The United States Patent and Trademark Office (USPTO) has issued Axcentua Pharmaceuticals the USPTO patent no 7, 863, 325 B2 entitled "Crystalline Genistein Sodium Salt Dihydrate". The patent covers Axcentua's novel crystalline composition of genistein, AXP107-11 and its medical uses. AXP107-11 is currently in phase Ib/IIa clinical trials for pancreatic cancer at the Karolinska University Hospital in Huddinge, Sweden.
"We are very pleased to have received the patent grant after an examination period of only 13 months" says Dr. Stefan Rehnmark, CEO of Axcentua Pharmaceuticals. "The Patent is proof that meaningful intellectual property can be obtained through crystal-re-engineering of natural compounds and it is rewarding to see the original business idea validated."
AXP107-11 was discovered in a screen for new crystalline forms of a well known natural compound with improved pharmaceutical properties. AXP107-11 is an orally active, non-toxic, multi-targeted chemosensitizer that sensitizes human pancreatic cancer cells to gemcitabine and reduces metastasis in animal models of cancer. These properties of AXP107-11 make the compound a promising new agent for the treatment of genetically complex and heterogenous solid tumors such as pancreatic cancer.
Axcentua Pharmaceuticals is an innovative drug discovery and development company located at the Karolinska Institute Science Park. Axcentua is pioneering a unique strategy, crystal re-engineering, for accelerated development of novel therapeutics to the clinic. The core business idea and competitive advantage is to decrease drug development times and the risk for failure in the clinic by using natural compounds. Our lead compound, AXP107-11, is a multi-targeted crystal re-engineered natural compound, currently in clinical trials for pancreatic cancer, targeting the complex fibrotic desmoplasia of the pancreatic tumors making the tumors more accessible to chemotherapy. IP protection of the crystalline form, the crystallization process, composition of matter, and therapeutic use of AXP107-11 is secured through a recent US patent and a pending PCT. Pipeline expansion through novel formulations of AXP107-11 as well as crystal re-engineering of backup candidates is ongoing. Our development strategy enables a fast proof of principle of candidate drugs in the clinic, leading to early value enhancement and commercial opportunities.
Axcentua Pharmaceuticals AB today announced that the first patient has been enrolled in the clinical trial AXP-CT-001. The study is designed as a phase Ib/IIa study for the treatment of pancreatic cancer with AXP107-11 in combination with gemcitabine. In the phase Ib part of the study, the safety and the maximum tolerated dose will be determined using a classical dose escalation scheme, continuing directly into the phase IIa part to determine the efficacy of this new therapy.
"We are very excited to initiate this first clinical study with AXP107-11 as we strongly believe in the multi-targeted properties of AXP107-11 for the treatment of pancreatic cancer" says CEO Stefan Rehnmark.