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Schottelius was primair verantwoordelijk voor pre klinische productontwikkeling. Dat is kennelijk op een laag pitje gezet. Hoess heeft al zoveel (goeie) mensen aan de dijk gezet. Het wordt tijd dat hij ook inziet dat zijn tijd gekomen is. Ach, Ablynx is ooit opgekocht en daar was het management ook niet state of the art.
Affimed to Host Investor Conference Call Highlighting Clinical Data for Acimtamig (AFM13) and AFM24 Review clinical data of acimtamig in combination with cord-blood derived NK cells presented at ASH 2023; provide progress update on the LuminICE-203 Review clinical data for AFM24 in solid tumors Conference call/webcast on Monday, December 11, 2023 at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET MANNHEIM, Germany, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will host a conference call on December 11 at 1:30 p.m. PST / 4:30 p.m. EST to review clinical data presented from the combination trial of acimtamig with cord-blood derived NK cells during the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA. During the call, the Company will also provide a clinical data update from the AFM24-102 trial.
Collega Merus komt met haar EGFR "oplossing" niet verder dan een beperkt aantal partial responses:finance.yahoo.com/news/merus-presents... Longkanker met de EGFR mutatie is blijkbaar een lastige tegenstander. Waarom zou Affimed met veel fanfare data op de ASH publiceren? Het doet toch vermoeden dat ze beter gaan scoren dan Merus. ESMO Asia lijkt me minder standing hebben dan de ASH.
Kleine correctie: de AFM24 data worden alleen verspreid via het company event. De AFM13 data worden wel op de ASH gepubliceerd.
@tom3 wat verwacht jij van de ASH data ? vuurwerk voor de aandelen koers of blijven we dobberen op dit niveau ? ik heb een kleine positie ingenomen...
KVE83 schreef op 5 december 2023 16:29 :
@tom3 wat verwacht jij van de ASH data ? vuurwerk voor de aandelen koers of blijven we dobberen op dit niveau ? ik heb een kleine positie ingenomen...
Ik verwacht weinig nieuws bij AFM13, de markt denkt er net zo over vrees ik. AFM24 is m.i. spannender, maar een deal op dat gebied verwacht ik ook niet. Het zou het fonds wel een mega boost geven. Wellicht dat de lamme en de blinde elkaar nog vinden. Galapagos heeft wel geld betaald voor CAR-t maar niet voor NK technologie. Ze hebben zelfs afscheid van reuma genomen: hoe droevig wil je het hebben. Een overname a.u.b., zelfs door Galapagos, wordt zeer op prijs gesteld door mij.
Galapagos, niet bij me opgekomen nog, maar zou inderdaad kunnen. Wat moeten we anders dan hopen. Heb op 100 en 40 cent nog flink bijgekocht, op hoop van zegen. De gak moest echt naar beneden.
De beurs rekent gezien de belabberde koers en omzetten waarschijnlijk op gemengde berichten, bevestiging van AFM13 resultaten en teleurstellende AFM24 uitkomsten. Waarom men bij AFM24 niet wacht op een congres is mij niet geheel duidelijk. Dat laatste is toch de standaard procedure bij het bedrijf? Kan positief maar ook negatief uitgelegd worden. Hoess moet toch ergens mee scoren zou je denken in het vroege voorjaar.
Tom3 schreef op 20 november 2023 19:19 :
[...]
Sinterklaas is weer in land, lang gewacht, stil gezwegen...en toch (nog) gekregen ???
Sinterklaas is al weer vertrokken uit het land......
4finance schreef op 7 december 2023 17:23 :
[...]
Sinterklaas is al weer vertrokken uit het land......
ja die is naar de VS gegaan om de aandeelhouders van junk als Heliogen te plezieren... op 11 december weten we weer iets meer.
Chasse_Patate schreef op 11 november 2023 13:15 :
[...]
Niet zo raar, hier heb ik mij ook vreselijk in vergist.
De techniek en resultaten zijn goed dus leek mij dit een juiste investering.
Maar, de study completion date van de fase 2 is 30-11-2027 (zoek NCT05883449).
Affimed verbrandt 100 miljoen per jaar, nou dan heb je het bij de huidige koers en huidige sentiment over nog heel veel offerings met heel veel verwatering en mogelijk meerdere keren een reverse split.
En dan nog een langdurige fase 3, dan ben je kort aan de 10 jaar verder.
Best kansloos allemaal, ik zeg assets verkopen aan grote farmaceut, opdoeken en verdelen wat er nog te verdelen is, maar helaas heb ik het niet voor het zeggen.
