On April 1, 2020 Stamford pharmaceuticals a clinical stage immunology and inflammation focused company developing novel combination therapies for cancers, reported a clinical collaboration with Roche (SIX:RO, ROG) to explore SP-002 (formerly ASN-002/TG1042), Stamford’s adenoviral vector immunotherapy, in combination with Roche’s vismodegib (Erivedge), a Hedgehog Pathway inhibitor approved for the treatment of adult patients presenting with locally advanced and metastatic basal cell carcinoma (Press release, Ascend Biopharmaceuticals, APR 1, 2020, View Source [SID1234556083]). The combination study will be conducted in patients with multiple basal cell carcinomas (BCCs).

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"This collaboration is an opportunity to create a new treatment paradigm for patients with multiple BCCs." said Clement Leong, PhD., Stamford Pharmaceutical’s Chief Executive Officer. "We believe that SP-002 when combined with vismodegib has potential to enhance the response rate1 of BCC lesions directly injected with SP-002 but can also confer responses in distant non-injected BCCs. This would represent a major advancement for the management of patients with multiple BCCs who currently have to endure the morbidity that arises from many surgical procedures."

SP-002 is an adenoviral-5 vector-based immunotherapy encoding the gene for human Interferon-. It will be evaluated in combination with a reduced duration of vismodegib treatment. It is expected that the combination will alter the tumor microenvironment to support more potent and durable anti-tumor responses, while using a shorter duration of vismodegib treatment to optimize tolerability. Stamford 1

Based on a composite endpoint of Complete Response (clinical assessment) and Histological Clearance W: www.stamfordpharmaceuticals.com E: info@ stamfordpharmaceuticals.com US Connecticut Office Melbourne Office Level 2, 330 Railroad Ave, 1/159 Dorcas Street Greenwich, CT 0683 South Melbourne, VIC 3205 USA Australia Pharmaceuticals plans to initiate an open-label, multicenter Phase 2a clinical trial of SP-002 administered as an intra-lesional injection to patients who have multiple basal cell carcinomas in both the basal cell nevus and sporadic BCC populations. The primary objective of the study is to evaluate the efficacy, safety and tolerability of SP-002 in combination with vismodegib in both target (lesions injected with SP-002) and non-target (non-injected) lesions. Stamford Pharmaceuticals will be the sponsor of the study and Roche will provide vismodegib and clinical and scientific support for the study.