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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 its financial results for 2021 and updates on clinical programs. The company reported total revenue of €40.4 million, up from €28.4 million in 2020, mainly driven by collaborations. However, net loss increased to €57.5 million, or €0.48 per share. As of December 31, 2021, cash and equivalents stood at €197.6 million, ensuring a runway into the second half of 2023. Key developments include completed enrollment for the AFM13-202 study and ongoing trials for AFM24 and AFM28. Results from several studies are anticipated in 2022.
Affimed N.V. (Nasdaq: AFMD) will release its full year 2021 results on March 31, 2022. A conference call will follow at 8:30 a.m. EDT, accessible via phone and webcast. Interested parties can dial +1 (409) 220-9054 for U.S. access or +44 (0) 8000 323836 for international calls, using conference ID 6590614. The company specializes in immuno-oncology, leveraging its ROCK® platform to develop innovative therapies that harness the innate immune system to target various tumors. Further information is available on their website.
Affimed N.V. (Nasdaq: AFMD) announced two abstracts with clinical data accepted for presentation at the AACR Annual Meeting 2022 in New Orleans, from April 8-13.
One presentation will focus on the phase 1/2 study of AFM13, evaluated with NK cells for treating CD30-positive lymphomas. The other will feature AFM24's dose-escalation study in patients with solid tumors. AFM13 and AFM24 are both innate cell engagers (ICE®) targeting hematologic and solid tumors, respectively, showcasing Affimed's commitment to enhancing cancer treatment through innovative therapies.
Affimed announced promising pre-clinical data on NK cells precomplexed with ICE® molecules showing maintained cytotoxic potency post-cryopreservation. This finding supports the development of off-the-shelf NK cell therapeutics, critical for patient access. The study highlighted NK cells precomplexed with EpCAM/CD16A ICE® molecules, achieving superior cytotoxicity against EpCAM-positive tumors and retaining activity after freezing. High cytotoxicity was noted in an ongoing phase 1-2 study targeting CD30-positive lymphomas with a 100% objective response rate at the highest dose. The manuscript was published in the journal Antibodies.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announces upcoming presentations at investor conferences in February 2022. Key events include the SVB Leerink 2022 Global Healthcare Conference on February 16, 2022, at 11:20 a.m. EST, and Citi’s Virtual Immuno-Oncology Summit on February 17, 2022, at 2:30 p.m. EST. Both presentations will be available via webcast. The company aims to leverage its ROCK® platform for innovative tumor-targeted therapies, focusing on harnessing innate immune responses to fight various cancers.
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.
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