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    AFMD   NL0010872420


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Affimed N.V. to Discuss Treatment of Cd30-Positive Lymphoma Patients with Cord Blood-Derived Natural Killer Cells Pre-Complexed with Innate Cell Engager AFM13

12/09/2021 | 07:30am EDT

Affimed N.V. will host a financial community call to discuss recent findings from the investigator sponsored tria at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager AFM13, pre-complexed with cord blood-derived natural killer cells. 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 monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×10 7 and 13 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight. Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance. In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy. The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. AFM13 is a first-in-class innate cell engager that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides. The study is actively recruiting.

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All news about AFFIMED N.V.
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Analyst Recommendations on AFFIMED N.V.
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Sales 2022 35,7 M 37,2 M 37,2 M
Net income 2022 -101 M -105 M -105 M
Net cash 2022 89,0 M 92,6 M 92,6 M
P/E ratio 2022 -4,02x
Yield 2022 -
Capitalization 471 M 490 M 490 M
EV / Sales 2022 10,7x
EV / Sales 2023 12,5x
Nbr of Employees 197
Free-Float 96,7%
Duration : Period :
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Technical analysis trends AFFIMED N.V.
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Mean consensus BUY
Number of Analysts 9
Last Close Price 3,15 €
Average target price 11,22 €
Spread / Average Target 256%
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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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