Benzinga | Apr 9, 2021 06:01AM EDT

Affimed Highlights Presentation Of Initial Data From Phase 1 Study Of Cord Blood-Derived Natural Killer Cells Pre-Complexed With Innate Cell Engager At American Association For Cancer Research Meeting Apr. 13 at 1:30 p.m. EDT

Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today positive initial clinical data from an investigator-sponsored study at The University of Texas MD Anderson Cancer Center evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimed's innate cell engager (ICE(r)) AFM13 (CD16A/CD30).

This approach was developed in the laboratory of Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, who is presenting the data as part of the Major Symposia and Advances sessions at the virtual American Association for Cancer Research (AACR) Annual Meeting. The presentation is available for viewing by registered participants through June 21, 2021. Dr. Rezvani will take part in a live panel discussion as part of the presentation on April 13, 2021 at 1:30 p.m. EDT.

"We are encouraged by the initial safety and efficacy data from this groundbreaking first in-human study. The finding of an objective response rate of 100% amongst our first four patients enrolled is impressive," said Andreas Harstrick, M.D., Chief Medical Officer of Affimed. "These initial results indicate AFM13 may have the potential to help NK cells target and destroy cancer cells. We plan to continue to develop and customize approaches that leverage the unique and differentiating features of our ICE(r) molecules in combination with adoptive NK cell transfer to provide options for treating a variety of hematologic and solid tumors."

The open-label, non-randomized, single-center, dose-escalation trial is evaluating the pre-complexing of AFM13 with cbNK cells followed by three weekly infusions of AFM13 monotherapy in adult patients with recurrent/refractory CD30-positive lymphomas. The trial is led by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.

"There remains a high unmet need for effective treatments in relapsed/refractory (R/R) CD30+ lymphomas. We are encouraged by the data generated from the first patients treated with cbNK cells pre-complexed with AFM13," said Dr. Rezvani. "The results suggest this combination is facilitating clinical responses with minimal toxicity, warranting further study as we continue to explore novel cell therapies for our patients."

As of March 31, 2021, three patients have been dosed with two cycles of therapy in dose cohort 1 (1x106 AFM13-cbNK/kg) and one patient has received a single cycle of therapy in dose cohort 2 (1x107 AFM13-cbNK/kg). The study is currently enrolling patients in the second dose cohort of NK cells, and further updates are expected later in 2021. Results from the first cycle of the first dose cohort are being presented by Dr. Rezvani at AACR, and Affimed is supplementing the data with best responses as of March 31, 2021, as summarized below.

Patient cbNK Cancer Prior CRS/ Bestnumber Cell Patient Type Treatment Neurotoxicity Response Dose / GVHDCohort 1 ? completed 4 lines of therapy (ABVD, 1x106 Hodgkin ICE, Partial#1 / kg 43-year-old-male lymphoma brentuximab None response vedotin, nivolumab + ruxolitinib) 14 lines of therapy (ABVD, brentuximab vedotin, HDACi /P13Ki, 1x106 Hodgkin pembrolizumab, Partial#2 / kg 31-year-old-male lymphoma nivolumab, None response allo-HSCT, hypercytoxan, ibrutinib, niraparib, bendamustine, everolimus) 5 lines of therapy (ABVD, Complete 1x106 Hodgkin ICE, response#3 / kg 53-year-old-female lymphoma brentuximab None after vedotin, cycle 2 nivolumab, GemOx)Cohort 2 ? ongoing (1 of 3 patients enrolled) 9 lines of therapy (ABVD, ICE + brentuximab vedotin, radiation, nivolumab, CD30-CART, TTI-622,#4 1x107 26-year-old-male Hodgkin brentuximab None Complete / kg lymphoma vedotin + response bendamustine, allo-HSCT, brentuximab vedotin + bendamustine with brentuximab vedotin maintenance)

ABVD = Adriamycin (doxorubicin), Bleomycin, Vinblastine, Dacarbazine (DTIC)

ICE = chemotherapy combination includes the drugs: ifosfamide, carboplatin, & etoposide phosphate

GemOx= gemcitabine, oxaliplatin

There were no observed events of cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease.

Response evaluation followed the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed/refractory Hodgkin Lymphoma and were heavily pretreated, with between 4 and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris(r)) and anti-PD1 antibodies. Of note, patient #4 had also previously received a CD30-CAR-T.

Conference Call/Webcast Details

Affimed will host a conference call and webcast on April 14, 2021, at 4:05 p.m. EDT to discuss the initial study findings. The conference call will be available via phone and webcast. To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 1788338 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.