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 that their abstract focusing on AFM24 dose optimization has been accepted for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025).
The presentation will detail dose optimization using exposure response analysis for AFM24, both as monotherapy and in combination with atezolizumab, in patients with advanced/metastatic non-small cell lung cancer. The poster presentation is scheduled for Tuesday, April 29, 2025, from 9:00 AM to 12:00 PM CDT in Poster Section 49.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference 2025. The company's CEO, Dr. Shawn Leland, will engage in a fireside chat on Tuesday, March 11, 2025, at 2:20 p.m. EDT.
Investors and interested parties can access a live webcast of the presentation through Affimed's website investor section. The presentation recording will remain available for 30 days following the event. For those interested in one-on-one meetings with Affimed's management team, arrangements can be made through Leerink Partners representatives or by contacting Alex Fudukidis.
Affimed (AFMD) reported positive clinical data from the AFM24-102 trial combining AFM24 with atezolizumab in non-small cell lung cancer (NSCLC) patients. In 33 EGFR wild-type patients, the combination showed a 21% overall response rate and 76% disease control rate, with tumor shrinkage in 48% of patients. The median progression-free survival was 5.6 months.
In 17 EGFR mutant patients, results showed a 24% overall response rate and 71% disease control rate, with tumor shrinkage in 41% of patients. Both patient groups demonstrated manageable side effects. A post-hoc analysis revealed that patients with higher AFM24 exposure had significantly better outcomes, leading to plans for using a higher 720mg weekly dose in future development.
Affimed announced promising Phase 1 data for AFM28 in treating relapsed/refractory Acute Myeloid Leukemia (R/R AML). The study, involving 29 heavily pretreated patients, demonstrated a 40% composite complete remission rate at the highest dose level (300 mg). Key findings include:
- Well-managed safety profile with mainly Grade 1 and 2 infusion-related reactions in 45% of patients
- No neurotoxicity or immune-related side effects
- One complete remission at 250 mg dose level with 6.5-month treatment duration
- At 300 mg dose level, achieved 1 CR and 3 CRi in 10 evaluable patients
The study included patients with a median of two prior treatment lines, with 86% having adverse risk profiles. Based on these results, evaluation of higher dose levels is planned.
Affimed N.V. (Nasdaq: AFMD) announced it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST / 14:30 CET to review clinical data from AFM24-102, a combination trial of its AFM24 innate cell engager ICE® with atezolizumab in non-small cell lung cancer. The call will be accessible via phone and webcast through the company's website, with dial-in details provided upon registration. A replay will be available for 30 days following the call.
Affimed (NASDAQ: AFMD) announced positive results from the LuminICE-203 phase 2 study, evaluating the combination of acimtamig with AlloNK® in relapsed/refractory classical Hodgkin Lymphoma patients. The trial included 22 heavily pretreated patients who had received a median of 5 prior therapies.
The combination demonstrated an overall response rate of 86% and a complete response rate of 55%. The treatment showed a well-manageable safety profile with no unexpected safety signals, and notably, no cases of graft-versus-host disease or immune effector cell-associated neurotoxicity syndrome were reported.
All patients had previously received intensive combination chemotherapy, PD(L)1 checkpoint inhibitors, and brentuximab vedotin, with approximately two-thirds having undergone stem cell transplant.
Affimed (NASDAQ: AFMD) announces FDA's RMAT designation for its combination therapy of acimtamig and AlloNK® for treating relapsed/refractory Hodgkin Lymphoma (R/R HL). The designation was granted based on impressive early efficacy data showing an 83.3% overall response rate and 50% complete response rate in 12 patients, with a well-managed safety profile.
The RMAT designation provides expedited review benefits similar to Breakthrough Therapy Designation, potentially accelerating the therapy's path to market. The combination therapy is currently being evaluated in the LuminICE-203 phase 2 trial, with complete data from all four cohorts to be presented at the 66th ASH Annual Meeting. The company also sees potential application in CD30 positive lymphomas, including peripheral T-cell lymphoma (PTCL).
Affimed N.V. (AFMD) reported Q3 2024 financial results and clinical updates. The company completed enrollment for its AFM24-atezolizumab combination NSCLC EGFRwt cohort, with data presentation scheduled for December 17, 2024. Cash position was €24.1 million as of September 30, 2024, with runway projected into Q4 2025. Q3 revenue decreased to €0.2 million from €2.0 million year-over-year. Net loss improved to €15.1 million (€0.94 per share) compared to €24.4 million (€1.63 per share) in Q3 2023. R&D expenses decreased to €10.1 million from €21.5 million, while G&A expenses reduced to €4.3 million from €5.4 million.
Affimed N.V. (Nasdaq: AFMD) announced it will release its third quarter 2024 financial results and corporate update on Thursday, November 14, 2024. The clinical-stage immuno-oncology company will host a conference call at 8:30 a.m. EST / 14:30 CET. Investors can access the live audio webcast through the company's website and participate in the call via phone by registering through the provided link. A replay will be available for 30 days following the call.
Affimed announced the acceptance of three abstracts for presentation at the 66th ASH Annual Meeting in December 2024. The presentations include clinical results from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML), featuring promising efficacy and safety data. Additionally, preclinical data will showcase AFM28's in vitro efficacy combined with NK cells against leukemic blasts. The company will also present updated clinical results from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK® for relapsed/refractory Hodgkin Lymphoma.
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