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Pagina: «« 1 ... 278 279 280 281 282 ... 294 »» | Laatste | Omlaag ↓
  1. forum rang 6 Tom3 29 maart 2024 09:37
    twitter.com/RNAiAnalyst/status/177331...

    Dirk signaleert een verschuiving van aandacht van het management (of wat daarvan nog over is na het verlaten van Hoess, Smith en Schottelius en 50% van het overige personeel) van AFM13 naar AFM24. Daar liggen kennelijk kansen. Samenwerking met Roche?
  2. forum rang 6 Tom3 29 maart 2024 09:50
    Jan en alleman stort zich inmiddels op CAR-t medicaties, ik wist niet dat BioNtech (met zijn Covid miljarden) ook een bloeiende CAR-t tak had. Galapagos wordt niet eens genoemd in onderstaand artikel:

    www.labiotech.eu/best-biotech/car-t-c...

    Waar blijft de aandacht voor CAR-NK en/of NK cel engagers?
  3. forum rang 5 Hulskof 29 maart 2024 12:53
    quote:

    Tom3 schreef op 29 maart 2024 09:37:

    twitter.com/RNAiAnalyst/status/177331...

    Dirk signaleert een verschuiving van aandacht van het management (of wat daarvan nog over is na het verlaten van Hoess, Smith en Schottelius en 50% van het overige personeel) van AFM13 naar AFM24. Daar liggen kennelijk kansen. Samenwerking met Roche?
    Ja, redelijk wat speculatie hierover. Voor het eerst dat Afm24 als eerste wordt genoemd in een persbericht. Zien ze hier het meeste in? Grootste markt natuurlijk. Of vallen de initiële data van Afm13 tegen?
    Ik geloof het allemaal niet zo. Volgens mij hebben ze Afm24 vooraan gezet omdat ze daarmee het verste zijn en de meeste (mature) data verwachten. Afm24 en 28 zijn nog niet zo ver.
  4. forum rang 6 Tom3 29 maart 2024 17:56
    quote:

    Hulskof schreef op 29 maart 2024 12:53:

    [...]

    Ja, redelijk wat speculatie hierover. Voor het eerst dat Afm24 als eerste wordt genoemd in een persbericht. Zien ze hier het meeste in? Grootste markt natuurlijk. Of vallen de initiële data van Afm13 tegen?
    Ik geloof het allemaal niet zo. Volgens mij hebben ze Afm24 vooraan gezet omdat ze daarmee het verste zijn en de meeste (mature) data verwachten. Afm24 en 28 zijn nog niet zo ver.
    Het verst met AFM24 ? Zijn ze niet verder met AFM13 als ze de FDA in april kunnen overtuigen van versnelde toelating? De combi van AFM24 + PD1 lijkt in mijn ogen geknipt voor een Roche gezien het waarschijnlijk giga marktpotentieel. Kans op complete remissie bij longkanker is toch echt een waanzinnig vooruitzicht. Wie weet hebben ze sedert begin januari nog een verdere verbetering van de uitkomsten gezien maar weten we dat nog niet. De conference call was trouwens wel magertjes qua belangstelling van de dames en heren analisten. Gelukkig was Graybosch wel van de partij. Die is echt op de hoogte van de materie.
  5. forum rang 5 Hulskof 29 maart 2024 19:39
    quote:

    Tom3 schreef op 29 maart 2024 17:56:

    [...]

    Het verst met AFM24 ? Zijn ze niet verder met AFM13 als ze de FDA in april kunnen overtuigen van versnelde toelating? De combi van AFM24 + PD1 lijkt in mijn ogen geknipt voor een Roche gezien het waarschijnlijk giga marktpotentieel. Kans op complete remissie bij longkanker is toch echt een waanzinnig vooruitzicht. Wie weet hebben ze sedert begin januari nog een verdere verbetering van de uitkomsten gezien maar weten we dat nog niet. De conference call was trouwens wel magertjes qua belangstelling van de dames en heren analisten. Gelukkig was Graybosch wel van de partij. Die is echt op de hoogte van de materie.
    Ik bedoel dat er in het volgende kwartaal nog maar weinig data van Afm13 te verwachten zijn, aangezien ze net de safety meetings van cohorts 1 en 2 hebben afgerond en in april pas die van cohort 3 en 4 verwachten. Afm13 staat strikt genomen weer opnieuw in de startblokken, afm24 loopt in dat opzicht al een stuk langer.
  6. forum rang 6 Tom3 29 maart 2024 20:11
    quote:

    Hulskof schreef op 29 maart 2024 19:39:

    [...]

