- A pre-clinical data set of AFM13 in combination with Artiva Biotherapeutics Inc.’s allogeneic NK cell AB-101 shows that AFM13 enhances the cytotoxic activity of AB-101 against tumor cells and has been accepted for poster presentation
- An encore oral presentation will share the safety and efficacy results from the phase 2 REDIRECT study, investigating AFM13 monotherapy in patients with CD30-positive relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL)
HEIDELBERG, Germany, June 09, 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 that two abstracts have been accepted for presentation at the 17th International Conference on Malignant Lymphoma (17-ICML) taking place in Lugano, Switzerland on June 13-17, 2023. A poster presentation will share a preclinical data set of Affimed’s innate cell engager (ICE®) AFM13 in combination with Artiva Biotherapeutics Inc.’s (“Artiva”) off-the-shelf NK cell AB-101. An additional encore oral presentation will show the final results of the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL patient population.
The preclinical data set shows that AFM13 binds homogenously to thawed AB-101, directs the NK cells to CD30-positive tumor cells and enhances the cytotoxic activity of AB-101 against the tumor cells. Associated with the AFM13-induced cytotoxic activity was an increased functional activation status of AB-101 demonstrated through degranulation and IFN-γ production. Importantly, in a mouse xenograft model, adoptive transfer of AB-101 in combination with AFM13 conferred tumor growth control.
The data of AFM13 in combination with the allogeneic, cryopreserved, off-the-shelf, cord blood-derived AB-101 NK cells demonstrate synergistic anti-tumor activity in vivo. Building on the unprecedented efficacy results of the phase 1 study with AFM13 in combination with fresh cord blood-derived NK cells (NCT04074746), as reported at ASH 2022, the Company recently received Food and Drug Administration (FDA) IND clearance and is expecting to initiate a phase 2 study, LuminICE-203, with AFM13 and AB-101 in patients with r/r classical Hodgkin lymphoma in Q3 2023. The study will also include a cohort of 20 PTCL patients.
“These preclinical data of AFM13 + AB-101 as well as the clinical data from the phase 1 combination study demonstrate that AFM13 plus NK cells can achieve remarkable cytotoxicity against CD30-positive cancers,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. “As a next step we want to bring this therapeutic approach to more patients in need and we look forward to initiate the LuminICE-203 study.”
Details of the AFM13 + AB-101 poster presentation are as follows:
Title: AFM13 enhances the anti-tumor activity of AB-101 towards CD30+ tumors, conferring tumor growth control in vivo
Presenting Author: Jens Pahl
Poster Presentation Time: Thursday, 15 June 2023, 12:30 - 13:00 CET
Poster and Abstract Book Code: 419
In addition, an encore presentation of the final results of the phase 2 REDIRECT study will be given by Dr. Won Seog Kim, Professor of Hematology-Oncology at Samsung Medical Center in Seoul and a principal investigator of the study. AFM13 monotherapy exhibited clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL population and a well-managed safety profile.
Details of the REDIRECT oral presentation are as follows:
Title: AFM13 in patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL): Results from the Phase 2 REDIRECT study
Presenting Author: Won Seog Kim
Session: Focus on… Session: T-Cell Lymphomas
Presentation Time: Thursday, 15 June 2023, 17:00 - 18:00 CET
Poster and Abstract Book Code: 126
More details about the 17-ICML conference are available online at Home - ICML
About AFM13
AFM13 is a first-in-class tetravalent bispecific 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 was evaluated as monotherapy in a phase 2 trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT, NCT04101331). In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored Phase 1 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas (NCT04074746). The company reported data from this study at ASH 2022 annual meeting. To find out more about AFM13 and the studies, please visit: www.affimed.com.
About AB-101
AB-101 is Artiva’s non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using Artiva’s AlloNK® platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering.
Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL) who have progressed beyond two or more prior lines of therapy. This study is progressing at multiple clinical sites across the U.S., and AB-101 is administered weekly in the out-patient setting over one-month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva presented data from the first-in-human phase 1/2 clinical trial of AB-101 in combination with rituximab in R/R non-Hodgkin lymphoma at the 2023 ASCO Annual Meeting.
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.
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
