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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 (Nasdaq: AFMD) announced the acceptance of three abstracts for poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), scheduled for November 10-14, 2021. The abstracts showcase preclinical data on their innate cell engagers (ICE®), highlighting the potential of AFM24 in enhancing tumor cell phagocytosis and improving NK cell response. Full details of the abstracts will be available on November 9, 2021.
Affimed N.V. (Nasdaq: AFMD) reported its Q2 2021 financial results, highlighting a significant revenue increase to €9.7 million, up from €2.9 million in Q2 2020, thanks to collaborations with Genentech and Roivant. As of June 30, cash reserves stood at €222.7 million, expected to fund operations into the second half of 2023. The company is making steady progress in its clinical trials for AFM13 and AFM24, with enrollment for various studies on track and promising safety data reported. However, net loss widened to €18.8 million, indicating continued investment in R&D.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology firm, announced its participation in several investor conferences in September 2021. Notable events include the Citi’s 16th Annual BioPharma Virtual Conference on September 8, offering one-on-one meetings, and the 2021 Wells Fargo Virtual Healthcare Conference on September 9, featuring a presentation at 8:00 a.m. Eastern Time. Additional meetings will take place at the Morgan Stanley Global Healthcare Conference and Cantor Fitzgerald Virtual Global Healthcare Conference. For inquiries or to schedule meetings, contact Alex Fudukidis.
Affimed N.V. (Nasdaq: AFMD) will release its second quarter 2021 financial results on September 8, 2021, followed by a conference call at 8:30 a.m. EDT. The call aims to discuss the financial results and recent corporate developments. Interested parties can access the call via phone or webcast, with details provided for both U.S. and international callers. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to develop targeted treatments against various tumors. A replay of the call will be available for 30 days post-event.
Affimed N.V. (Nasdaq: AFMD) announces significant findings regarding its innate cell engager, AFM24, targeting EGFR-expressing tumors. Preclinical data highlight AFM24’s ability to engage the innate immune system effectively, emphasizing its unique mechanism that operates independently of EGFR mutations. Notably, toxicity studies in cynomolgus monkeys revealed a favorable safety profile at doses up to 75 mg/kg. These results bolster AFM24's potential in the ongoing Phase 1/2a study for patients with advanced solid tumors, reflecting promising advancements in immuno-oncology.
Affimed N.V. (Nasdaq: AFMD) reported strong financial results for Q1 2021, with total revenue reaching €11.7 million, up from €5.1 million year-over-year. The company's cash and cash equivalents stood at €240.7 million, ensuring operations through the second half of 2023. Key clinical updates include positive interim results for AFM13 in PTCL and a 100% response rate in a combination therapy trial with NK cells. Comprehensive plans for upcoming trials of AFM24 and AFM28 show promise for further development. A conference call is scheduled for July 1, 2021, to discuss these results.
Affimed N.V. (Nasdaq: AFMD) will release its first-quarter 2021 financial results on July 1, 2021. A conference call will occur at 8:30 a.m. EDT to discuss these results and recent corporate developments. Stakeholders can access the call via phone or live audio webcast. Additionally, the company's innovative ROCK® platform aims to enhance cancer treatment through the innate immune system, positioning Affimed as a leader in immuno-oncology with a clinical-stage ICE®. Further information is available on their website.
Affimed N.V. (Nasdaq: AFMD) announced the appointment of Ms. Uta Kemmerich-Keil to its Supervisory Board, effective immediately from June 15, 2021. Approved during the Annual General Meeting, her extensive experience in the life sciences sector, particularly in leading global pharmaceutical companies, positions her to provide significant guidance in advancing Affimed's immuno-oncology pipeline. Kemmerich-Keil previously held senior roles at companies like P&G and Merck KGaA, bringing valuable financial and strategic expertise to Affimed’s growth strategy.
Affimed N.V. (Nasdaq: AFMD) announced that its CEO, Dr. Adi Hoess, will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 8:30 a.m. Eastern Time.
A live webcast can be accessed on Affimed’s website, with an archived replay available for 30 days post-event.
Affimed is focused on immuno-oncology and utilizes its proprietary ROCK® platform to harness the innate immune system in cancer treatment, developing innovative therapies to target various tumors.
Affimed N.V. (Nasdaq: AFMD) announced that its 2021 Annual General Meeting (AGM) will take place on June 15, 2021, at 17:30 PM CET (11:30 AM EDT). In light of the ongoing COVID-19 pandemic, the meeting will be held virtually to ensure the safety of shareholders. Interested parties can access the meeting via the designated link. The notice and agenda for the meeting are accessible on the company’s website and the SEC’s website.