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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 the completion of enrollment in its REDIRECT study (AFM13-202) aimed at evaluating AFM13 for relapsed or refractory CD30-positive T-cell lymphoma, with topline results expected in 2H 2022. The FDA approved a protocol amendment allowing 40 patient enrollments at the highest dose in a related trial. The company has launched a broad development strategy for AFM24, targeting EGFR-expressing tumors, and plans to initiate a first-in-human study for AFM28 in late 2022. Affimed's cash reserves are projected to sustain operations into 2H 2023.
Affimed N.V. (Nasdaq: AFMD) announced that CEO Dr. Adi Hoess will present at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 10:30 a.m. EST. The event will showcase Affimed's commitment to immuno-oncology and its innovative ROCK® platform for cancer treatment. A live webcast of the presentation will be available on Affimed’s website and can be accessed for 30 days post-event. For further inquiries or to schedule meetings, contact Alex Fudukidis, the Director of Investor Relations.
Affimed (Nasdaq: AFMD) revealed promising preclinical data on its Innate Cell Engager (ICE®) programs, AFM28 and AFM13, at the ASH Annual Meeting. AFM28 showed significant effectiveness in targeting CD123+ cells in acute myeloid leukemia and myelodysplastic syndrome, with a potent NK cell activation and low risk of cytokine release syndrome. Additionally, AFM13 demonstrated its potential as an off-the-shelf product with retained efficacy post-cryopreservation. Both advancements highlight Affimed's commitment to enhancing cancer treatments through innovative immunotherapy approaches.
Affimed N.V. (Nasdaq: AFMD) announced promising results from a clinical study investigating AFM13 for CD30-positive lymphoma. In a trial involving 19 patients, the overall response rate reached 89.5%, with a 36.8% complete response rate. Patients treated at the recommended phase 2 dose showed a remarkable 100% response after one cycle, with a 38.5% complete response rate. The treatment demonstrated a favorable safety profile, with minimal adverse effects reported. The company plans to present complete results at future conferences, indicating significant advancements in addressing challenging lymphomas.
Affimed N.V. (Nasdaq: AFMD) has commenced patient recruitment for a phase 1/2a study focusing on the innate cell engager (ICE®) AFM24 combined with Roche’s atezolizumab, targeting solid tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the combination. AFM24 engages natural killer cells to enhance anti-tumor activity. The study involves patients with various solid tumors who have undergone prior treatments. Preclinical data suggests a favorable safety profile and anti-tumor efficacy, emphasizing the potential of this novel therapy.
Affimed N.V. (Nasdaq: AFMD) announced positive interim results from a phase 1-2 study, showing a 100% objective response rate in patients with CD30-positive relapsed or refractory lymphomas after one treatment cycle involving the pre-complexed cbNK cells with their innate cell engager AFM13. Of 12 patients treated at the recommended phase 2 dose, 42% achieved a complete response, with no serious adverse events reported. A virtual investor event is scheduled for December 9 to discuss these findings further.
Affimed N.V. (Nasdaq: AFMD) announced the presentation of preclinical data on its innate cell engagers (ICE®) AFM13 and AFM24 at the SITC Annual Meeting. The findings, derived from a collaboration with Karolinska Institutet, demonstrate enhanced NK cell activity and macrophage involvement in tumor cell killing. AFM24's ability to induce antibody-dependent cellular phagocytosis (ADCP) was highlighted, enhancing potential anti-tumor effects across various tumor types. AFM24 is currently in Phase 1/2a trials for EGFR-expressing solid tumors, with additional studies planned with an anti-PD-L1 checkpoint inhibitor.
Affimed N.V. (Nasdaq: AFMD) reported its third quarter 2021 financial results, highlighting a net loss of €17.1 million or €0.14 per share, worsening from a net loss of €6.0 million in Q3 2020. Cash and cash equivalents increased to €198.7 million, projected to sustain operations into the second half of 2023. Significant clinical updates include ongoing patient recruitment for the AFM13 and AFM24 trials. Both candidates are expected to generate multiple catalysts, with AFM24's expansion phase set to start by year-end 2021.
Affimed N.V. (Nasdaq: AFMD) announced participation in two upcoming investor conferences in November 2021. The Stifel 2021 Virtual Healthcare Conference will be held from November 15-17, 2021, with a presentation on the 15th at 8:00 a.m. EST. The Jefferies London Healthcare Conference takes place from November 16-19, 2021, featuring a fireside chat available on November 18 at 3:00 a.m. EST. Affimed is dedicated to advancing immuno-oncology therapies, leveraging its proprietary ROCK® platform to develop novel treatments for cancer.
Affimed and NKGen Biotech have initiated patient recruitment for a phase 1/2a clinical trial (NCT05099549) to evaluate the safety and effectiveness of AFM24 combined with SNK01 NK cells in treating advanced EGFR-expressing cancers such as non-small cell lung cancer, squamous cell carcinoma, and colorectal cancer. This study follows promising preclinical data presented at the AACR-NCI-EORTC conference, showing enhanced anti-tumor activity from the combination therapy. The trial aims to determine the maximum tolerated dose of AFM24 and further explore its efficacy in cancer therapy.
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