NATICK, Mass. & LONDON--(BUSINESS WIRE)--Aleta Biotherapeutics (Aleta), a clinical stage, immuno-oncology company with a CAR T-Cell Engager (CTE) platform that enables cell cancer therapies to work more effectively, and Cancer Research UK’s Centre for Drug Development, today announce the first patient was dosed in a Phase 1/2 clinical trial.

马萨诸塞州内蒂克和伦敦——（商业新闻短讯）——Aleta Biotherapeutics（Aleta）是一家临床阶段的免疫肿瘤学公司，拥有一个CAR T细胞接受者（CTE）平台，可以使细胞癌治疗更有效地发挥作用，英国癌症研究药物开发中心今天宣布，第一名患者在1/2期临床试验中服用了药物。

This trial is evaluating the Company’s first-in-class biologic CAR T-Cell Engager, ALETA-001, for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19-targeting CAR T-cell therapy..

该试验正在评估该公司第一批生物CAR T细胞接受者ALETA-001，用于治疗针对CD19靶向CAR T细胞疗法复发/难治的B细胞恶性肿瘤患者。。

Cancer Research UK’s Centre for Drug Development is sponsoring and conducting the Phase 1/2 clinical trial of ALETA-001, the lead agent in Aleta's portfolio.

英国癌症研究中心的药物开发中心正在赞助和进行ALETA-001的1/2期临床试验，ALETA-001是ALETA投资组合的主要代理。

“It is very exciting and meaningful to have ALETA-001 now in the clinic. Clinical evaluation of ALETA-001 is a key milestone toward a much-needed treatment option for the many cancer patients whose CD19-targeted CAR T-cell therapies ultimately stop working. ALETA-001 restores and increases the effectiveness with which CAR T-cells can kill cancer cells, and we believe that it will enable more patients to successfully benefit from cell therapies,” stated Dr.

“现在将ALETA-001应用于临床是非常令人兴奋和有意义的。ALETA-001的临床评估是许多癌症患者迫切需要的治疗选择的关键里程碑，这些患者的CD19靶向CAR T细胞疗法最终停止工作。ALETA-001恢复并提高了CAR T细胞杀死癌细胞的有效性，我们相信它将使更多的pa患者成功地从细胞疗法中受益，”Dr。

Paul Rennert, President and Chief Scientific Officer, Aleta Biotherapeutics..

Paul Rennert，Aleta Biotherapeutics总裁兼首席科学官。。

The ALETA-001 Phase 1/2 clinical trial is an open-label, dose-expansion trial which will evaluate safety and tolerability, pharmacokinetic and pharmacodynamic effects, and early signals of clinical efficacy of ALETA-001 as a single agent. Chief Investigator Dr. Sridhar Chaganti is leading the trial from University Hospital Birmingham NHS Foundation Trust in Birmingham, UK, and will enroll patients who are relapsed/refractory following treatment with available CD19-targeting CAR T-cell therapies.

ALETA-001 1/2期临床试验是一项开放标签的剂量扩展试验，将评估ALETA-001作为单一药物的安全性和耐受性，药代动力学和药效学效应以及临床疗效的早期信号。首席研究员Sridhar Chaganti博士正在英国伯明翰大学医院NHS基金会信托基金会领导这项试验，并将招募使用靶向CD19的CAR T细胞疗法治疗后复发/难治的患者。

For more information on this trial, please visit clinicaltrials.gov (NCT06045910).

有关此试验的更多信息，请访问clinicaltrials.gov（NCT06045910）。

Dr. Lars Erwig, Cancer Research UK’s Director of Drug Development, said, 'A significant number of patients with blood cancers unfortunately relapse following CD19-directed CAR T-cell therapy. ALETA-001 is being developed to provide patients with these cancers a better chance for a successful treatment outcome.

英国癌症研究所药物开发主任拉尔斯·埃尔维格博士说，“在CD19指导的CAR T细胞治疗后，许多血癌患者不幸复发。ALETA-001的开发旨在为这些癌症患者提供更好的成功治疗机会。

At Cancer Research UK, we are very excited to study the clinical potential of ALETA-001 to transform a patient’s treatment journey - which can possibly be lifesaving in many cases.'.

在英国癌症研究所（Cancer Research UK），我们非常兴奋地研究ALETA-001改变患者治疗过程的临床潜力，这在许多情况下可能会挽救生命。”。

“Aleta-001 is a uniquely designed new molecule with a novel mechanism of action, coating tumor cells densely with the target antigen, thereby stimulating the tumor killing ability of activated CAR T-cells,” commented Dr. Sridhar Chaganti, Chief Investigator, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.

英国伯明翰大学医院NHS基金会信托基金会首席研究员Sridhar Chaganti博士评论道：“Aleta-001是一种独特设计的新分子，具有新颖的作用机制，用靶抗原密集地包裹肿瘤细胞，从而刺激活化的CAR T细胞的肿瘤杀伤能力。”。

“This is an important new strategy being investigated to improve outcomes for patients with relapsed or refractory lymphomas who experience disease progression after CAR T-cell therapy and have a poor prognosis.”.

