Cell therapy weekly: Forge Biologics secure US$90 million in Series C funding
This week: Forge Biologics secure US$90 million in Series C funding, Cellusion and Celregen enter into exclusive license agreement for corneal endothelial cell regenerative therapy and otoferlin gene (OTOF)-mediated hearing loss gene therapy receives FDA clearance of investigational new drug (IND) application.
The news highlights:
Forge Biologics secure US$90 million in Series C funding
Forge Biologics (OH, USA) announced it has raised US$90 million in Series C financing, co-led by Drive Capital (OH, USA) and Aisling Capital (NY, USA). The gene therapy contract development and manufacturing organization will use the capital to increase client offerings including proprietary technologies and manufacturing systems and to strengthen its end-to-end manufacturing platform.
CEO, President and Co-Founder of Forge Biologics, Timothy Miller stated: “We continue our ambitious mission to enable access to life changing gene therapies by fulfilling a key goal of bringing them from concept to reality. To deliver on that mission, we’ve made great strides in our facility development, technology advancement, and hiring expansion. These new funds will help support this next measured phase of our growth focused on delivering new services to our clients so that we can support them from idea to impact. Each advancement we make goes towards serving our clients and their patient communities, and we are grateful to our investors for their confidence in our mission.”
Cellusion and Celregen enter into exclusive license agreement for corneal endothelial cell regenerative therapy
Cellusion Inc. (Tokyo, Japan) and Celregen Therapeutics Ltd. (Shanghai, China), a member of Fosun Pharma Group (Shanghai, China), announced an exclusive license agreement for Celregen to develop, manufacture and commercialize Cellusion’s novel treatment for bullous keratopathy, CLS001. The cell therapy utilizes corneal endothelial cell substitute from induced pluripotent stem cells (CECSi cells) for regeneration of the corneal endothelium. Under the Agreement, Celregen have the exclusive right to develop, manufacture and commercialize CLS001 in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan, while Cellusion retains these rights in other regions including Japan, the USA, and EU.
“Today’s announcement with a global industry leader in induced pluripotent stem cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.”
OTOF-mediated hearing loss gene therapy receives FDA clearance of investigational new drug (IND) application
The precision genetic medicine company, Akouos (MA, USA), has received FDA clearance for its IND application to proceed with a Phase I/II, first in human pediatric clinical trial of AK-OTOF. Intended for the treatment of patients with OTOF-mediated hearing loss, AK-OTOF is a dual adeno-associated viral vector-based gene therapy, which will deliver transgenes encoding OTOF to the inner hair cells of the cochlea.
Jen Wellman, Chief Operating Officer of Akouos stated: “We are excited to advance AK-OTOF into clinical development. There is a significant unmet need in OTOF-mediated hearing loss, as individuals typically have Severe to Profound sensorineural hearing loss from birth, and there are currently no approved pharmacologic options. This clinical trial is designed not only to evaluate the safety and potential benefit of AK-OTOF for individuals with OTOF-mediated hearing loss, but also to help us demonstrate the applicability of our novel delivery approach to a broad range of inner ear conditions. We look forward to sharing what we learn from this pioneering work.”
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