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    AFMD   NL0010872420

AFFIMED N.V.

(AFMD)
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Press Release: Affimed Announces Publication of Preclinical Data in Clinical Cancer Research Supporting Therapeutic Potential of AFM13 in Combination with Natural Killer Cells

05/13/2021 | 04:01pm EDT
 
 
 
 
   -- AFM13 in combination with natural killer (NK) cells demonstrated improved 
      tumor recognition and enhanced tumor cell killing in vitro and in vivo. 
 
   -- Preclinical data from this publication supported the Investigational New 
      Drug (IND) application for the ongoing Phase I clinical study of AFM13 
      pre-complexed with NK cells. 
 
 
   Heidelberg, Germany, May 13, 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 the publication of 
preclinical in vitro and in vivo research of its lead innate cell 
engager (ICE(R) ), AFM13 (CD16A/CD30), combined with healthy 
donor-derived NK cells in 
https://www.globenewswire.com/Tracker?data=_hg2Ybz35PKZrOT6ojUCHXAiOuOaa7uTGNKMph_6lG5AwIpUmmrsnq1pEyvqQwcbxv3XqUA4mC9ENmL_xNyjt0g7cAGAz61dwg0wlbbB2AVFlXPXf-x4U2KpEvN45Q7DNZu64HfHzpANRvAN5Bv0rSrgX5-LMAurSeItltoh8-B-FJKHaWoZxkywUJU8xH5b 
Clinical Cancer Research. The preclinical data demonstrated that AFM13 
strongly binds to NK cells, including cytokine-activated or cord 
blood-derived NK (cbNK) cells, resulting in enhanced tumor recognition 
and antibody-dependent cellular cytotoxicity (ADCC). The research was 
generated through a collaboration with The University of Texas MD 
Anderson Cancer Center and Washington University School of Medicine and 
supports use of AFM13 combined with NK cells as a promising therapy for 
CD30-positive hematological malignancies. 
 
   "Our ROCK(R) platform forms the basis to generate ICE(R) molecules which 
have the ability to strongly and durably bind to CD16A on NK cells, 
resulting in unique antitumor properties," said Arndt Schottelius, M.D., 
Ph.D., Chief Scientific Officer of Affimed. "As demonstrated by the 
recent presentation of initial Phase 1 data at the American Association 
for Cancer Research (AACR) Annual Meeting 2021 -- which showed an 
emerging profile that appears to have the potential to provide 
meaningful benefit with a safety profile consistent with previous AFM13 
data -- pre-complexing AFM13 with NK cells presents an innovative and 
promising therapeutic approach for patients with impaired NK cell 
activity." 
 
   "This study provided new insights into how ICE(R) molecules such as 
AFM13 may be impacted by NK cell receptor ligand alterations using 
multidimensional mass cytometry," said Todd Fehniger, M.D., Ph.D., 
Professor of Medicine, Oncology Division, at Washington University. 
"Further, blood NK cells primed and differentiated into memory NK cells 
exhibit potent responses to CD30+ cancer cells when directed by AFM13, 
providing further evidence for their powerful CD16-triggered cytokine 
production and killing." 
 
   Additional key findings from the research are outlined below: 
 
 
   -- AFM13 combined with donor NK cells, including conventional NK cells from 
      healthy donors, cytokine-induced memory-like NK cells from peripheral 
      blood and preactivated and expanded cbNK cells, enhanced tumor cell 
      killing compared to NK cells alone. 
 
   -- When combined with AFM13, Hodgkin lymphoma patient-derived NK cells do 
      not reach the same level of cytotoxicity compared to healthy 
      donor-derived NK cells in vitro. 
 
   -- AFM13-directed tumor cell killing was enhanced when combined with 
      cytokine (IL-12, IL-15 and IL-18) preactivated cbNK cells compared to 
      non-cytokine preactivated cbNK cells. 
 
   -- Cytokine preactivated cbNK cells express different markers when compared 
      to noncytokine preactivated cbNK cells, potentially accounting for 
      superior cytotoxicity which is further enhanced with AFM13. 
 
 
   "This preclinical study confirmed the synergy between the cbNK cell 
platform developed at MD Anderson and AFM13 as a precomplexed product 
and provided the rationale to test this novel NK cell-based adoptive 
immunotherapy strategy for patients with relapsed/refractory CD30+ 
malignancies," said Katy Rezvani, M.D., Ph.D., Professor of Stem Cell 
Transplantation and Cellular Therapy at MD Anderson. 
 
   The preclinical data published in Clinical Cancer Research supported the 
Investigational New Drug (IND) application for the ongoing Phase I 
clinical study of AFM13 precomplexed with cytokine-preactivated cbNK 
cells followed by AFM13 monotherapy in patients with 
CD30-positivemalignancies. Results of the 
https://www.globenewswire.com/Tracker?data=L_b5PGcMc-4EzivY149nom9XxcvGD9PO-9ePUrEJ_WE6hxZJluzWz1yxEd8-llgrzVGvvQ-J7wkdUk4UC0f5pZUVt8d-SxwqKK9YR3yIkQImr2kGZJY6fvChnkugMl3wmxglHfw6lH17DRGUzXNSSYwokWBGg93z8P8drwt-PBn2e1bXElUQuMqHmwGIE6ELXlO73Q2j-L1-fe_y5WeUuKTkF0fok9RlsGzKNIZjwepuZPt8wL_iSsaqZS7w83r2cagRE_zhn8I75ciec8BQYId6z6n4MHtLnkr1GnDBAVE7cORo9tmvGkCbDjw_bauZ 
Phase 1 study as of March 31, 2021, demonstrated an objective response 
rate of 100% (ORR=4/4; PR=2/4; CR=2/4) among the first patients enrolled 
who were all heavily pretreated. There were no observed events of 
cytokine release syndrome, neurotoxicity, or graft-versus-host disease. 
The study will progress to the higher dose cohorts with additional 
updates expected throughout this year. 
 
