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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) has announced promising pre-clinical data for its Innate Cell Engager (ICE®) AFM24, demonstrating significant tumor cell killing capabilities independent of KRAS mutations. Presented at the AACR Virtual Annual Meeting, AFM24 shows potential in combination with adoptively transferred NK cells, leading to dose-dependent tumor regression. This innovative mechanism may change the treatment landscape for EGFR-expressing solid tumors. The company continues to evaluate AFM24 for patients with advanced malignancies, supported by regulatory approvals for ongoing clinical trials.
Affimed N.V. (Nasdaq: AFMD) announced promising initial results from a Phase 1 trial at MD Anderson, showcasing a 100% objective response rate in four patients with recurrent/refractory CD30-positive lymphomas. Among these, two achieved complete responses and two had partial responses. Importantly, there were no signs of cytokine release syndrome or neurotoxicity. The trial, which utilizes cord blood-derived NK cells pre-complexed with Affimed's AFM13, is continuing to enroll patients for further cohorts. A conference call is scheduled for April 14 to discuss these findings.
Affimed N.V. (Nasdaq: AFMD) will report its 2020 financial results and corporate updates on April 15, 2021, with a conference call at 8:30 a.m. EDT. Investors can join via phone or webcast, accessing the call with specific dial-in numbers and a conference ID.
Affimed is focused on immuno-oncology, leveraging its proprietary ROCK® platform to develop therapies aimed at treating various tumors. The company aims to empower patients' innate immunity to combat cancer effectively.
Affimed N.V. (NASDAQ: AFMD) and NKMax America Inc. announced the FDA's clearance of an IND for a Phase 1/2a study. This trial will explore the combination of AFM24, an EGFR/CD16A innate cell engager, with SNK-01, an autologous NK-cell product, targeting solid tumors expressing EGFR. The aim is to improve treatment outcomes for patients who have failed conventional therapies. The study will assess safety, pharmacokinetics, and preliminary efficacy, marking a significant step for both companies in advancing innate immunity-based therapies.
Affimed N.V. (Nasdaq: AFMD) announced that preclinical data on AFM24 will be showcased via e-poster at the AACR Virtual Annual Meeting I from April 10-15, 2021. The poster presents AFM24 as a potent bispecific innate cell engager targeting EGFR for cancer treatment. Additionally, AFM13 data will be highlighted in a symposium on April 13, focusing on its use in combination with NK cells for treating CD30-expressing lymphomas. These presentations aim to advance understanding of the efficacy of these therapies in oncology.
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.
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