    Ik bedoel dat er in het volgende kwartaal nog maar weinig data van Afm13 te verwachten zijn, aangezien ze net de safety meetings van cohorts 1 en 2 hebben afgerond en in april pas die van cohort 3 en 4 verwachten. Afm13 staat strikt genomen weer opnieuw in de startblokken, afm24 loopt in dat opzicht al een stuk langer.
    As we are now beyond the period of staggered enrollment for cohorts 1 and 2, we see steady progress and expect to initiate recruitment into cohorts 3 and 4 in the next couple of weeks.

    Citaat uit het verslag van gisteren.

    In april zullen ze alleen cohort 1 en 2 bespreken met de FDA. Wat de status hiervan zal zijn is onduidelijk. Het schiet allemaal niet op als je eind oktober bent begonnen en evaluatie kan worden gedaan na het einde van een kuur die 43 dagen duurt.
  7. forum rang 6 Tom3 29 maart 2024 20:33
    In de vragenronde wordt trouwens nog uitgebreid stil gestaan bij de voortgang van AFM13. Met een beetje geluk komt er in Q2 nog een definitief antwoord:

    Srikripa Devarakonda

    Hey, guys, thank you so much for taking my questions. Given that LuminICE-203 has been advancing. Can you provide a little bit more clarity on how many patients we will see data from? Will we see from all the patients enrolled? And in terms of duration on therapy for these patients, can you help us understand the bookends, like what is the longest time patients have been on? And what is the minimum amount of time they've been on? And just regarding the Safety Review Committee meeting that you're expected to have in April for initiations of Cohorts 3 and 4, just wanted to confirm that you don't need any additional conversations with the FDA before you move into Cohorts 3 and 4. Thank you.

    Andreas Harstrick

    Okay. Thank you, Srikripa. That was quite a lot of questions, so I hope I remember all of them. So, to start with the SRC meeting, no, we do not need any conversation or any feedback with FDA. We have clear guidelines that governs the transition from Cohort 1 to 2 to Cohorts 3 and 4, and this can be handled by the SRC meeting only. As far as the data that we expect in Q2, we believe that we have – while we are quite certain that we have fully recruited Cohorts 1 and 2. So this will be 12 patients.

    Now, again, Cohorts 3 and 4, the first three patients have this staggering enrollment where basically you assign a slot to a patient, can start this patient, then two weeks later, you can assign the next slot, start the next patient, provided that this patient drops not out during the screening period. This happened to a couple of patients in Cohorts 1 and 2, and then you have to restart the slot allocation process again, which caused somewhat a little delay in the first six patients in Cohort 1 and 2.

    Again, it's a little bit hard to predict, but we expect to have a reasonable number of Cohorts 3 and 4 patients for our initial report in Q2 as well. Important probably also to note is that we expect that the data of Cohorts 1 and 2 will already be very informative as we are using a cell dose, three cell applications of 2 billion cells each per cycle that we believe is a therapeutic cell dose.
  8. forum rang 5 Hulskof 30 maart 2024 15:24
    AFM24 seems to be the main focus of $AFMD now. Probably because of the results so far, the target market size, and because a partner may be able to take this to either a larger p2 or even 3 relatively soon.

    also interesting, the presentation mentions additional indications

    twitter.com/RNA_Biotech/status/177400...

    I can't imagine $AFMD looking at additional indications after first narrowing to NSCL. My guess would be Roche has some ideas about which indications would be interesting to try.

