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 the dosing of the first patient in a phase 1 clinical trial for its innate cell engager (ICE®) AFM28, targeting CD123-positive relapsed/refractory acute myeloid leukemia (AML). This study aims to evaluate the safety, tolerability, and pharmacokinetics of AFM28, which directs natural killer (NK) cells to attack leukemic cells. With AFM28's entry into clinical trials, Affimed expands its pipeline of innovative therapies in hematological cancers, promising new treatment options for patients in dire need. The company anticipates multiple data readouts in 2023.
Affimed N.V. (Nasdaq: AFMD) reported its 2022 financial results and provided updates on its clinical pipeline as of March 23, 2023. The company is on track to file an IND for AFM13 in combination with AB-101 NK cells in H1 2023 and to initiate a clinical study within the year. It highlighted a strong cash position of €190.3 million, anticipated to last into 2025, and an increase in total revenue to €41.4 million, compared to €40.4 million in 2021. However, net loss widened to €86.0 million, reflecting increased R&D and administrative expenses. The company showcased promising AFM13 and AFM24 data at scientific conferences and continues recruiting for AFM28.
Affimed N.V. (Nasdaq: AFMD) announced that it will release its full year 2022 results and a corporate update on March 23, 2023. The release will be followed by a conference call at 8:30 a.m. EDT / 13:30 CET for shareholders and stakeholders.
The call will be accessible via phone and webcast, with a replay available for 30 days following the event. Affimed specializes in immuno-oncology, focusing on harnessing the innate immune system to combat cancer through its proprietary ROCK® platform, which facilitates the development of innovative therapies targeting various tumors.
Affimed N.V. (Nasdaq: AFMD) announced two accepted abstracts for presentation at the AACR Annual Meeting 2023, showcasing the efficacy of AFM13 in treating CD30-positive relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The oral presentation will detail results from the phase 2 REDIRECT study, demonstrating an objective response rate (ORR) of 32.4% with a duration of response (DOR) of 2.3 months. Additionally, a poster will discuss research on CD16A shedding's role in enhancing natural killer (NK) cell functionality against tumors. Both presentations highlight AFM13's promise in the immuno-oncology field.
AbCheck s.r.o., based in the Czech Republic, has successfully completed its research grant project on antibody isolation technology, receiving over €1 million from the Ministry of Industry and Trade since 2019. As of December 31, 2022, the company not only fulfilled its project objectives but also advanced its novel microfluidics technology, developing additional functional assays in rabbit, chicken, and mouse models. This technology enables faster identification of functional antibodies compared to traditional methods. AbCheck is now applying this technology in commercial projects targeting neurological disorders, inflammatory diseases, and oncology.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced CEO Dr. Adi Hoess will participate in a fireside chat at the H.C. Wainwright Cell Therapy Conference on February 28, 2023, at 8:30 a.m. EST / 14:30 CET. The webcast will be available on Affimed’s website, with a replay accessible for 30 days post-event.
Affimed focuses on leveraging the innate immune system to fight cancer through its ROCK® platform, generating Innate Cell Engager (ICE®) molecules that target tumors. The company is headquartered in Heidelberg, Germany, with a mission to empower patients in their cancer battle.
AbCheck s.r.o. has announced a collaboration with a biotech company focused on developing antibodies for peripheral neural response, backed by a European Venture Capital firm. This agreement entails utilizing AbCheck's advanced antibody discovery technologies to create antibodies targeting a challenging undisclosed profile. The company's microfluidics technology facilitates functional screening of millions of cells daily, enhancing drug discovery success rates. Dr. Volker Lang highlighted their commitment to delivering promising candidates for clinical development, aiming to provide novel treatment options for severe neurological disorders.
Affimed N.V. (Nasdaq: AFMD) announced that Dr. Adi Hoess, the CEO, will present at the SVB Securities 2023 Global Biopharma Conference on February 14, 2023, at 2:20 p.m. EST / 20:20 CET. The presentation will be available via a live webcast on Affimed's website, with a replay accessible for 30 days post-event. Affimed is focused on immuno-oncology, utilizing its proprietary ROCK® platform to develop innovative treatments targeting hematologic and solid tumors. The company aims to empower patients' innate immune responses against cancer, making strides in personalized cancer therapy.
Affimed N.V. (Nasdaq: AFMD) announced progress in its immuno-oncology pipeline, including support from the FDA for an IND filing of AFM13 combined with Artiva’s AB-101 for r/r Hodgkin lymphoma, planned for H1 2023. The AFM24 studies will present data updates in Q2/Q3 2023, while phase 1 study initiation for AFM28 is expected in Q2 2023, following CTA clearance in France and Spain. As of Dec 31, 2022, the company reported cash and equivalents of approximately €190 million, anticipated to fund operations into 2025.
Affimed N.V. (Nasdaq: AFMD) has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) for a clinical trial application (CTA) for its AFM28 in a phase 1 study targeting relapsed/refractory acute myeloid leukemia (AML). The trial, set to initiate in the first half of 2023, aims to investigate the safety and tolerability of AFM28, a bispecific Innate Cell Engager. This marks a significant milestone in Affimed's strategy to provide viable treatment options for AML patients, addressing a critical need in oncology.
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