Affimed prices public offering to finance NK cell trials

German Affimed N.V. has priced its previously announced public offering of 22,500,000 common shares at a  $4.00 per common share. A 30-day over-allotment option allows to purchase up to additional 3,375,000 common shares at the public offering price. After deducting the underwriting discounts, the net proceeds of the public offering are expected to be $84.6m.

The announcement came three days after the presentation of Phase I/II clincal data at the  American Association of Cancer Research (AACR) meeting in New Orleans (USA). The preliminary data demonstrate that treatment of 19 lymphoma patients with Affimed’s  innate NK cell engager AFM13 plus precomplexed with cord blood-derived natural killer (cbNK) cells led to remission in 17 patients. Though, the investigator-initiated trial at MD Anderson Hospital was small the results are impressive.

Combined with Affimed’s results from a trial at University of Texas  which showed a 100% objective response rate (ORR) and an improvement of complete response (CR) rate to 62% at the recommended Phase II dose (RP2D) in 13 patients after 2 cycles of therapy its sensational. In Affimeds study a total of 8 complete remissions have now been observed.

The study, presented by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, included 19 evaluable patients, all of whom have now completed both planned cycles. With the caveat of a relatively short follow-up period (median 11 months), 53% of patients are progression-free and 79% are still alive. The safety profile would be excellent with few and no serious side effects.

AFM13 is a bispecific antibody that targets CD30 and CD16A, thus acting as a bridge with NK cells. The MD Anderson phase I trial was conducted in patients with CD30-positive Hodgkin’s disease or T-cell lymphoma who had been massively pre-treated (an average of six therapies) but had suffered another relapse. The MD Anderson trial differs from Afimed’s own approach in that it also includes NK cells derived from allogeneic cord blood, which are activated, expanded and combined with AFM13 before being infused into the patient. This must be done within 24 hours.