Affimed Therapeutics AG Reports Phase 1 Clinical Data for Its Immunotherapy AFM13 in Relapsing/Refractory Hodgkin Lymphoma Patients

HEIDELBERG, GERMANY--(Marketwired - June 24, 2013) - Affimed Therapeutics AG, the TandAb antibody company, today announced encouraging results from a phase 1 clinical trial of AFM13 as monotherapy for the treatment of patients with advanced relapsing/refractory Hodgkin lymphoma. AFM13 appears to be well tolerated with evidence of meaningful anti-tumor activity, including partial responses and stable diseases. AFM13 is a bispecific TandAb antibody recruiting host NK cells via its CD16A-binding domains to engage and kill CD30-positive malignant cells. The data were presented by Andreas Engert, Professor of Medicine at The University of Cologne and Chairman of the German Study Hodgkin’s Group (GSHG) at the 12th International Conference on Malignant Lymphoma, Lugano, Switzerland.

The 28-patient phase 1 trial was designed to determine the safety profile, maximum tolerated dose (MTD) and pharmacokinetics (PK), and to provide an indication of activity of AFM13. In the dose escalation part, 24 patients received increasing doses of AFM13 ranging from 0.01 mg/kg to 7.0 mg/kg on a weekly dosing schedule for 4 weeks. In addition, 4 patients were treated with 4.5 mg/kg twice a week for 4 weeks. The median number of prior therapies was 6 (ranging from 3 to 11), and 9 out of 28 patients had received brentuximab vedotin prior to enrollment. In the trial, 14 of the 28 patients were refractory to prior therapy.

“Relapsing/refractory Hodgkin lymphoma is a disease with very limited treatment options even after the advent of brentuximab vedotin and most conventional treatments are associated with high toxicity and short response duration. Data from this phase 1 trial support further evaluation of AFM13 in relapsing/refractory Hodgkin lymphoma patients,” said Prof. Engert. “The data warrant further trials to elucidate the therapeutic potential of AFM 13. Immunotherapy with AFM13 might become an attractive component to further improve the treatment of Hodgkin lymphoma.”

Key Safety and Clinical Data from AFM13 Phase 1 Trial

• AFM13 was safe and well tolerated in the phase 1 study, without reaching the MTD. One dose-limiting toxicity (DLT) was observed at 0.5 mg/kg and this dose level was increased to 6 patients. No further DLTs were observed.

• The most frequent adverse events were infusion-related reactions (headache, fever, fatigue and myalgia) that often occurred after the first administration. Nearly all adverse events were short-lived.

• AFM13 induced dose-dependent reduction of shed CD30 antigen and activation of NK cells.

• According to the Cheson criteria, 2 patients achieved partial responses and 14 patients had stable disease.

• AFM13 exhibited activity in brentuximab vedotin relapsing/refractory patients with 7 out of 9 patients achieving stable disease after AFM13 treatment.

• 13 patients received AFM13 as dose levels at and above 1.5 mg/kg. The drug showed substantial anti-tumor activity in these patients with 8 out of the 13 patients exhibiting a reduction in both, tumor volume (as assessed by CT scan) and tumor activity (as assessed by FDG-PET scan imaging). Furthermore, 3 out of 13 patients (23%) exhibited a reduction in tumor volume of more than 50%.
  

“Recently, an increasing number of diseases have been reported in which malignant cells express the CD30 antigen. The encouraging data obtained from this phase 1 trial with AFM13 in patients with relapsing/refractory Hodgkin lymphoma warrant further development of AFM13 not just in Hodgkin lymphoma, but also in other CD30-positive malignancies such as T-cell lymphomas,” said Miroslav Ravic, MD PhD, Chief Medical Officer of Affimed. “Furthermore, to the best of our knowledge, AFM13 is currently the only CD30-directed immunotherapy in clinical development and has the potential to become an important component of therapy in CD30-positive malignancies.”

About TandAbs and AFM13
TandAbs®, which were invented and developed by Affimed scientists, are tetravalent bispecific antibody formats that have two binding sites for each antigen. They bind to target molecules on the surface of tumor cells and specifically activate immune effector cells such as cytotoxic T-cells or natural killer (NK) cells in the presence of tumor cells. TandAbs® possess the same avidity and affinity for each target as an IgG. Combined with their bispecificity, this format represents a potent further development of therapeutic monoclonal antibodies and, potentially, a superior alternative to first generation antibody formats/scaffolds.

The TandAb® AFM13 is specifically designed to treat CD30-positive malignancies. It targets CD30 on malignant cells and CD16A on NK-cells. The simultaneous binding to both cells leads to an effective lysis of the tumor cells. In cytotoxicity assays, AFM13 has been shown to possess higher potency than antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced CD30 IgGs. A robust production process for AFM13 has been established with excellent stability of the drug substance and drug product.

About Hodgkin Lymphoma
Hodgkin lymphoma is a malignant type of cancer targeting the lymphatic system, with the highest incidence among those aged between 20-40 years, and over 70 years. According to estimates by the American Cancer Society, Hodgkin lymphoma has a yearly incidence of about 8,500 new patients in the US. Despite the strong potential for recovery at the early stage of the disease, therapeutic approaches have so far been insufficient, particularly with regard to those patients who do not respond to aggressive chemo- and radiotherapy. Due to the severe side-effects and the toxicity of this combined chemo- and radiotherapy, there is a great medical need for new treatments.

About Affimed Therapeutics AG
Affimed Therapeutics AG is a therapeutic antibody company developing unique antibody therapeutics as novel treatments for life threatening diseases with high unmet medical needs. The company has generated a growing pipeline of drug candidates based on its proprietary TandAb® antibody platform. Affimed’s product candidates are developed for the treatment of CD19-positive (AFM11) and CD30-positive tumors (AFM13). Further novel product candidates are in development to treat solid tumors and autoimmune diseases. Affimed’s proprietary and highly productive TandAb® technology enables the company to generate unique tetravalent, bispecific, fully human antibody formats that promise increased therapeutic potential and superior profiles compared to monoclonal antibodies. The private company Affimed, which employs 30 people in Heidelberg, is a spin-off from the German Cancer Research Centre (DKFZ), Heidelberg.

Press release (PDF)
http://hugin.info/142251/R/1711403/567780.pdf