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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 (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.
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.
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