Share price an volume spiked at the open after Affimed N.V. released the following news…..
Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today reported additional preliminary patient data from two separate clinical studies of its lead NK cell engager candidate AFM13. The data demonstrate that AFM13 was well-tolerated and showed promising therapeutic efficacy both in combination with the anti-PD-1 antibody Keytruda® (pembrolizumab) in Hodgkin lymphoma (HL) and as monotherapy in CD30-positive lymphoma.
“We are extremely encouraged by these new data which indicate that the first-in-class NK cell engager AFM13 has achieved clinically meaningful responses both as single agent and in combination with a checkpoint inhibitor” said Dr. Adi Hoess, CEO of Affimed. “In particular, in our combination trial with Keytruda, we are excited to have increased both overall and complete metabolic response rates.”
AFM13 in combination with Keytruda® in relapsed/refractory HL
Best response preliminary assessment data from 9 patients treated at the highest AFM13 dose level (7 mg/kg) as reported by central read, showed an objective response rate (ORR) of 89% (8/9), including complete metabolic responses (CmR) in 44% (4/9) and partial metabolic responses (PmRs) in 44% (4/9) of patients. One patient experienced stable disease (SD). This ORR of 89% compared favorably to the historical ORR of Keytruda (58-63%) as monotherapy in a similar patient population. Namely, these patients were R/R HL and post autologous stem cell transplantation (ASCT) or ineligible for ASCT and had failed brentuximab vedotin (BV). Importantly, the reported CR rate of 44% represents a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).
The combination was well-tolerated with most of the adverse events observed mild to moderate in nature and manageable with standard of care.
The data shown here comprise six previously reported patients, including one patient evaluated as a PmR at the three-month assessment and who was converted into CmR at the six-month assessment, as well as three additional patients. In total, the extension cohort includes 21 patients and enrollment has recently been completed.
AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma
In an ongoing investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg) has been completed. The data demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2/3). In detail, one complete response (CR), one partial response (PR) and one stable disease (SD) were observed, as determined by global response score (GRS).
“AFM13 is a truly novel immuno-therapeutic that recruits NK cells and targets CD30-expressing lymphomas. Our early clinical experience has been impressive”, said Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator of the study. “The treatment was well-tolerated and, importantly, it could provide a new treatment for relapsed/refractory CD30-positive lymphoma patients, who currently have limited to no options.”