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    AFMD   NL0010872420

AFFIMED N.V.

(AFMD)
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Affimed Announces Interim Clinical Results from the Investigator-Initiated Phase 1-2 Study At the University of Texas MD Anderson Cancer Center

11/22/2021 | 07:11am EST

Affimed N.V. announced interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimed?s innate cell engager (ICE?) AFM13. As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1x106, three patients with 1x107 and 12 patients with 1x108 AFM13-pre-complexed cbNK cells per kg body weight. As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses and nine partial responses. Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.


ę S&P Capital IQ 2021
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Financials
Sales 2021 38,2 M 43,5 M 43,5 M
Net income 2021 -56,0 M -63,7 M -63,7 M
Net cash 2021 172 M 196 M 196 M
P/E ratio 2021 -8,20x
Yield 2021 -
Capitalization 479 M 547 M 545 M
EV / Sales 2021 8,03x
EV / Sales 2022 7,94x
Nbr of Employees 153
Free-Float 97,2%
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Mean consensus BUY
Number of Analysts 7
Last Close Price 3,89 €
Average target price 11,61 €
Spread / Average Target 199%
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Managers and Directors
Adolf Hoess Chief Commercial Officer
Angus W. Smith Chief Financial Officer
Thomas O. Hecht Chairman-Supervisory Board
Andreas Harstrick Chief Medical Officer
Arndt Schottelius Chief Scientific Officer
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