On March 4, 2020 Alopexx Oncology, LLC reported 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 (Press release, Alopexx Pharmaceuticals, MAR 4, 2020, View Source [SID1234555174]). Alopexx will receive an upfront payment, various development and commercial milestones and royalties on sales.
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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.
About DI-Leu16-IL2
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."