share_log

Cynata Therapeutics' Breakthrough in Regenerative Medicine

Cynata Therapeutics' Breakthrough in Regenerative Medicine

Cynata Therapeutics 在再生医学领域的突破
sharecafe ·  03/14 06:30

Peter Milios: I am Peter Milios from the Finance News Network, and today I am talking with Cynata Therapeutics. Cynata is a clinical stage stem cell and regenerative medicine company. Their ASX code is CYP and they have a market cap of around $35 million. Here to tell us more is Cynata's CEO and the Managing Director, Kilian Kelly. Kilian, welcome to the network.

彼得·米利奥斯:我是金融新闻网的彼得·米利奥斯,今天我正在和Cynata Therapeutics交谈。Cynata是一家临床阶段的干细胞和再生医学公司。他们的澳大利亚证券交易所代码为CYP,市值约为3500万美元。要告诉我们更多的是Cynata的首席执行官兼董事总经理基利安·凯利。Kilian,欢迎来到这个网络。

Kilian Kelly: Thank you and nice to be here, Peter.

基利安·凯利:谢谢你,很高兴来到这里,彼得。

Peter Milios: First off, could you provide some background of Cynata for people who might not know or be familiar with the company?

彼得·米利奥斯:首先,你能否为可能不了解或不熟悉公司的人提供一些Cynata的背景信息?

Kilian Kelly: Yeah. So Cynata is a biotechnology company based in Melbourne. We've been operating for a bit over 10 years. We're focused on the development of stem cell and regenerative medicine products. So really what that means is we're making novel therapies for various serious medical disorders that have unmet needs at the moment. And we've got a total of four active clinical trial programs at the moment in graft versus host disease, diabetic foot ulcers, osteoarthritis and kidney transplantation. So we've got quite a wide and broad portfolio. And those trials are at various stages, but there's really a lot of activity happening right now.

基利安·凯利:是的。因此,Cynata是一家总部位于墨尔本的生物技术公司。我们已经运营了十多年。我们专注于干细胞和再生医学产品的开发。因此,这实际上意味着我们正在为目前需求未得到满足的各种严重疾病开发新疗法。目前,我们在移植物抗宿主病、糖尿病足溃疡、骨关节炎和肾脏移植方面共有四个正在进行的临床试验项目。因此,我们有相当广泛和广泛的产品组合。这些试验处于不同的阶段,但是现在确实有很多活动正在进行。

Peter Milios: So what does the competitive landscape look like for Cynata's therapies and what makes Cynata unique overall?

彼得·米利奥斯:那么,Cynata疗法的竞争格局是什么样子,是什么让Cynata在整体上与众不同呢?

Kilian Kelly: Yeah. So look, the field of stem cells and regenerative medicine has really exploded over the last, say 10 years or thereabout. And there's a lot of companies operating in this space as you would expect, because there's a huge amount of potential from these kinds of therapies. But what really sets Cynata apart is the way that we make our stem cell products. And so a conventional way of making these cells and the way that pretty much everybody else does it, is that they get donations from donors who donate their bone marrow or fat or placenta, for example, various tissues. And they then isolate the stem cells of interest and turn those into therapeutic products. And that works to an extent but there's some fundamental challenges with it. And in particular, you get a lot of variability from one donor to another. And there's also a limit to how many doses you can produce from any one donation.