Dit was geloof ik mijn laatste post hier, maar ik kreeg toch weer een sprankje hoop bij het lezen van het Q3 bericht. Werd al wel eerder gemeld, maar voor mijn gevoel wordt de term accelerated approval hier wat nadrukkelijker benoemd. The FDA is highly engaged in supporting the progress and design of the study evaluating the combination of acimtamig and AlloNK® as evidenced by the fast-track designation and Type C meeting feedback. According to written feedback for the Type C meeting, the LuminICE-203 study, designed based on the FDA’s recommendations and guidelines, could support accelerated approval , depending on the demonstrated magnitude of clinical benefit. In addition, the FDA agrees with Affimed’s approach to address the contribution of single components by adding a cohort to the study evaluating AlloNK®/IL-2 only. Waar praten we dan over, iemand hier ervaring mee? Want 30-11-2027 als einddatum van een fase 2 klinkt tamelijk rampzalig in de Affimed situatie. Als dit een kans geeft op een eerdere voorlopige toelating dan wordt het wellicht een ander verhaal.
Tom3 schreef op 20 november 2023 19:19 :
[...]
Sinterklaas is weer in land, lang gewacht, stil gezwegen...en toch (nog) gekregen ???
Je geloofd nog te veel in Sinterklaas.
4finance schreef op 7 december 2023 21:09 :
[...]
Je geloofd nog te veel in Sinterklaas.
Nou nee, ik geloof in AFM13 en haar marktkansen. Dat die Hoess er onderhand een zootje van dreigt te maken (wat nog niet helemaal vaststaat) is doodzonde. Ik geloof ook niet dat het een praatjesmaker is als onze Onno van Galapagos, eerder een gebrek aan visie/durf.
Mogelijk zijn er wat partijen die nu liever aan de zijlijn staan vanwege de update op maandag. Het vertrek van 2 management team leden naar ander bedrijven wordt misschien ook negatief uitgelegd, al lees ik dan dat de een als Amerikaan terugkeert naar de USA wat ook door familieomstandigheden kan komen en dat de ander gevraagd is om ergen CEO te worden. Daar kun je eigenlijk niet echt iets negatiefs uit halen. Misschien is er een samengaan in de maak met de NK partner of een overname door een andere partij, waar andere mensen voorkeur genoten voor hun rollen. wie zal het zeggen? Maandag horen wij meer. ik hou gewoon vast en zie wel wat het wordt.
@harvester, hedgefunds hebben kennelijk iets opgevangen in de wandelgangen. De geschiedenis heeft geleerd dat m.u.v de deal met Genentech er nogal wat lekken in de organisatie blijken te zitten. Als ze samengaan met een overnemende partij (zou Merck KgA nog in de markt zijn na hun laatste debacle?) is het management als eerste aan de beurt voor een wissel. Schottelius en Smith hebben hun knopen kennelijk geteld. Verder is het zo dat Affimed (zoals bij elke slechte want autoritaire CEO het geval) in het verleden talloze managementwisselingen heeft gehad.
Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs) In 32 patients with relapsed/refractory (r/r) Hodgkin lymphoma (HL) treated at the recommended phase 2 dose level (RP2D), the objective response rate (ORR) was 97% and the complete response (CR) rate was 78% In this cohort median EFS was 9.8 months with 84% patients alive at 12 months, and median duration of response (DoR) was 8.8 months Patients were heavily pretreated (median of 7 prior lines), all had previously received CPIs and BV, and were refractory to their most recent line of therapy Patients received up to four cycles of therapy and the treatment was well tolerated with no instances of cytokine release syndrome (CRS), graft versus host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS) MANNHEIM, Germany, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced updated data on its lead innate cell engager (ICE®) acimtamig. Data from the investigator-initiated trial is being presented today at the American Society of Hematology (ASH) 2023 Annual Meeting by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study. Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig’s future development. A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received CPIs and BV, and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an ORR of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of CRS, ICANS or GvHD of any grade. Mild to moderate infusion related reactions (IRRs) were seen in 7.7% of the acimtamig infusions. Across all dose levels, median event free survival (EFS) was 8.8 months and median overall survival (OS) was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months - with 84% patients alive at 12 months. The median DoR was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months. “When we conduct studies in a patient population that has failed their previous line of therapy, demonstrating even a modest response is encouraging. To see this magnitude of responses in terms of ORR (97%) and CR (78%) is remarkable and fuels our commitment to bring this therapy to more patients,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “Building on these results, we are well underway with our Phase 2 LuminICE-203 study. We have enrolled and dosed patients in the first two cohorts and we look forward to sharing data in the first half of 2024.” The Company will host a call today at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET to discuss the data presented at ASH and provide a strategic update. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at www.affimed.com/investors/webcasts-an... To access the call by phone, please use the link: register.vevent.com/register/BIb2258d... , and you will be provided with dial-in details and a pin number. Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call. About the AFM13-104 Phase 1/2 Study The University of Texas MD Anderson Cancer Center is studying acimtamig (AFM13) in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase that recruited 36 patients with r/r CD30 positive lymphomas, treated with the RP2D of 1×108 NK cells/kg followed by three weekly doses of 200 mg acimtamig monotherapy. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine (30 mg/m² per day) and cyclophosphamide (300 mg/m² per day) followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with acimtamig. Three weekly infusions of acimtamig (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746). About Acimtamig Acimtamig (AFM13) is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.
Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype non-small cell lung cancer (NSCLC) expansion cohort Responses observed in 4 of 15 patients, including 1 confirmed partial response (PR), 1 unconfirmed complete response (CR) awaiting confirmation, 2 unconfirmed PRs awaiting confirmation; an additional 7 of 15 patients exhibiting stable disease (SD) leading to a disease control rate of 73% Tumor shrinkage observed in 7 of 15 (47%) patients All patients were pretreated with and ultimately progressed while on PD-[L]1 targeting therapy The majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile in combination with atezolizumab Company to host a conference call / webcast today at 4:30 p.m. EST to discuss the data MANNHEIM, Germany, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced interim safety and efficacy data on its innate cell engager (ICE®) AFM24 from the ongoing AFM24-102 combination study with atezolizumab, an anti-PD-L1 checkpoint inhibitor, in patients with advanced EGFR-expressing solid tumors. The data update as of December 6th, 2023, includes 15 patients from the EGFR-wildtype NSCLC cohort with a median of 2 prior lines of therapy. Importantly, all patients were pretreated with and ultimately progressed while on PD-[L]1 targeting therapy. The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 unconfirmed CR, 3 PRs (1 confirmed, 2 unconfirmed) and 7 patients exhibiting SD. All eleven patients with a confirmed response, unconfirmed response or stable disease (73%) are continuing treatment, with 4 patients exceeding 3 months of therapy; 2 patients improved from SD at the first scan to PR at the second scan based on RECIST criteria. “Most patients with advanced NSCLC will need additional treatment after first-line therapy, and currently available options for patients in the 2L+ setting provide only modest response rates and short progression-free survival,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “Given the severity of this cancer and the urgent need for new treatments, we are very encouraged by the early safety and efficacy results demonstrated by the combination of AFM24 and atezolizumab in this cohort. We look forward to seeing the data in this cohort mature as well as to sharing data from the EGFR-mutant NSCLC cohort, anticipated in the first half of 2024.” Affimed’s ICE® AFM24, in combination with atezolizumab, has the potential to reactivate the innate and consequently the adaptive immune system to recognize and destroy EGFR-positive NSCLC tumors. Considering the low ORR reported on atezolizumab monotherapy in checkpoint inhibitor-relapsing and refractory patients, Affimed believes the clinical activity observed in AFM24-102 is likely due to the synergy of AFM24 with atezolizumab. AFM24 has demonstrated a positive safety and tolerability profile as both a monotherapy and in combination therapy. The combination with atezolizumab has not led to unexpected toxicity, and the toxicity observed to date is in line with the toxicity profile of the individual agents alone. The majority of patients experienced only mild to moderate treatment-related adverse events. Affimed also announced that it has discontinued enrollment in AFM24-102 into the gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer and hepatocellular carcinoma. While clinical activity was observed in both cohorts, neither cohort is likely to achieve response rates that would meet the Company’s efficacy hurdle and the Company’s strategic focus is to advance the NSCLC program as fast as possible. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at www.affimed.com/investors/webcasts-an... To access the call by phone, please use link register.vevent.com/register/BIb2258d... , and you will be provided with dial-in details and a pin number. Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call. About the AFM24-102 Phase 1/2a Study AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGFR-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies (NCT05109442). The Company also announced data from the phase 1/2 data study of acimtamig in combination with allogeneic NK in relapsed/refractory Hodgkin Lymphoma patients conducted at the University of Texas MD Anderson Cancer Center. The Company will host a call today at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET to discuss both the acimtamig and AFM24 clinical data updates and to provide an update on the status of the acimtamig LuminICE-203 study. About AFM24 AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. In addition to studying AMF24 in combination with the checkpoint inhibitor atezolizumab, Affimed is also evaluating options for a combination of AFM24 with an allogeneic off-the-shelf NK cell product that the Company expects to be well suited for heavily pretreated patient populations.
AFFIMED, Met onderstaande bekendmaking vandaag van positie data kan het aandeel weer terug boven de $1+ gaan noteren. Benieuwd of grotere spelers hier op gaan anticiperen. Affimed N.V. Mon, December 11, 2023 at 12:02 PM GMT+1 Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients
4finance schreef op 11 december 2023 12:31 :
AFFIMED,
Met onderstaande bekendmaking vandaag van positie data kan het aandeel weer terug boven de $1+ gaan noteren.
Benieuwd of grotere spelers hier op gaan anticiperen.
Affimed N.V.
Mon, December 11, 2023 at 12:02 PM GMT+1
Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients
Tja zo denk ik er ook over, voorlopig zie ik voorbeurs echter vooral veel volume en wilde schommelingen. Het was nog mooier geweest als er voor AFM24 bijvoorbeeld een aantrekkelijke deal was gepresenteerd.
Op zich blij hiermee. Maar denk dat alleen een mooie deal ons kan redden.
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Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
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RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
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Samas Groep
Sapec
SBM Offshore
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Schuitema
Seagull
Sequana Medical
Shurgard
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Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
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SNS Small & Midcap Competitie
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Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
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Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
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Value8 Cum Pref
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Vastned
Vastned Retail Belgium
Vedior
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Via Net.Works
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Vivendi
Vivoryon Therapeutics
VNU
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Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
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What's Cooking
Wolters Kluwer
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