Press Release - November 3, 2022
Heidelberg, Germany, November 3, 2022 – 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 two upcoming data presentations at the American Society of Hematology (ASH) 2022 Annual Meeting.
Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, will provide a clinical update from the ongoing phase 1/2 trial with Affimed’s lead innate cell engager (ICE®) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells followed by three weekly infusions of AFM13 in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas in an oral presentation, on Saturday, December 10 at 1:15 p.m. CST.
Since the last study update in April 2022 until the end of July, an additional 11 patients were enrolled, resulting in 24 patients treated at the recommended phase 2 dose (RP2D) with up to 4 cycles; a total of 30 patients have now been enrolled in the study. The combination treatment continues to show a 100% overall response rate (ORR) at the highest dose level and a further improvement in the complete response (CR) rate, from the previously reported 62% to 70.8%.
Affimed will also present updated preclinical data from its AFM28 program in a poster on December 12 from 6:00 – 8:00 p.m. CST, demonstrating the highly potent and selective killing of CD123-positive leukemic cells as well as leukemic stem cells and progenitor cells, supporting AFM28’s potential to achieve durable responses in relapsed or refractory Acute Myeloid Leukemia patients.
“Our ICE® possess very high affinity to CD16A on NK cells and are considered highly efficient in redirecting such cells, both allogeneic and autologous, to attack tumor cells,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “The extremely high efficacy seen with AFM13 in combination with NK cells is the basis of taking forward our other ICE®, such as AFM24 and AFM28, to develop therapies that can serve the high unmet needs of cancer patients.”
Title: Innate Cell Engager AFM13 Combined with Preactivated and Expanded Cord Blood-Derived NK Cells for Patients with Double Refractory CD30+ Lymphoma
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Lymphoma Presentation Date & Time: Saturday, December 10, 2022, 1:15 p.m. CST
Location: Ernest N. Morial Convention Center, La Nouvelle Orleans Ballroom AB
The AFM13-104 study is evaluating a combination of the ICE® AFM13 with cbNK in late-stage patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma. As of the abstract data cut-off on July 31, the study had enrolled 30 patients across three different dose levels DL1 (106 NK/kg), DL2 (107NK/kg) and DL3 (108 NK/kg); a total of 24 patients had been treated at DL3 (108 NK/kg) which was established as the RP2D. Each cycle of treatment consists of a lymphodepletion, followed by single dose of AFM13 precomplexed with cbNK cells and three subsequent infusions of AFM13 monotherapy. Two cycles of therapy were administered to patients 1 – 19 and up to four cycles were administered starting with patient 20.
At the data-cut-off, across all dose cohorts, the ORR was 97% with a CR rate of 63%. At the RP2D, the study continued to demonstrate a 100% ORR in all 24 patients treated, with 17 patients achieving a CR (70.8%).
Across all dose levels at median follow-up of 8 months (range 1-23) months, an event-free survival (EFS) rate of 57% and an overall survival (OS) rate of 83% was observed. Five patients had a response consolidated with a stem cell transplant. Analyses of patient serum from day one after infusion with AFM13 precomplexed with cbNK cells suggest that no sensitization effects in patients occur.
Overall, the treatment continues to show a manageable safety profile. There were no infusion-related reactions (IRR) after infusing AFM13-NK and 11 IRR in 182 infusions of AFM13 alone (6%) (1 grade 3, 10 grade 2). In addition, no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade.
A more in-depth analysis of the data will be presented in Dr. Nieto’s oral presentation at ASH and through a company press release.
Title: The Novel Bispecific Innate Cell Engager (ICE®) AFM28 Efficiently Directs Allogeneic NK Cells to CD123-positive leukemic cells
Session: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster III Presentation Date & Time: Monday, December 12, 2022, 6:00 p.m. – 8:00 p.m. CST
Location: Ernest N. Morial Convention Center, Hall D
Innate Cell Engager (ICE®) AFM28 aims to direct a patient’s own or allogeneic NK cells towards CD123-positive AML blasts and leukemic stem cells (LSC) providing a promising approach to achieving long-term remissions. Data from a collaboration between Affimed and the Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University will be presented at the ASH conference. The study evaluated the efficacy of AFM28 in preclinical AML models. In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD123-positive tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was independent of leukemic cell mutational profiles and was also effective in targeting cells with low levels of CD123 surface expression.
Residual leukemic stem cells are a frequent cause for relapse and associated with poor prognosis. Patient-derived AML cell cultures incubated with AFM28 and allogeneic NK cells showed significantly reduced numbers of outgrowing colonies compared to controls. That indicates that LSCs and progenitor cells were eliminated. These results were confirmed in an AML mouse model demonstrating complete inhibition of tumor growth throughout a 42-day treatment period in comparison to untreated control mice who all developed systemic disease.
AFM28 is currently being prepared for a first-in-human clinical investigation as monotherapy and in combination with allogeneic NK cells.
The full abstracts for both presentations are available on the ASH conference website via the following link: https://www.hematology.org/meetings/annual-meeting.
The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase, recruiting up to 40 patients with r/r CD30 positive lymphomas, treated with the RP2D (and 1×108 NK cells/kg followed by three weekly doses of 200 mg AFM13 monotherapy.
MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).
AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE® clinical program and is currently being evaluated as monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331).
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE® developed on Affimed’s ROCK® platform, is designed to bring a new immunotherapeutic treatment to patients with CD123+ myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.
Affimed N.V. (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.
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, AFM28 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, the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict 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.
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