    Interessant... Zou Roche dan toch een deal met ze aangaan?
  9. forum rang 5 Hulskof 30 maart 2024 18:19
    One last tweet for Affimed:
    1) I’m certain if they had the data for AFM13’s LuminICE we’d be seeing initial numbers at ASCO.
    The staggering & dropout issues (totally unrelated to treatment) set back the trial by up to 3-4 wks per dropout.
    2) Regarding AFM24 (next tweet)

    I agree with Leerink’s Daina Graybosch that investor’s expectations for the Q2 readout are probably way too high.
    The data will focus on PFS for a small N of pts, the real data won’t be available until end of year.

    twitter.com/BrianUherek/status/177404...
  10. forum rang 5 Hulskof 30 maart 2024 18:24
    quote:

    Hulskof schreef op 29 maart 2024 19:39:

    [...]

    Ik bedoel dat er in het volgende kwartaal nog maar weinig data van Afm13 te verwachten zijn, aangezien ze net de safety meetings van cohorts 1 en 2 hebben afgerond en in april pas die van cohort 3 en 4 verwachten. Afm13 staat strikt genomen weer opnieuw in de startblokken, afm24 loopt in dat opzicht al een stuk langer.
    Don’t mean to sound condescending but I see no prioritizing one ICE over the other two clinical assets.
    Affimed’s business plan actually suggests the opposite.
    LuminICE, however, remains the one to watch given the unprecedented numbers posted by MDACC.
    #AFM13
    #NK_CellTherapy

    Response van X:

    Well, the TAM is greater for NSCLC than HL

    Also, I'm not sure that solid data from AFM13+AB101 will put to rest the thesis "it's the nk that's doing the work".

    AFM24+atezo data in r/r NSCLC should resolve whether it's the engager, and provide better clarity on valuation.

    Brian:
    To date (comparing apples to oranges which is never advisable unless there’s nothing else to make comparisons) —> AFM13 is proving to be the best NK cell engager out there.
    All the nonsense about whether it’s the NKs or the engagers is just that. Nonsense.

    twitter.com/BrianUherek/status/177372...
  11. forum rang 5 Hulskof 30 maart 2024 18:26
    Belangrijkste conclusie nav de call m.i.:

    You may have noticed on the call that Harstrick’s & the board’s priority were/are directed towards the company and its shareholders.
    As fundamentally basic as that is, the previous CEO did not share those priorities vis-à-vis the shareholders.
    Hoess is gone, thank you Lord. ??

    twitter.com/BrianUherek/status/177374...
  12. forum rang 5 Hulskof 30 maart 2024 18:36
    Nog eentje van Brian:

    Listened to yesterday’s @affimed call again this morning, two things that I didn’t pick up on yesterday:

    1/ They are waiting to hear from ASCO regarding AFM24.

    2/ Dr Harstrick gave a proverbial wink and a nod when asked if LuminICE safety is on par with MDACC.

    I’m predicting Q2 will be the turning point for Affimed investors who’ve been dragged through the coals for countless years.
    For investors who continue to be patient the return will be a stock with a triple digit valuation.
    I continue to hold the best strategy has been to continue adding on weakness. Personally I have a shitload of stock bought at 35 cents per share (3.50 r/s adjusted).

    Prediction: most will be out of the name way before the price action starts in a meaningful way.
    I guess I’m one of the few still believing in NK cells as a viable therapeutic in cancer.

    twitter.com/BrianUherek/status/177345...
  13. forum rang 5 Hulskof 30 maart 2024 18:39
    Brian voorziet 1 miljard waarde per asset mits ze zich positief ontwikkelen. Hij gaat daarbij nog steeds niet uit van een overname. Zelf lijkt me de kans op een buyout voor die tijd een stuk groter. We gaan het zien.
  14. forum rang 6 Tom3 31 maart 2024 15:29
    Persimmonstree over AFM24

    Notes from Earnings Call, my Affimed Opus:

    AFM24 + atezolizumab

    AFM24 now takes pole position as lead candidate in corporate presentation, which is notable.

