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    AFMD   NL0010872420

AFFIMED N.V.

(AFMD)
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Press Release: Affimed Announces Presentation at AACR Highlighting Initial Data from Phase 1 Study of Cord Blood-derived Natural Killer Cells Pre-complexed with Innate Cell Engager AFM13

04/09/2021 | 06:00am EDT
 
 
 
 
   -- All four patients experienced significant disease reduction, with two 
      complete responses and two partial responses as assessed by the 
      investigator, with an objective response rate of 100% 
 
   -- There were no observed events of cytokine release syndrome, neurotoxicity 
      syndrome or graft-versus-host disease 
 
   -- Study is continuing enrollment of the second dose cohort 
 
   -- Company to host conference call/webcast on April 14 at 4:05 p.m. EDT 
 
 
 
 
   Heidelberg, Germany, April 9, 2021 -- 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 (1x10(6) AFM13-cbNK/kg) and one patient has 
received a single cycle of therapy in dose cohort 2 (1x10(7) 
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 Cell  Patient             Cancer     Prior Treatment               CRS/ Neurotoxicity/  Best Response 
 number   Dose                           Type                                     GVHD 
-------  ---------  ------------------  ---------  ----------------------------  -------------------  ----------------- 
Cohort 1 -- completed 
----------------------------------------------------------------------------------------------------------------------- 
#1       1x10(6)    43-year-old-male    Hodgkin    4 lines of therapy (ABVD,     None                 Partial response 
          / kg                           lymphoma   ICE, brentuximab vedotin, 
                                                    nivolumab + ruxolitinib) 
-------  ---------  ------------------  ---------  ----------------------------  -------------------  ----------------- 
#2       1x10(6)    31-year-old-male    Hodgkin    14 lines of therapy           None                 Partial response 
          / kg                           lymphoma   (ABVD, brentuximab vedotin, 
                                                    HDACi/P13Ki, pembrolizumab, 
                                                    nivolumab, allo-HSCT, 
                                                    hypercytoxan, ibrutinib, 
                                                    niraparib, bendamustine, 
                                                    everolimus) 
-------  ---------  ------------------  ---------  ----------------------------  -------------------  ----------------- 
#3       1x10(6)    53-year-old-female  Hodgkin    5 lines of therapy (ABVD,     None                 Complete response 
          / kg                           lymphoma   ICE, brentuximab vedotin,                          after cycle 
                                                    nivolumab, GemOx)                                  2 
-------  ---------  ------------------  ---------  ----------------------------  -------------------  ----------------- 
Cohort 2 -- ongoing (1 of 3 patients enrolled) 
----------------------------------------------------------------------------------------------------------------------- 
#4       1x10(7)    26-year-old-male    Hodgkin    9 lines of therapy (ABVD,     None                 Complete response 
          / kg                           lymphoma   ICE + brentuximab vedotin, 
                                                    radiation, nivolumab, 
                                                    CD30-CART, TTI-622, 
                                                    brentuximab vedotin 
                                                    + 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.globenewswire.com/Tracker?data=ag-nKRNVUHnnKpowj5nE8asMZ4y6J__tKwcw76AtAAneC2d4cCsrpAbs4SGGQVXV8HLXkvAQ0KBGaaOUNVed10fsN06ijdYFDwiMfojA3SXHgvgmeFXnii-bLtkFPYv_lRDTvDA5-oQRsSob7mCcBWLQIgWgbwFpXjyV3D7CutY= 
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. 
 
   About the Phase 1 Study 
 
   The University of Texas MD Anderson Cancer Center is studying AFM13 in 
an investigator-sponsored Phase 1 trial in combination with cord 
blood-derived allogeneic NK cells in patients with recurrent or 
refractory CD30-positive lymphomas. The study is a dose-escalation trial 
of pre-complexed NK cells, with patients receiving 1x10(6) NK cells/kg 
in Cohort 1; 1x10(7) NK cells/kg in Cohort 2; and, 1x10(8) NK cells/kg 
in Cohort 3. The trial is designed to explore safety and activity and 
determine the recommended Phase 2 dose. In each cohort, the dose of the 
pre-complexed NK cells with AFM13 is to be 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. Additional 
information about the study can be found at 
https://www.globenewswire.com/Tracker?data=KAYDMXlVJBnpr_vlT6Hw5r4VOBpMxrsrsyzXHBFiabo8aDL0ScUg2ATYfGhZGCw9SuX8L6h-GmQGGCMOiMof8UkQc-_XpKO_2bhrZFKHP4w= 
www.clinicaltrials.gov (NCT04074746). 
 
   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. 
 
   About AFM13 
 
   AFM13 is a first-in-class innate cell engager (ICE(R)) 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 (NK) cells and macrophages. AFM13 
is Affimed's most advanced ICE(R) 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 

(MORE TO FOLLOW) Dow Jones Newswires

April 09, 2021 05:59 ET (09:59 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
AFFIMED N.V. -4.38% 9.38 Delayed Quote.61.17%
DJ INDUSTRIAL -0.10% 34742.82 Delayed Quote.13.63%
NASDAQ COMP. -2.55% 13401.857613 Delayed Quote.3.98%
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Financials
Sales 2021 32,9 M 39,9 M 39,9 M
Net income 2021 -49,9 M -60,6 M -60,6 M
Net Debt 2021 - - -
P/E ratio 2021 -16,8x
Yield 2021 -
Capitalization 919 M 1 116 M 1 116 M
Capi. / Sales 2021 27,9x
Capi. / Sales 2022 16,0x
Nbr of Employees 153
Free-Float 83,5%
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Mean consensus BUY
Number of Analysts 5
Average target price 12,84 €
Last Close Price 7,73 €
Spread / Highest target 94,1%
Spread / Average Target 66,1%
Spread / Lowest Target 50,0%
EPS Revisions
Managers and Directors
NameTitle
Adolf Hoess Chief Executive 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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