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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 positive interim results from a phase 1-2 study, showing a 100% objective response rate in patients with CD30-positive relapsed or refractory lymphomas after one treatment cycle involving the pre-complexed cbNK cells with their innate cell engager AFM13. Of 12 patients treated at the recommended phase 2 dose, 42% achieved a complete response, with no serious adverse events reported. A virtual investor event is scheduled for December 9 to discuss these findings further.
Affimed N.V. (Nasdaq: AFMD) announced the presentation of preclinical data on its innate cell engagers (ICE®) AFM13 and AFM24 at the SITC Annual Meeting. The findings, derived from a collaboration with Karolinska Institutet, demonstrate enhanced NK cell activity and macrophage involvement in tumor cell killing. AFM24's ability to induce antibody-dependent cellular phagocytosis (ADCP) was highlighted, enhancing potential anti-tumor effects across various tumor types. AFM24 is currently in Phase 1/2a trials for EGFR-expressing solid tumors, with additional studies planned with an anti-PD-L1 checkpoint inhibitor.
Affimed N.V. (Nasdaq: AFMD) reported its third quarter 2021 financial results, highlighting a net loss of €17.1 million or €0.14 per share, worsening from a net loss of €6.0 million in Q3 2020. Cash and cash equivalents increased to €198.7 million, projected to sustain operations into the second half of 2023. Significant clinical updates include ongoing patient recruitment for the AFM13 and AFM24 trials. Both candidates are expected to generate multiple catalysts, with AFM24's expansion phase set to start by year-end 2021.
Affimed N.V. (Nasdaq: AFMD) announced participation in two upcoming investor conferences in November 2021. The Stifel 2021 Virtual Healthcare Conference will be held from November 15-17, 2021, with a presentation on the 15th at 8:00 a.m. EST. The Jefferies London Healthcare Conference takes place from November 16-19, 2021, featuring a fireside chat available on November 18 at 3:00 a.m. EST. Affimed is dedicated to advancing immuno-oncology therapies, leveraging its proprietary ROCK® platform to develop novel treatments for cancer.
Affimed and NKGen Biotech have initiated patient recruitment for a phase 1/2a clinical trial (NCT05099549) to evaluate the safety and effectiveness of AFM24 combined with SNK01 NK cells in treating advanced EGFR-expressing cancers such as non-small cell lung cancer, squamous cell carcinoma, and colorectal cancer. This study follows promising preclinical data presented at the AACR-NCI-EORTC conference, showing enhanced anti-tumor activity from the combination therapy. The trial aims to determine the maximum tolerated dose of AFM24 and further explore its efficacy in cancer therapy.
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.
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