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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 its Q2 2020 financial results, reporting revenue of €2.9 million, down from €4.0 million in Q2 2019. The company has €92.6 million in cash, projected to support operations into H1 2022. The AFM13 study has activated 54 sites across 10 countries, with interim analysis expected mid-2021. Additionally, AFM24 is advancing in Phase 1/2a trials, and the collaboration with Genentech has achieved a milestone triggering a payment. Despite a net loss of €12.2 million, the management team is optimistic about ongoing projects and future developments.
Affimed N.V. (Nasdaq: AFMD) has appointed Dr. Annalisa Jenkins and Mr. Harry Welten to its Supervisory Board, effective from August 4, 2020. Dr. Jenkins brings over 25 years of pharmaceutical experience, having held leadership roles at companies like Merck Serono and Bristol-Myers Squibb, while Mr. Welten offers extensive financial and U.S. market expertise from his roles in various biotech firms. These appointments aim to enhance corporate governance and strengthen the company's strategic positioning in the biotech industry.
Affimed N.V. (Nasdaq: AFMD) will hold its Annual General Meeting of Shareholders on August 4, 2020, at the Sheraton Amsterdam Airport Hotel, starting at 11:00 a.m. CET. The meeting's notice and agenda can be found on Affimed’s Investor Relations page and the SEC website. The company is focused on developing therapies for cancer, using its ROCK® platform for patient-specific treatments. Current studies include AFM13 for CD30-positive peripheral T cell lymphoma and AFM24 for advanced EGFR-expressing solid tumors.
Affimed N.V. (Nasdaq: AFMD) announced progress in its clinical trials, completing the first dose cohort of its Phase 1/2A study for AFM24, with recruitment for cohort 2 now open. Financial results for Q1 2020 showed total revenue of €5.1 million, down from €11.4 million year-over-year, and a net loss of €8.3 million. Cash and equivalents stood at €88.2 million as of March 31, 2020, with expectations to fund operations into the first half of 2022. Key management appointments completed with Angus Smith as CFO, enhancing the leadership team.
Affimed N.V. (Nasdaq: AFMD) showcased promising data on its Innate Cell Engagers (ICE) at the AACR Virtual Annual Meeting II. The research highlighted the effectiveness of AFM24 and Genentech’s RO7297089 in preclinical models, targeting tumor cells with low expression. Both agents demonstrated significant tumor cell killing via dual mechanisms, activating innate immune systems while maintaining favorable safety profiles in cynomolgus monkeys. AFM24 is currently progressing into further clinical studies, suggesting potential for broader application in treating EGFR-positive tumors.
Affimed has announced the successful completion of the first dose cohort in a Phase 1/2a clinical trial for AFM24, a novel bispecific innate cell engager targeting EGFR-expressing malignancies. No dose-limiting toxicities were observed, allowing progression to the second dose cohort. While efficacy was not expected at this stage, the trial aims to gather data on the safety and potential effectiveness of AFM24 as a treatment option. The company emphasizes that AFM24 could provide a new mechanism of action that utilizes innate immunity to combat cancer.
Heidelberg, Germany, June 16, 2020 – Affimed N.V. (Nasdaq: AFMD) will release its first quarter 2020 financial results on June 23, 2020, at 8:30 a.m. EDT, followed by a conference call. Investors can join via phone or webcast, with details provided in the PR. Additionally, CEO Dr. Adi Hoess will participate in a fireside chat at the BMO Healthcare Conference on the same day at 1:30 p.m. EDT. Affimed focuses on immuno-oncology, developing therapies for various cancers, including studies for AFM13 and AFM24.
Affimed N.V. (Nasdaq: AFMD) announced the appointment of Angus Smith as the new Chief Financial Officer, effective July 13, 2020. This appointment completes the company's leadership team. Smith brings extensive biopharmaceutical experience, having previously served as CFO at Rockwell Medical. His expertise in financial management and US capital markets is expected to enhance Affimed's strategic position during its upcoming growth phase. The company develops innovative cancer treatments using its ROCK® platform and is advancing clinical studies for therapies targeting hematologic and solid tumors.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, will have its CEO, Dr. Adi Hoess, present at the Jefferies Virtual Healthcare Conference on June 3, 2020, at 8:00 a.m. Eastern Time. The presentation will be available via a live webcast on Affimed’s website and accessible for 30 days post-event. Affimed focuses on innovative therapies to empower patients against cancer, currently developing AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma, and AFM24 for advanced EGFR-expressing solid tumors. For further details, visit www.affimed.com.
Affimed N.V. (Nasdaq: AFMD) announced participation in the AACR Virtual Annual Meeting II on June 22-24, 2020, with two studies on innate cell engagers from its ROCK® platform. Researchers from Affimed will present data on AFM24, a bispecific EGFR/CD16A Innate Cell Engager, and RO7297089, an anti-BCMA/CD16a antibody for multiple myeloma. A live teleconference will be held on May 15, 2020, at 8 am Eastern to discuss the abstracts and updates. Affimed continues to advance its clinical programs targeting cancer treatment.
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