Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

Core Insights - Calidi Biotherapeutics has received FDA clearance for its Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy targeting solid tumors in adults, specifically breast cancer, head & neck cancer, and soft tissue sarcoma [1][2][3] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted antitumor virotherapies using adipose tissue-derived stem cells combined with oncolytic viruses [5] - The company aims to enhance the immune system's ability to fight cancer through its proprietary technology and platforms [5] Clinical Development - The IND application included preclinical data showing CLD-201's ability to evade immune system inactivation and effectively target cancer cells [2] - Upcoming clinical trials will evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with challenging solid tumors [2][4] Leadership Statements - The CEO of Calidi emphasized that the FDA clearance is a significant milestone that could transform cancer treatment, highlighting the uniqueness of CLD-201 [3] - The President of Medical and Scientific Affairs expressed excitement about the potential of CLD-201 to revolutionize treatment for multiple solid tumors [3][4]