CONCORD, Mass., March 4, 2020 /PRNewswire/ -- Alopexx Oncology, LLC announced today that it has entered into an exclusive license agreement with Beijing Shenogen Pharma Group to develop and commercialize DI-Leu16-IL2 in China and other parts of Asia. Alopexx will receive an upfront payment, various development and commercial milestones and royalties on sales.
DI-LEU16-IL2 is a novel antibody-cytokine fusion protein (or immunocytokine) targeting the B cell antigen, CD20. The CD20 antibody recognizes the same target on B cells as Rituxan and maintains the activities of both the antibody and cytokine components. In addition, it is also involved in tumor targeting, engagement of the immune system, and induction of an anti-cancer vaccine effect.
In a Phase I study of DI-LEU16-IL2 conducted in the 3 US centers, fifteen of 18 patients with relapsed or refractory B-cell CD20 positive lymphoma who received 2 or more cycles of therapy had tumor regression or stabilization including 3 complete and 2 partial responses. The durations of response were over 12 months in many cases. The durability of those responses was maintained in patients months after stopping treatment suggesting a vaccine effect had occurred. These study results are similar to a previous investigator sponsored Phase 1 study conducted at the City of Hope by Dr. Andrew Raubitschek.
"We believe that DI-Leu16-IL2 will significantly help individuals with B-cell malignancies," said Dr. Daniel Vlock, founder and CEO of Alopexx Enterprises. "We are delighted to be working with Shenogen to advance the development of this promising therapeutic."
Dr. Kun Meng, Chairman of Shenogen Pharma Group, commented, "We are very excited with this exclusive in-license opportunity of DI-Leu16-IL2 antibody-cytokine fusion protein from Alopexx, which opens the door for us to get into the B-cell lymphoma space of immunotherapy." Given the advantage of combining the benefits of anti-CD20 and IL2, two targets with approved anti-cancer drugs, Dr. Meng said, "We believe DI-Leu16-IL2 can offer superior efficacy and better serve the unmet medical needs of patients with B-cell lymphomas, especially with the relapsed and refractory forms of diseases." Shenogen plans to develop this drug as a potential single agent, or as combination therapy with other drugs.
CD20 is a protein frequently expressed on cancer cells associated with NHL. Pre-clinical studies have shown that DI-Leu16-IL2, which has activities of both the anti-CD20 antibody and cytokine components, targets the tumor cells, engages the immune system and has the potential to produce an anti-cancer vaccine effect. As a result of this vaccine-like effect, long- term anti-cancer activity should continue and future cancer cells could be destroyed even without the need for re-dosing.
"The fusion of the anti-CD20 antibody and the cytokine IL2 creates an effect that is far more powerful than administering those therapeutics individually or in combination," explained Stephen Gillies, Ph.D., Chief Scientific Officer of Alopexx Oncology. "In this therapeutic approach the drug elicits a T-cell response and also activates the innate immunity to kill tumor cells, and that is a very important distinction between this and other treatments."
About Alopexx Oncology/Alopexx Enterprises
Alopexx Oncology, LLC, a portfolio company of Alopexx Enterprises, licensed the rights to develop and commercialize its lead drug candidate DI-Leu16-IL2 from Provenance Biopharmaceuticals Corp. in 2011. This molecule was originally developed by Merck KGaA (now Merck Healthcare KGaA). In 2009 Merck KGaA license the global rights of DI-Leu16-IL2 to Provenance Biopharmaceuticals Corp.
Alopexx Enterprises consists of experts with deep industry knowledge and technical expertise in all areas of drug development including, pharmacology, CMC, toxicology, medical and clinical operations, quality and regulatory affairs. For more information, please visit www.alopexx.com.
Shenogen Pharma Group is a drug discovery and development company founded in 2006 at Beijing, China. Shenogen aims to develop and commercialize first-in-class therapeutics for cancer and autoimmune diseases. With the mission of "Better Medicine, Better Life", Shenogen aim to be a leading Chinese biopharmaceutical company with growing footprint worldwide. Shenogen has a highly skilled research & development team with rich international experience in drug discovery and development Utilizing modern biotech platforms, novel targets and properatural intellectual properties, Shenogen has generated a rich research portfolio consisting of drug candidates from small molecules, oncolytic viruses, to various forms of antibody based biologics. Currently, Shenogen is establishing a full pharma value chain from research to production and commercialization. For more information, please visit www.shenogen.com.
SOURCE Alopexx Oncology, LLC