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) has announced the acceptance of two abstracts showcasing new data on their innate cell engager (ICE®) AFM24 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, scheduled for November 8-12, 2022. The first poster will detail findings from a phase 1 study of AFM24 monotherapy, while the second will present initial results from a phase 1 dose escalation study of AFM24 in combination with Roche’s atezolizumab. AFM24 targets EGFR-expressing solid tumors and is part of Affimed's innovative cancer treatment approach.
Affimed N.V. (Nasdaq: AFMD) announced the phase 1 data on its innate cell engager AFM24 at the ESMO Congress. The recommended phase 2 dose (RP2D) was set at 480 mg, with ongoing enrollment in specific disease cohorts. The trial observed stable disease in 10 of 27 evaluable patients, with some patients maintaining stable disease for over four months. The treatment was well tolerated, with no on-study deaths and no maximum tolerated dose reached. AFM24 activates both the innate and adaptive immune systems, marking a significant milestone for its development.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced its participation in several investor conferences in September 2022. Key events include:
- Wells Fargo Healthcare Conference on September 7, 2022, at 3:10 p.m. EDT in Boston, MA, with a webcast available.
- Citi’s Annual BioPharma Virtual Conference on September 8, 2022, for one-on-one meetings in Boston, MA.
- Morgan Stanley’s Global Healthcare Conference on September 13, 2022, for one-on-one meetings in New York, NY.
- Jefferies Cell and Genetic Medicine Summit on September 29, 2022, for one-on-one meetings in New York, NY.
Affimed (AFMD) reported second quarter 2022 financial results, revealing a net loss of €19.4 million, or €0.13 per share, compared to a loss of €18.8 million, or €0.16 per share, in Q2 2021. Cash and cash equivalents stood at €237.2 million as of June 30, 2022, with a runway into mid-2024. The company is on track to release data from its AFM13 monotherapy REDIRECT trial and ongoing studies for AFM24 and AFM28. Research and development expenses decreased by 4% year-over-year, while general administrative expenses surged by 54%. A conference call to discuss results is scheduled for August 11, 2022.
Affimed N.V. (Nasdaq: AFMD) will release its second quarter 2022 financial results and corporate updates on August 11, 2022. The presentation will be followed by a conference call at 8:30 a.m. EDT, accessible via phone or webcast. Affimed focuses on harnessing the innate immune system to fight cancer, featuring its proprietary ROCK® platform which creates innovative innate cell engager (ICE®) molecules. This approach positions Affimed as a pioneer in clinical-stage ICE® development.
Affimed N.V. (Nasdaq: AFMD) has established a Scientific Advisory Board (SAB) composed of leading experts in immuno-oncology to guide its innate cell engagers (ICE®) programs. This advisory board includes renowned figures such as Stephen M. Ansell and Todd A. Fehniger, who will provide insights into cancer therapies. The SAB aims to enhance Affimed's development strategy and evaluate emerging technologies. Chief Scientific Officer Dr. Arndt Schottelius emphasized the board's vital expertise in advancing their promising pipeline of therapies designed to leverage the innate immune system against cancer.
Affimed N.V. (Nasdaq: AFMD) showcased promising preclinical data for its bispecific innate cell engager, AFM28, targeting CD123 in treating relapsed/refractory acute myeloid leukemia (AML) at the EHA Annual Meeting. AFM28 demonstrated potent anti-tumor activity against CD123-positive cells, even at low expression levels, while sparing healthy cells. In vivo studies indicated strong anti-tumor efficacy and a favorable safety profile. A first-in-human phase 1 clinical trial is set to commence in the second half of 2022, aiming to assess AFM28’s safety and efficacy as a monotherapy and in combination with NK cell therapies.
Affimed N.V. (Nasdaq: AFMD) reported its first quarter 2022 financial results and clinical updates. The REDIRECT study for AFM13 monotherapy completed enrollment, with topline data expected in Q4 2022. At AACR 2022, AFM13 showed a 100% objective response rate and a rise in complete responses. The cash position is strong, with €257.5 million expected to support operations into mid-2024. However, net loss for Q1 2022 was €16.7 million, down from a profit a year ago, while R&D expenses surged by 61% to €18.4 million, indicating increased investment in their product pipeline.
Affimed (Nasdaq: AFMD) announced three clinical trial designs for its AFM24 innate cell engager (ICE®), showcased at the ASCO Annual Meeting from June 3-7, 2022. The trials include AFM24 monotherapy and combinations with atezolizumab and SNK01 autologous NK cells, targeting advanced EGFR-expressing solid tumors. AFM24 aims to activate the innate immune system, showing a well-managed safety profile and established recommended phase 2 dose (RP2D) of 480 mg. These innovative approaches represent potential advancements in treatment for patients resistant to current therapies.
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.
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