Welcome to our dedicated page for Affimed N.V. news (Ticker: AFMD), a resource for investors and traders seeking the latest updates and insights on Affimed N.V. stock.
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 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.
Affimed has reported promising results from its phase 1/2 study of AFM13 combined with cord blood-derived NK cells in patients with CD30-positive Hodgkin and Non-Hodgkin lymphomas. Among 31 Hodgkin lymphoma patients, an impressive objective response rate (ORR) of 97% and a complete response (CR) rate of 77% were observed. Notably, all participants had failed previous treatments. The study showed a favorable safety profile, with no significant adverse events reported. Affimed continues to explore the market potential for AFM13, aiming to address unmet needs in this patient population.
Affimed N.V. (Nasdaq: AFMD) announced an investor event to review clinical data and development plans for AFM13 in CD30 expressing malignancies. This event will take place on December 10, 2022, at 4:00 p.m. CST during the 64th American Society of Hematology Annual Meeting in New Orleans. AFM13 has shown promising efficacy in Hodgkin Lymphoma and T cell lymphoma, with high response rates in both monotherapy and combination trials. Affimed recently partnered with Artiva to further develop AFM13 with NK cell therapies. A webcast of the event will be available for those unable to attend.
Affimed reported Q3 2022 results highlighting a revenue increase to €14.9 million, up from €8.7 million year-over-year, primarily from collaborations with Genentech and Roivant. The company has entered a partnership with Artiva Biotherapeutics to advance AFM13 for CD30-positive lymphomas. AFM13's combination therapy maintains a 100% overall response rate in trials. Operating cash usage was €19 million, with cash reserves at €222.9 million expected to last through mid-2024. The net loss for Q3 was €16.5 million, or €0.11 per share, showing slight improvement from the previous year.
Affimed N.V. (Nasdaq: AFMD) has announced promising results from two phase 1/2a trials involving AFM24, a bispecific innate cell engager targeting EGFR in patients with solid tumors. Findings indicate that AFM24 activates NK cells and shows initial signs of clinical activity when combined with atezolizumab, an immune checkpoint inhibitor, without dose-limiting toxicities. The data will be presented during the Society for Immunotherapy of Cancer (SITC) conference on November 10 and 11, 2022, with further updates available on Affimed’s website.
Affimed N.V. (Nasdaq: AFMD) will release its third quarter 2022 results and corporate update on November 15, 2022, followed by a conference call at 8:30 a.m. EST / 14:30 CET. Investors can join via phone or through a webcast available on the company’s website. The call features the latest updates on Affimed’s immuno-oncology initiatives and its ROCK® platform designed to combat various cancers by utilizing the innate immune system. A replay will be accessible for 30 days post-call.
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