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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 reported its Q1 2024 financial results, revealing a significant decline in revenue to €0.2 million from €4.5 million in Q1 2023, due to decreased collaboration payments. However, operating expenses also decreased, with R&D expenses down to €15.4 million from €29.5 million and general administrative expenses down to €4.5 million from €6.9 million. Net loss improved to €19.2 million from €32 million in Q1 2023.
Clinical updates include promising results from the LuminICE-203 study, showing an 85.7% ORR in Hodgkin Lymphoma patients and 33% CR/CRi rate in the AFM28 monotherapy study. AFM24-a combination with atezolizumab in NSCLC patients showed a 71% disease control rate and a 5.9-month mPFS.
Financially, Affimed has a cash runway into H2 2025 with €48.5 million in cash and equivalents as of March 31, 2024.
Affimed (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced it will release its first quarter 2024 financial results and provide a corporate update on June 12, 2024. The company will host a conference call at 8:30 a.m. EDT / 14:30 CET, accessible via phone and webcast. The live audio webcast will be available on the 'Investors' page of the Affimed website, and a replay will be accessible for 30 days.
Affimed has announced promising follow-up data for its AFM24 and atezolizumab combination therapy in heavily pretreated non-small cell lung cancer (NSCLC) patients. In the EGFR wild-type (EGFRwt) cohort, 4 out of 15 response-evaluable patients showed objective responses, with a median progression-free survival (PFS) of 5.9 months. Additionally, 8 patients achieved stable disease, resulting in a disease control rate of 71%. In the EGFR mutant (EGFRmut) cohort, 4 out of 13 response-evaluable patients also showed objective responses, with all responses ongoing. The combination therapy demonstrated a manageable safety profile, with mild to moderate side effects. The company is hosting a conference call to discuss these findings further. Recruitment for both cohorts is ongoing, with updates expected in the second half of 2024.
Affimed has received FDA Fast Track designation for its combination therapy of AFM24 with atezolizumab for advanced and metastatic EGFR wild-type non-small cell lung cancer (NSCLC). This designation is based on initial efficacy data from the ongoing AFM24-102 phase 1/2a study, which evaluates this combination in patients who have progressed after PD-(L)1 therapy and platinum-based chemotherapy. Fast Track status is intended to expedite the development of drugs that address serious conditions with unmet medical needs. Affimed will present updated data from the AFM24-102 study at the American Society of Clinical Oncology meeting on June 1, 2024.
Affimed, a clinical-stage immuno-oncology company, announced its 2024 Annual General Meeting of Shareholders. The meeting will take place on June 26, 2024, at 09:00 a.m. CET at De Brauw Blackstone Westbroek N.V. in Amsterdam, Netherlands. Key documents, including the notice and agenda of the Annual Meeting, can be found on Affimed's investor section on its website and the SEC's website.
Affimed has announced promising early results from its AFM24-102 study involving 15 evaluable patients with metastatic EGFR wild-type non-small cell lung cancer (NSCLC). These patients, pretreated with platinum doublet chemotherapy and checkpoint inhibitors, received a combination of AFM24 and atezolizumab, resulting in a disease control rate (DCR) of 73.3%. This included one complete response and three partial responses, with a median progression-free survival of 5.9 months. The study's data cut-off was March 18, 2024. These findings will be presented at the ASCO annual meeting on June 1, 2024. Affimed will also host a conference call/webcast the same day to discuss these results and other clinical data.
Affimed has announced the acceptance of an abstract showcasing preclinical data on its innate cell engager, AFM28, at the European Hematology Association (EHA) 2024 Congress. AFM28 targets CD123-positive cancer cells in acute myeloid leukemia (AML). Preclinical results demonstrated dose-dependent tumor growth control in a mouse model, leading to increased median lifespan compared to controls. Additionally, in an ex vivo bone marrow model, AFM28 combined with allogeneic NK cells effectively reduced CD123-expressing AML blasts and stem cells. This research, conducted in collaboration with Dr. Hind Medyouf's group, suggests that AFM28 could potentially eradicate residual disease in AML patients safely and effectively.
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