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Continued progress for AFM13 and AFM24 clinical studies
Strengthened cash position provides anticipated runway into the first half of 2023
Heidelberg, Germany, January 7, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced an update on its pipeline and business.
“Affimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023,” commented CEO Adi Hoess. “With three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A ICE®)
AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), remains ahead of schedule and Affimed expects to complete the interim data analysis during the first half of 2021.
The first dose cohort of AFM13-104, an investigator sponsored Phase 1 study at The University of Texas MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK cells (cbNK) followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, is ongoing.
AFM24 (EGFR/CD16A ICE®)
AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE® for treatment of patients with EGFR-expressing solid tumors, has completed dose cohort 3 (80 mg per patient) without showing dose limiting side effects and patients are currently being enrolled and treated in dose cohort 4 (160 mg per patient).
Affimed and NKMax America completed a pre-IND meeting with the U.S. Food and Drug Administration in December 2020. The companies plan to submit an IND in the first half of 2021 for a Phase1/2a study to investigate different dose levels of AFM24 in combination with NKMax America`s autologous NK cell product SNK01 in patients with EGFR expressing solid tumors.
Other Business Updates
As of December 31, 2020, Affimed’s preliminary unaudited cash and cash equivalents were approximately €147 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the first half of 2023.
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. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.
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 our ICE® molecules, 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 Securities and Exchange Commission. 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.
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Mary Beth Sandin
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