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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), 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.
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.
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