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Kiadis Pharma april 2019

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  1. [verwijderd] 18 april 2019 09:14

    Misschien dat de toekomst uit zal wijzen dat de overname van CytoSen een goede zet is.

    De koersstijging van gisteren was echter zeer voorbarig:

    • CytoSen heeft nog geen klinische pijplijn.
    • Statistisch gezien is daarmee de kans dat hun therapie ooit de markt haalt kleiner dan 20%
    • Het duurt nog minimaal 4 jaar voordat de CytoSen therapie commercieel vermarkt mag worden
    • En ondertussen kunnen de aandeelhouders van CytoSen meeprofiteren van een eventuele koerswinst van Kiadis bij goedkeuring van Atir101

    Verder is het altijd verbazingwekkend dat in de media (bijvoorbeeld het FD) een koopprijs van € 15 miljoen blijft hangen, terwijl de koopprijs in potentie boven de € 100 miljoen uit kan stijgen.

  2. [verwijderd] 18 april 2019 09:21
    quote:

    StandaardVerlies schreef op 18 april 2019 09:10:

    [...]

    je bent een echte aanwinst voor dit forum
    Ik doe nochtans gewoon wat de mensen in de posts boven de mijne ook deden...: er gewoon op los fantaseren.

    Soit, ik heb grote vraagtekens bij de overname. Dit mag toch wel gezegd worden, denk ik? Of moeten we allemaal uitermate positief (of is het naïef) zijn?

  3. Badeend 18 april 2019 09:23
    @AD,

    Vergeet niet dat het risico van de prijs ook ingedamd is dmv prestatiebeloningen. Mocht het middel een succes blijken, dan heeft Kiadis een tweede middel die ze gecombineerd kunnen gebruiken met het eigen ATIR. De investering is het dan zeker waard, aangezien ze op dezelfde markt bijna fungeren en ze met deze overname ook ingangen bij Amerikaanse ziekenhuizen hebben. Maar eens, als ATIR goedgekeurd is en het aandeel is over 2 jaar(na lockup) €25 waard is, is het een overname van €200 milj. Investeren is risico nemen, ik vind het zelf een goede zet maar gelukkig zijn er ook andere meningen.
  4. [verwijderd] 18 april 2019 09:24
    En nog een artikel over de overname:

    Kiadis is set to buy CytoSen Therapeutics to expand into anti-cancer natural killer (NK) cell therapies. The all-stock transaction will give Kiadis control of a preclinical NK cell therapy and see it add CAR-T pioneer Carl June to its scientific advisory board.

    Dutch biotech Kiadis has focused its efforts to date on T cell therapies, specifically a drug designed to improve outcomes in cancer patients who undergo partially matched, haploidentical hematopoietic stem cell transplants (HSCT). That drug, ATIR101, could come to market in Europe later this year and is on the road to the phase 3 data needed to win global approvals.

    With ATIR101 potentially closing in on the end of clinical development, Kiadis is set to add another asset to its pipeline by acquiring CytoSen for 1.94 million shares upfront. Kiadis trades at around €10 ($11) a share.

    CytoSen has spent the past few years working on NK cell technology licensed from the University of Central Florida. Using a nanoparticle processing technology, CytoSen thinks it can improve the expansion and activation of NK cells, thereby facilitating multiple high-dose infusions with potent anti-cancer effects. The goal is to augment a patient’s innate immunity to wipe out cancer cells, either as a monotherapy or in combination with T cells that dial up the adaptive immune response.

    “I believe the fields of NK cells and T cells are enormously synergistic and the combination could potentially help patients with devastating diseases,” the University of Pennsylvania’s Carl June said in a statement. June, a scientific adviser to CytoSen, will join Kiadis’ scientific advisory board when the deal closes.

    Stefan Ciurea and Dean Lee, co-founders of CytoSen, demonstrated the potential of NK cell therapy in proof-of-concept work performed with their colleagues at MD Anderson Cancer Center. NK cells were given in conjunction with haploidentical HSCT to 13 leukemia patients. One of the patients relapsed, resulting in a relapse rate the authors called “remarkably low.”

    CytoSen set out to build on the findings by holding a pre-IND meeting with the FDA last year ahead of a planned phase 2 trial of its lead NK program, CSDT002-NK, in high-risk acute myeloid leukemia or myelodysplastic syndrome patients undergoing haploidentical HSCT.

