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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) reported its first quarter 2022 financial results and clinical updates. The REDIRECT study for AFM13 monotherapy completed enrollment, with topline data expected in Q4 2022. At AACR 2022, AFM13 showed a 100% objective response rate and a rise in complete responses. The cash position is strong, with €257.5 million expected to support operations into mid-2024. However, net loss for Q1 2022 was €16.7 million, down from a profit a year ago, while R&D expenses surged by 61% to €18.4 million, indicating increased investment in their product pipeline.
Affimed (Nasdaq: AFMD) announced three clinical trial designs for its AFM24 innate cell engager (ICE®), showcased at the ASCO Annual Meeting from June 3-7, 2022. The trials include AFM24 monotherapy and combinations with atezolizumab and SNK01 autologous NK cells, targeting advanced EGFR-expressing solid tumors. AFM24 aims to activate the innate immune system, showing a well-managed safety profile and established recommended phase 2 dose (RP2D) of 480 mg. These innovative approaches represent potential advancements in treatment for patients resistant to current therapies.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced that CEO Dr. Adi Hoess will present at the 2022 Jefferies Healthcare Conference on June 8, 2022, at 1:00 PM EDT. The presentation will focus on Affimed's commitment to empowering the innate immune system to fight cancer. A live webcast will be available on Affimed's website, with a replay accessible for 30 days post-event. For inquiries about the conference or to schedule meetings, interested parties can contact Jefferies or reach out to Alex Fudukidis.
Affimed N.V. (Nasdaq: AFMD) announced that its 2022 Annual General Meeting of Shareholders will take place on June 22, 2022, at 09:00 a.m. CET in Amsterdam. The meeting aims to discuss company performance and future strategies. Shareholders can access the notice and agenda on Affimed's website or through the SEC's site. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to develop innovative therapies targeting various cancers. The company is committed to enhancing patients' innate ability to combat cancer.
Affimed N.V. (Nasdaq: AFMD) announced it will release its Q1 2022 financial results and provide a corporate update on June 1, 2022. A conference call will take place at 8:30 a.m. EDT, available via phone and webcast. The call can be accessed by dialing +1 (409) 220-9054 for U.S. participants and +44 (0) 8000 323836 for international callers, using conference ID 4440407. Affimed focuses on immuno-oncology and utilizes its proprietary ROCK® platform to develop innovative cancer therapies.
Affimed N.V. (Nasdaq: AFMD) presented new data on AFM24 and AFM28 at the NK2022 conference, highlighting their potential in cancer treatment. The AFM24 data showed its efficacy as a CD16A/EGFR-targeting bispecific innate cell engager, stimulating anti-cancer immunity in patients with EGFR-expressing tumors. Meanwhile, AFM28 demonstrated anti-leukemic effects when combined with NK cells, suggesting it could offer an off-the-shelf therapy for AML and MDS patients. Both compounds are currently undergoing phase 1/2a clinical studies.
Affimed N.V. (Nasdaq: AFMD) announced the upcoming first-in-human phase 1 study of its bispecific innate cell engager AFM28, targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). This innovative therapy showed promising results in preclinical studies, effectively destroying CD123-positive tumor cells while sparing healthy cells. Toxicology models indicated low risks of side effects such as cytokine release syndrome. The study is set to begin in the second half of 2022, with a poster presentation scheduled at the EHA Annual Meeting in June 2022.
Affimed N.V. (Nasdaq: AFMD) announced that the American Society of Clinical Oncology (ASCO) has removed the oral presentation of the AFM13-104 trial from its conference program. This decision was due to ASCO's embargo policy, following the recent data presentation at the AACR Annual Meeting on April 10, 2022. Affimed clarified that this removal is unrelated to the ongoing trial's status or results. The company is collaborating with The University of Texas MD Anderson Cancer Center to submit additional data on AFM13-104 to a future scientific forum.
Affimed N.V. (Nasdaq: AFMD) announced acceptance of four abstracts for the American Society of Clinical Oncology (ASCO) Annual Meeting, occurring June 3-7, 2022, in Chicago.
The presentations will cover phase 1/2 studies of AFM13 and AFM24, targeting CD30-positive lymphomas and advanced EGFR-expressing solid tumors, respectively. Notably, an oral presentation will detail AFM13 combined with NK cells in CD30-positive lymphoma patients, while three posters will outline the AFM24 studies involving monotherapy and combinations with other treatments.
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