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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 interim results from its phase 1/2 study of AFM24 have been accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023. The study includes a non-small cell lung cancer (NSCLC) cohort with a poster session on June 3, and results from a colorectal cancer (CRC) cohort accepted for online publication. AFM24 is a bispecific innate cell engager designed to activate the innate immune system against tumors, leveraging its unique mechanism to bind CD16A on immune cells and EGFR on cancer cells. The full abstracts will be available on May 26, 2023. This innovative treatment is being evaluated both as a monotherapy and in combination with other therapies.
Affimed N.V. (Nasdaq: AFMD) announced significant findings from a poster presentation at the AACR Annual Meeting in Orlando, Florida. The preclinical study, developed in collaboration with Prof. Björn Önfelt, highlights the ability of AFM13 to enhance serial killing of tumor cells by natural killer (NK) cells, even those exhibiting low CD30 levels. Results indicate that AFM13 achieved higher killing efficiency through antibody-dependent cellular cytotoxicity (ADCC) compared to existing monoclonal antibodies. Moreover, the study suggests that CD16A shedding enables NK cells to migrate to additional target cells after the initial kill. The company plans to submit an IND for a Phase 2 study combining AFM13 with NK cells in 2023, following encouraging Phase 1/2a trial outcomes.
Affimed N.V. (Nasdaq: AFMD) reported promising results from its phase 2 REDIRECT study of AFM13, an innate cell engager (ICE®) targeting relapsed/refractory peripheral T cell lymphoma (PTCL). The study achieved an objective response rate (ORR) of 32.4% and a complete response (CR) rate of 10.2% among all patients. Notably, patients with Angioimmunoblastic T cell lymphoma (AITL) had the highest ORR of 53.3%. The median duration of response (DoR) was 2.3 months, median progression-free survival (PFS) was 3.5 months, and median overall survival (OS) was 13.8 months. The safety profile was tolerable with infusion-related reactions occurring in 25% of patients. Affimed plans to develop AFM13 further in combination with AB-101 NK cells, discontinuing plans for accelerated approval of AFM13 monotherapy.
Affimed N.V. (Nasdaq: AFMD) announced that it has received a notice from Nasdaq regarding non-compliance with the Minimum Bid Price Rule, as the bid price of its common shares has been below $1.00 for thirty consecutive business days as of April 4, 2023. The company has a 180-day grace period until October 2, 2023, to regain compliance. If unsuccessful, Affimed may apply to transfer its shares to the Nasdaq Capital Market, granting an additional 180 days until April 1, 2024, to meet the requirement. Currently, the notice does not affect the listing or trading of the company's common shares. Affimed is dedicated to monitoring its share price and exploring options to comply with Nasdaq regulations.
Affimed N.V. (Nasdaq: AFMD) announced the dosing of the first patient in a phase 1 clinical trial for its innate cell engager (ICE®) AFM28, targeting CD123-positive relapsed/refractory acute myeloid leukemia (AML). This study aims to evaluate the safety, tolerability, and pharmacokinetics of AFM28, which directs natural killer (NK) cells to attack leukemic cells. With AFM28's entry into clinical trials, Affimed expands its pipeline of innovative therapies in hematological cancers, promising new treatment options for patients in dire need. The company anticipates multiple data readouts in 2023.
Affimed N.V. (Nasdaq: AFMD) reported its 2022 financial results and provided updates on its clinical pipeline as of March 23, 2023. The company is on track to file an IND for AFM13 in combination with AB-101 NK cells in H1 2023 and to initiate a clinical study within the year. It highlighted a strong cash position of €190.3 million, anticipated to last into 2025, and an increase in total revenue to €41.4 million, compared to €40.4 million in 2021. However, net loss widened to €86.0 million, reflecting increased R&D and administrative expenses. The company showcased promising AFM13 and AFM24 data at scientific conferences and continues recruiting for AFM28.
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