Press Release - October 15, 2019
Heidelberg, Germany, October 15, 2019 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1/2a study of AFM24. The initial goal of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with advanced cancers known to express the epidermal growth factor receptor, EGFR. The second part of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.
Affimed also announced that the FDA has cleared an IND application for a Phase 1 study to evaluate a stable complex of AFM13, its lead innate cell engager, pre-mixed with cord blood-derived allogeneic NK cells (cbNK cells) as an investigational treatment for patients with relapsed/refractory CD30-positive lymphoid malignancies. In addition, the registration-directed study of AFM13 as monotherapy in relapsed/refractory peripheral T cell lymphoma (pTCL), where patients have very few treatment options, is on track to initiate this year.
“Our goal at Affimed is to develop medicines that activate the innate immune system, the body’s first line of defense, as a powerful way to treat patients living with cancer,” said Dr. Adi Hoess, Chief Executive Officer of Affimed. “The IND filing is an important step toward the development of AFM24, our innate cell engager designed to target EGFR-expressing cancers, including those with resistance to existing EGFR-targeted therapies.”
AFM24, a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager from Affimed’s fit-for-purpose ROCK® platform, is designed to address limitations associated with other EGFR-targeted therapies, such as toxicities or resistance, by using a new mechanism of action to target EGFR-expressing solid tumors through activation of innate immunity rather than inhibition of EGFR-mediated signal transduction.
AFM24 has the potential to provide meaningful benefit to patients with certain mutations that cannot be addressed by existing EGFR-targeted therapies. According to internal market research, leading clinical experts across multiple cancer indications see a tremendous need for novel immuno-oncology approaches for the treatment of solid tumors. Preclinical data showed AFM24’s ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines and induce cell lysis through antibody-dependent cellular cytotoxicity (ADCC), independent of RAS mutational status, and antibody-dependent cellular phagocytosis (ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapeutics.
“We also continue to progress our lead innate cell engager, AFM13,” said Dr. Hoess. “The clearance of the IND for AFM13 pre-mixed with cord blood-derived NK cells is a significant milestone in our overall clinical development plan. The planned clinical study will investigate the potential for adoptive cellular therapy together with our AFM13 innate cell engager to overcome a patient’s dysfunctional immune system to treat cancer.”
AFM13 binds to CD16A on NK cells with high affinity, which enables the formation of a stable complex of AFM13 and cbNK cells that results in pre-mixed AFM13 with cbNK cells. This will be investigated in CD30-positive lymphoma patients and the study will be conducted by The University of Texas MD Anderson Cancer Center (MDACC) as an investigator-sponsored study. It builds upon encouraging in vitro and in vivo data that showed a significant enhancement of antitumor activity of pre-mixed AFM13 with cbNK cells versus cbNK cells alone.
Enrollment is ongoing for a Phase 1b/2a study of AFM13 led by Columbia University, with 13 patients now recruited. Previously reported data from this investigator-sponsored translational study in patients with relapsed/refractory CD30-positive lymphoma with cutaneous manifestation confirmed single-agent activity of AFM13, with an objective response rate of 50% (5 out of 10 patients). Patients who responded showed increased infiltration of NK cells, as well as NK cell-mediated killing in the patients’ tumors. These encouraging data supported Affimed’s rationale to study AFM13 in patients with relapsed/refractory CD30-positive pTCL and the registration-directed Phase 2 study of AFM13 is on track to enroll patients this quarter.
Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical 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. 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 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, expectations regarding 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 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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