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) has decided to continue enrollment in its REDIRECT trial evaluating AFM13 for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) following a preplanned interim futility analysis. The analysis showed that the response rate in Cohort A qualified for continuation, and Cohorts A and B will merge for further evaluation. Objective responses were observed in heavily pretreated patients with a safety profile consistent with prior trials. An investor conference call is scheduled for March 10, 2021, at 8:30 a.m. EST.
Affimed N.V. (Nasdaq: AFMD) announced a collaboration with Roche to explore AFM24, its innate cell engager, in combination with Roche’s PD-L1 inhibitor atezolizumab for treating patients with advanced solid tumors expressing EGFR. The Phase 1/2a clinical trial will assess safety and efficacy, funded and conducted by Affimed with Roche supplying atezolizumab. This partnership aims to leverage the potential synergistic effects of AFM24 and PD-(L)1 inhibition. Previous studies suggest promising safety and activity profiles for AFM24 in preclinical settings.
Affimed N.V. announced the completion of its public offering of 19,166,667 common shares at a price of $6.00 per share, raising $115 million in gross proceeds. This includes the underwriters' full exercise option for an additional 2,500,000 shares. The offering underlines Affimed's commitment to advancing its immuno-oncology pipeline, which includes therapies for hematologic and solid tumors. Despite the capital raised, potential risks associated with the offering and market conditions remain.
Affimed N.V. (Nasdaq: AFMD) announced the pricing of a public offering of 16,666,667 common shares at $6.00 per share, aiming to raise approximately $94 million after underwriting discounts. The offering includes a 30-day over-allotment option for underwriters to purchase an additional 2,500,000 shares. The proceeds are expected to support the company's clinical-stage immuno-oncology initiatives. The offering is scheduled to close around January 15, 2021, subject to standard conditions.
Affimed N.V. (Nasdaq: AFMD) announced the commencement of an underwritten public offering of common shares on January 12, 2021. The offering is expected to include a 30-day over-allotment option for underwriters to purchase an additional 15% of shares sold. Jefferies, SVB Leerink, and Credit Suisse are serving as joint book-running managers. The offering is contingent on market conditions, and there is uncertainty surrounding its completion or specific terms.
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.
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