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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), a clinical-stage immuno-oncology company, announced that CEO Dr. Adi Hoess will present at the 2022 Jefferies Healthcare Conference on June 8, 2022, at 1:00 PM EDT. The presentation will focus on Affimed's commitment to empowering the innate immune system to fight cancer. A live webcast will be available on Affimed's website, with a replay accessible for 30 days post-event. For inquiries about the conference or to schedule meetings, interested parties can contact Jefferies or reach out to Alex Fudukidis.
Affimed N.V. (Nasdaq: AFMD) announced that its 2022 Annual General Meeting of Shareholders will take place on June 22, 2022, at 09:00 a.m. CET in Amsterdam. The meeting aims to discuss company performance and future strategies. Shareholders can access the notice and agenda on Affimed's website or through the SEC's site. Affimed focuses on immuno-oncology, leveraging its proprietary ROCK® platform to develop innovative therapies targeting various cancers. The company is committed to enhancing patients' innate ability to combat cancer.
Affimed N.V. (Nasdaq: AFMD) announced it will release its Q1 2022 financial results and provide a corporate update on June 1, 2022. A conference call will take place at 8:30 a.m. EDT, available via phone and webcast. The call can be accessed by dialing +1 (409) 220-9054 for U.S. participants and +44 (0) 8000 323836 for international callers, using conference ID 4440407. Affimed focuses on immuno-oncology and utilizes its proprietary ROCK® platform to develop innovative cancer therapies.
Affimed N.V. (Nasdaq: AFMD) presented new data on AFM24 and AFM28 at the NK2022 conference, highlighting their potential in cancer treatment. The AFM24 data showed its efficacy as a CD16A/EGFR-targeting bispecific innate cell engager, stimulating anti-cancer immunity in patients with EGFR-expressing tumors. Meanwhile, AFM28 demonstrated anti-leukemic effects when combined with NK cells, suggesting it could offer an off-the-shelf therapy for AML and MDS patients. Both compounds are currently undergoing phase 1/2a clinical studies.
Affimed N.V. (Nasdaq: AFMD) announced the upcoming first-in-human phase 1 study of its bispecific innate cell engager AFM28, targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). This innovative therapy showed promising results in preclinical studies, effectively destroying CD123-positive tumor cells while sparing healthy cells. Toxicology models indicated low risks of side effects such as cytokine release syndrome. The study is set to begin in the second half of 2022, with a poster presentation scheduled at the EHA Annual Meeting in June 2022.
Affimed N.V. (Nasdaq: AFMD) announced that the American Society of Clinical Oncology (ASCO) has removed the oral presentation of the AFM13-104 trial from its conference program. This decision was due to ASCO's embargo policy, following the recent data presentation at the AACR Annual Meeting on April 10, 2022. Affimed clarified that this removal is unrelated to the ongoing trial's status or results. The company is collaborating with The University of Texas MD Anderson Cancer Center to submit additional data on AFM13-104 to a future scientific forum.
Affimed N.V. (Nasdaq: AFMD) announced acceptance of four abstracts for the American Society of Clinical Oncology (ASCO) Annual Meeting, occurring June 3-7, 2022, in Chicago.
The presentations will cover phase 1/2 studies of AFM13 and AFM24, targeting CD30-positive lymphomas and advanced EGFR-expressing solid tumors, respectively. Notably, an oral presentation will detail AFM13 combined with NK cells in CD30-positive lymphoma patients, while three posters will outline the AFM24 studies involving monotherapy and combinations with other treatments.
Affimed N.V. (Nasdaq: AFMD) announced the successful closure of its public offering of 22,500,000 common shares at $4.00 per share. The underwriters exercised their option for an additional 3,375,000 shares, raising total gross proceeds to $103.5 million. The offering was facilitated by Jefferies LLC, SVB Leerink, Truist Securities, and Wells Fargo Securities, among others. Effective from April 6, 2022, the shelf registration statement allows the company to issue these securities. Funds raised will support Affimed's immuno-oncology initiatives.
Affimed N.V. (Nasdaq: AFMD) announced a public offering of 22,500,000 common shares priced at $4.00 each, with a potential additional 3,375,000 shares from underwriters. The offering is expected to generate approximately $84.6 million after discounts and is projected to close around April 18, 2022. This funding is aimed at supporting the company's clinical-stage immuno-oncology research and initiatives. Jefferies LLC and other firms are managing the offering, which will be conducted through a prospectus filed with the SEC.
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