Affimed Therapeutics, LLS partner to co-fund AFM13 phase 2 trial for treatment of Hodgkin Lymphoma

Affimed Therapeutics AG and The Leukemia & Lymphoma Society (LLS) today announced a partnership to co-fund a phase 2 trial with the Recruit-TandAb AFM13, a novel tetravalent bispecific antibody directed against human CD30 and CD16A in Hodgkin Lymphoma (HL) patients for whom currently available treatments have failed. AFM13 is a first-in-class immunotherapy drug designed to treat HL patients and patients with CD30-positive malignancies. LLS has committed to investing up to $4.4 million over 2 years to support the project. 

Dr. Richard Winneker, SVP Research for LLS, stated, "Though the cure rate for Hodgkin Lymphoma is high compared to other types of blood cancers, refractory and relapsed patients have few therapeutic options. More importantly current treatments for HL patients involve cytotoxic drug therapies and radiotherapy, which are likely responsible for secondary tumors and other considerable long term side effects developing later in a patient's life, leaving open a critical need for safer and more durable therapies. LLS is committed to advancing breakthrough therapies, particularly for patients with unmet medical needs, and Affimed's immunotherapy is emerging as a promising therapeutic option for HL patients."

"The partnership between Affimed and LLS is a significant validation of the high potential of our TandAb platform and reinforces our strategy to develop this novel bispecific construct for hematological tumors", said Dr. Adi Hoess, CEO of Affimed AG. "We very much welcome LLS's commitment to AFM13, and we look forward to an accelerated development of this therapy for patients with limited treatment options to date."

In a phase 1 trial, AFM13 has shown a good safety profile, as it was well tolerated at all dose levels tested. Furthermore, AFM13 showed clear and meaningful signs of efficacy in some patients deemed to have a poor prognosis, including patients who had not benefited from the recently approved CD30 targeting drug, brentuximab vedotin (Adcetris®, Seattle Genetics). These encouraging data warrant the further investigation of AFM13 in a phase 2 trial to further assess its efficacy. Moreover, these trials could provide proof of concept for using bispecific antibodies to elicit natural killer (NK) cells, vital lymphocytes of the innate immune system, to effectively kill cancer cells.