SEC Filing - Affimed NV

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of November, 2018

Commission File Number: 001-36619

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Affimed N.V.

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Im Neuenheimer Feld 582,

69120 Heidelberg,

Germany

(Address of principal executive offices)

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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

AFFIMED N.V.

Affimed N.V. (“Affimed” or the “Company”) today announced that six abstracts highlighting data from the Company’s innate immune cell and T cell-based therapeutic programs have been accepted for presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA.

A copy of the Company’s press release is filed as Exhibit 99.1 to this Report on Form 6-K, and is incorporated herein by reference.

INCORPORATION BY REFERENCE

This Report on Form 6-K (including Exhibit 99.1 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-207235) and Form S-8 (Registration Number 333-198812) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Heidelberg, Germany, November 1, 2018.

AFFIMED N.V.

By:	/s/ Adi Hoess
	Name:	Adi Hoess
	Title:	Chief Executive Officer


By:	/s/ Florian Fischer
	Name:	Florian Fischer
	Title:	Chief Financial Officer

EXHIBIT INDEX

Exhibit	Description of Exhibit
99.1	Press Release dated November 1, 2018

EXHIBIT 99.1

FOR IMMEDIATE RELEASE

Affimed Announces Oral Presentation and Five Poster Presentations at the 2018 American Society of Hematology Annual Meeting

Heidelberg, Germany, November 1, 2018 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK cells, macrophages and T cells), today announced that six abstracts highlighting data from the Company’s innate immune cell and T cell-based therapeutic programs have been accepted for presentation at the 60^th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA.

Presentations related to Affimed’s CD16A innate immune cells engager programs include 6-month follow-up data from the clinical study of AFM13, Affimed’s lead CD30/CD16A bispecific ROCK® antibody, in combination with Merck’s Keytruda® (pembrolizumab), interim data from Columbia University on AFM13 in relapsed or refractory CD30-positive lymphoma with cutaneous manifestation including translational data, and preclinical data from The University of Texas MD Anderson Cancer Center on cord blood-derived allogeneic NK cells in combination with AFM13. Additional abstracts on CD16A engagers include updates on the Company’s research on the role of AFM13 activating CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data supporting further development of Affimed’s partnered ROCK®-based development candidate AFM26 (BCMA/CD16A) as a promising treatment for patients with multiple myeloma.

Preliminary results, including clinical activity and safety, from a dose escalation trial in relapsed/refractory acute lymphoblastic leukemia for AFM11, Affimed’s CD19 targeting T cell engager, will also be presented.

Full abstracts of the presentations can be accessed on the ASH website at http://www.hematology.org/. Details for ASH presentations are as follows:

Oral Presentation

Abstract: Cord Blood Derived Natural Killer Cells Loaded with a Tetravalent Bispecific Antibody Construct (AFM13) As Off-the-Shelf Cell Therapy for CD30+ Malignancies

Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Immunologic approaches

Date and Time: Sunday, December 2, 2018 9:30 AM - 11:00 AM

Location: San Diego Convention Center, Room 28D

Poster Presentations

Abstract: A Phase 1b Study Investigating the Combination of the Tetravalent Bispecific NK Cell Engager AFM13 and Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM - 8:15 PM