Calidi Biotherapeutics and SIGA Technologies Partner to Advance RTNova Virotherapy for Lung Cancer and Metastatic Tumors

Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a clinical-stage biotechnology firm, has unveiled a collaboration with SIGA Technologies (Nasdaq: SIGA). The agreement, established in the first quarter of 2024, is set to bolster the development of Calidi’s systemic and targeted virotherapy platform, RTNova (CLD-400). This partnership aims to develop a universal treatment for various tumor types, with an initial focus on lung cancer and metastatic solid tumors, the leading causes of cancer fatalities.

Calidi’s RTNova platform represents an innovative approach in targeted virotherapy. It utilizes a potent vaccinia virus enveloped by a human cell membrane to evade immune detection and enhance therapeutic effects. This technology aims to offer a feasible solution for targeting disseminated tumors through systemic administration, a significant milestone in the biopharma sector. The RTNova platform is designed to survive in the bloodstream, target multiple tumor sites, and kill tumor cells while altering the tumor immune microenvironment. This approach not only simplifies administration but also potentially benefits a broader patient population.

A crucial element of the collaboration is SIGA’s contribution of TPOXX® (Tecovirimat), an antiviral agent effective against the vaccinia virus. Initially approved by the U.S. FDA in July 2018 for treating smallpox, TPOXX’s efficacy against orthopoxviruses, including vaccinia, has been demonstrated in preclinical studies. This makes it a valuable addition to the development of vaccinia-based cancer therapies. The collaboration will explore TPOXX's potential as a safety switch to manage RTNova’s spread in vivo, ensuring patient safety during the development process.

Antonio F. Santidrian, Chief Scientific Officer of Calidi Biotherapeutics, expressed optimism about the partnership’s potential to revolutionize cancer treatment. He emphasized that the collaboration with SIGA would provide a safety mechanism during clinical trials, offering assurance to patients, physicians, and regulatory authorities. Santidrian highlighted the opportunity to significantly impact the treatment landscape for various tumor types through this innovative virotherapy.

Calidi Biotherapeutics, headquartered in San Diego, focuses on leveraging its proprietary stem cell-based platforms to enhance the immune system’s ability to fight cancer. These platforms utilize potent allogeneic stem cells to deliver oncolytic viruses, targeting high-grade gliomas and solid tumors. The company’s off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses, thus improving efficacy and patient safety. Their preclinical enveloped virotherapies aim at targeting disseminated solid tumors, potentially offering treatment or prevention of metastatic disease.

SIGA Technologies, a commercial-stage pharmaceutical company, specializes in health security countermeasures for biological, chemical, radiological, and nuclear threats. Their lead product, TPOXX®, is a novel antiviral drug approved for treating smallpox. The U.S. holds a supply of TPOXX under Project BioShield, underscoring its importance in health security. The drug received approval from the EMA and the UK's MHRA in 2022 for treating smallpox, monkeypox, cowpox, and vaccinia complications post-vaccination. SIGA's collaboration with BARDA extends to further procurement and development of TPOXX’s oral and intravenous formulations.

This strategic collaboration between Calidi and SIGA embodies a significant step forward in the development of innovative cancer therapies, combining Calidi’s advanced virotherapy platform with SIGA’s proven antiviral expertise. By focusing on the development of RTNova, the partnership aims to provide new therapeutic options for patients battling lung cancer and metastatic solid tumors, ultimately striving to reduce the impact of cancer-related deaths.