基利安·凯利:是的。所以你看,干细胞和再生医学领域在过去十年左右确实发生了爆炸式增长。正如你所预料的那样,有很多公司在这个领域运营,因为这类疗法有巨大的潜力。但是,真正让Cynata与众不同的是我们生产干细胞产品的方式。因此,制造这些细胞的一种传统方法以及几乎所有其他人制造这些细胞的方法是,它们从捐赠骨髓、脂肪或胎盘(例如各种组织)的捐赠者那里获得捐赠。然后,他们分离出感兴趣的干细胞,并将其转化为治疗产品。这在一定程度上是行之有效的,但它存在一些根本性的挑战。特别是,从一个捐赠者到另一个捐赠者,你会有很大的差异。而且,任何一笔捐赠可以产生多少剂量也是有限制的。

And that's because the cells that you isolate in that way, they don't have the ability to just continuously grow in a lab, which is really how they make these products into a scalable technology. And what we do is a completely different sort of a process. It's based on a type of stem cell called an induced pluripotent stem cell. And what that means is really that these cells have the ability to reproduce themselves in a lab to an effectively limitless degree, and you can then turn those cells into the type of cell that you want to use for therapy. So what that means is we can make an essentially limitless number of doses from one donor one time. So we don't have to go back and get new donors, and we don't have that problem with variability or with the limitation in the number of doses that we can produce from one donor. So it really completely allows us to make this in a consistent and scalable way well into the future.

那是因为你用这种方式分离出来的细胞,它们无法在实验室中持续生长,而这正是它们将这些产品变成可扩展技术的方式。而我们所做的是一个完全不同的过程。它基于一种叫做诱导多能干细胞的干细胞。这实际上意味着这些细胞能够在实验室中无限地自我繁殖,然后你可以将这些细胞转化为你想要用于治疗的那种细胞。因此,这意味着我们一次可以从一个捐赠者那里获得基本上无限数量的剂量。因此,我们不必回去寻找新的捐赠者,也不存在可变性或我们可以从一个捐赠者身上生产的剂量数量有限的问题。因此,它确实完全允许我们在未来很长一段时间内以一致和可扩展的方式实现这一目标。

Peter Milios: Moving on to recent news, congratulations on the appointment of your first chief business officer, Matthias Kroll. What can you tell us about Matthias role, and why now and what will Matthias bring to Cynata?

彼得·米利奥斯:接下来是最近的新闻,恭喜你的第一任首席商务官马蒂亚斯·克罗尔被任命。关于马蒂亚斯扮演的角色,你能告诉我们什么,为什么是现在,以及马蒂亚斯将为Cynata带来什么?

Kilian Kelly: Yeah, so we've really created this role with an eye on the next stage of the company's growth. So now we've got four clinical programs ongoing. As I said, we're generating a lot of very exciting data and we have a partnership driven business model. So we're seeking to partner with larger companies, big pharmaceutical companies and so on who have the wherewithal to take these products right through to commercialization. And the role is really aimed at focusing on that and building those partnerships. And Matthias himself has a fantastic track record in that space. He's worked in the industry for over 25 years. He's done some huge deals, many of which involve smaller companies with a novelty technology like ours and partnering that with bigger companies. So I think it's a great appointment for the company and it really positioned us to help move to that next stage and start putting some of these partnerships in place.

Kilian Kelly:是的,所以我们创建这个职位的确着眼于公司的下一阶段的发展。因此,现在我们有四个临床项目正在进行中。正如我所说,我们正在生成许多非常令人兴奋的数据,而且我们有一个以伙伴关系为导向的商业模式。因此,我们正在寻求与大型公司、大型制药公司等合作,这些公司有足够的资金将这些产品直接推向商业化。而这个角色实际上是为了专注于这个问题并建立这些伙伴关系。而且马蒂亚斯本人在这个领域有着出色的往绩。他在该行业工作了超过25年。他做了一些大笔交易,其中许多涉及小型公司使用像我们这样的新兴技术,并与大型公司合作。因此,我认为这对公司来说是一个很好的任命,它确实使我们能够帮助我们进入下一阶段并开始建立其中一些合作伙伴关系。

Peter Milios: You recently released promising results in a trial for treatment of diabetic foot ulcer. Could you talk us through what the condition is, what the key findings from the child were and what do these results mean for people with DFU?

彼得·米利奥斯:你最近在一项治疗糖尿病足溃疡的试验中发布了令人鼓舞的结果。你能否告诉我们病情是什么,孩子的关键发现是什么,这些结果对DFU患者意味着什么?

