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Affimed N.V. (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company headquartered in Mannheim, Germany, with additional offices in New York, NY. Affimed is dedicated to leveraging the power of the innate immune system to develop innovative immuno-oncology therapies primarily aimed at treating various cancers. The company is at the forefront of developing its proprietary innate cell engagers (ICE®), which are designed to target and eliminate both hematologic and solid tumors.
At the core of Affimed's innovation is their ROCK® platform, a state-of-the-art technology that generates customized ICE® molecules. These molecules harness the natural power of immune cells, such as natural killer (NK) cells and T-cells, to target and destroy cancer cells. Affimed's lead products include AFM13 (acimtamig), AFM24, and AFM28, which are currently undergoing various stages of clinical trials.
AFM13, the company's flagship innate cell engager, shows promise in treating CD30-positive hematologic tumors. It has demonstrated significant clinical efficacy in heavily pretreated patients with refractory Hodgkin lymphoma, achieving high objective response rates (ORR) and complete response (CR) rates. AFM13 is being investigated in combination with NK cells in the LuminICE-203 study, with initial data expected in the first half of 2024.
AFM24 is another key candidate, targeting EGFR-expressing solid tumors. It is currently being tested in combination with atezolizumab, a checkpoint inhibitor, in the AFM24-102 Phase 1/2a study. Recent data showed a disease control rate of 73.3% in heavily pretreated patients with EGFR wild-type non-small cell lung cancer (NSCLC), including significant objective responses. The FDA has granted Fast Track designation for this combination therapy, highlighting its potential to meet unmet medical needs.
AFM28 targets CD123-positive acute myeloid leukemia (AML). Preclinical studies have shown that AFM28 can effectively reduce tumor growth and eliminate leukemic blasts and stem cells. The drug is currently in early clinical development, with future plans to test it in combination with allogeneic off-the-shelf NK cells.
Affimed is also committed to strategic collaborations and partnerships to advance its clinical programs. Notable collaborations include those with Artiva Biotherapeutics, The University of Texas MD Anderson Cancer Center, and Roche. These partnerships are aimed at enhancing the efficacy and safety profiles of Affimed's therapies and bringing innovative treatments to patients more quickly.
Despite facing challenges such as restructuring and a reduction in workforce, Affimed remains focused on advancing its clinical pipeline. The company's strong leadership team, extensive experience in biotechnology and pharmaceuticals, and a clear mission to revolutionize cancer treatment underscore its commitment to giving patients back their innate ability to fight cancer.
For more information about Affimed's people, pipeline, and ongoing projects, please visit www.affimed.com.
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.
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.
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