Apogenix, a German biopharmaceutical company developing next-generation immuno-oncology therapeutics, confirmed it received Notices of Allowance from the U.S. Patent and Trademark Office for two crucial patents for APG101, the company’s lead immuno-oncology candidate to treat glioblastoma.
Apogenix specializes in therapeutics for the treatment of cancer and other illnesses. The company has developed a promising pipeline of immuno-oncology drug candidates targeting diverse tumor necrosis factor super-family (TNFSF)-dependent signaling pathways that restore the immune system’s response against tumors.
APG101 is a fully human fusion protein under development for the treatment of solid tumors and malignant hematological diseases. By blocking the CD95 ligand, APG101 inhibits invasive tumor cell growth and restores the immune response against tumors.
The “method of use” patent covers the use of CD95 ligand inhibitors (just like APG101) to treat glioblastoma and is valid until 2029. The “composition of matter” patent protects APG101 as a product and its manufacturing process until 2033.
Glioblastoma is a type of tumor that arises from astrocytes – the star-shaped cells that constitute the supportive tissue, or “glue-like” tissue of the brain. This tumor is frequently highly malignant due to the fast rate at which cells reproduce, supported by a large network of blood vessels. These tumors are usually found anywhere in the cerebral hemispheres of the brain or spinal cord.
“Apogenix already has a broad patent portfolio covering APG101. These two patents greatly expand the protection of APG101 and its use in the treatment of glioblastoma,” Apogenix CEO Thomas Hoeger, Ph.D., said in a press release. “The prospective granting of these two patents in the most important pharmaceutical market further validates our innovative drug development approach and the therapeutic potential of CD95 ligand inhibitors for the treatment of malignant brain tumors, among other indications.”
The safety, tolerability and efficacy of APG101 were validated in a controlled Phase 2 proof-of-concept clinical trial in patients with recurrent glioblastoma. A combined treatment of the company’s compound and radiotherapy showed clinical superiority in all study endpoints when compared to radiotherapy alone, which resulted in an overall survival benefit in patients with glioblastoma treated with the leading candidate. Interim data of a Phase 1 trial for the treatment of myelodysplastic syndromes further confirmed the efficacy of APG101 in this hematological illness.