Affimed Therapeutics B.V. - AFMD
was ist mit move to sponsorship gemeint? Vielen Dank!
Vermutlich im Kontext mit der MD Anderson Studie bezüglich der aus dem Blut der Nabelschnur gewonnenen und mit AFM13 präparierten NK Zellen?
wann ist etwa mit accelerated approval zu rechnen wenn alles gut läuft?
2023 sagtest du mal glaub ich, sorry.
danke
Ist da noch eine Partnerschaft denkbar oder zieht AFMD das allein durch bis zur Zulassung.
setzt die Erwartungen für mit AFM13 vorgeladene cb-NK-cells von MD Anderson für die ersten 18 Patienten um die ASH herum in der höchsten Dosis auf 70% ORR als sehr gut. Dem kann ich nur zustimmen und sollte den Markt von der 100% ORR Erwartung ins richtige Licht rücken.
I’m I getting this right? Adi just set the bar at a minimum of 70%?? Followed up with anywhere from 70% - 100%?? Somebody with some credibility please confirm. #Stifel #AFM13+cbNK #ORR $AFMD
"we believe we can bring this forward to any CD30 positive lymphoma"
von wievielen fällen pro jahr reden wir da?
wir werden noch viel freude haben, hoffentlich beginnend im dezember21
So safe und so wirksam.
das hört sich einfach nach einem gamechanger an.
Wie ist das aus Expertensicht itechDachs? Schonmal was ähnlich vielversprechendes gesehen (natürlich noch ziemlich frühklinisch)
was kann da noch kommen. unglaublich eigentlich
einschliesslich der Implikationen für eine FDA Zulassung / Konkurrenz am Markt.
CEO Adi Hoess bei Maury Roycraft at Jefferies
ich bin gespannt wie der berühmte flitzebogen.
affimed und die serial killers....
Die tatsächlichen Zahlen erfährt man aber erst ab dem 11-ten Dezember auf der ASH oder in einem Firmensymposium.
100% objective response rate with a 42% complete response rate in 12 patients, according to investigator assessment, after the 1st of 2 planned cycles at the recommended phase 2 dose of 108 cord blood-derived natural killer (cbNK) cells/kg pre-complexed with AFM13
No cases of serious adverse events such as cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease were observed
Affimed to host virtual investor event on December 9th to discuss the results
HEIDELBERG, Germany, Nov. 22, 2021 (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 interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimeds innate cell engager (ICE®) AFM13.
As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1x106, three patients with 1x107 and 12 patients with 1x108 AFM13-pre-complexed cbNK cells per kg body weight.
As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses (CR) and nine partial responses (PR). Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.
The patients enrolled in this study were all heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy, said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. We are encouraged by the response rates that we continue to observe in these difficult to treat patients. The data are in line with data presented at AACR earlier this year. We also continue to see a very good safety profile of the combination, which is important as many of these patients have been very heavily pretreated and cannot tolerate aggressive therapies. Combining our ICE® molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach.