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

VAC85135 is a novel clinical candidate developed by Nouscom and Janssen under a multi-project agreement

BASEL, Switzerland, May 17, 2022 /PRNewswire/ -- 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."

About Nouscom

Nouscom is a clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Nouscom's proprietary technology platform harnesses the full power of the immune response by combining viral vectored vaccines based on multiple neoantigens with other immunomodulators.

Nouscom is currently advancing the clinical development of its wholly owned programs:

• NOUS-209 (lead), an off-the-shelf cancer immunotherapy for the treatment of Microsatellite Instable High (MSI-H) solid tumors that reported positive interim safety, immunogenicity and clinical data at recent ESMO and SITC 2021 conferences; and
• NOUS-PEV, a personalized vaccine for the treatment of advanced melanoma or lung cancer

Nouscom is led by an experienced management team with deep roots in the pharma and biotech industry and are veterans in the field of viral vectored vaccines.

Nouscom, which was founded in 2015 and is headquartered in Basel, Switzerland with operations in Rome, Italy, is backed by international life sciences investors.

For more information on Nouscom, please visit the company's website at nouscom.com or follow us on LinkedIn at www.linkedin.com/company/nouscom-ag/

Contacts

Nouscom
Richard Davis, CBO
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MEDiSTRAVA Consulting
Sylvie Berrebi, Eleanor Perkin
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