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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.
AbCheck announced a grant from the Ministry of Industry and Trade of the Czech Republic, valued at up to €1.44 million over the next 3 years. This funding supports the development of a microfluidic system for discovering rare therapeutic antibodies. The innovative technology allows screening millions of droplets containing antibody-expressing cells daily, enhancing the discovery of functional antibodies critical for cancer treatments. The grant will expedite the creation of specialized bioassays, reinforcing AbCheck's commitment to advanced antibody discovery.
Heidelberg, Germany, September 29, 2020 – Affimed N.V. (Nasdaq: AFMD) announced its presentation at the Jefferies Virtual Cell Therapy Conference on October 6 at 8:00 a.m. Eastern Time. The event's live webcast will be accessible via the “Investors” section on Affimed’s website and will remain available for 30 days post-event. Affimed focuses on innovative immuno-oncology treatments, leveraging its ROCK® platform for tailored therapies aimed at hematologic and solid tumors. The company is currently advancing studies on AFM13 and AFM24.
Heidelberg, Germany, September 2, 2020 – Affimed N.V. (Nasdaq: AFMD) announced its participation in several investor conferences throughout September 2020. These include:
- Wells Fargo Virtual Healthcare Conference on September 9, 2020, featuring a fireside chat at 8:00 a.m. ET.
- Citi’s 15th Annual BioPharma Virtual Conference on September 10, 2020.
- Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 12:40 p.m. ET.
- Oppenheimer Fall Healthcare Life Sciences Summit on September 21, 2020, at 3:20 p.m. ET.
Affimed N.V. (Nasdaq: AFMD) announced its Q2 2020 financial results, reporting revenue of €2.9 million, down from €4.0 million in Q2 2019. The company has €92.6 million in cash, projected to support operations into H1 2022. The AFM13 study has activated 54 sites across 10 countries, with interim analysis expected mid-2021. Additionally, AFM24 is advancing in Phase 1/2a trials, and the collaboration with Genentech has achieved a milestone triggering a payment. Despite a net loss of €12.2 million, the management team is optimistic about ongoing projects and future developments.
Affimed N.V. (Nasdaq: AFMD) has appointed Dr. Annalisa Jenkins and Mr. Harry Welten to its Supervisory Board, effective from August 4, 2020. Dr. Jenkins brings over 25 years of pharmaceutical experience, having held leadership roles at companies like Merck Serono and Bristol-Myers Squibb, while Mr. Welten offers extensive financial and U.S. market expertise from his roles in various biotech firms. These appointments aim to enhance corporate governance and strengthen the company's strategic positioning in the biotech industry.
Affimed N.V. (Nasdaq: AFMD) will hold its Annual General Meeting of Shareholders on August 4, 2020, at the Sheraton Amsterdam Airport Hotel, starting at 11:00 a.m. CET. The meeting's notice and agenda can be found on Affimed’s Investor Relations page and the SEC website. The company is focused on developing therapies for cancer, using its ROCK® platform for patient-specific treatments. Current studies include AFM13 for CD30-positive peripheral T cell lymphoma and AFM24 for advanced EGFR-expressing solid tumors.
Affimed N.V. (Nasdaq: AFMD) announced progress in its clinical trials, completing the first dose cohort of its Phase 1/2A study for AFM24, with recruitment for cohort 2 now open. Financial results for Q1 2020 showed total revenue of €5.1 million, down from €11.4 million year-over-year, and a net loss of €8.3 million. Cash and equivalents stood at €88.2 million as of March 31, 2020, with expectations to fund operations into the first half of 2022. Key management appointments completed with Angus Smith as CFO, enhancing the leadership team.
Affimed N.V. (Nasdaq: AFMD) showcased promising data on its Innate Cell Engagers (ICE) at the AACR Virtual Annual Meeting II. The research highlighted the effectiveness of AFM24 and Genentech’s RO7297089 in preclinical models, targeting tumor cells with low expression. Both agents demonstrated significant tumor cell killing via dual mechanisms, activating innate immune systems while maintaining favorable safety profiles in cynomolgus monkeys. AFM24 is currently progressing into further clinical studies, suggesting potential for broader application in treating EGFR-positive tumors.
Affimed has announced the successful completion of the first dose cohort in a Phase 1/2a clinical trial for AFM24, a novel bispecific innate cell engager targeting EGFR-expressing malignancies. No dose-limiting toxicities were observed, allowing progression to the second dose cohort. While efficacy was not expected at this stage, the trial aims to gather data on the safety and potential effectiveness of AFM24 as a treatment option. The company emphasizes that AFM24 could provide a new mechanism of action that utilizes innate immunity to combat cancer.
Heidelberg, Germany, June 16, 2020 – Affimed N.V. (Nasdaq: AFMD) will release its first quarter 2020 financial results on June 23, 2020, at 8:30 a.m. EDT, followed by a conference call. Investors can join via phone or webcast, with details provided in the PR. Additionally, CEO Dr. Adi Hoess will participate in a fireside chat at the BMO Healthcare Conference on the same day at 1:30 p.m. EDT. Affimed focuses on immuno-oncology, developing therapies for various cancers, including studies for AFM13 and AFM24.
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