Alopexx Oncology Presents Encouraging Phase I/II Clinical Data On DI-Leu16-IL2 At The American Society Of Hematology Annual Meeting

Dec 07, 2015, 07:00 ET from Alopexx Oncology, LLC

CONCORD, Mass., Dec. 7, 2015 /PRNewswire/ -- Alopexx Oncology, LLC announced today data from an ongoing Phase I/II trial of DI-Leu16-IL2, a novel immunocytokine that is a fusion of an anti-CD20 antibody and the cytokine IL2, in patients with relapsed/refractory Non-Hodgkin lymphoma (NHL). The initial results of the study (abstract #81799) were presented at the 57th annual American Society of Hematology (ASH) meeting in Orlando, FL. Alopexx Oncology is a portfolio company of Alopexx Enterprises, LLC.

To date, 16 patients with relapsed or refractory B-cell CD20 positive lymphoma have been entered, all of whom were treated previously with rituximab-containing chemotherapy, and several with prior radiation therapy or autologous transplantation. Thirteen of those patients are evaluable for a response. While dose escalation is ongoing, thus far 12 of 13 patients receiving 2 cycles of therapy had tumor regression or stabilization including a complete response (no detectable tumor) in one patient after 2 cycles of therapy. Of patients receiving 6 cycles, all 8 showed sustained disease control with 2 complete responses, 2 partial responses (55% and 75% tumor size reduction) and 4 with stable disease. A third patient with a complete response has not yet received 6 cycles of therapy. Three patients have had durable responses of 11 or more months. These study results are similar to a previous Phase 1 study conducted at the City of Hope (Nakamura R., 2013).

Thus far, the study found that DI-Leu16-IL2 was well tolerated, with mild skin reactions and some flu-like symptoms reported. Subcutaneous dosing was employed in the study to deliver the drug directly into the lymphatic system, allowing for higher dosing and lower side effects than with IV infusion.

"The findings to date are very encouraging and support our belief that DI-Leu16-IL2 has the potential to become an effective therapy in the treatment of refractory NHL," said Dr. Daniel Vlock, founder and CEO of Alopexx Enterprises.

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 model, 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 Non-Hodgkin Lymphoma (NHL)
Non-Hodgkin lymphoma (also known as non-Hodgkin's lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in cells called lymphocytes, which are part of the body's immune system. The American Cancer Society estimates about 71,850 new cases of NHL this year and 19,790 deaths.

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. Alopexx Enterprises consists of experts who have deep industry knowledge and technical expertise in all areas of drug development including, pharmacology, CMC, toxicology, medical and clinical operations, quality and regulatory affairs. Alopexx forms collaborations with academic institutions, biotech and pharmaceutical companies to advance its portfolio to deliver breakthrough therapies to patients in need. For more information, please go to www.alopexx.com.

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SOURCE Alopexx Oncology, LLC



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