    Taking stock of the big picture, if AFM24 can show that it can safely & durably sensitize and/or potentiate atezolizumab (or perhaps any PD-1, PD-L1) in 2L+ NSCLC, it would be a blockbuster, and Affimed is worth multiples of current market cap on those prospects alone.

    Beyond the sheer size of the NSCLC 2L+ need (214k annually, per slide deck), let's review the big pharma market dynamics -- PD-1/PD-(L)1s have been the out and out cash kings for big pharma, with Merck's king Keytruda leading the way, and Bristol's Opdivo following on the king's coattails. However, despite PD-1 success, it faces two challenges -- one from the very beginning, and one on the horizon:

    From the beginning, PD-1s are limited by the patient population in which they prove to be efficacious, only a fraction of the total intent to treat. The reasons for limited efficacy are various, including checkpoint score (how much PD-1 is endogenously available to block) and immunogenicity of the tumor/histology itself.

    The challenge on the horizon is none other than oncoming loss of exclusivity, with $MRK alone expected to lose many billions of annual revenue from Keytruda generics by the end of decade.

    Now consider AFM24 within this milieu -- again, if the efficacy and durability bears out (a huge IF), it could very well address both of PD-(L)1s' challenges: 1) Increasing the percentage of patients that meaningfully respond to PD-1, and 2) Offering a combo administration route that could effectively extend exclusivity for the PD-(L)1 with which it is combined (atezo, for now...).

    And all of that before even considering other possibilities for therapeutic combinations, for which AFM24's safety profile (to date) seems well suited. Just to name a couple, how about AFM24 + a targeted ADC, perhaps in triplet with PD-1? And to any and all of these combos, what about adding some allogeneic NK cells (Artiva's or otherwise) to boost the patient's endogenous innate capabilities/response?

    Again, the greenfield opportunity for AFM24 is, in a word, vast.

    Now, taking our heads out of the clouds to return to the here and now -- in AFM24-102 EGFRwt cohort, we have seen some initial promise. Although latest corporate deck doesn't feature a swimmer plot, recalling from prior decks, it seems that a "mature" median PFS could fall at around 6.5 to 8.5 months. If so, that would arguably represent relatively strong results (of course pending safety, as well) given the current standard of care in 2L+ NSCLC.

    Note that in current corporate slides, $AFMD's language regarding SoC's PFS: "Current standard of care provides less than 6 months PFS" could be something of a "tell" that management expects AFM24-102 EGFRwt to show PFS that clearly bests 6 months, which could point to a figure closer to the 8.5mo side of the range.

    Interestingly, with respect to ORR, I think that AFM24 might just have a surprise up its sleeves in EGFRwt. Again, no swimmer plot to see the details, but I believe that some of the "near-RECIST responders" could still be on therapy, with the possibility of deepening tumor regression that could meet the 30% reduction RECIST bar on subsequent efficacy scan. Also, remember that one of the cohort's 16 total N had not yet received first efficacy scan, which could skew ORR up (or down) as that patient is not yet in the ORR denominator. A quick side note that Slide 9 seems to have a discrepancy in the total N overall, with the safety chart on the righthand side showing N=17. It's hard to say where that final patient is coming from to bring the number to 17, as my numbers show: efficacy evaluable of 15 + 1 not yet evaluated should = 16...

    Either way, we should know more about EGFRwt (and initial ORR on EGFRmut) soon. According to a response to question in conference call, it appears that $AFMD has submitted AFM24-102 data to ASCO, with the company expecting to hear the results of that submission sometime in the coming week. If the submission results are positive (Oral presentation?), this could lead to a PR that serves as upward catalyst to share price in its own right.
  15. forum rang 6 Tom3 31 maart 2024 15:32
    En Persimmonstree over AFM13 +28:

    Acimtamig (AFM13) + Artiva NK

    Again, taking a look at the big picture, $AFMD looks to address a Hodgkin's Lymphoma landscape with high unmet need, particularly in later lines with patients who are refractory to both ADCETRIS and PD-1.

