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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 and Artiva have announced a strategic partnership to develop a combination therapy targeting CD30-positive lymphoma patients. This collaboration will utilize Affimed's AFM13 and Artiva's AB-101, which has shown impressive response rates in clinical studies. The investigational new drug submission to the FDA is expected in the first half of 2023. Affimed will retain 67% of the revenue generated from the therapy, while Artiva will receive 33%. This partnership builds on two years of preclinical research and aims to expedite treatment for patients with significant unmet medical needs.
Affimed announced promising results from its ongoing phase 1/2 trial of AFM13 combined with allogeneic NK cells for CD30-positive lymphoma patients. Among 24 patients, the treatment achieved a 100% overall response rate and a 70.8% complete response rate. Patients tolerated the treatment well, receiving up to four cycles. Further details will be presented on December 10, 2022, during the ASH Annual Meeting. Additionally, preclinical data for AFM28 highlights its potential efficacy against CD123-positive leukemic cells, set to be presented on December 12, 2022.
Affimed N.V. (Nasdaq: AFMD) announced its CEO, Dr. Adi Hoess, will present at the 2022 Jefferies London Healthcare Conference on November 16, 2022, at 12:55 p.m. GMT. A live webcast will be available on the company's website, with a replay accessible for 30 days post-event. Affimed is a clinical-stage immuno-oncology firm focused on enhancing patients' immune responses against cancer through its innovative ROCK® platform. The company aims to utilize the innate immune system to combat various tumors, showcasing a strong commitment to cancer research.
Affimed N.V. (Nasdaq: AFMD) has announced the acceptance of two abstracts showcasing new data on their innate cell engager (ICE®) AFM24 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, scheduled for November 8-12, 2022. The first poster will detail findings from a phase 1 study of AFM24 monotherapy, while the second will present initial results from a phase 1 dose escalation study of AFM24 in combination with Roche’s atezolizumab. AFM24 targets EGFR-expressing solid tumors and is part of Affimed's innovative cancer treatment approach.
Affimed N.V. (Nasdaq: AFMD) announced the phase 1 data on its innate cell engager AFM24 at the ESMO Congress. The recommended phase 2 dose (RP2D) was set at 480 mg, with ongoing enrollment in specific disease cohorts. The trial observed stable disease in 10 of 27 evaluable patients, with some patients maintaining stable disease for over four months. The treatment was well tolerated, with no on-study deaths and no maximum tolerated dose reached. AFM24 activates both the innate and adaptive immune systems, marking a significant milestone for its development.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced its participation in several investor conferences in September 2022. Key events include:
- Wells Fargo Healthcare Conference on September 7, 2022, at 3:10 p.m. EDT in Boston, MA, with a webcast available.
- Citi’s Annual BioPharma Virtual Conference on September 8, 2022, for one-on-one meetings in Boston, MA.
- Morgan Stanley’s Global Healthcare Conference on September 13, 2022, for one-on-one meetings in New York, NY.
- Jefferies Cell and Genetic Medicine Summit on September 29, 2022, for one-on-one meetings in New York, NY.
Affimed (AFMD) reported second quarter 2022 financial results, revealing a net loss of €19.4 million, or €0.13 per share, compared to a loss of €18.8 million, or €0.16 per share, in Q2 2021. Cash and cash equivalents stood at €237.2 million as of June 30, 2022, with a runway into mid-2024. The company is on track to release data from its AFM13 monotherapy REDIRECT trial and ongoing studies for AFM24 and AFM28. Research and development expenses decreased by 4% year-over-year, while general administrative expenses surged by 54%. A conference call to discuss results is scheduled for August 11, 2022.
Affimed N.V. (Nasdaq: AFMD) will release its second quarter 2022 financial results and corporate updates on August 11, 2022. The presentation will be followed by a conference call at 8:30 a.m. EDT, accessible via phone or webcast. Affimed focuses on harnessing the innate immune system to fight cancer, featuring its proprietary ROCK® platform which creates innovative innate cell engager (ICE®) molecules. This approach positions Affimed as a pioneer in clinical-stage ICE® development.
Affimed N.V. (Nasdaq: AFMD) has established a Scientific Advisory Board (SAB) composed of leading experts in immuno-oncology to guide its innate cell engagers (ICE®) programs. This advisory board includes renowned figures such as Stephen M. Ansell and Todd A. Fehniger, who will provide insights into cancer therapies. The SAB aims to enhance Affimed's development strategy and evaluate emerging technologies. Chief Scientific Officer Dr. Arndt Schottelius emphasized the board's vital expertise in advancing their promising pipeline of therapies designed to leverage the innate immune system against cancer.
Affimed N.V. (Nasdaq: AFMD) showcased promising preclinical data for its bispecific innate cell engager, AFM28, targeting CD123 in treating relapsed/refractory acute myeloid leukemia (AML) at the EHA Annual Meeting. AFM28 demonstrated potent anti-tumor activity against CD123-positive cells, even at low expression levels, while sparing healthy cells. In vivo studies indicated strong anti-tumor efficacy and a favorable safety profile. A first-in-human phase 1 clinical trial is set to commence in the second half of 2022, aiming to assess AFM28’s safety and efficacy as a monotherapy and in combination with NK cell therapies.
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