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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.
Heidelberg, Germany, January 11, 2021 – Affimed N.V. (Nasdaq: AFMD) announced that CEO Dr. Adi Hoess will present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 7:30 a.m. EST. A live webcast of the presentation will be available on Affimed’s website for 30 days post-event. Affimed focuses on immuno-oncology, developing therapies like AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and AFM24 for advanced EGFR-expressing solid tumors. For details, visit Affimed’s investor site.
Affimed N.V. (Nasdaq: AFMD) announced a debt financing agreement with Silicon Valley Bank, offering up to €25 million in term loans. The structure includes €10 million available at closing, and two additional tranches of €7.5 million, contingent on specific milestones. Interest is set at a minimum of 5.5%, with the loan maturing in November 2025. Proceeds will support research and development of Affimed's ICE® molecules and general working capital.
Affimed N.V. (Nasdaq: AFMD) reported progress in its clinical studies for AFM13 and AFM24 as the company aims to advance its immuno-oncology pipeline. CEO Adi Hoess highlighted a robust cash position of approximately €147 million, enabling operations into H1 2023. Key updates include the AFM13-202 trial for CD30-positive T-cell lymphoma, which is ahead of schedule, and the AFM24-101 trial, now in the fourth dose cohort. The company anticipates regulatory submissions and continued clinical development, positioning it well for future growth and innovation.
Affimed N.V. (Nasdaq: AFMD) announced promising results for its AFM13 bispecific Innate Cell Engager, achieving a 42% Objective Response Rate (ORR) in heavily pretreated patients with relapsed or refractory CD30-positive lymphoma. The data presented at the 62nd American Society of Hematology Meeting highlighted that AFM13 was well tolerated, with evidence of NK cell activity and recruitment in patients. This development is significant given the high therapeutic need in this patient population, especially after brentuximab vedotin failure.
Affimed N.V. (Nasdaq: AFMD) announced promising results from its Phase 1b study of AFM13 in combination with KEYTRUDA for relapsed/refractory Hodgkin lymphoma. The study showed a complete response (CR) rate of 46% and an objective response rate (ORR) of 88% at the recommended dose, significantly outperforming KEYTRUDA alone, which had a CR of 22.4% and an ORR of 69%. The treatment was reported as well-tolerated with manageable adverse effects. Results suggest AFM13 could enhance current therapies.
Affimed announced a partnership with Roivant Sciences, receiving $60 million upfront and potential future milestones worth up to $2 billion.
The company ended Q3 2020 with €97.3 million in cash and equivalents, projecting runway into H1 2023.
Total revenue for Q3 was €10.5 million, a significant increase from €2.1 million year-over-year, driven by the Genentech collaboration.
Net loss decreased to €6 million, or €0.07 per share, from €10.9 million, or €0.17 per share, in Q3 2019.
Affimed N.V. (Nasdaq: AFMD) has announced a licensing agreement with Roivant Sciences to develop and commercialize novel ICE® molecules in oncology, significantly broadening its pipeline. The agreement includes a $60 million upfront payment, consisting of $40 million in cash and $20 million in newly issued shares. Affimed is eligible for up to $2 billion in future milestone payments based on the achievement of specific development and regulatory goals. This collaboration will enhance the potential of Affimed's ROCK® platform in targeting cancer therapies.
Affimed N.V. (Nasdaq: AFMD) announced a virtual presentation of preclinical data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 11, 2020. The data, focusing on the use of ICE® AFM13 in combination with various natural killer (NK) cells to target CD30-positive malignancies, showed promising results. AFM13-preloaded NK cells exhibited enhanced efficacy against tumor cells, suggesting a potential for novel immunotherapy approaches. This data supports a Phase 1 clinical evaluation currently underway.
Artiva Biotherapeutics and Affimed N.V. have entered an exclusive collaboration to explore the feasibility and activity of allogeneic NK cell combination therapies targeting EGFR and other targets. The R&D partnership will focus on preclinical assessments of Artiva's NK cell product AB-101 combined with Affimed’s ICE® molecules. This combination aims for efficient anti-tumor activity without viral transduction. The collaboration includes shared manufacturing costs and may lead to further development of selected therapeutics, marking a strategic advancement in immuno-oncology.
Affimed N.V. (NASDAQ: AFMD) announced that two abstracts for its lead innate cell engager, AFM13, have been accepted for presentation at the virtual 62nd ASH Annual Meeting, December 5-8, 2020. AFM13 is a first-in-class bispecific antibody targeting CD30 and engaging NK cells to fight cancer. The first poster details a Phase Ib/IIa study in CD30-positive lymphoma, showing a 40% Objective Response Rate (ORR) post-brentuximab vedotin failure. The second highlights a Phase II trial in Hodgkin Lymphoma with a 16.6% ORR, though it was terminated early due to recruitment issues.
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