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Nouscom Announces Janssen Receives US FDA IND Clearance for VAC85135, an ‘Off-The-Shelf’ Cancer Immunotherapy Developed using Nouscom’s Proprietary Viral Vector Platform

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Nouscom Announces Janssen Receives US FDA IND Clearance for VAC85135, an 'Off-The-Shelf' Cancer Immunotherapy Developed using Nouscom's Proprietary Viral Vector Platform | Pharmtech Focus

Nouscom, a clinical stage immuno-oncology company developing both off-the-shelf and personalized cancer neoantigen immunotherapies, today announced that Janssen Research & Development, LLC (Janssen) received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) candidate VAC85135, an off-the-shelf, viral vector-based cancer vaccine for an oncologic indication. VAC85135 has been exclusively licensed to Janssen.

VAC85135 is based on Nouscom’s proprietary viral vector platform and is the first vaccine candidate to advance to this stage under a multi-project agreement with Janssen. Nouscom and Janssen have collaborated on the design and specific product research, with Nouscom accountable for process development activities and GMP manufacturing for VAC85135.

Under the terms of the agreement, Janssen has sole responsibility for clinical development of VAC85135. Financial terms, including individual product-specific upfront payments, potential development and commercial milestones, and future tiered royalties remain confidential.

Dr. Marina Udier, Chief Executive Officer of Nouscom, said, “We are very excited about Janssen’s IND clearance of VAC85135, the result of a long-standing and productive collaboration. This is another important milestone for Nouscom, the first licensed program, and the third clinical candidate after NOUS-209 and NOUS-PEV, to emerge from our immunologically potent viral vector platform.

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