Kilian Kelly: Yeah, so diabetic foot ulcers are a huge problem and it's becoming a growing problem. And really it is one of various complications that happens to people with chronic diabetes. And of course that is becoming a more and more common condition, especially in the western world. And what happens is because the diabetes affects the blood flow in their lower limbs, they tend to get these wounds that occur and those wounds then just don't heal. So that's a huge problem. It can lead to obviously pain and discomfort, but then it can lead to serious infections and often even results in amputation of the foot or the lower limb. So it's an enormous problem, and current treatments just don't work very well. So the product that we have is a novel dressing, which is seeded with the MSC stem cells and applied to the wound. And this trial that we've got ongoing, it's a randomized trial where patients receive either that novel stem cell dressing or just standard of care dressings.

基利安·凯利:是的,所以糖尿病足溃疡是个大问题,而且问题越来越严重。实际上,这是慢性糖尿病患者发生的各种并发症之一。当然,这正变得越来越普遍,尤其是在西方世界。之所以会发生什么,是因为糖尿病会影响他们下肢的血液流动,他们往往会出现这些伤口,然后这些伤口就无法愈合。所以这是一个很大的问题。它可能导致明显的疼痛和不适,但随后可能导致严重的感染,甚至经常导致足部或下肢截肢。因此,这是一个巨大的问题,而目前的治疗方法效果不佳。因此,我们拥有的产品是一种新型的敷料,它接种了MSC干细胞并涂抹在伤口上。而我们正在进行的这项试验,它是一项随机试验,患者要么接受新的干细胞敷料,要么只接受标准的护理敷料。

We released data very recently in the first 16 patients in this trial, so there's eight in each group and they'd reached the 10-week follow-up. And what we saw was that in the active stem cell group, we saw a median wound healing, a reduction in the size of the wounds of almost 90% compared to just over 50% in the control. So that's obviously a huge improvement. And what it shows is those patients are very close to being completely healed, which is of course what we're trying to do. So if we can show that sort of an effect with the full trial and obviously then continue through further development, we believe that we've really got a product that has huge potential in this setting. And what that could mean is really that these patients, instead of having these chronic wounds that just don't go away and just end up causing further problems, that perhaps that they could then have a treatment that's actually able to resolve these wounds and let them get back to living a normal life. So it's a really exciting program.

我们最近发布了该试验的前16名患者的数据,因此每组有8名患者,他们已经进入了为期10周的随访时间。我们看到的是,在活性干细胞组中,我们看到的伤口愈合度为中位数,伤口大小减小了近 90%,而对照组的略高于 50%。因此,这显然是一个巨大的进步。它表明这些患者已经接近完全康复了,这当然是我们想要做的。因此,如果我们能够在全面试用中表现出这种效果,然后继续进行进一步的开发,那么我们相信我们确实有了一款在这种环境下具有巨大潜力的产品。这实际上可能意味着,这些患者与其患有无法消失的慢性伤口,最终会造成更多问题,不如他们得到一种真正能够治愈这些伤口并让他们恢复正常生活的治疗。因此,这是一个非常令人兴奋的节目。

Peter Milios: Yeah, it does sound very positive. Just on that note, when is the trial due for completion and is it anticipated the patch will be available broadly to people with DFU?

彼得·米利奥斯:是的,听起来确实很积极。顺便说一句,试用版何时完成?预计该补丁会向拥有DFU的人广泛提供吗?

Kilian Kelly: Yeah, so this trial is very close to finishing recruitment. And we hope that that will happen very imminently, perhaps within the next month or two. And then there's a six-month follow-up of all the patients. So we should have final results of that trial hopefully late this calendar year. And in terms of making the trial more broadly available, what we'd expect is that there'll have to be a larger clinical trial conducted first. And then ultimately, of course, we want get this product on the market and widely available. And again, that's really where our partnership driven business model comes in. We're already talking to various companies who have an interest in partnering with us to help take this product through to market.

