the expansion of the company’s discovery platforms, including its core platform, which scans the entire genome and identifies genetic edits that can give immune cells novel properties.
“Cell therapies have shown, at least in blood cancers, that we can aim to completely cure patients that have even the most advanced diseases rather than just prolong their survival,” stated Mat Legut, co-founder and CEO of OverT. “With OverT’s ability to rapidly screen and engineer thousands of genes, we are building next-generation therapies to cure advanced cancers of the solid tissues.”
Obsidian Therapeutics appoints new Chief Technology Officer
Obsidian Therapeutics has appointed Dana Alexander as Chief Technology Officer. Alexander brings over two decades of experience in cell and gene therapy and biologics process development and most recently served as Senior Vice President of Technical Operations at AlloVir (MA, USA).
Obsidian’s lead product candidate, OBX-115, is currently being investigated in two ongoing clinical trials in advanced or metastatic melanoma and non-small cell lung cancer. OBX-115 is a tumor-infiltrating lymphocyte cell therapy that is genetically engineered to express membrane-bound IL-15, a cytokine that plays an important role in generating and maintaining CD8+ memory T-cells.
Dana Alexander stated: “I am thrilled to be joining the highly accomplished and passionate Obsidian leadership team and to have the opportunity to grow and expand the company’s [chemistry, manufacturing and controls] capabilities. I look forward to collaborating with the team to advance OBX-115 and maximizing the company’s platform for manufacturing patient-specific engineered cell and gene therapies as Obsidian’s pipeline expands.”
In vivo gene insertion therapy receives FDA Fast Track designation
The FDA has granted Fast Track designation to iECURE’s (PA, USA) in vivo gene insertion therapy for Ornithine Transcarbamylase (OTC) deficiency. The gene therapy, ECUR-506, has previously obtained Orphan designation from the European Commission (Brussels, Belgium) and Rare Pediatric and Orphan Drug designations from the FDA.
ECUR-506 uses two AAV capsids to deliver two different payloads: an ARCUS® nuclease that cuts the genome at a specific locus and a functional copy of the OTC gene. The cut site serves as the insertion site for the functional copy of the OTC gene.
“Receipt of Fast Track designation from the FDA is a validation of the severe unmet need for patients with neonatal onset OTC deficiency and a testament to the preclinical data generated to date for ECUR-506,” said Joe Truitt, CEO of iECURE. “The benefits of Fast Track designation may accelerate our ability to get ECUR-506 into physicians’ hands, which is incredibly important when every second counts for these babies.”
