SEATTLE--(BUSINESS WIRE)--KayoThera, Inc. (“KayoThera”), an early-stage therapeutics company developing first-in-class, oral, small molecule inhibitors of the retinoid pathway, today announces that it has selected KAYO-1609 as its first drug development candidate. KAYO-1609 has demonstrated a differentiated safety profile across a variety of species with ideal drug-like properties.

西雅图-（商业线）-KayoThera，Inc.（“KayoThera”）是一家开发类视黄醇途径一流，口服，小分子抑制剂的早期治疗公司，今天宣布它已选择KAYO-1609作为其第一个药物开发候选人。KAYO-1609在各种具有理想药物特性的物种中表现出不同的安全性。

Preclinical studies in multiple models of cancer support the potential of KAYO-1609 in the treatment of genetically-defined cancers based on the molecule’s mechanism of action. With the nomination of KAYO-1609 as the development candidate, KayoThera is well-positioned for IND-enabling studies, clinical planning, and partnering activities..

多种癌症模型的临床前研究支持KAYO-1609基于分子的作用机制治疗遗传定义的癌症的潜力。随着KAYO-1609被提名为开发候选人，KayoThera在IND开展研究，临床计划和合作活动方面处于有利地位。。

Retinoid signaling is known to both inhibit helper CD4 T cells that mediate tumor cell destruction, and cause maturation of regulatory T cells that dampen the immune system’s response to cancer. Retinoid signaling further forces differentiation of monocytes into tumor-associated macrophages that can promote tumor growth and metastasis.

已知类视黄醇信号传导既抑制介导肿瘤细胞破坏的辅助性CD4T细胞，又引起调节性T细胞的成熟，从而抑制免疫系统对癌症的反应。类视黄醇信号传导进一步迫使单核细胞分化成可促进肿瘤生长和转移的肿瘤相关巨噬细胞。

Collectively, these activities reduce the immune system’s ability to detect and eliminate malignant cells. Inhibition of the amplified retinoid signaling found in unique tumor types could potentially restore or enhance the anti-tumor immune activity, enabling a unique approach to cancer immunotherapy in patients with few therapeutic options..

总的来说，这些活动降低了免疫系统检测和消除恶性细胞的能力。抑制在独特肿瘤类型中发现的扩增的类视黄醇信号传导可以潜在地恢复或增强抗肿瘤免疫活性，从而在几乎没有治疗选择的患者中实现独特的癌症免疫治疗方法。。

“Despite its known roles in blunting the body’s anti-tumor immune defense, previous efforts to develop retinoid signaling antagonists have failed due to unacceptable toxicity in preclinical development,” said Mark Esposito, Ph.D., vice president of R&D, and co-founder of KayoThera. “The discoveries on which KayoThera was founded enable the development of orally available, small molecule inhibitors of this important signaling pathway that have very favorable safety profiles.

研发副总裁兼KayoThera联合创始人Mark Esposito博士说：“尽管已知其在减弱人体抗肿瘤免疫防御方面的作用，但由于在临床前开发中具有不可接受的毒性，以前开发类视黄醇信号拮抗剂的努力失败了。”。“KayoThera成立的发现使得开发这种重要信号通路的口服小分子抑制剂具有非常有利的安全性。

The preclinical safety and efficacy data generated to date in studies of KAYO-1609 are exceptionally promising, and we intend to move as rapidly as possible toward initiating human clinical trials of this novel molecule in genetically-defined cancers.”.

迄今为止在KAYO-1609研究中产生的临床前安全性和有效性数据非常有希望，我们打算尽快开展这种新型分子在基因定义癌症中的人体临床试验。

KAYO-1609 has demonstrated excellent safety and tolerability, with no dose-limiting toxicities observed in studies across five different species. Preclinical studies also have identified a dose-responsive biomarker for target engagement that is expected to facilitate the IND-enabling studies. KayoThera expects to initiate IND-enabling studies of KAYO-1609 in the third quarter of 2023 and anticipates filing an IND application with the FDA by the end of 2024.

KAYO-1609已证明具有出色的安全性和耐受性，在五种不同物种的研究中未观察到剂量限制性毒性。临床前研究还确定了目标参与的剂量反应性生物标志物，预计将促进IND的研究。KayoThera预计将在2023年第三季度启动对KAYO-1609的IND研究，并预计到2024年底向FDA提交IND申请。

Following acceptance of the IND, the company plans to initiate a human clinical trial of KAYO-1609 in patients with genetically-defined cancers that are most likely to demonstrate clinical benefit based on the mechanism of action of KAYO-1609..

