Alopexx Oncology licensed the rights to develop and commercialize DI-Leu16-IL2 from Provenance Biopharmaceuticals Corp in 2011. DI-Leu16-IL2 is an immune therapeutic, a type of medication that fights cancer by enlisting the body’s own immune system and is a fusion of two known cancer therapeutics (an anti-CD20 antibody and the cytokine IL2) using a well-developed, proprietary technology that creates an effect that is far more powerful than administering those therapeutics individually or in combination.
DI-Leu16-IL2 Proof of Principle for NHL: In vivo activity against NHL in SCID mice. At 33 days, all untreated mice had died and mice treated with high doses of Rituxan had 100% mortality in 85 days. Treating with a combination of Rituxan (an antibody) and IL-2 (a cytokine) improved outcomes, but could not even approximate the effectiveness of DI-Leu16-IL2, an immunocytokine fusion protein. The SCID mice treated with Rituxan + IL-2 had initially better results than Rituxan alone, but again most had succumbed to disease by day 85. In marked contrast, 100% of the SCID mice treated with DI-Leu16-IL2 survived for the entire test period (up to day 113-not shown), implying a theoretical cure of the NHL.
An Investigator Initiated Study of DI-Leu16-IL2, conducted at the City of Hope National Medical Center, treated patients with refractory NHL and was completed in 2014 (clinicaltrials.gov: NCT00720135).
Of the 6 patients treated, 5 were noted to have clinical benefit with 1 complete, 1 partial, 1 possible partial response and 2 patients with stable disease.
The scans below are from a patient with lymphoma who failed multiple prior therapies. The first 2 images are before treatment with DI-Leu16-IL2. The last image on the right was obtained ~ 2 months after starting therapy and shows almost complete disappearance of the tumor nodules.
Alopexx Oncology filed an Investigative New Drug Application with the FDA in 1Q13 and a Phase I/II clinical trial treating patients with Non-Hodgkins Lymphoma (NHL) was initiated in the U.S. (clinicaltrials.gov: NCT01874288) and is enrolling and treating NHL patients.