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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 progress on AFM28, its novel Innate Cell Engager targeting Acute Myeloid Leukemia (AML) and related conditions. Derived from the ROCK® platform, AFM28 binds to CD123 and CD16A, demonstrating superior activity in preclinical studies compared to traditional monoclonal antibodies. A preclinical toxicology study indicated AFM28 was well-tolerated. An IND application is anticipated in the first half of 2022, with a clinical trial expected to start in the latter half.
Affimed (Nasdaq: AFMD) announced poster presentations at the 63rd ASH Annual Meeting, focusing on AFM28 and AFM13, two of its innovative innate cell engagers (ICE®). AFM28 targets CD123+ myeloid malignancies, showing promise for Acute Myeloid Leukemia treatment, while AFM13 maintains NK cell potency after cryopreservation. An investor event in mid-December will provide updates on AFM13's clinical development, currently under two trials for T-cell lymphoma and CD30-positive lymphomas. The first-in-human study for AFM28 is anticipated to begin in late 2022.
Affimed N.V. (Nasdaq: AFMD) announced it will release its third quarter 2021 results on November 10, 2021, followed by a conference call at 8:30 a.m. EST. The call will discuss financial results and recent corporate developments. Interested parties can join by dialing +1 (409) 220-9054 for U.S. callers or +44 (0) 8000 323836 for international participants. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to target and kill tumors using patients' innate immune cells. The call will be accessible via webcast and will be archived for 30 days.
Affimed (Nasdaq: AFMD) announced the acceptance of three abstracts for poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), scheduled for November 10-14, 2021. The abstracts showcase preclinical data on their innate cell engagers (ICE®), highlighting the potential of AFM24 in enhancing tumor cell phagocytosis and improving NK cell response. Full details of the abstracts will be available on November 9, 2021.
Affimed N.V. (Nasdaq: AFMD) reported its Q2 2021 financial results, highlighting a significant revenue increase to €9.7 million, up from €2.9 million in Q2 2020, thanks to collaborations with Genentech and Roivant. As of June 30, cash reserves stood at €222.7 million, expected to fund operations into the second half of 2023. The company is making steady progress in its clinical trials for AFM13 and AFM24, with enrollment for various studies on track and promising safety data reported. However, net loss widened to €18.8 million, indicating continued investment in R&D.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology firm, announced its participation in several investor conferences in September 2021. Notable events include the Citi’s 16th Annual BioPharma Virtual Conference on September 8, offering one-on-one meetings, and the 2021 Wells Fargo Virtual Healthcare Conference on September 9, featuring a presentation at 8:00 a.m. Eastern Time. Additional meetings will take place at the Morgan Stanley Global Healthcare Conference and Cantor Fitzgerald Virtual Global Healthcare Conference. For inquiries or to schedule meetings, contact Alex Fudukidis.
Affimed N.V. (Nasdaq: AFMD) will release its second quarter 2021 financial results on September 8, 2021, followed by a conference call at 8:30 a.m. EDT. The call aims to discuss the financial results and recent corporate developments. Interested parties can access the call via phone or webcast, with details provided for both U.S. and international callers. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to develop targeted treatments against various tumors. A replay of the call will be available for 30 days post-event.
Affimed N.V. (Nasdaq: AFMD) announces significant findings regarding its innate cell engager, AFM24, targeting EGFR-expressing tumors. Preclinical data highlight AFM24’s ability to engage the innate immune system effectively, emphasizing its unique mechanism that operates independently of EGFR mutations. Notably, toxicity studies in cynomolgus monkeys revealed a favorable safety profile at doses up to 75 mg/kg. These results bolster AFM24's potential in the ongoing Phase 1/2a study for patients with advanced solid tumors, reflecting promising advancements in immuno-oncology.
Affimed N.V. (Nasdaq: AFMD) reported strong financial results for Q1 2021, with total revenue reaching €11.7 million, up from €5.1 million year-over-year. The company's cash and cash equivalents stood at €240.7 million, ensuring operations through the second half of 2023. Key clinical updates include positive interim results for AFM13 in PTCL and a 100% response rate in a combination therapy trial with NK cells. Comprehensive plans for upcoming trials of AFM24 and AFM28 show promise for further development. A conference call is scheduled for July 1, 2021, to discuss these results.
Affimed N.V. (Nasdaq: AFMD) will release its first-quarter 2021 financial results on July 1, 2021. A conference call will occur at 8:30 a.m. EDT to discuss these results and recent corporate developments. Stakeholders can access the call via phone or live audio webcast. Additionally, the company's innovative ROCK® platform aims to enhance cancer treatment through the innate immune system, positioning Affimed as a leader in immuno-oncology with a clinical-stage ICE®. Further information is available on their website.
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