Affimed Announces Publication in the Journal mAbs on Leveraging FcRn-pH-HPLC as a Method to Select Bispecific Antibodies with Optimal Developability

• By coupling the chromatography method FcRn-HPLC to a pH monitor, an optimized FcRn-pH-HPLC methodology was developed allowing correlation of antibodies’ serum half-life with FcRn column dissociation pH
  
• Leveraging the full potential of FcRn-pH-HPLC enables Affimed an early selection of innate cell engagers (ICE^®) with tailored pharmacokinetic (PK) profiles and to thereby develop drug candidates with optimal developability, including reduced costs, accelerated timelines and ultimately a convenient dosing schedule for our patients
  

HEIDELBERG, Germany, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the publication of a manuscript that demonstrates how the FcRn-pH-HPLC technology can be leveraged to predict PK properties of various ICE^® formats built on the ROCK^® platform.

“The earlier we know which antibody format has the highest probability to succeed in the clinic, the better,” states Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. “We want to develop ICE^® molecules that are effective and safe, and the optimized FcRn-pH-HPLC methodology enables us to make accurate estimations of the in vivo serum half-life of our antibodies.”

PK parameters – such as half-life – impact the efficacy, tolerability, dose, and administration schedule of therapeutic antibodies. Identification of antibody candidates with optimal PK properties can therefore inform on the antibody with the best clinical developability. The PK profiles of therapeutic antibodies in vivo are largely governed by their pH-dependent binding to the human neonatal Fc receptor, FcRn. In the presented study, the FcRn-HPLC methodology has been further optimized by coupling it to a pH monitor and determining the pH of FcRn dissociation of antibodies, thus providing a potential surrogate assay for estimating in vivo serum half-lives.

Leveraging the FcRn-pH-HPLC revealed that the antibody architecture, e.g. sequence of antigen-binding domains, as well as number, structure, and orientation of these domains significantly alters the FcRn dissociation pH. Certain antibody structures are therefore predicted to have better PK properties in vivo than others.

Please find the publication on the website of mAbs here.

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^® 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 the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK^® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and 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 the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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