Cell therapy weekly: investment for reproductive stem cell therapy trial
This week: Avista Therapeutics (PA, USA) and Forge Biologics (OH, USA) formed a partnership to develop and manufacture a gene therapy for retinal disease, Sartorius Stedim Biotech (Aubagne, France) and Nanotein Technologies (CA, USA) announced a collaboration to develop cell and gene therapy solutions using Nanotein’s NanoSpark® platform technology, and Gameto (NY, USA) secured US$44 million in Series C funding to advance its iPSC-derived fertility treatment.
The news highlights:
- Development and manufacturing partnership
- Partnership for reagent development
- Investment for reproductive stem cell therapy trial
Development and manufacturing partnership
Avista Therapeutics and Forge Biologics have entered a strategic partnership to advance the development and manufacturing of Avista’s lead gene therapy candidate for X-linked retinoschisis (XLRS), AVST-101.
“Partnering with Avista to support the advancement of AVST-101, their innovative intravitreal gene therapy for XLRS, aligns with our mission to help our clients accelerate the path to gene therapies for patients with urgent needs,” said John Maslowski, President and CEO of Forge. “Our AAV manufacturing services are designed to support programs like Avista’s with the speed, consistency, and quality required for success.”
Forge will provide process development, cGMP manufacturing, toxicology and analytical development support to Avista. The agreement also enables Avista to utilize Forge’s proprietary FUEL™ technology platform, specifically their HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid system.
Partnership for reagent development
Sartorius Stedim Biotech has formed a partnership with Nanotein Technologies, investing up to $3 million for a minority stake. The agreement grants Sartorius exclusive distribution rights to Nanotein’s NanoSpark platform products: STEM-T and GROW-NK soluble activators, which enhance T cell and natural killer cell expansion for cancer therapies. These innovations address manufacturing challenges by eliminating the need for feeder cells while improving cell quality and quantity. The companies will jointly develop additional solutions for cell and gene therapy markets using the NanoSpark platform technology.
“Nanotein’s soluble activators are designed to improve cell therapy expansion by enhancing the quality and quantity of T cells and providing a feeder-free soluble activator for NK cell activation and expansion, addressing critical challenges in the manufacturing process,” said Curtis Hodge, co-founder and CEO of Nanotein Technologies.
Investment for reproductive stem cell therapy trial
Gameto has secured US$44 million in Series C funding to complete its ongoing Phase III trial for the iPSC-derived fertility treatment Fertilo. This round of financing was led by Overwater Ventures (CA, USA) and brings the total investment to US$127 million.
Fertilo uses iPSC-derived ovarian support cells to mature eggs in vitro and dramatically reduces IVF ovarian stimulation from two weeks of daily hormone injections to just 2-3 days, potentially transforming reproductive care approaches.
“This is a defining moment for Gameto and for our broader mission of advancing women’s and family health,” said Dina Radenkovic Turner, CEO and co-founder of Gameto. “With this fundraising round we are now positioned to complete our robust Phase III trial of Fertilo and evaluate its safety and efficacy across leading US study sites. Fertilo In Vitro Research Study and Trial (FIRST)1 is the first randomized, controlled, double-blind trial to evaluate the maturation of eggs outside the body in the US, despite this technique’s decades of clinical use, as well as the first to explore stem cell technology in IVF. This funding enables us to advance and expand our pipeline of next-generation therapeutics and solidify our position as an emerging biopharma innovator in a field that remains deeply underserved, underresearched, and ripe for modernization.”