基利安·凯利:是的,所以这次审判已经接近完成招募了。我们希望这将很快发生,也许在接下来的一两个月内。然后对所有患者进行为期六个月的随访。因此,我们有望在本日历年晚些时候得出该试验的最终结果。在更广泛地提供试验方面,我们预计必须首先进行更大规模的临床试验。当然,最终,我们希望将该产品投放市场并广泛使用。再说一遍,这确实是我们以伙伴关系为导向的商业模式的用武之地。我们已经在与多家有兴趣与我们合作以帮助将该产品推向市场的公司进行交谈。

Peter Milios: And moving on to another indication, you announced earlier this month that you treated the first patient for acute graft versus host disease. Could you share more details about this please?

彼得·米利奥斯:接下来是另一个适应症,你在本月早些时候宣布,你治疗了第一位急性移植物抗宿主病患者。你能分享更多关于这个的细节吗?

Kilian Kelly: Yeah, so graft versus host disease is a rare condition thankfully because it's a truly horrible condition. It occurs in patients who've received a bone marrow transplant or a similar procedure. And those procedures are used to treat certain types of blood cancers. And the transplant can work well, but graft versus host disease often occurs and it basically involves immune cells in that transplant attacking the recipient as if the recipient's body is foreign. And it has really awful symptoms and it unfortunately often leads to death. So in patients who don't respond to steroids which is the standard treatment, something like 80% of them won't survive for about two years normally. We conducted a phase one trial where we got really, really exciting results. We saw a response in 13 out of 15 patients treated with our cells and a complete response in eight out of 15. And we've now started a phase two trial, which is a global trial in Australia, Europe, and the US. And just very recently we recruited the first patient in that trial, which of course is a very exciting milestone in any project. And we're hoping to complete recruitment of that trial by the end of this calendar year. And if we achieve that, we should have results around about the second half of next year. So really not that long until we would have the second phase of results in this program.

基利安·凯利:是的,谢天谢地,移植物抗宿主病是一种罕见的疾病,因为它是一种非常可怕的疾病。它发生在接受过骨髓移植或类似手术的患者身上。这些手术用于治疗某些类型的血液癌。而且移植可以很好地进行,但是移植物抗宿主病经常发生,它基本上涉及移植中的免疫细胞攻击接受者,就好像接受者的身体是异物一样。而且它的症状非常糟糕,不幸的是,它经常导致死亡。因此,在对类固醇(标准治疗方法)没有反应的患者中,大约80%的患者无法正常存活大约两年。我们进行了第一阶段试验,取得了非常令人兴奋的结果。在接受我们细胞治疗的15名患者中,有13名出现了反应,在15名患者中有8名出现了完全的反应。我们现在已经开始了第二阶段试验,这是一项在澳大利亚、欧洲和美国进行的全球试验。就在最近,我们在该试验中招募了第一位患者,这在任何项目中当然都是一个非常令人兴奋的里程碑。我们希望在本日历年年底之前完成该试验的招募工作。而且,如果我们实现了这一目标,我们应该在明年下半年左右取得成果。因此,不久之后我们就会得出该计划的第二阶段结果。

Peter Milios: And you touched on it briefly, and when is further trial recruitment likely?

彼得·米利奥斯:你简短地谈到了这个问题,何时可能进行进一步的试用招聘?

Kilian Kelly: We've got multiple sites open for recruitment right now. Now unfortunately, this is a rare condition so even the major clinical centers don't see patients with this disease every day of the week. Well, I say unfortunately, it's actually fortunate for patients but it makes it somewhat slow to recruit the patients. But we are aiming to get more than 30 clinical sites open in this trial, and we're really getting that critical mass going now. So we're expecting recruitment to really kick on from here, and we'll be seeing new patients coming in on a regular basis.

