ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China. The ODD award signifies the potential of IMM01 in treating treatment-naïve patients with chronic myelomonocytic leukemia (CMML) in combination with azacitidine.
IMM01’s Development and Mechanism
IMM01 was discovered and developed by ImmuneOnco utilizing its proprietary “mAb-Trap” technology platform. This drug features a dual mechanism of action, demonstrating strong anti-tumor activity within the body. The unique design of IMM01 allows it to engage with both the immune system and tumor cells, offering a novel approach to cancer treatment.
Preclinical Efficacy and Combination Therapy Potential
Preclinical in vivo efficacy trials have shown that IMM01, when combined with targeted drugs or immunotherapy drugs, exhibits strong anti-tumor activity against a range of hematological and solid tumors. This suggests that IMM01 has the potential to be a versatile component in combination therapies, enhancing the treatment options for patients with various types of cancer.- Flcube.com
