ASX Health Stocks: Telix seeks FDA approval for Illucix; Chimeric releases viral vector
Health & Biotech
Health & Biotech
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Telix Pharma (ASX:TLX) has expanded its partnership with California-based RefleXion Medical to co-develop Telix’s prostate cancer imaging agent, Illuccix.
The co-development and commercialisation agreement will see Telix and RefleXion conduct and co-fund a BgRT (biology-guided radiotherapy) clinical program using Illuccix as a biological guide.
The two companies will also seek regulatory approval and jointly pursue commercialisation, initially in the US.
RefleXion’s BgRT platform is the first and only cancer treatment designed to integrate PET (positron-emission tomography) technology as part of external-beam radiotherapy delivery.
It uses PET tracers as biological guides to signal the location of the cancer, and guide the delivery of radiotherapy to tumours in real-time.
BgRT has the potential to offer significant advantages over conventional radiotherapy, as it may one day enable treatment of multiple tumours per session for metastatic diseases.
The technology could also increase the conformality of radiotherapy delivery, and reduce toxicity to healthy tissues. This approach may facilitate treatment of later stage cancers than is currently practical.
If approved, Illuccix for BgRT could potentially open a broad new market opportunity for Illuccix as a therapy guidance agent.
More than 60,000 men undergo external-beam radiotherapy for prostate cancer every year in the US alone.
“Following a successful evaluation period, we are pleased to expand our relationship with RefleXion and move ahead with a clinical program with the objective of regulatory approval of Illuccix for BgRT,” said Dr Christian Behrenbruch, CEO of Telix.
The clinical program is expected to commence in 2023.
Meanwhile, Chimeric Therapeutics (ASX:CHM) says it has completed the manufacturing and quality release for CHM 1101 (CLTX CAR T) viral vector, a key milestone in its development.
Chimeric explained that one of the most challenging and critical components of cell therapy is the timely manufacturing and release of viral vector.
Viral vector is considered the backbone for the manufacture of a CAR T cell therapy, as it holds the genetic engineering instructions.
A current shortage of vector manufacturing capacity has significantly delayed other companies’ cell therapy development programs, as well as challenging commercial manufacturers.
Given these difficulties, today’s announcement is a critical milestone for Chimeric in supporting the broader Phase 1 clinical program expansion of CHM 1101.
“This marks a major milestone for advancing the development of CHM 1101,” said Chimeric CEO, Jennifer Chow.
“Vector supply significantly challenges the cell therapy industry with current backlogs of more than a year to access vector manufacturing.
“Securing vector for the expansion of our CHM 1101 development program enables us to move forward, and is a clear demonstration of the benefit of our experienced cell therapy development team,” she said.
Chimeric is currently focused on expanding the CHM 1101 clinical program with new clinical sites for the Phase 1 glioblastoma trial, as well as a new Phase 1 clinical trial in solid tumours.