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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, has announced its participation in the Cantor Global Healthcare Conference 2024. CEO Shawn M. Leland will engage in a fireside chat on September 17, 2024, at 8:00 a.m. EDT / 14:00 CET.
A live webcast of the presentation will be available on Affimed's website, with a 30-day replay option. Investors interested in one-on-one meetings with Affimed's management can contact their Cantor Fitzgerald representative or reach out to Alex Fudukidis at a.fudukidis@affimed.com or +1 (917) 436-8102.
This event provides an opportunity for Affimed to showcase its progress in developing therapies that harness patients' innate ability to fight cancer.
Affimed N.V. (Nasdaq: AFMD) reported Q2 2024 financial results and provided clinical updates. Key highlights include:
1. AFM24 combination with atezolizumab: In EGFRmut NSCLC, 23.5% ORR and 70.6% DCR observed in 17 evaluable patients.
2. Acimtamig (AFM13) combination with AlloNK®: In r/r Hodgkin Lymphoma, 83.3% ORR and 50% CRR observed in 12 patients.
3. AFM28 monotherapy: In r/r AML, 50% CR/CRi rate observed in 6 patients at 300 mg dose.
4. Financial position: €34.4 million in cash and equivalents as of June 30, 2024, with runway into H2 2025.
5. Q2 2024 financials: €0.2 million revenue, €11.7 million R&D expenses, €4.0 million G&A expenses, and €15.5 million net loss.
Affimed N.V. (Nasdaq: AFMD) has appointed Shawn M. Leland as its new Chief Executive Officer. Leland brings over 15 years of experience in the pharmaceutical and biotechnology industry, with a strong track record in advancing oncology assets, raising capital, and establishing strategic partnerships. He previously served as Interim CEO of ForeBio and founded Elevation Oncology, where he raised over $200M in capital. Dr. Andreas Harstrick, who has been acting CEO since January 2024, will continue as Chief Medical Officer.
Leland's appointment comes as Affimed focuses on its three active clinical programs, with important data readouts expected in the near future. The company's strategy centers on harnessing the innate immune system to fight cancer, and Leland's expertise is expected to drive Affimed's growth and shape its corporate development strategy.
Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, has announced that it will release its second quarter 2024 financial results and corporate update on September 5, 2024. The company will host a conference call at 8:30 a.m. EDT / 14:30 CET on the same day. Investors and interested parties can access the live audio webcast of the call through the 'Webcasts' section on Affimed's website. For those who prefer to join by phone, a registration link is provided to obtain dial-in details and a pin number. To ensure a timely start, participants are encouraged to dial in 15 minutes before the scheduled time. A replay of the webcast will be available for 30 days following the call.
Affimed reported its Q1 2024 financial results, revealing a significant decline in revenue to €0.2 million from €4.5 million in Q1 2023, due to decreased collaboration payments. However, operating expenses also decreased, with R&D expenses down to €15.4 million from €29.5 million and general administrative expenses down to €4.5 million from €6.9 million. Net loss improved to €19.2 million from €32 million in Q1 2023.
Clinical updates include promising results from the LuminICE-203 study, showing an 85.7% ORR in Hodgkin Lymphoma patients and 33% CR/CRi rate in the AFM28 monotherapy study. AFM24-a combination with atezolizumab in NSCLC patients showed a 71% disease control rate and a 5.9-month mPFS.
Financially, Affimed has a cash runway into H2 2025 with €48.5 million in cash and equivalents as of March 31, 2024.
Affimed (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced it will release its first quarter 2024 financial results and provide a corporate update on June 12, 2024. The company will host a conference call at 8:30 a.m. EDT / 14:30 CET, accessible via phone and webcast. The live audio webcast will be available on the 'Investors' page of the Affimed website, and a replay will be accessible for 30 days.
Affimed has announced promising follow-up data for its AFM24 and atezolizumab combination therapy in heavily pretreated non-small cell lung cancer (NSCLC) patients. In the EGFR wild-type (EGFRwt) cohort, 4 out of 15 response-evaluable patients showed objective responses, with a median progression-free survival (PFS) of 5.9 months. Additionally, 8 patients achieved stable disease, resulting in a disease control rate of 71%. In the EGFR mutant (EGFRmut) cohort, 4 out of 13 response-evaluable patients also showed objective responses, with all responses ongoing. The combination therapy demonstrated a manageable safety profile, with mild to moderate side effects. The company is hosting a conference call to discuss these findings further. Recruitment for both cohorts is ongoing, with updates expected in the second half of 2024.
Affimed has received FDA Fast Track designation for its combination therapy of AFM24 with atezolizumab for advanced and metastatic EGFR wild-type non-small cell lung cancer (NSCLC). This designation is based on initial efficacy data from the ongoing AFM24-102 phase 1/2a study, which evaluates this combination in patients who have progressed after PD-(L)1 therapy and platinum-based chemotherapy. Fast Track status is intended to expedite the development of drugs that address serious conditions with unmet medical needs. Affimed will present updated data from the AFM24-102 study at the American Society of Clinical Oncology meeting on June 1, 2024.
Affimed, a clinical-stage immuno-oncology company, announced its 2024 Annual General Meeting of Shareholders. The meeting will take place on June 26, 2024, at 09:00 a.m. CET at De Brauw Blackstone Westbroek N.V. in Amsterdam, Netherlands. Key documents, including the notice and agenda of the Annual Meeting, can be found on Affimed's investor section on its website and the SEC's website.
Affimed has announced promising early results from its AFM24-102 study involving 15 evaluable patients with metastatic EGFR wild-type non-small cell lung cancer (NSCLC). These patients, pretreated with platinum doublet chemotherapy and checkpoint inhibitors, received a combination of AFM24 and atezolizumab, resulting in a disease control rate (DCR) of 73.3%. This included one complete response and three partial responses, with a median progression-free survival of 5.9 months. The study's data cut-off was March 18, 2024. These findings will be presented at the ASCO annual meeting on June 1, 2024. Affimed will also host a conference call/webcast the same day to discuss these results and other clinical data.
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