    At one point, that trial was due to get underway in the first half of this year, but Kiadis is aiming toward a 2020 start date. By then, Kiadis may have won approval for ATIR101 in Europe and could be about a year away from generating the phase 3 data it needs to support filings in the U.S. and other regions.

    The CytoSen deal provides Kiadis with a fairly low-risk way to gain a backup to ATIR101 and set the stage for possible combinations of NK and T cell therapies. Kiadis will absorb the $6 million in cash held by CytoSen when it closes the deal, partly offsetting the upfront stock costs. And it will pay milestones tied to six clinical development and regulatory events using 5.82 million shares, at most.
  5. [verwijderd] 18 april 2019 09:36
    En bij deze nog een kritisch artikel aangaande de overname:

    Kiadis moves to reduce reliance on its in-house lead
    Jacob Plieth

    Perhaps sensing trouble ahead Kiadis diversifies beyond ATIR101 by buying Cytosen, but it is a scientific appointment that will cause real excitement.

    Given Molmed’s problems in trying to sell Zalmoxis, a product for averting stem cell transplant complications, it is understandable that Kiadis should try to diversify beyond its competing offering, ATIR101. However, it is debatable whether Cytosen Therapeutics, which Kiadis bought this morning, holds the answer.

    Cytosen is a specialist in natural killer (NK) cell therapeutics, an area that has promised much and delivered virtually nothing so far. Perhaps investors will be much more excited about the fact that, as part of the deal, the cell therapy pioneer Dr Carl June is joining the combined company’s scientific advisory board.

    Dr June and his colleagues at the University of Pennsylvania were the scientific originators of Novartis’s Kymriah, the first CAR-T therapy to secure US approval. He does not appear to have been involved with Cytosen before, and will be seen as providing a strong endorsement of the combined company.

    Coup

    His appointment is quite a coup, given the documented problems of NK cell therapeutics. Ziopharm and Nantkwest are two groups that have talked up the potential of NK cells transduced to express CAR constructs, but they have stalled clinically.

    One problem is NK cells’ plasticity, meaning that their phenotype is relatively unstable and their function unpredictable; it is also debatable whether they can be frozen and thawed efficiently, making the prospect of commercial manufacturing very problematic.

    Perhaps this is where Cytosen comes in: the group claims to have discovered and patented a method of using nanoparticle-bound 4-1BBL and IL-21 to stimulate and expand NK cells. This, it says, enables production at highly potent and therapeutically effective dosages.

    Its lead asset using this technology is coded CSTD002, and is this year supposed to start phase II as a treatment for AML relapse in high-risk post-transplant patients. This is based on the results of early clinical work carried out at MD Anderson Cancer Center.

    Cytosen is a private, virtually operating company that was incorporated in Florida five years ago. Another advantage for Kiadis is that its acquisition will not cost it anything: the takeover is structured as an all-stock move worth 1.94m Kiadis shares now, followed by up to 5.82m based on future milestones.

    A valid question is why, if Cytosen’s technology holds such promise, the company could not apparently raise the cash it needed from venture capitalists, thus remaining independent.

    Diversification

    Cytosen should provide a welcome diversification away from Kiadis's ATIR101, and on an investor call today Kiadis said it had been looking for an acquisition target for the past year.

    ATIR101 is a procedure that allows stem cell transplantation to take place when only a haploidentical – half-matched – but not fully matched donor is available. It is awaiting EU approval, though the CHMP’s decision on it has been put back.

    Particularly worrying is the precedent set by Molmed, whose Zalmoxis has failed to generate significant sales since being launched for the same use, and this fact has also unnerved investors in Bellicum, whose EU filing for the Rivo-cel procedure has been delayed (Is Molmed the canary in Bellicum and Kiadis’s coalmine?, July 31, 2018).

    Kiadis will now have a chance to show that NK cells do, after all, have commercial potential. Among other NK cell players, Nantkwest has managed to start clinical trials of a product based on the disputed NK-92 cell line, while clinical CAR-NK work is being advanced by MD Anderson and Chinese groups like Persongen and Allife Medical Science.

    Nantkwest had promised to start clinical trials of CAR-NK cells targeting CD19 and Her2 in 2016, but its investors are still waiting.

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