wert WKN: A407ZR ISIN: NL0015001ZQ0 Kürzel: AFMD Forum: Aktien User: value3000

Program Updates Acimtamig (AFM13; CD30 / CD16A) Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs. All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT). Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK® related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling. Continued updates from the study to be provided on upcoming earnings calls and scientific conferences. AFM24 (EGFR / CD16A) In the AFM24-102 trial (combination with atezolizumab): 4 confirmed responses (1CR, 4PR) and 8SD in 17 heavily pretreated EGFRwt NSCLC patients; mPFS of 5.9 months; 3 out of 4 responses ongoing for more than 7 months. All patients were pretreated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1. On May 29, the Company announced that it received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients. In 13 response-evaluable, heavily pretreated EGFRmut NSCLC patients, the combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs and 6 SDs. All responses are ongoing and have been confirmed by follow up scan. ORR and PFS data from the 25 patient EGFRmut NSCL cohort is expected in Q3 2024; data from the 40 patient EGFRwt cohort is expected in Q4 2024. AFM28 (CD123 / CD16A) Completed enrollment of the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r acute myeloid leukemia (AML). Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of 33%. Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a SD as best response. No dose-limiting toxicities were reported in dose levels 5 and 6. Data from the study is expected to be presented at a future scientific conference. Further clinical development of AFM28 to be pursued in combination with an allogeneic, off-the-shelf NK cell product. Upcoming Milestones: Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024. ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024. ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.

Positiv 👍🏻

TOP! Acimtamig (AFM13) combination with AlloNK® (AB-101) natural killer (NK) cells: Recruitment in cohorts 1 and 2 completed. In the first 7 treatment refractory Hodgkin Lymphoma (HL) patients, an ORR of 85.7% observed, with 4 CRs and 2 partial responses (PRs) were observed by independent read. AFM24 combination with atezolizumab: In 17 EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients who failed chemotherapy and PD-1/PD-L1 treatment, 1CR, 3PRs and 8 SDs were observed. Disease control was 71%.

Aber egal, wie gut die Nachrichten sind, wird das Ding immer sofort wieder runtergeprügelt.

https://transkript.de/artikel/2024/hat-sich-bei-affimed-das-warten-gelohnt/

Zieht an

Nicht handelbar

Wenn die Studiendaten weiterhin so positiv ausfallen, ist hier nach oben noch viel Kurspotential vorhanden.. Bei ersten Zulassungen kann das hier auch schnell in Richtung dreistellig gehen (nur meine persönliche Meinung)

Wo läuft das noch hin

Plötzlich bin ich mit Affimed im Plus.. ein ganz ungewohnter Anblick 😆

Die Daten sind wieder mal sehr gut und das Kurspotenzial nach oben offen 😁

Heute werden die Geduldigen ein wenig belohnt.

MANNHEIM, Germany, May 23, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that an update from the Company’s AFM24-102 study in advanced EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago on May 31 – June 4, 2024. Patients in the study are treated with the combination of AFM24, Affimed’s innate cell engager (ICE®), and atezolizumab, Roche’s checkpoint inhibitor (CPI). As of the March 18 cut-off for the poster, 17 patients with EGFRwt NSCLC received the combination treatment and 15 patients were response evaluable. One patient showed a confirmed complete response, and three patients showed confirmed partial responses (PR). In addition, seven patients achieved stable disease, resulting in a disease control rate of 73.3% (11/15 patients). Median progression-free survival was 5.9 months. All responders were resistant to checkpoint inhibitor treatment prior to the study, which supports the hypothesis that combining AFM24 with atezolizumab may enhance the cancer-immunity cycle and provide an alternative strategy to overcome resistance to existing therapies for EGFR-expressing tumors. AFM24 and atezolizumab were given at their respective single agent doses. Treatment in these heavily pretreated patients was well tolerated. Side effects were consistent with the known safety profiles of these agents. The most frequent side effects observed were mild to moderate infusion related reactions and transient mild to moderate increase in liver enzymes. “We are very encouraged to see objective and lasting responses in patients who have failed multiple lines of therapy including platinum doublets and checkpoint inhibitors,” said Dr. Andreas Harstrick, Chief Medical and acting Chief Executive Officer of Affimed. “These data support our hypothesis that the combination of AFM24 and PD-1 targeting may act synergistically on the immunity cycle. It is remarkable that this can be achieved with a chemotherapy-free approach. We are committed to continuing clinical development of this therapy and are enrolling additional patients for both EGFRwt and EGFRmut NSCLC.”

Ich aktiviere hier mal einen neuen Thread..