Synthetic Biologics (SYN) Announces Presentation at SIOP on New Preclinical Data Supporting Evaluation of VCN-01 and Topotecan for Treatment of Refractory Retinoblastoma

Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced the presentation of new data from collaborators at Fundació Sant Joan de Déu that further support evaluation of VCN-01, an oncolytic adenovirus expressing hyaluronidase, and topotecan for the treatment of refractory retinoblastoma. Preclinical results were featured in an oral presentation at the SIOP 2022 Congress of the International Society of Pediatric Oncology, being held in Barcelona, Spain from September 28-October 1, 2022.

“The exciting new data presented at SIOP demonstrate that administration of VCN-01 in combination with topotecan chemotherapy may improve VCN-01 activity against retinoblastoma, ” said Manel Cascallό, Ph.D., General Director of Synthetic Biologics’ European Subsidiary. “These results further underscore VCN-01’s therapeutic potential in chemo-refractory retinoblastoma and will inform our planned clinical study, which is expected to initiate in the second half of 2023. More broadly, these results support the development of our novel OV platform and demonstrate that VCN-01 holds tremendous promise as an adjunct to intravitreal chemotherapy in patients who fail currently available treatments. We remain encouraged by the potential of this novel combination approach to provide superior clinical benefits for devastating cancers with high unmet need.”

The oral presentation (#1380), entitled “Topotecan enhances oncolytic adenovirus infection, replication and antitumor activity in retinoblastoma,” featured Dr. Victor Burgueño, Professor at Fundació Sant Joan de Déu and lead investigator of the study. Key data and conclusions showcased in the SIOP presentation include:

• VCN-01 treatment in combination with topotecan, but not with carboplatin or melphalan, significantly increased VCN-01 infection and replication in retinoblastoma cells (p=0.0007) in vitro.
• In athymic mice engrafted with human retinoblastomas, topotecan administered systemically after intratumoral VCN-01 increased viral genome replication and the number of VCN-01 infected cells when compared to administration of VCN-01 alone (p = 0.0002).
• Sequential administration of intratumoral VCN-01 followed by systemic topotecan significantly increased median ocular survival, compared to VCN-01 alone (p =0.0364).

Details on the presentation can be found below.

• Session: (1460 - FPS 07) Retinoblastoma and Germ Cell Tumors
• Date and Time: Friday, September 30, 2022 at 10:40 a.m. CEST
• Location: Barcelona International Convention Center, Room 11

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