NOXXON Pharma reports interim data from two phase IIa studies of anti-CXCL12/SDF-1 Spiegelmer NOX-A12

NOXXON Pharma AGDec 9 2013

NOXXON Pharma disclosed interim data from two independent clinical phase IIa studies of the anti-CXCL12/SDF-1 Spiegelmer^® olaptesed pegol (NOX-A12) at the 55^th annual meeting of the American Society of Hematology (ASH) in New Orleans, LA, USA from 7-10 December 2013.

In the first study, olaptesed was administered to relapsed chronic lymphocytic leukemia (CLL) patients in combination with bendamustine and rituximab. In the second study, olaptesed was combined with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM). Data from the 9 patient pilot groups in each study were presented.

In the trial focusing on relapsed CLL, olaptesed treatment resulted in an effective and prolonged mobilization of CLL cells into the peripheral blood. This mobilization reflects olaptesed's ability to block tumor-microenvironment interactions, which is thought to increase tumor cell sensitivity to killing by chemotherapeutic agents. In addition, the 100% overall response rate (ORR) and 22% complete response (CR) rate as well as the virtual absence of additional toxicity on top of the treatment with bendamustine and rituximab (BR) observed in this pilot group compares very favorably with historical controls. Provided that this promising clinical picture is maintained in the total sample of 33 patients, NOXXON plans to further develop this novel anti-CXCL12/SDF-1 Spiegelmer^®.

In patients with relapsed MM, anti-CXCL12/SDF-1 Spiegelmer^® olaptesed showed the same effect of mobilization of plasma cells into the peripheral blood. In addition, an overall response rate (ORR) of 67% including 22% very good partial responses (vgPR) was achieved in this pilot group. Importantly, treatment with olaptesed was not associated with additional toxicity on top of Velcade^®/bortezomib and dexamethasone (VD). If these preliminary results can be maintained in the total sample of 28 patients, then again further development of this novel anti-CXCL12/SDF-1 Spiegelmer^® will be warranted.

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

• Saturday, December 7, 5:30 PM - 7:30 PM, Hall E; Session 642, Publication number: 1635

Anti-CXCL12/SDF-1 Spiegelmer^® NOX-A12 Alone and In Combination With Bendamustine and Rituximab In Patients With Relapsed Chronic Lymphocytic Leukemia (CLL): Results From A Phase IIa Study

Marco Gobbi, Michael Steurer, Federico Caligaris-Cappio, Marco Montillo, Ann Janssens, Livio Trentin, Thomas Dümmler, Stefan Zöllner, Stefan Zeitler, Kai Riecke, Anna Kruschinski

• Saturday, December 7, 5:30 PM - 7:30 PM, Hall G, Session 653, Publication number: 1951

Anti-CXCL12/SDF-1 Spiegelmer^® NOX-A12 Alone and In Combination with Bortezomib and Dexamethasone In Patients With Relapsed Multiple Myeloma: Results From A Phase IIa Study

Heinz Ludwig, Katja Weisel, Monika Engelhardt, Richard Greil, Anna Maria Cafro, Maria Teresa Petrucci, Thomas Dümmler, Stefan Zöllner, Stefan Zeitler, Kai Riecke, Anna Kruschinski

Three more poster presentations at ASH have the following titles and contributors:

• Sunday, December 8, 6:30 PM - 8:30 PM, Hall E, Session 506, Publication Number: 2454

SDF-1 Inhibition Using Spiegelmer^® NOX-A12 as a Novel Strategy for Targeting AML Cells Within their BM Microenvironment

Rodrigo Jacamo, Zhihong Zeng, Ye Chen, Yuexi Shi, Teresa McQueen, Anna Kruschinski, Marina Konopleva, Peter P. Ruvolo, Michael Andreeff

• Monday, December 9, 6:00 PM - 8:00 PM, Hall E, Session 604, Publication Number: 3851

Targeting the Protective Microenvironment in Multiple Myeloma (MM): An Analysis of The CXCL12/CXCR4-Axis and its Inhibitors AMD3100 and NOX-A12 Combined with Antimyeloma Substances, Such As Pomalidomide and Carfilzomib

Anna Simon, Dagmar Wider, Marie Follo, Johannes Waldschmidt, Martina Kleber, Ralph Waesch, Monika Engelhardt

• Monday, December 9, 6:00 PM - 8:00 PM, Hall E, Session 641, Publication Number: 4111

The Spiegelmer^® NOX-A12 Abrogates Homing of Human CLL Cells To Bone Marrow and Mobilizes Murine CLL Cells in the Eμ-TCL1 Transgenic Mouse Model Of CLL

Elisabeth Hinterseer, Tamara Girbl, Evelyn Hutterer, Petra Berghammer, Sylvia Ganghammer, Eveline Sifft, Josefina Pinon Hofbauer, Alexander Egle, Anna Kruschinski, Richard Greil, Tanja Nicole Hartmann

Members of NOXXON's drug development team and collaboration partners will be at the ASH conference to explain the mode of action and clinical potential of this innovative drug candidate.