基利安·凯利:我们现在有多个招聘网站可供招聘。不幸的是,这是一种罕见的疾病,因此即使是主要的临床中心也不会在一周中的每一天都看这种疾病的患者。好吧,不幸的是,这对患者来说实际上是幸运的,但这使得招募患者变得有些缓慢。但是我们的目标是在这项试验中开放30多个临床场所,而我们现在的确正在达到如此临界的规模。因此,我们预计招募工作将从这里真正开始,我们将定期看到新的患者进来。

Peter Milios: You closed your osteoarthritis trial just before Christmas, when will the results be made to the public?

彼得·米利奥斯:你在圣诞节前结束了骨关节炎试验,结果何时会公布?

Kilian Kelly: Yeah, so that was a really huge trial. 320 patients were recruited, and the last of them in November. We're looking to show a disease modifying effect in this trial, which means that not just that the cells improve pain and inflammation, but they also actually change the progress of the disease and hopefully stop further deterioration. And so because of that, we have to follow the patients for two years. So the last patient visit will be in November next year, and then we'll have results within a few months of that. So likely early 2026 for the results of that one.

基利安·凯利:是的,那是一项非常大规模的试验。招募了320名患者,最后一次是在11月。我们希望在这项试验中显示出一种改善疾病的作用,这意味着细胞不仅可以改善疼痛和炎症,而且它们实际上还能改变疾病的进展,并有望阻止进一步恶化。因此,正因为如此,我们必须对患者进行两年的随访。因此,最后一次患者就诊将在明年11月,然后我们将在此后的几个月内得出结果。那场比赛的结果很可能是2026年初。

Peter Milios: And could you comment on your kidney transplant trial?

彼得·米利奥斯:你能评论一下你的肾脏移植试验吗?

Kilian Kelly: Yeah, so this is a trial that was approved late last yea and it's just about to start. It's going to take place in the Netherlands in partnership with a major center over there called Leiden University Medical Center. And the idea here is that, as you may know, patients who get a kidney transplant have to take immunosuppressant drugs which stop the transplant being rejected. And they usually have to take those drugs for the rest of their lives, and while they work well, the problem is they're very toxic. They cause an increased rate of infection, increased rate of cancer, and they can actually damage the kidneys as well which is of course very unfortunate in these patients. So what we're seeking to do is to use our MSC stem cell product to allow the dose of those immunosuppressant drugs to be dramatically reduced or potentially withdrawn completely. And if we can show that we can do that without causing an increase in the rejection of the transplant, it could really kind of transform the way that those patients are managed.

基利安·凯利:是的,所以这是一项去年年底批准的试验,而且即将开始。它将与荷兰的一个名为莱顿大学医学中心的主要中心合作在荷兰举行。正如你可能知道的那样,这里的想法是,接受肾脏移植的患者必须服用免疫抑制剂来阻止移植被拒绝。而且他们通常必须在余生中服用这些药物,虽然效果很好,但问题在于它们的毒性很大。它们会导致感染率增加,癌症发病率增加,实际上还会损害肾脏,这对于这些患者来说当然是非常不幸的。因此,我们想要做的是使用我们的MSC干细胞产品来大幅减少这些免疫抑制剂的剂量或有可能完全停用。而且,如果我们能够证明我们可以在不增加移植排斥反应的情况下做到这一点,那么它确实可以改变这些患者的管理方式。

Peter Milios: Kilian Kelly, thank you for your time today. And we'll be watching the company's progress with interest.

彼得·米利奥斯:基利安·凯利,感谢你今天抽出宝贵时间。我们将饶有兴趣地关注公司的进展。

Kilian Kelly: Thank you very much.

基利安·凯利:非常感谢。

Ends.

结束。

1x1.png?futu_img_keep_extra_domain=1

译文内容由第三方软件翻译。


以上内容仅用作资讯或教育之目的,不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
    抢沙发