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Affimed N.V. (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company headquartered in Mannheim, Germany, with additional offices in New York, NY. Affimed is dedicated to leveraging the power of the innate immune system to develop innovative immuno-oncology therapies primarily aimed at treating various cancers. The company is at the forefront of developing its proprietary innate cell engagers (ICE®), which are designed to target and eliminate both hematologic and solid tumors.
At the core of Affimed's innovation is their ROCK® platform, a state-of-the-art technology that generates customized ICE® molecules. These molecules harness the natural power of immune cells, such as natural killer (NK) cells and T-cells, to target and destroy cancer cells. Affimed's lead products include AFM13 (acimtamig), AFM24, and AFM28, which are currently undergoing various stages of clinical trials.
AFM13, the company's flagship innate cell engager, shows promise in treating CD30-positive hematologic tumors. It has demonstrated significant clinical efficacy in heavily pretreated patients with refractory Hodgkin lymphoma, achieving high objective response rates (ORR) and complete response (CR) rates. AFM13 is being investigated in combination with NK cells in the LuminICE-203 study, with initial data expected in the first half of 2024.
AFM24 is another key candidate, targeting EGFR-expressing solid tumors. It is currently being tested in combination with atezolizumab, a checkpoint inhibitor, in the AFM24-102 Phase 1/2a study. Recent data showed a disease control rate of 73.3% in heavily pretreated patients with EGFR wild-type non-small cell lung cancer (NSCLC), including significant objective responses. The FDA has granted Fast Track designation for this combination therapy, highlighting its potential to meet unmet medical needs.
AFM28 targets CD123-positive acute myeloid leukemia (AML). Preclinical studies have shown that AFM28 can effectively reduce tumor growth and eliminate leukemic blasts and stem cells. The drug is currently in early clinical development, with future plans to test it in combination with allogeneic off-the-shelf NK cells.
Affimed is also committed to strategic collaborations and partnerships to advance its clinical programs. Notable collaborations include those with Artiva Biotherapeutics, The University of Texas MD Anderson Cancer Center, and Roche. These partnerships are aimed at enhancing the efficacy and safety profiles of Affimed's therapies and bringing innovative treatments to patients more quickly.
Despite facing challenges such as restructuring and a reduction in workforce, Affimed remains focused on advancing its clinical pipeline. The company's strong leadership team, extensive experience in biotechnology and pharmaceuticals, and a clear mission to revolutionize cancer treatment underscore its commitment to giving patients back their innate ability to fight cancer.
For more information about Affimed's people, pipeline, and ongoing projects, please visit www.affimed.com.
Affimed N.V. (Nasdaq: AFMD) announced that it will release its full year 2022 results and a corporate update on March 23, 2023. The release will be followed by a conference call at 8:30 a.m. EDT / 13:30 CET for shareholders and stakeholders.
The call will be accessible via phone and webcast, with a replay available for 30 days following the event. Affimed specializes in immuno-oncology, focusing on harnessing the innate immune system to combat cancer through its proprietary ROCK® platform, which facilitates the development of innovative therapies targeting various tumors.
Affimed N.V. (Nasdaq: AFMD) announced two accepted abstracts for presentation at the AACR Annual Meeting 2023, showcasing the efficacy of AFM13 in treating CD30-positive relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The oral presentation will detail results from the phase 2 REDIRECT study, demonstrating an objective response rate (ORR) of 32.4% with a duration of response (DOR) of 2.3 months. Additionally, a poster will discuss research on CD16A shedding's role in enhancing natural killer (NK) cell functionality against tumors. Both presentations highlight AFM13's promise in the immuno-oncology field.
AbCheck s.r.o., based in the Czech Republic, has successfully completed its research grant project on antibody isolation technology, receiving over €1 million from the Ministry of Industry and Trade since 2019. As of December 31, 2022, the company not only fulfilled its project objectives but also advanced its novel microfluidics technology, developing additional functional assays in rabbit, chicken, and mouse models. This technology enables faster identification of functional antibodies compared to traditional methods. AbCheck is now applying this technology in commercial projects targeting neurological disorders, inflammatory diseases, and oncology.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced CEO Dr. Adi Hoess will participate in a fireside chat at the H.C. Wainwright Cell Therapy Conference on February 28, 2023, at 8:30 a.m. EST / 14:30 CET. The webcast will be available on Affimed’s website, with a replay accessible for 30 days post-event.
Affimed focuses on leveraging the innate immune system to fight cancer through its ROCK® platform, generating Innate Cell Engager (ICE®) molecules that target tumors. The company is headquartered in Heidelberg, Germany, with a mission to empower patients in their cancer battle.
AbCheck s.r.o. has announced a collaboration with a biotech company focused on developing antibodies for peripheral neural response, backed by a European Venture Capital firm. This agreement entails utilizing AbCheck's advanced antibody discovery technologies to create antibodies targeting a challenging undisclosed profile. The company's microfluidics technology facilitates functional screening of millions of cells daily, enhancing drug discovery success rates. Dr. Volker Lang highlighted their commitment to delivering promising candidates for clinical development, aiming to provide novel treatment options for severe neurological disorders.
Affimed N.V. (Nasdaq: AFMD) announced that Dr. Adi Hoess, the CEO, will present at the SVB Securities 2023 Global Biopharma Conference on February 14, 2023, at 2:20 p.m. EST / 20:20 CET. The presentation will be available via a live webcast on Affimed's website, with a replay accessible for 30 days post-event. Affimed is focused on immuno-oncology, utilizing its proprietary ROCK® platform to develop innovative treatments targeting hematologic and solid tumors. The company aims to empower patients' innate immune responses against cancer, making strides in personalized cancer therapy.
Affimed N.V. (Nasdaq: AFMD) announced progress in its immuno-oncology pipeline, including support from the FDA for an IND filing of AFM13 combined with Artiva’s AB-101 for r/r Hodgkin lymphoma, planned for H1 2023. The AFM24 studies will present data updates in Q2/Q3 2023, while phase 1 study initiation for AFM28 is expected in Q2 2023, following CTA clearance in France and Spain. As of Dec 31, 2022, the company reported cash and equivalents of approximately €190 million, anticipated to fund operations into 2025.
Affimed N.V. (Nasdaq: AFMD) has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) for a clinical trial application (CTA) for its AFM28 in a phase 1 study targeting relapsed/refractory acute myeloid leukemia (AML). The trial, set to initiate in the first half of 2023, aims to investigate the safety and tolerability of AFM28, a bispecific Innate Cell Engager. This marks a significant milestone in Affimed's strategy to provide viable treatment options for AML patients, addressing a critical need in oncology.
Affimed N.V. (Nasdaq: AFMD) presented promising preclinical data for its Innate Cell Engager (ICE®) AFM28 at the 64th ASH Annual Meeting, targeting CD123-positive leukemic cells in patients with Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS).
AFM28 effectively redirected NK cells to deplete leukemic stem cells, showing potential for deep anti-leukemic responses. The program has demonstrated strong anti-tumor activity while maintaining a favorable safety profile. A first-in-human study is planned for the first half of 2023, highlighting AFM28 as a viable treatment option for refractory AML patients.
Affimed announced positive data from its phase 2 REDIRECT study on AFM13 monotherapy for relapsed/refractory peripheral T cell lymphoma (r/r PTCL). The treatment achieved an objective response rate (ORR) of 32.4% and a complete response rate (CR) of 10.2%. Key outcomes included a median duration of response of 2.3 months, median progression-free survival of 3.5 months, and median overall survival of 13.8 months. The company will now focus on investigating a combination therapy with NK cells, rather than seeking accelerated approval for monotherapy.
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