Welcome to our dedicated page for Affimed news (Ticker: AFMD), a resource for investors and traders seeking the latest updates and insights on Affimed stock.
Overview of Affimed N.V.
Affimed N.V. (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company that focuses on the discovery and development of targeted immuno-oncology therapies. With a rigorous scientific approach, the company leverages its proprietary ROCK® platform to generate innovative, tetravalent, bispecific antibodies known as tandAbs®. These agents are designed to engage key immune cells, such as natural killer (NK) cells and T-cells, and direct them toward tumor cells, thereby triggering a robust immunologic response against both hematologic and solid tumors. Early-stage clinical candidates are advancing through various phases with a clear emphasis on efficacy and manageable safety profiles.
Core Technology and Mechanism
The foundation of Affimed's approach lies in its capability to harness the body's innate immune defense mechanisms. By developing bispecific molecules that target both immune effector cells and cancer cells, Affimed creates a 'bridge' that facilitates a potent antibody-dependent cellular cytotoxicity response. The unique tetravalent architecture means that these tandAbs® possess four binding domains, enabling high affinity interactions with both the immune and tumor cell surfaces. This design not only assures precise targeting but also allows for the dosing flexibility required in clinical applications, as these agents can be administered via standard intravenous infusions.
Product Pipeline and Innovations
Affimed's pipeline includes multiple candidates developed to address a range of challenging cancer indications. The company is actively involved in the preclinical and clinical development of several innovative product candidates, such as those targeting antigens on both blood cancers and solid tumors. For instance, candidates like its CD123- and CD16A-binding molecules are designed with a dual mechanism that recruits NK cells to eliminate malignant cells effectively. The integration of these molecules into combinatorial therapies further exemplifies the company's pursuit of expanded clinical applicability.
Revenue Model and Market Significance
In addition to its clinical development efforts, Affimed generates revenue from delivering research and development services. These services are based on both group-owned and third-party intellectual property, highlighting a diversified approach that complements its core therapeutic innovations. The company's operational reach extends across strategic markets, notably in the United States and Europe, ensuring a broad impact within the dynamic biopharmaceutical environment.
Competitive Landscape and Differentiation
Affimed stands out in the competitive immuno-oncology space by virtue of its distinctive methodology and proprietary technology. Unlike traditional antibody therapies, its focus on engaging innate immune cells through a sophisticated bispecific mechanism establishes a strong competitive differentiation. This nuanced approach, combined with active collaborations and a commitment to rigorous clinical evaluation, reinforces its position as a significant player in advancing cancer immunotherapies. The company's strategic emphasis on both monotherapy and combination therapy regimens addresses unmet patient needs without oversimplifying the underlying science.
Scientific Rigor and Industry Expertise
Throughout its operations, Affimed demonstrates deep scientific and clinical expertise. The careful engineering of its molecules, alongside a clear understanding of antibody kinetics and immune cell activation, underscores its commitment to delivering precision-based oncology treatments. The company’s ongoing trials, regulatory milestones, and adaptive clinical strategies further illustrate its role not just as a developer of targeted therapies, but as an innovator in the broader biopharmaceutical industry.
Summary
- Clinical-Stage Focus: Engaged in advanced clinical development of targeted immuno-oncology therapies.
- Innovative Technology: Utilizes a proprietary ROCK® platform to develop four-binding-domain bispecific antibodies.
- Dual Mechanism: Designed to recruit and activate innate immune cells for effective tumor cell killing.
- Revenue Streams: Generates income through R&D services leveraging both proprietary and third-party intellectual property.
- Global Presence: Operates in key markets including the United States and Europe.
- Scientific Expertise: Combines robust clinical trials with advanced biotechnological innovation, ensuring an in-depth approach to cancer immunotherapy.
This comprehensive profile of Affimed N.V. outlines the company's mission to transform cancer treatment by activating the body's innate defenses. It reflects a deep understanding of the industry, advanced scientific methodologies, and a differentiated business model that positions the company as an influential contributor to the evolving landscape of cancer immunotherapy.
Affimed N.V. (Nasdaq: AFMD) announced promising results from a clinical study investigating AFM13 for CD30-positive lymphoma. In a trial involving 19 patients, the overall response rate reached 89.5%, with a 36.8% complete response rate. Patients treated at the recommended phase 2 dose showed a remarkable 100% response after one cycle, with a 38.5% complete response rate. The treatment demonstrated a favorable safety profile, with minimal adverse effects reported. The company plans to present complete results at future conferences, indicating significant advancements in addressing challenging lymphomas.