在接受IND后，公司计划根据KAYO-1609的作用机制，对最有可能显示临床获益的基因定义癌症患者启动KAYO-1609人体临床试验。。

'The selection of KAYO-1609 as our lead oncology development candidate is the most recent demonstration of the significant progress, we have made over the past few months to position KayoThera for success,” said Kendall Mohler, Ph.D., chief development officer and board member of KayoThera. “In May we announced the expansion of our pipeline into the cardiometabolic disease space, with a focus on Type 2 diabetes and in July we strengthened our financial position with multiple grants and the expansion of our Series A financing.

“选择KAYO-1609作为我们的主要肿瘤开发候选者是最近的重大进展证明，我们在过去几个月中已经取得了成功，以定位KayoThera，”首席开发官Kendall Mohler博士说。和KayoThera的董事会成员。“5月份，我们宣布扩大我们的管道进入心脏代谢疾病领域，重点是2型糖尿病，7月份我们通过多次拨款和扩大我们的a系列融资来加强我们的财务状况。

Taken together, we now have the financial resources to advance exciting and differentiated candidates in cancer and Type 2 diabetes, diseases with significant unmet clinical need that are associated with significant mortality and morbidity. We are committed to developing retinoid signaling pathway inhibitors as novel therapeutic modalities that can improve outcomes for patients living with these and other serious diseases.”.

综合起来，我们现在拥有财政资源来推动癌症和2型糖尿病患者中令人兴奋和分化的候选人，这些疾病具有显着未满足的临床需求，并且与显着的死亡率和发病率相关。我们致力于开发类视黄醇信号通路抑制剂作为新的治疗方式，可以改善患有这些和其他严重疾病的患者的预后。

About KayoThera Inc

关于KayoThera公司

KayoThera, Inc. is an early-stage therapeutics company focused on the development of first-in-class, oral, small molecule inhibitors of the retinoid pathway. This pathway plays a critical role in a variety of serious diseases, including cardiometabolic diseases and cancer. KayoThera is developing therapies to treat diabetes and late-stage and metastatic cancers including breast, lung, pancreatic, colorectal, brain, and kidney cancers.

KayoThera，Inc。是一家早期治疗公司，专注于开发类视黄醇途径的一流，口服，小分子抑制剂。该途径在各种严重疾病中起关键作用，包括心脏代谢疾病和癌症。KayoThera正在开发治疗糖尿病以及晚期和转移性癌症的疗法，包括乳腺癌，肺癌，胰腺癌，结肠直肠癌，脑癌和肾癌。

The company was founded based on discoveries from Dr. Mark Esposito’s post-doctoral research at Princeton University and professor Yibin Kang, PhD. For more information, visit www.kayothera.com..

该公司成立于普林斯顿大学Mark Esposito博士博士后研究和康一斌教授博士的发现。欲了解更多信息，请访问www.kayothera.com。。

About Accelerator Life Science Partners

关于加速器生命科学合作伙伴

Accelerator Life Science Partners (ALSP) is an early-stage life science accelerator and investment firm that creates and builds next generation biotechnology companies centered on innovative science. ALSP catalyzes the development and commercialization of breakthrough biotechnology innovations by providing a holistic toolkit and leveraging its network and entrepreneurial expertise to accelerate the establishment and operation of early-stage biotechnology companies.

加速器生命科学合作伙伴（ALSP）是一家早期生命科学加速器和投资公司，致力于创建和建立以创新科学为中心的下一代生物技术公司。ALSP通过提供整体工具包并利用其网络和创业专业知识，加速早期生物技术公司的建立和运营，促进突破性生物技术创新的发展和商业化。

ALSP’s portfolio companies are backed by renowned life science investors and are comprised of industry-leading, transformative companies, including KayoThera, Inc., Lodo Therapeutics (acquired by Zymergen, now Ginkgo BioWorks), Petra Pharma (acquired by a global pharmaceutical company), Proniras Corporation, and Rodeo Therapeutics (acquired by Amgen Inc.).

ALSP的投资组合公司得到知名生命科学投资者的支持，由行业领先的转型公司组成，包括KayoThera，Inc.，Lodo Therapeutics（由Zymergen收购，现为Ginkgo BioWorks），Petra Pharma（由全球制药公司收购），Proniras Corporation和Rodeo Therapeutics（由Amgen Inc.收购）。

For more information, please visit www.acceleratorlsp.com..

欲了解更多信息，请访问www.acceleratorlsp.com。。