On June 9, 2023 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, reported 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 (Press release, Affimed, JUN 9, 2023, View Source [SID1234632618]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (Free ASH Whitepaper) 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 View Source

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 (Free ASH Whitepaper) 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 (Free ASCO Whitepaper) Annual Meeting.