MIAMI--(BUSINESS WIRE)--Makana™ Therapeutics, a global leader in the field of xenotransplantation, announced today that the company’s scientists have discovered that pigs contain a fourth gene that when inactivated will greatly reduce the risk of organ rejection in a human recipient.

迈阿密--（商业新闻短讯）--异种移植领域的全球领导者Makana™Therapeutics今天宣布，该公司的科学家发现猪含有第四种基因，该基因失活后将大大降低人类受体器官排斥的风险。

Makana’s Triple Knockout Pig (“TKO”) is the current foundational genetics used across the field, and is deficient in three genes which drive hyperacute rejection of pig tissue transplanted into humans. In 2012, Makana scientists discovered the first two of the TKO’s genetic pig modifications and, in 2014, discovered the third.

马卡纳的三基因敲除猪（“TKO”）是目前该领域使用的基础遗传学，缺乏三种基因，这些基因会导致移植到人类体内的猪组织超急性排斥反应。2012年，马卡纳科学家发现了TKO基因猪的前两个修饰，2014年发现了第三个。

Now in 2024, Makana has found a fourth genetic knockout required to address the early rejection seen in clinical application of pig organs transplanted into human recipients..

现在，在2024年，马卡纳发现了第四个基因敲除，需要解决移植到人类受体中的猪器官的临床应用中出现的早期排斥反应。。

In recently publicized pig-to-human xenotransplantations, the transplanted organs were rejected by their human recipients within a two-month period. Each of those transplants were approved under “compassionate use” protocols and were not part of a U.S. Food and Drug Administration (FDA) clinical trial.

在最近公布的猪对人异种移植中，移植的器官在两个月内被人类受体排斥。这些移植中的每一个都是根据“同情使用”方案批准的，并且不是美国食品和药物管理局（FDA）临床试验的一部分。

These consistent early losses led Makana to direct its discovery efforts to identify the mechanism responsible for the failures. Every human sample Makana analyzed contained antibodies to the antigen eliminated by Makana’s fourth genetic target..

这些持续的早期损失导致Makana指导其发现工作，以确定导致故障的机制。马卡纳分析的每个人类样本都含有针对马卡纳第四个遗传靶标消除的抗原的抗体。。

Joe Tector, MD, PhD, FACS, Makana’s founder and a practicing transplant surgeon at the Miami Transplant Institute, said, “Our research continues to focus on better understanding the mechanisms of organ rejection in xenotransplantation. As a result, we have discovered an additional human immune system response responsible for early xenograft organ failure.

迈阿密移植研究所（Miami transplant Institute）马卡纳（Makana）创始人兼执业移植外科医生乔·特克托（Joe Tector）医学博士、博士、FACS表示：“我们的研究继续集中于更好地了解异种移植中器官排斥的机制。因此，我们发现了另一种导致早期异种移植器官衰竭的人体免疫系统反应。

We have already created healthy pigs that inactivate the fourth gene to evade this immune response. This is a major breakthrough that will pave the way for clinical success in xenotransplantation.”.

我们已经创造了健康的猪，使第四个基因失活以逃避这种免疫反应。这是一项重大突破，将为异种移植的临床成功铺平道路。”。

Mark Platt, Makana’s Chief Executive Officer, said pigs incorporating this knockout were produced last year as part of its research collaboration with the University of Miami. He added that Makana is preparing to launch its Definitive Preclinical Study in 2025 with plans to conduct a First-in-Human Clinical Trial in kidney xenotransplantation in early 2026 (upon FDA approval)..

。他补充说，Makana正准备在2025年启动其最终的临床前研究，计划在2026年初（经FDA批准）进行首次人体异种肾移植临床试验。。

Specifics of Makana’s research will be detailed in a scientific paper to be published in the coming weeks.

马卡纳研究的细节将在未来几周发表的一篇科学论文中详细介绍。

Platt said Makana’s first focus will be in the kidney space. According to the National Kidney Foundation, there were 786,000 patients in the U.S. living with kidney failure in 2021. In 2022, there were approximately 25,000 kidney transplants performed in the U.S. However there are still an estimated twelve people dying each day in the U.S.

普拉特说，马卡纳的第一个重点将是肾脏空间。根据国家肾脏基金会的数据，2021年美国有786000名肾衰竭患者。2022年，美国大约进行了25000例肾脏移植。然而，据估计，美国每天仍有12人死亡。

while waiting to receive a life-saving kidney transplant. Currently there are more than 93,000 people on the U.S. kidney transplant waitlist. “This has been an enduring challenge for organ transplantation, with the waiting list substantially larger than the supply of donor organs,” Platt said. “Our sole focus is to restore an entirely normal life to every patient with organ failure.”.

在等待接受挽救生命的肾脏移植时。目前，美国肾脏移植候补名单上有93000多人。普拉特说：“这对器官移植来说是一个持久的挑战，等待名单远远超过了供体器官的供应。”。“我们唯一的重点是让每个器官衰竭患者恢复完全正常的生活。”。

About Makana Therapeutics

关于Makana Therapeutics

Founded in 2009, Makana Therapeutics is focused on developing swine with reduced xenoantigen expression, making human transplantation of cells, tissues and organs from these animals possible. Makana's focus on scientifically validated genetics, optimized pig cloning techniques and careful patient selection is expected to streamline product development and result in safer more efficacious products.

Makana Therapeutics成立于2009年，专注于开发异种抗原表达减少的猪，使这些动物的细胞，组织和器官的人体移植成为可能。马卡纳专注于科学验证的遗传学，优化的猪克隆技术和仔细的患者选择，有望简化产品开发，并产生更安全更有效的产品。

For more information on Makana, please visit www.makanatherapeutics.com..

有关Makana的更多信息，请访问www.makanatherapeutics.com。。