“这是一项重要的新策略，正在研究以改善复发或难治性淋巴瘤患者的预后，这些患者在CAR T细胞治疗后出现疾病进展，预后不良。”。

About CAR T-Cell Therapy Engager (CTE) ALETA-001

关于CAR T细胞治疗参与者（CTE）ALETA-001

Aleta’s lead clinical stage program, ALETA-001, was designed specifically for the treatment of B-cell malignancies in patients who have received a CD19-directed CAR T-cell therapy and are at risk of treatment failure. Developed to improve the effectiveness of CD19-directed CAR T-cell therapies by increasing CD19 antigen density and restoring lost CD19 expression on the cancer cell, ALETA-001 contains the CD19 target protein which is further linked to an CD20 antibody domain.

Aleta的主要临床阶段计划Aleta-001专门用于治疗接受CD19指导的CAR T细胞治疗且有治疗失败风险的患者的B细胞恶性肿瘤。ALETA-001通过增加CD19抗原密度和恢复癌细胞上丢失的CD19表达来提高CD19定向CAR T细胞疗法的有效性，ALETA-001含有CD19靶蛋白，其进一步与CD20抗体结构域连接。

This allows CD19+/CD20+ cancer cells to be easily recognized and killed by CD19-directed CAR T-cells that were previously administered and are already circulating within a patient..

这使得CD19+/CD20+癌细胞很容易被CD19定向的CAR T细胞识别和杀死，这些CAR T细胞先前已经给药并且已经在患者体内循环。。

Aleta previously secured landmark clinical support and funding from Cancer Research UK for the ALETA-001 Phase 1/2 clinical trials, and ALETA-001 has received a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

Aleta之前为Aleta-001 1/2期临床试验获得了英国癌症研究所（Cancer Research UK）具有里程碑意义的临床支持和资金，Aleta-001已获得英国药品和保健品管理局（MHRA）的创新许可和获取途径（ILAP）下的英国创新护照。

ILAP designation is granted to medicines that address life-threatening or seriously debilitating conditions, and where there exists a significant patient or public health need..

ILAP指定用于解决危及生命或严重衰弱状况的药物，以及存在重大患者或公共卫生需求的药物。。

About Aleta Biotherapeutics

关于Aleta Biotherapeutics

Aleta Biotherapeutics is pioneering a transformation of cancer treatment by enabling CAR T-cell cancer therapies to work more effectively. The Company’s unique portfolio of multi-antigen CAR T Engagers (CTEs) are simple, potent biologic therapies designed to transform the expression of cancer tumor cells to match CAR T-cell therapies circulating in patient blood.

Aleta Biotherapeutics通过使CAR T细胞癌症疗法更有效地发挥作用，开创了癌症治疗的转变。该公司独特的多抗原CAR T参与者（CTE）组合是简单有效的生物疗法，旨在转化癌肿瘤细胞的表达，以匹配患者血液中循环的CAR T细胞疗法。

These CTEs are being developed to produce deeper and more durable responses in patients receiving CAR T-cell therapies through increasing cancer target density, and preventing resistance and escape from therapy, thus increasing the speed and effectiveness with which CAR T-cells can kill cancer cells..

正在开发这些CTE，以通过增加癌症靶标密度，预防耐药性和逃避治疗，从而提高CAR T细胞杀死癌细胞的速度和有效性，从而在接受CAR T细胞治疗的患者中产生更深入和更持久的反应。。

Aleta’s lead clinical stage biologic, ALETA-001 was designed specifically for the treatment of B-cell malignancies in patients who have received a CD19-directed CAR T-cell therapy and are at risk of treatment failure. Aleta is further developing its CTE platform technology to address acute myeloid leukemia, multiple myeloma, and solid tumors including breast cancer, gastric cancer, and pediatric brain cancers.

Aleta的首席临床阶段生物制剂Aleta-001专门用于治疗接受CD19定向CAR T细胞治疗且有治疗失败风险的患者的B细胞恶性肿瘤。Aleta正在进一步开发其CTE平台技术，以解决急性骨髓性白血病，多发性骨髓瘤和实体瘤，包括乳腺癌，胃癌和小儿脑癌。

aletabio.com.

aletabio.com。

About Cancer Research UK’s Centre for Drug Development

关于英国癌症研究药物开发中心

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of over 20 new anti-cancer agents in preclinical development, Phase 1, or early Phase 2a clinical trials.

英国癌症研究院（CancerResearch UK）在开发新型癌症治疗方法方面有着令人印象深刻的记录。英国癌症研究药物开发中心（CancerResearch UK Centre for Drug Development）30年来一直在开创新癌症治疗方法的开发，将160多种潜在的新型抗癌药物纳入患者的临床试验。目前，它在临床前开发，1期或早期2a期临床试验中拥有20多种新型抗癌药物。

Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. 13 other drugs are still undergoing active development. www.cruk.org.uk/cdd.

这些新药中有六种已上市，包括用于脑癌的替莫唑胺、用于前列腺癌的阿比特龙和用于卵巢癌的鲁卡帕利。其他13种药物仍在积极开发中。www.cruk.org.uk/cdd。