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 pricing of a public offering of 16,666,667 common shares at $6.00 per share, aiming to raise approximately $94 million after underwriting discounts. The offering includes a 30-day over-allotment option for underwriters to purchase an additional 2,500,000 shares. The proceeds are expected to support the company's clinical-stage immuno-oncology initiatives. The offering is scheduled to close around January 15, 2021, subject to standard conditions.
Affimed N.V. (Nasdaq: AFMD) announced the commencement of an underwritten public offering of common shares on January 12, 2021. The offering is expected to include a 30-day over-allotment option for underwriters to purchase an additional 15% of shares sold. Jefferies, SVB Leerink, and Credit Suisse are serving as joint book-running managers. The offering is contingent on market conditions, and there is uncertainty surrounding its completion or specific terms.
Heidelberg, Germany, January 11, 2021 – Affimed N.V. (Nasdaq: AFMD) announced that CEO Dr. Adi Hoess will present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 7:30 a.m. EST. A live webcast of the presentation will be available on Affimed’s website for 30 days post-event. Affimed focuses on immuno-oncology, developing therapies like AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and AFM24 for advanced EGFR-expressing solid tumors. For details, visit Affimed’s investor site.
Affimed N.V. (Nasdaq: AFMD) announced a debt financing agreement with Silicon Valley Bank, offering up to €25 million in term loans. The structure includes €10 million available at closing, and two additional tranches of €7.5 million, contingent on specific milestones. Interest is set at a minimum of 5.5%, with the loan maturing in November 2025. Proceeds will support research and development of Affimed's ICE® molecules and general working capital.
Affimed N.V. (Nasdaq: AFMD) reported progress in its clinical studies for AFM13 and AFM24 as the company aims to advance its immuno-oncology pipeline. CEO Adi Hoess highlighted a robust cash position of approximately €147 million, enabling operations into H1 2023. Key updates include the AFM13-202 trial for CD30-positive T-cell lymphoma, which is ahead of schedule, and the AFM24-101 trial, now in the fourth dose cohort. The company anticipates regulatory submissions and continued clinical development, positioning it well for future growth and innovation.
Affimed N.V. (Nasdaq: AFMD) announced promising results for its AFM13 bispecific Innate Cell Engager, achieving a 42% Objective Response Rate (ORR) in heavily pretreated patients with relapsed or refractory CD30-positive lymphoma. The data presented at the 62nd American Society of Hematology Meeting highlighted that AFM13 was well tolerated, with evidence of NK cell activity and recruitment in patients. This development is significant given the high therapeutic need in this patient population, especially after brentuximab vedotin failure.
Affimed N.V. (Nasdaq: AFMD) announced promising results from its Phase 1b study of AFM13 in combination with KEYTRUDA for relapsed/refractory Hodgkin lymphoma. The study showed a complete response (CR) rate of 46% and an objective response rate (ORR) of 88% at the recommended dose, significantly outperforming KEYTRUDA alone, which had a CR of 22.4% and an ORR of 69%. The treatment was reported as well-tolerated with manageable adverse effects. Results suggest AFM13 could enhance current therapies.
Affimed announced a partnership with Roivant Sciences, receiving $60 million upfront and potential future milestones worth up to $2 billion.
The company ended Q3 2020 with €97.3 million in cash and equivalents, projecting runway into H1 2023.
Total revenue for Q3 was €10.5 million, a significant increase from €2.1 million year-over-year, driven by the Genentech collaboration.
Net loss decreased to €6 million, or €0.07 per share, from €10.9 million, or €0.17 per share, in Q3 2019.
Affimed N.V. (Nasdaq: AFMD) has announced a licensing agreement with Roivant Sciences to develop and commercialize novel ICE® molecules in oncology, significantly broadening its pipeline. The agreement includes a $60 million upfront payment, consisting of $40 million in cash and $20 million in newly issued shares. Affimed is eligible for up to $2 billion in future milestone payments based on the achievement of specific development and regulatory goals. This collaboration will enhance the potential of Affimed's ROCK® platform in targeting cancer therapies.
Affimed N.V. (Nasdaq: AFMD) announced a virtual presentation of preclinical data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 11, 2020. The data, focusing on the use of ICE® AFM13 in combination with various natural killer (NK) cells to target CD30-positive malignancies, showed promising results. AFM13-preloaded NK cells exhibited enhanced efficacy against tumor cells, suggesting a potential for novel immunotherapy approaches. This data supports a Phase 1 clinical evaluation currently underway.
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