On September 14, 2020 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), reported the receipt of positive guidance from the FDA on the reactivation of the SVV-001 IND and Phase I/II protocol (Press release, Seneca Therapeutics, SEP 14, 2020, https://www.businesswire.com/news/home/20200914005006/en/Seneca-Therapeutics-Inc.-Receives-Positive-Feedback-from-FDA-on-Reactivation-of-the-SVV-001-IND-and-Phase-III-Protocol [SID1234565108]). The Phase I/II study will be in combination with a checkpoint inhibitor and include patients with either neuroendocrine tumors (NET) or carcinomas (NEC). The Phase I/II clinical study should begin during 2nd quarter, 2021.
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"We are pleased to receive this guidance from FDA regarding reactivating the SVV-001 IND and starting our Phase I/II protocol in patients with neuroendocrine tumors," stated Dr. Paul Hallenbeck, Founder, President, and Chief Scientific Officer of Seneca Therapeutics.
SVV-001 is a best in class oncolytic immunotherapeutic intended to enable and broaden the number of patients that respond to a checkpoint inhibitor. Seneca’s approach follows a resurgence in the field of oncolytic immunotherapeutics. These agents have demonstrated the ability to synergize with immune checkpoint inhibitors to elicit a robust immune response to the tumor. Further, STI’s trial will also involve enrolling only patients that have key biomarkers, such as the receptor for SVV, which will enhance the probability of obtaining significant patient responses.
Currently, patients with neuroendocrine tumors have limited treatment options. Seneca is seeking to demonstrate an improvement on ORR and OS responses when SVV-001 is utilized in combination with immune checkpoint blockade vs the historical data from several large studies with the immune checkpoint blockade agent alone.
About Neuroendocrine Cancers:
It is estimated that there are over 150,000 patients with neuroendocrine neoplasms in the United States (US) and the incidence is increasing (Dasari et al, 2017). Tumor grade and morphology predicts clinical outcome. Median overall survival is reported to be 16.2 years, 8.3 years, and 10 months in low-grade well NETs, intermediate-grade NETs, and NECs, respectively (Dasari et al, 2017).
Treatment options for NETs are limited. Current options include somatostatin analogues, mTOR inhibitor-everolimus, tyrosine kinase inhibitor-sunitinib, and peptide receptor radionuclide therapy (Pokuri et al, 2017).