    Though not apples to apples, AFM13-104 (MDACC Cord NK combo) full results shed light on what we might expect for LuminICE-203 to benchmark. There, in N=32 P2 at median lines of Tx=7, the combo showed a 97% ORR and 78% CR, with approx. 30% of patients experiencing a response longer than 12 months. And notably, 6 patients with CRs were able to receive SCT, with 5 of those patients with an ongoing response (all of these 5 with responses at 12 months or more, and 2 of whom have continuing CRs at the 2 year mark...).

    So can we expect the same from LuminICE? Who knows... But Harstrick seems to evince strong confidence in conference call that, even with some delays to initial recruitment in cohorts 1 and 2, the midyear update will show meaningful safety and early efficacy data. In particular, Harstrick notes that, though he still expects some cohort 3 and 4 patient data, even within cohort 1 and 2 alone, meaningful data should be available, given $AFMD expectation that these introductory cohorts are at a therapeutic NK cell dose.

    Also note that in prior earnings call, Harstrick noted that preclinical data seem to suggest that, if anything, an AFM13 + allogeneic NK cell "real-time" in-vivo combo could be more potent than the AFM13 + cordNK precomplexing of AFM13-104...

    In any case, we won't know anything more about AFM13 until we see the initial LuninICE data, but the earnings call does give me the feel of conference calls in quarters' past that were leading up to initial AFM13+MDACC data...

    AFM28

    My expectations for AFM28 update in dose escalation are more muted. I doubt that we will see any efficacy, although it seems likely that AFM28 will be safe throughout the dosing range.

    Management has pretty clearly indicated that the path forward with AFM28 is in combo with allogeneic NK cells (and I believe that agreement with Artiva holds an option for $AFMD to combo their cells with AFM28).

    But AFM28 safety and PK data could be pretty telling in their own way. Note that naked/non-targeted adoptive NK cell infusion has been shown to have initial efficacy in AML, though lacking durability of response. And separately, the scientific community has know that CD123 should be a highly effective tumor associated antigen, but Tx approaches (T cell dominated) have been hampered by lack of safety.

    Combining the two -- adoptive allogeneic NK cells along with the safe targeting of AFM28 (with the hope that the combo could induce some "memory-like" durability of resultant in-vivo NK cells, as well as provide options for safe redosing of the combo) -- could very well prove to be an effective AML modality, thought the path forward may be a long one.

    In any case, depending on how things unfold with AFM24 and AFM13, I suspect that the further development of AFM28 could be the least of $AFMD's concerns, including the possibility that AFM28 development may no longer be in $AFMD's hands entirely...
  16. forum rang 6 Tom3 31 maart 2024 15:34
    quote:

    Hulskof schreef op 30 maart 2024 15:24:

    AFM24 seems to be the main focus of $AFMD now. Probably because of the results so far, the target market size, and because a partner may be able to take this to either a larger p2 or even 3 relatively soon.

    also interesting, the presentation mentions additional indications

    twitter.com/RNA_Biotech/status/177400...

    I can't imagine $AFMD looking at additional indications after first narrowing to NSCL. My guess would be Roche has some ideas about which indications would be interesting to try.

    Interessant... Zou Roche dan toch een deal met ze aangaan?
    Dit is ook mijn idee als je Persimmonstree goed leest.
  17. forum rang 6 Tom3 31 maart 2024 15:50
    Persimmonstree: "Either way, we should know more about EGFRwt (and initial ORR on EGFRmut) soon. According to a response to question in conference call, it appears that $AFMD has submitted AFM24-102 data to ASCO, with the company expecting to hear the results of that submission sometime in the coming week. If the submission results are positive (Oral presentation?), this could lead to a PR that serves as upward catalyst to share price in its own right."

    Zou dit de reden zijn dat we bij de laatste cijferpresentatie geen update mbt AFM24 hebben gehad?

    Voor een late breaker is 11 maart de deadline, kunnen ze toch de data mbt januari en februari meenemen:

    conferences.asco.org/am/abstract-subm...
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