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) presented promising preclinical data for its Innate Cell Engager (ICE®) AFM28 at the 64th ASH Annual Meeting, targeting CD123-positive leukemic cells in patients with Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS).
AFM28 effectively redirected NK cells to deplete leukemic stem cells, showing potential for deep anti-leukemic responses. The program has demonstrated strong anti-tumor activity while maintaining a favorable safety profile. A first-in-human study is planned for the first half of 2023, highlighting AFM28 as a viable treatment option for refractory AML patients.
Affimed announced positive data from its phase 2 REDIRECT study on AFM13 monotherapy for relapsed/refractory peripheral T cell lymphoma (r/r PTCL). The treatment achieved an objective response rate (ORR) of 32.4% and a complete response rate (CR) of 10.2%. Key outcomes included a median duration of response of 2.3 months, median progression-free survival of 3.5 months, and median overall survival of 13.8 months. The company will now focus on investigating a combination therapy with NK cells, rather than seeking accelerated approval for monotherapy.
Affimed has reported promising results from its phase 1/2 study of AFM13 combined with cord blood-derived NK cells in patients with CD30-positive Hodgkin and Non-Hodgkin lymphomas. Among 31 Hodgkin lymphoma patients, an impressive objective response rate (ORR) of 97% and a complete response (CR) rate of 77% were observed. Notably, all participants had failed previous treatments. The study showed a favorable safety profile, with no significant adverse events reported. Affimed continues to explore the market potential for AFM13, aiming to address unmet needs in this patient population.
Affimed N.V. (Nasdaq: AFMD) announced an investor event to review clinical data and development plans for AFM13 in CD30 expressing malignancies. This event will take place on December 10, 2022, at 4:00 p.m. CST during the 64th American Society of Hematology Annual Meeting in New Orleans. AFM13 has shown promising efficacy in Hodgkin Lymphoma and T cell lymphoma, with high response rates in both monotherapy and combination trials. Affimed recently partnered with Artiva to further develop AFM13 with NK cell therapies. A webcast of the event will be available for those unable to attend.
Affimed reported Q3 2022 results highlighting a revenue increase to €14.9 million, up from €8.7 million year-over-year, primarily from collaborations with Genentech and Roivant. The company has entered a partnership with Artiva Biotherapeutics to advance AFM13 for CD30-positive lymphomas. AFM13's combination therapy maintains a 100% overall response rate in trials. Operating cash usage was €19 million, with cash reserves at €222.9 million expected to last through mid-2024. The net loss for Q3 was €16.5 million, or €0.11 per share, showing slight improvement from the previous year.
Affimed N.V. (Nasdaq: AFMD) has announced promising results from two phase 1/2a trials involving AFM24, a bispecific innate cell engager targeting EGFR in patients with solid tumors. Findings indicate that AFM24 activates NK cells and shows initial signs of clinical activity when combined with atezolizumab, an immune checkpoint inhibitor, without dose-limiting toxicities. The data will be presented during the Society for Immunotherapy of Cancer (SITC) conference on November 10 and 11, 2022, with further updates available on Affimed’s website.
Affimed N.V. (Nasdaq: AFMD) will release its third quarter 2022 results and corporate update on November 15, 2022, followed by a conference call at 8:30 a.m. EST / 14:30 CET. Investors can join via phone or through a webcast available on the company’s website. The call features the latest updates on Affimed’s immuno-oncology initiatives and its ROCK® platform designed to combat various cancers by utilizing the innate immune system. A replay will be accessible for 30 days post-call.
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.
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