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Agreements

Date: 2017-05-08

Type of information: Clinical research agreement

Compound: REGN2810 in combination with Pexa-Vec (pexastimogene devacirepvec)

Company: Regeneron Pharmaceuticals (USA - NY) Sillajen (Republic of Korea)

Therapeutic area: Cancer - Oncology

Type agreement: clinical research

Action mechanism: oncolytic virus/gene therapy/oncolytic immunotherapy/monoclonal antibody/immune checkpoint inhibitor. Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy that utilizes the vaccinia poxvirus strain as its backbone. This strain has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec is designed to attack cancer through three diverse mechanisms of action: 1) the lysis of cancer cells through viral replication, 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. REGN2810 is a fully human anti-PD-1 monoclonal antibody. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers.

Disease: renal cell carcinoma

Details:

  • • On May 8, 2017, Regeneron Pharmaceuticals and SillaJen announced a new clinical and supply agreement for a Phase 1b dose-escalation study in renal cell carcinoma. The study will evaluate Regeneron's PD-1 inhibitor, REGN2810, in combination with SillaJen's oncolytic vaccinia virus, Pexa-Vec, in patients with previously treated metastatic or unresectable renal cell carcinoma.
  • The open-label trial is expected to begin later this year, and is designed to evaulate the safety and efficacy of REGN2810 in combination with Pexa-Vec compared to treatment with REGN2810 as monotherapy. The study will initially open in Korea, with expansion to sites in the U.S.
  • Under the terms of the agreement, the trial will be solely conducted and funded by SillaJen based upon a mutually developed study design," and Regeneron will provide REGN2810.
 

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