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Affimed N.V. - AFMD STOCK NEWS

Welcome to our dedicated page for Affimed N.V. news (Ticker: AFMD), a resource for investors and traders seeking the latest updates and insights on Affimed N.V. stock.

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.

Rhea-AI Summary
Affimed N.V. (AFMD) reports positive results from clinical trials for AFM24 and acimtamig, with plans for further data updates in Q2 2024. The company has completed restructuring, focusing on advancing its three clinical programs. Cash runway is secured until H2 2025. Financially, the company saw a decrease in revenue and an increase in net loss for the year ended December 31, 2023.
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Affimed N.V. (AFMD) to release full year 2023 results and corporate update on March 28, 2024. Conference call scheduled for investors to discuss the latest developments in the clinical-stage immuno-oncology company.
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Affimed N.V. announces a 1-for-10 reverse stock split of its outstanding common shares to maintain NASDAQ listing compliance. Shareholders will receive cash payments in lieu of fractional shares.
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Affimed N.V. (AFMD) provides update on AFM24-102 Phase 1/2a study for EGFR-wildtype (wt) non-small cell lung cancer (NSCLC), showing promising responses in heavily pre-treated patients. The study will be expanded to 40 patients, with data from both EGFRwt and EGFRmut cohorts expected in H1 2024.
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Affimed N.V. (AFMD) announced that Dr. Adi Hoess is stepping down as CEO and Management Board Member, with Dr. Andreas Harstrick appointed as Interim CEO. The company is undergoing a strategic restructuring, reducing headcount by up to 50% and extending cash runway into H2 2025. Affimed will focus on advancing clinical programs and confirms guidance on data readouts for AFM24-102 and LuminICE-203 in H1 2024.
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Affimed N.V. (Nasdaq: AFMD) has announced a definitive agreement to sell its subsidiary, AbCheck s.r.o., to Ampersand Biomedicines for $6 million, including $5 million in cash and $1 million in Ampersand common stock. Affimed will also receive milestone payments from a pre-existing partnership with AbCheck.
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Affimed N.V. (Nasdaq: AFMD) announced interim safety and efficacy data on its innate cell engager (ICE®) AFM24 from the ongoing AFM24-102 combination study with atezolizumab, an anti-PD-L1 checkpoint inhibitor, in patients with advanced EGFR-expressing solid tumors. The data includes 15 heavily pre-treated patients from the EGFR-wildtype non-small cell lung cancer (NSCLC) expansion cohort, with responses observed in 4 of 15 patients, including 1 confirmed partial response (PR), 1 unconfirmed complete response (CR) awaiting confirmation, 2 unconfirmed PRs awaiting confirmation, and an additional 7 of 15 patients exhibiting stable disease (SD) leading to a disease control rate of 73%. Tumor shrinkage was observed in 7 of 15 (47%) patients. The majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile in combination with atezolizumab. Affimed also announced that it has discontinued enrollment in AFM24-102 into the gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer, and hepatocellular carcinoma.
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Affimed N.V. (AFMD) announced updated data on its lead innate cell engager (ICE®) acimtamig, presented at the American Society of Hematology (ASH) 2023 Annual Meeting. The objective response rate (ORR) for r/r Hodgkin lymphoma (HL) patients was 97%, with a complete response (CR) rate of 78%. The median event-free survival (EFS) was 9.8 months, with 84% of patients alive at 12 months. The treatment was well tolerated with no instances of cytokine release syndrome (CRS), graft versus host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS).
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Affimed N.V. (Nasdaq: AFMD) to review clinical data of acimtamig in combination with cord-blood derived NK cells and provide progress update on the LuminICE-203 and AFM24-102 trials at ASH 2023. Conference call/webcast on December 11, 2023, to discuss the clinical data.
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Affimed N.V. (Nasdaq: AFMD) reported financial results and clinical progress for Q3 2023. Initiatives include LuminICE-203 study, fast-track designation for acimtamig, FDA feedback, AFM13-104 presentation, AFM24 combination study, AFM28 progress, cash runway into 2025, and upcoming milestones.
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FAQ

What is the current stock price of Affimed N.V. (AFMD)?

The current stock price of Affimed N.V. (AFMD) is $1.24 as of December 24, 2024.

What is the market cap of Affimed N.V. (AFMD)?

The market cap of Affimed N.V. (AFMD) is approximately 20.3M.

What does Affimed N.V. specialize in?

Affimed N.V. specializes in developing immuno-oncology therapies that harness the innate immune system to fight cancer.

What is the ROCK® platform?

The ROCK® platform is Affimed's proprietary technology that generates customized innate cell engagers (ICE®) to target and kill cancer cells.

What are Affimed's key clinical candidates?

Affimed's key clinical candidates include AFM13 (acimtamig), AFM24, and AFM28, targeting various hematologic and solid tumors.

What is AFM13 used for?

AFM13 targets CD30-positive hematologic tumors and is showing promising results in treating refractory Hodgkin lymphoma.

What is the significance of AFM24's Fast Track designation?

The Fast Track designation by the FDA for AFM24 in combination with atezolizumab expedites its development and review process to address unmet medical needs in NSCLC patients.

How does AFM28 work?

AFM28 targets CD123-positive AML cells, engaging NK cells to initiate tumor cell killing through antibody-dependent cellular cytotoxicity.

What collaborations does Affimed have?

Affimed collaborates with entities like Artiva Biotherapeutics, The University of Texas MD Anderson Cancer Center, and Roche to enhance the efficacy and development of its therapies.

Where is Affimed N.V. headquartered?

Affimed N.V. is headquartered in Mannheim, Germany, with additional offices in New York, NY.

What are the recent achievements of Affimed?

Recent achievements include positive clinical data from AFM24 and AFM13 studies, FDA Fast Track designation for AFM24, and strategic partnerships to advance its clinical programs.

What is the company's mission?

Affimed's mission is to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system.

Affimed N.V.

Nasdaq:AFMD

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AFMD Stock Data

20.33M
15.48M
6.01%
36.99%
6.27%
Biotechnology
Healthcare
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United States of America
Mannheim