On December 10, 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, reported topline data from its phase 2 REDIRECT study investigating AFM13 monotherapy in patients with advanced-stage r/r PTCL (Press release, Affimed, DEC 10, 2022, View Source [SID1234625068]).

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Primary efficacy measures include ORR of 32.4% and a complete response (CR) rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, progression free survival and overall survival. The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13. Median DoR was 2.3 months, median PFS was 3.5 months and median OS was 13.8 months.

"These are remarkable data for AFM13 as a single agent and they confirm that the activation of innate immunity can lead to robust clinical activity," said Dr. Adi Hoess, Chief Executive Officer at Affimed. "Our parallel study investigating AFM13 in combination with allogeneic NK cells shows that this combination can materially improve clinical outcomes for patients with CD30-postive lymphomas. We will therefore be focusing further development of AFM13 in PTCL on the combination with NK cells to improve the durability of response and build on the already meaningful activity with the goal of obtaining regulatory approval to give this difficult to treat patient population another therapeutic option."

"The activity of AFM13 in heavily pretreated patients with peripheral T cell lymphoma is very encouraging with an objective response rate of 32% and a PFS of 3.5 months," said Dr. Won Seog Kim, Professor of Hematology-Oncology at Samsung Medical Center in Seoul and a principal investigator for the study. "The data demonstrate that the innate immune system can successfully attack lymphomas and thus AFM13 provides a new mechanism of action that could expand our options in treating this difficult disease."

REDIRECT is a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with CD30-positive r/r PTCL. The primary outcome measure was the objective response rate (ORR) following treatment with AFM13 as measured by an independent review committee (IRC) by FDG-PET. Secondary and exploratory outcome measures included DoR, PFS, OS, the safety of AFM13 as well as pharmacokinetics and immunogenicity of AFM13. In the trial, 108 patients received treatment with AFM13 as weekly intravenous infusions of 200 mg for the duration of the trial participation. Disease assessment was conducted at screenings every 8 weeks for the first 2 assessments and every 12 weeks thereafter.

Peripheral T cell lymphomas are highly aggressive and one of the most difficult to treat forms of lymphoma with very poor prognosis for patients. Based on the compelling data seen in Hodgkin lymphoma for the combination of AFM13 with cord blood-derived NK cells in the AFM13-104 study, the Company believes that the combination with AB-101 has a higher probability to deliver increased anti-tumor activity and a more durable clinical benefit to address the unmet need in this patient population. Accordingly, Affimed does not intend to pursue an accelerated approval for AFM13 monotherapy in PTCL and will focus investment on clinical development in the combination of AFM13 with Artiva’s AB-101 NK cell product.

Investor Event & Webcast Details

Affimed will host an investor event to review AFM13 clinical data and development plans in CD30 expressing malignancies. The investor event will take place in-person and virtually and a webcast of the event will be available in the "Webcasts" section on the "Investors" page of Affimed’s website at View Source To access the event via phone, please dial +1 (929) 205-6099 for U.S. callers, or +44 (203) 481-5240 for international callers, and reference meeting ID 847 4106 6227 approximately 15 minutes prior to the call. To reserve your place in the live event, please contact Alex Fudukidis via e-mail at [email protected].
A replay of the webcast/call will be archived on Affimed’s website for 30 days after the call.

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 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).

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.