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DEWB investment holding NOXXON Pharma: Phase IIa Results for Spiegelmer® Olaptesed Pegol (NOX-A12)

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Berlin, Germany and Boston, USA (pta011/05.12.2014/10:37) - 05 December 2014 - NOXXON Pharma will disclose promising data from two independent clinical Phase IIa studies of the anti-CXCL12/SDF-1 Spiegelmer® olaptesed pegol (NOX-A12) and show preclinical data supporting broad use of olaptesed pegol in combination with anti-cancer therapeutic antibodies at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco, CA from 06-09 December 2014.

In the first study, olaptesed pegol was administered with bortezomib and dexamethasone (VD) in patients with relapsed multiple myeloma (MM). In the second study, relapsed chronic lymphocytic leukemia (CLL) patients were treated with olaptesed pegol combined with bendamustine and rituximab (BR). Data from all 28 patients in each study will be presented.

In both studies, anti-CXCL12/SDF-1 Spiegelmer® olaptesed was able to mobilize cancer cells from protective niches in the body. This mobilization reflects olaptesed pegol's ability to block tumor-microenvironment interactions and to modify the bone marrow environment to make it less receptive for malignant cells.

In patients with relapsed MM, an overall response rate (ORR) of 68% including 18% very good partial responses (vgPR) and 7% complete responses (CR) was achieved in the 28 patients. Importantly, treatment with olaptesed pegol was not associated with additional toxicity on top of VD. Notably, the response rate was essentially the same in patients with high-risk cytogenetics and patients not bearing the high-risk mutations/translocations.

In relapsed CLL patients, 82% overall response rate (ORR) and 14% complete response (CR) rate was observed which compares very favorably with historical controls receiving the underlying BR therapy. Further, all high-risk patients responded with a partial response (PR) or complete response (CR).

Preclinical work showed that in contrast to tested inhibitors of BTK (ibrutinib) and PI3K (idelalisib), olaptesed does not inhibit antibody mediated cellular cytotoxicity or phagocytosis of rituximab. Furthermore, it not only mobilizes malignant cells, but also increases the number of circulating immune effector cells. Olaptesed pegol could thus be a partner of choice for anti-cancer monoclonal antibodies.

The titles and contributors for the three above mentioned poster presentations at ASH are as follows:

- Saturday, December 06, 2014, 5:30 PM-7:30 PM, West Building, Level 1 (Moscone Center), Session 653, Publication number: 2111 Final Results from the Phase IIa Study of the Anti-CXCL12 Spiegelmer® Olaptesed Pegol (NOX-A12) in Combination with Bortezomib and Dexamethasone in Patients with Multiple Myeloma Heinz Ludwig, Katja Weisel, Maria Teresa Petrucci, Xavier Leleu, Anna Maria Cafro, Laurent Garderet, Niklas Zojer, Robin Foa, Richard Greil, Ibrahim Yakoub-Agha, Anna Kruschinski, Thomas Dümmler, Kai Riecke, and Monika Engelhardt