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Kiadis Pharma - 4e kwartaal 2019

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But, even though Kiadis is moving to discontinue ATIR101’s phase III Hatcy study, it will not be able to draw a simple line under its troubles: subjects already enrolled into Hatcy must, for ethical reasons, be followed to completion. The study enrolled the first of 250 patients two years ago, and had been due to yield results in 2021.

Rendiertje schreef op 15 dec 2019 om 18:48:

wat een geruzie op de zondag.

ruzie? Dit heet discussie.
Kiadis dumps phase 3 drug, halves head count in pivot to NK cells
by Nick Paul Taylor | Nov 13, 2019 8:44am

Kiadis has dropped its lead program midway through a phase 3 trial. The action will see Kiadis lay off half of its staff and switch its attention to earlier-stage natural killer (NK) cell therapies against solid tumors and hematological cancers.

Amsterdam-based Kiadis has focused its attention on lead drug ATIR101 for years, hustling the T-cell immunotherapy through the clinic with a view to winning conditional approval in Europe in patients undergoing transplantation with genetically half-matched hematopoietic stem cells in 2019. That goal, which had slipped to 2020, evaporated last month when Kiadis braced investors for a regulatory rejection.

Now, Kiadis has killed off ATIR101 altogether by scrapping the phase 3 trial designed to generate data to support a full approval. Kiadis took the action after an unexpectedly high dropout rate in the ATIR101 arm led it to look into real-world outcomes achieved by post-transplant cyclophosphamide, the control in the phase 3. The data dive led Kiadis to conclude the trial is unlikely to succeed. At best, a much larger trial would be needed to show ATIR101 is effective.

Kiadis’ action came as a shock to analysts.

“The decision to terminate ATIR101 in the midst of its phase 3 comes as a surprise, even given recent EU regulatory setbacks,” analysts at Jefferies wrote in a note to investors.

Kiadis’ decision will cost half its employees their jobs. The Dutch biotech had begun preparing for the European launch of ATIR101, including by adding production capacity in Amsterdam, before learning regulators were set to reject the drug. Now, Kiadis again finds itself years from the market, ending its need for some of the capabilities it built up to support the push to commercialize ATIR101.

The remaining employees at Kiadis will focus on NK cell therapies. Kiadis moved into the NK space earlier this year through the acquisition of Cytosen Therapeutics. The deal gave Kiadis control of two NK cell therapy candidates it plans to test in phase 1/2 trials starting next year.

Kiadis ended the third quarter with €47 million ($52 million) in cash to fund the studies, but the Jefferies analysts think that may run out before data from the NK trials are available. With shares in Kiadis falling 33% following news of the changes and Jefferies identifying the “dent to management credibility” as an overhang, the biotech’s ability to raise more cash may be weakened by the pivot.

gokker schreef op 15 dec 2019 om 18:48:

But, even though Kiadis is moving to discontinue ATIR101’s phase III Hatcy study, it will not be able to draw a simple line under its troubles: subjects already enrolled into Hatcy must, for ethical reasons, be followed to completion. The study enrolled the first of 250 patients two years ago, and had been due to yield results in 2021.

Interessant artikel van AB van mij. De auteur zegt eigenlijk : Kiadis wil er wel mee stoppen, maar het gestarte onderzoek moet worden afgemaakt tot in het jaar 2021 (en daarom is Kiadis nog lang niet uit de financiele problemen).

Dit artikel verscheen 2 dagen nadat Kiadis had besloten om volledig te stoppen met ATIR101. En dat maakt de invalshoek van de auteur zo interessant. De schrijver komt niet met bronvermeldingen over het door moeten laten gaan van de onderzoeken, en wellicht zijn die er ook niet. Het is een interessante invalshoek.


ff_relativeren schreef op 15 dec 2019 om 18:21:

Het was nog minder dan gelijkwaardig. Met gelijkwaardige resultaten had Kiadis de voorwaardelijke goedkeuring gekregen. Die goedkeuring kwam er niet. Omdat ATIR101 niet gelijkwaardig was.

ATIR is een afgesloten hoofdstuk dat slecht geschreven was. Er zit geen waarde in ATIR101. Sterker nog, na afloop van het ATIR-verhaal moet er ineens zoveel geld worden uitgegeven, dat er tot half 2020 meer geld wordt verbrand, dan in het laatste (duurste) jaar van ATIR101.

Hoe heeft dit kunnen gebeuren? Met KBC analist die zeer positief was over het middel. De hamvraag blijft, heeft men in fase 2 ook de resultaten vergeleken met het Baltimoreprotocol? Dus niet na afronding fase 2. Nu zullen ze nooit bij Kiadis de info gaan delen of men het zag aankomen, dat er problemen waren met vergelijking. Beleggers kregen alleen maar een goed nieuws show te horen.
Hier nog wat achtergronden van de acquisitie van Cytosen (April 17, 2019):

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.

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.

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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