   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 
transformed mycosis fungoides (REDIRECT). The study is actively 
recruiting, and additional details can be found at 
https://www.globenewswire.com/Tracker?data=NQZ_Ti8b4HJuAv0mNq72p1o8WpsUV5ofecWd8CGT0XWLEMxFtFYupxH4yp7l2C1kBZPLR0bPjKEb3EGKVI2fNFyF6rCtr8oGN8qzk5vE_R8= 
www.clinicaltrials.gov (NCT04101331). 
 
   In addition, 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 precomplexed 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 precomplexed 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. 
 
   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. 
 
   Additional information about the study can be found at 
https://www.globenewswire.com/Tracker?data=NQZ_Ti8b4HJuAv0mNq72p1o8WpsUV5ofecWd8CGT0XWEEKAxHGECp6jeeHeAtjVZzjX5qmbF42GaUWyqqmoHRM--sYw5AuAybLs2rFyvwlU= 
www.clinicaltrials.gov (NCT04074746). 
 
 
 
 
 
   About Affimed N.V. 
 
   Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company 
committed to giving patients back their innate ability to fight cancer 
by actualizing the untapped potential of the innate immune system. The 
company's proprietary ROCK(R) platform enables a tumor-targeted approach 
to recognize and kill a range of hematologic and solid tumors, enabling 
a broad pipeline of wholly-owned and partnered single agent and 
combination therapy programs. The ROCK platform predictably generates 
customized innate cell engager (ICE(R) ) molecules, which use patients' 
immune cells to destroy tumor cells. This innovative approach enabled 
Affimed to become the first company with a clinical-stage ICE(R) . 
Headquartered in Heidelberg, Germany, with offices in New York, New York, 
Affimed is led by an experienced team of biotechnology and 
pharmaceutical leaders united by a bold vision to stop cancer from ever 
derailing patients' lives. For more about the company's people, pipeline 
and partners, please visit: 
https://www.globenewswire.com/Tracker?data=NQZ_Ti8b4HJuAv0mNq72p4GMN_3nhUuRixOwGfJcoZuQhUWisnUwjyuqhRyeH5iBA9mIUo1xeXktJCmo7bJKcQ== 
www.affimed.com. 
 
 
 
   FORWARD-LOOKING STATEMENTS 
 
   This press release contains forward-looking statements. All statements 
other than statements of historical fact are forward-looking statements, 
which are often indicated by terms such as "anticipate," "believe," 
"could," "estimate," "expect," "goal," "intend," "look forward to," "may, 
" "plan," "potential," "predict," "project," "should," "will," "would" 
and similar expressions. Forward-looking statements appear in a number 
of places throughout this release and include statements regarding our 
intentions, beliefs, projections, outlook, analyses and current 
expectations concerning, among other things, the potential of AFM13, 
including with cbNK cells, the value of our ROCK(R) platform, our 
ongoing and planned preclinical development and clinical trials, our 
collaborations and development of our products in combination with other 
therapies, the timing of and our ability to make regulatory filings and 
obtain and maintain regulatory approvals for our product candidates, our 
intellectual property position, our collaboration activities, our 
ability to develop commercial functions, clinical trial data, our 
results of operations, cash needs, financial condition, liquidity, 
prospects, future transactions, growth and strategies, the industry in 
which we operate, the trends that may affect the industry or us, impacts 
of the COVID-19 pandemic, the benefits to Affimed of orphan drug 
designation, and the risks, uncertainties and other factors described 
under the heading "Risk Factors" in Affimed's filings with the 
Securities and Exchange Commission. Given these risks, uncertainties and 

(MORE TO FOLLOW) Dow Jones Newswires

May 13, 2021 16:01 ET (20:01 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
AFFIMED N.V. -0.29% 6.89 Delayed Quote.18.38%
DJ INDUSTRIAL 0.80% 35116.4 Delayed Quote.14.14%
NASDAQ COMP. 0.55% 14761.294551 Real-time Quote.13.85%
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Financials
Sales 2021 36,2 M 43,0 M 43,0 M
Net income 2021 -28,7 M -34,0 M -34,0 M
Net Debt 2021 - - -
P/E ratio 2021 -23,2x
Yield 2021 -
Capitalization 691 M 820 M 820 M
Capi. / Sales 2021 19,1x
Capi. / Sales 2022 11,7x
Nbr of Employees 153
Free-Float 97,2%
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Number of Analysts 4
Last Close Price 5,81 €
Average target price 12,66 €
Spread / Average Target 118%
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Managers and Directors
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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