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Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK®


Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK® for the Treatment of Patients with Relapsed or Refractory Hodgkin Lymphoma

  • AFM13 in combination with AlloNK® (also known as AB-101) will be investigated in the LuminICE-203 open-label, multi-center, multi-cohort, phase 2 study evaluating the efficacy and safety of the treatment in patients with relapsed/refractory Hodgkin lymphoma

  • The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need

Mannheim, Germany, September 12, 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, today announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE®) AFM13 with AlloNK® for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL). The combination treatment is entering Phase 2 development and will be investigated in Affimed’s LuminICE-203 study (NCT05883449), which received IND-clearance earlier this year; the study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients.


“Our clinical data of AFM13 in combination with allogeneic NK cells has shown outstanding efficacy and a well-managed safety profile in late-stage, muti-refractory, patients with r/r Hodgkin and Non-Hodgkin lymphoma,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “The FDA fast track designation is a testament to the powerful potential our combination approach may deliver for these patients in high need, and we remain committed to working closely with the FDA to expedite development of this important therapy.”


Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on available data showing the potential of the AFM13 and AlloNK® combination therapy to overcome current limitations in the treatment of r/r HL. With the Fast Track Designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.


LuminICE-203 builds on the clinical findings from the phase 1/2 AFM13-104 trial (NCT04074746), in which investigators assessed AFM13 in combination with cord blood-derived natural killer cells in heavily pretreated patients with CD30-positive Hodgkin lymphoma and non-Hodgkin lymphoma. Data presented to date from this trial have shown outstanding clinical results in late-stage, multi-refractory, patients with a 94% overall response rate (ORR), a 71% complete response (CR) rate and a well-managed safety profile at the recommended phase 2 dose (RP2D); specifically in the 31 r/r HL patients treated, the ORR and CR were 97% and 77% respectively (see press release here).


About FDA Fast Track Designation

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track addresses a broad range of serious conditions. With Fast Track Designation, a new therapy is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

Please refer to Fast Track | FDA for further information.


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 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 Mannheim, 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


About AlloNK®

AlloNK® (also known as AB-101) is a 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 is investigating AlloNK® in a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617 ) to assess the safety and clinical activity of AlloNK® alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva is also investigating the safety and clinical activity of AlloNK® in combination with rituximab in patients with lupus nephritis. Artiva selects cord blood units with the high affinity variant of the CD16 receptor and a KIR-B haplotype for enhanced product activity. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of AlloNK® from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors, without the need for engineering. AlloNK® is being administered in the outpatient setting over multiple doses and multiple cycles.


About Artiva Biotherapeutics

Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies that are safe and accessible to patients. Artiva has taken a Manufacturing-First approach to create a highly scaled process integrating cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva’s pipeline includes AlloNK®, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates. Artiva is headquartered in San Diego. For more information, visit www.artivabio.com.


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