Affimed N.V. (Nasdaq: AFMD) has commenced patient recruitment for a phase 1/2a study focusing on the innate cell engager (ICE®) AFM24 combined with Roche’s atezolizumab, targeting solid tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the combination. AFM24 engages natural killer cells to enhance anti-tumor activity. The study involves patients with various solid tumors who have undergone prior treatments. Preclinical data suggests a favorable safety profile and anti-tumor efficacy, emphasizing the potential of this novel therapy.
Affimed N.V. (Nasdaq: AFMD) announced positive interim results from a phase 1-2 study, showing a 100% objective response rate in patients with CD30-positive relapsed or refractory lymphomas after one treatment cycle involving the pre-complexed cbNK cells with their innate cell engager AFM13. Of 12 patients treated at the recommended phase 2 dose, 42% achieved a complete response, with no serious adverse events reported. A virtual investor event is scheduled for December 9 to discuss these findings further.
Affimed N.V. (Nasdaq: AFMD) announced the presentation of preclinical data on its innate cell engagers (ICE®) AFM13 and AFM24 at the SITC Annual Meeting. The findings, derived from a collaboration with Karolinska Institutet, demonstrate enhanced NK cell activity and macrophage involvement in tumor cell killing. AFM24's ability to induce antibody-dependent cellular phagocytosis (ADCP) was highlighted, enhancing potential anti-tumor effects across various tumor types. AFM24 is currently in Phase 1/2a trials for EGFR-expressing solid tumors, with additional studies planned with an anti-PD-L1 checkpoint inhibitor.
Affimed N.V. (Nasdaq: AFMD) reported its third quarter 2021 financial results, highlighting a net loss of €17.1 million or €0.14 per share, worsening from a net loss of €6.0 million in Q3 2020. Cash and cash equivalents increased to €198.7 million, projected to sustain operations into the second half of 2023. Significant clinical updates include ongoing patient recruitment for the AFM13 and AFM24 trials. Both candidates are expected to generate multiple catalysts, with AFM24's expansion phase set to start by year-end 2021.
Affimed N.V. (Nasdaq: AFMD) announced participation in two upcoming investor conferences in November 2021. The Stifel 2021 Virtual Healthcare Conference will be held from November 15-17, 2021, with a presentation on the 15th at 8:00 a.m. EST. The Jefferies London Healthcare Conference takes place from November 16-19, 2021, featuring a fireside chat available on November 18 at 3:00 a.m. EST. Affimed is dedicated to advancing immuno-oncology therapies, leveraging its proprietary ROCK® platform to develop novel treatments for cancer.
Affimed and NKGen Biotech have initiated patient recruitment for a phase 1/2a clinical trial (NCT05099549) to evaluate the safety and effectiveness of AFM24 combined with SNK01 NK cells in treating advanced EGFR-expressing cancers such as non-small cell lung cancer, squamous cell carcinoma, and colorectal cancer. This study follows promising preclinical data presented at the AACR-NCI-EORTC conference, showing enhanced anti-tumor activity from the combination therapy. The trial aims to determine the maximum tolerated dose of AFM24 and further explore its efficacy in cancer therapy.
Affimed N.V. (Nasdaq: AFMD) announced progress on AFM28, its novel Innate Cell Engager targeting Acute Myeloid Leukemia (AML) and related conditions. Derived from the ROCK® platform, AFM28 binds to CD123 and CD16A, demonstrating superior activity in preclinical studies compared to traditional monoclonal antibodies. A preclinical toxicology study indicated AFM28 was well-tolerated. An IND application is anticipated in the first half of 2022, with a clinical trial expected to start in the latter half.
Affimed (Nasdaq: AFMD) announced poster presentations at the 63rd ASH Annual Meeting, focusing on AFM28 and AFM13, two of its innovative innate cell engagers (ICE®). AFM28 targets CD123+ myeloid malignancies, showing promise for Acute Myeloid Leukemia treatment, while AFM13 maintains NK cell potency after cryopreservation. An investor event in mid-December will provide updates on AFM13's clinical development, currently under two trials for T-cell lymphoma and CD30-positive lymphomas. The first-in-human study for AFM28 is anticipated to begin in late 2022.
Affimed N.V. (Nasdaq: AFMD) announced it will release its third quarter 2021 results on November 10, 2021, followed by a conference call at 8:30 a.m. EST. The call will discuss financial results and recent corporate developments. Interested parties can join by dialing +1 (409) 220-9054 for U.S. callers or +44 (0) 8000 323836 for international participants. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to target and kill tumors using patients' innate immune cells. The call will be accessible via webcast and will be archived for 30 days.
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