On May 11, 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 to EHA (Free EHA Whitepaper)2023, the annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place in Frankfurt, Germany on June 8-11, 2023 (Press release, Affimed, MAY 11, 2023, View Source [SID1234631576]).

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In the REDIRECT study, the AFM13 innate cell engager (ICE) exhibited clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL population. Overall, the objective response rate (ORR) based on FDG-PET assessed by an independent review committee was 32.4%, thus comparable to therapies approved for this indication. The median duration of response, progression-free survival, and overall survival were 2.3, 3.5, and 13.8 months, respectively. The highest objective response rate was observed in patients with angioimmunoblastic T-cell lymphoma (53.3%). AFM13 showed a well-managed safety profile. The most common adverse event (AE) was infusion-related reactions (IRRs) reported in 34 patients, with 6 patients and 5 patients reported to have Grade 3 and serious events, respectively. The data to be presented at EHA (Free EHA Whitepaper) are based on additional post-hoc efficacy analysis of AFM13 to identify potential patient characteristics which may predict a more favorable response to AFM13.

Details of the AFM13 poster presentation are as follows:

Title: AFM13 in Patients with R/R Peripheral T Cell Lymphoma: A Post-Hoc Subgroup Analysis from the Redirect Study

Presenting Author: Jake Shortt

Date and Time: Friday, June 9; 18:00 – 19:00 CET

Final Abstract Code: P1142

The AFM28 abstract describes the first-in-human study that aims to investigate the safety and tolerability of AFM28 monotherapy, establish the maximum tolerated dose (MTD), determine the recommended Phase 2 dose (RP2D), and establish the potential for this novel treatment modality to redirect NK cells to eliminate leukemic blasts and leukemic stem cells (LSCs), thereby potentially achieving durable remissions in patients with r/r AML.

AFM28 ICE is a bispecific monoclonal antibody with specificity for CD123 and the human Fc gamma receptor III-A (CD16A). AFM28 is intended to be developed as an antineoplastic agent for hematological malignancies known to express CD123, including AML. Its primary pharmacological mechanism of action is the induction of antibody-dependent cellular cytotoxicity (ADCC) by targeting CD16A-expressing immune effector cells, primarily natural killer (NK) cells, towards CD123-expressing cells.

Details of the AFM28 online publication are as follows:

Title: Engaging Innate Immunity: A Phase 1 Dose Escalation Study to Assess Safety and Tolerability of AFM28 Monotherapy in Patients with Relapsed/Refractory CD123-Positive Acute Myeloid Leukemia (AML)

Final Abstract Code: PB1884

More details about the EHA (Free EHA Whitepaper) 2023 meeting are available online at EHA (Free EHA Whitepaper)2023 Hybrid Congress (ehaweb.org).

About AFM13

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 was evaluated as monotherapy in a phase 2B trial in patients with relapsed/refractory peripheral T cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331). The study achieved an ORR of 32.4% demonstrating anti-tumor activity with a DOR of 2.3 months and a well-managed safety profile. AFM13 is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.

About AFM28

AFM28, a tetravalent bispecific CD123- and CD16A-binding Innate Cell Engager (ICE) developed on Affimed’s Redirected Optimized Cell Killing (ROCK) platform, is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia (AML) by engaging natural killer (NK) cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. A first-in-human clinical study with AFM28 monotherapy is ongoing in patients with relapsed/refractory CD123-positive AML (NCT05817058). In addition, development of AFM28 in combination with allogeneic NK cells is planned.