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Affimed Announces Publication of Preclinical Data Demonstrating Cytotoxic Potency and Efficacy of NK Cells Precomplexed with Innate Cell Engagers after Freezing & Thawing

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(Neutral)
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Rhea-AI Summary

Affimed announced promising pre-clinical data on NK cells precomplexed with ICE® molecules showing maintained cytotoxic potency post-cryopreservation. This finding supports the development of off-the-shelf NK cell therapeutics, critical for patient access. The study highlighted NK cells precomplexed with EpCAM/CD16A ICE® molecules, achieving superior cytotoxicity against EpCAM-positive tumors and retaining activity after freezing. High cytotoxicity was noted in an ongoing phase 1-2 study targeting CD30-positive lymphomas with a 100% objective response rate at the highest dose. The manuscript was published in the journal Antibodies.

Positive
  • NK cells precomplexed with ICE® molecules retain cytotoxicity after cryopreservation.
  • Superior activity of EpCAM/CD16A ICE® vs. EpCAM/NKG2D and EpCAM/NKp46 reported.
  • Ongoing phase 1-2 study shows 100% objective response rate for CD30-positive lymphomas.
Negative
  • None.
  • Precomplexing NK cells with Innate Cell Engagers (ICE® molecules) results in a CAR-like NK cell product, whose magnitude and specificity of antibody-dependent cellular cytotoxicity (ADCC) remain unaffected after one freeze-thaw cycle
  • Activity after cryopreservation is an important prerequisite for the development of off-the-shelf NK cell therapeutics and CD16A-specific ICE® molecules that are precomplexed with NK cells show promise for further development

HEIDELBERG, Germany, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the publication of pre-clinical data demonstrating the cytotoxic potency and efficacy of NK cells precomplexed with ICE® molecules after one cycle of cryopreservation. This is an important prerequisite for the development of off-the-shelf products which may allow accessibility to the novel treatment option for patients in need.

The data show experimental results of NK cells precomplexed with three bispecific, tetravalent ICE® molecules targeting the validated tumor target EpCAM and one of the NK cell-activating receptors CD16A, NKG2D or NKp46. NK cells precomplexed to the EpCAM/CD16A ICE® molecule demonstrated superior cytotoxicity against EpCAM-positive tumor cells in comparison to complexes with EpCAM/NKG2D and EpCAM/NKp46 ICE® formats. This effect may potentially be driven by a stronger NK cell activation through CD16A as compared to NKG2D or NKp46. After one cycle of cryopreservation, this effect continued - notably, NK cells precomplexed with all three ICE® constructs retained their cytotoxicity after freezing and thawing.

“The finding that NK cells precomplexed with the EpCAM/CD16A ICE® molecule show superior cytotoxic activity that remained unaffected after freezing and thawing, when compared to combinations with ICE® molecules targeting NKG2D or NKp46 after similar freezing and thawing is exciting. This finding holds promise for the future development of off-the-shelf precomplexed ICE® molecules targeting NK cells through CD16A,” said Arndt Schottelius, Chief Scientific Officer of Affimed.

“The high cytotoxicity of NK cells precomplexed with ICE® molecules after cryopreservation is important in the context of the exciting data that were generated in an ongoing investigator initiated phase 1-2 study of cord blood derived NK cells precomplexed with AFM13 in patients with CD30-positive lymphomas, where, at the highest dose level, a 100% objective response rate was seen,” added Andreas Harstrick, Chief Medical Officer of Affimed.

The manuscript has been published in a special issue on Antibodies for Effector Cell Redirection in the journal Antibodies and is available here: https://www.mdpi.com/2073-4468/11/1/12#

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK® 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®) 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®. Headquartered in Heidelberg, Germany, with offices in New York, NY, 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: 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, AFM24, and our other product candidates, the value of our ROCK® 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 SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
Tel.: +1 (484) 888-8195


Affimed N.V.

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