BURLINGAME, Calif.--(BUSINESS WIRE)--Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, today announced the first presentation of TAC-001 Phase 1 clinical safety and efficacy data in solid tumor patients. TAC-001 is an investigational, systemically delivered, TRAAC molecule comprised of a potent TLR9 Agonist conjugated to a CD22 antibody, designed to selectively activate B cells to drive an anti-tumor immune response..

BURLINGAME，加利福尼亚州-（商业线）-Tallac Therapeutics，Inc.，一家利用先天和适应性免疫力量对抗癌症的私营生物制药公司，今天宣布首次推出TAC-001 1期临床安全性和实体瘤患者的疗效数据。TAC-001是一种研究性的，全身递送的TRAAC分子，由与CD22抗体偶联的有效TLR9激动剂组成，旨在选择性激活B细胞以驱动抗肿瘤免疫应答。。

The findings presented in the TAC-001 poster “INCLINE-101: Preliminary Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAC-001 (TLR9 Agonist Conjugated to a CD22 mAb) in Patients With Advanced or Metastatic Solid Tumors” demonstrate that single-agent TAC-001 (0.1 to 3 mg/kg) given systemically every 2 weeks is well tolerated, demonstrates pharmacodynamic activity consistent with its proposed MOA and resulted in preliminary clinical activity with patients achieving durable stable disease (≥6 months) and partial response per RECIST v1.1..

TAC-001海报“Cline-101：晚期或转移性实体瘤患者中TAC-001（与CD22 mAb偶联的TLR9激动剂）的初步安全性，耐受性，药代动力学（PK）和药效学（PD）“证明每2周全身给予单药TAC-001（0.1至3 mg/kg）耐受性良好，证明药效学活性与其提出的MOA一致，并且导致患者达到持久稳定疾病（≥6个月）和每个RECIST v1.1的部分响应的初步临床活性。。

“These TAC-001 clinical data provide evidence that systemic administration of a TLR9 immune agonist targeting and activating B cells is generally well tolerated and induces immune activation consistent with preclinical studies. We also observed single-agent clinical benefit in late-stage metastatic cancer patients which supports the use of this novel agent for treating cancer,” said Kevin N.

“这些TAC-001临床数据提供的证据表明，靶向和激活B细胞的TLR9免疫激动剂的全身给药通常具有良好的耐受性并诱导与临床前研究一致的免疫激活。我们还观察到晚期转移性癌症患者的单药临床益处支持使用这种新药治疗癌症，”Kevin N.说。

Heller, M.D., Chief Medical Officer at Tallac Therapeutics. “The pharmacodynamic biomarker data collected from these patients is highly encouraging. We look forward to continuing TAC-001 monotherapy dose escalation and further evaluating activity in selected patient populations. We would like to thank the participants and their families for their participation in our study.”.

Tallac Therapeutics的首席医疗官Heller，M.D。“从这些患者收集的药效学生物标志物数据非常令人鼓舞，我们期待继续TAC-001单药治疗剂量递增，并进一步评估选定患者人群的活动，我们要感谢参与者及其家属参与我们的研究“。

Additionally, the Company presented preclinical data in the poster titled “TAC-003, a TLR9 Agonist Antibody Conjugate for Targeted Immunotherapy of Nectin-4 Expressing Tumors” that demonstrate TAC-003 induces robust immune cell activation, leading to innate and adaptive immunity against Nectin-4 positive cancers and potent single-agent anti-tumor activity.

此外，该公司在名为“TAC-003，用于表达Nectin-4的肿瘤的靶向免疫治疗的TLR9激动剂-抗体缀合物”的海报中展示了临床前数据，其证明TAC-003诱导强烈的免疫细胞活化，导致先天性和适应性免疫针对Nectin-4阳性癌症和有效的单药抗肿瘤活性。

TAC-003 single agent treatment results in durable curative responses in models with a range of low to high Nectin-4 expression, including anti-PD-1 refractory tumors, with improved efficacy compared to enfortumab vedotin. TAC-003 has completed pre-clinical testing, including exploratory toxicological studies in cynomolgus monkeys, and has been selected as the Company’s third clinical candidate..

TAC-003单药治疗在具有一系列低至高Nectin-4表达（包括抗PD-1难治性肿瘤）的模型中产生持久的治愈反应，与enfortumab vedotin相比具有改善的功效。TAC-003已完成临床前测试，包括食蟹猴的探索性毒理学研究，并被选为该公司的第三名临床候选人。。

“We are excited to see these initial clinical data with TAC-001, the first program from Tallac’s TRAAC platform,” said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. “As we advance the TAC-001 program, we are also progressing our pipeline of immunotherapy candidates. TAC-003 represents a differentiated asset with potential to address unmet medical needs in multiple cancer types.”.

Tallac Therapeutics总裁兼联合创始人Hong I.Wan博士说：“我们很高兴看到TAC-001这是Tallac TRAAC平台的第一个项目，这些初步临床数据。“随着我们推进TAC-001计划，我们也在推进我们的免疫治疗候选人渠道.TAC-003代表了一项差异化资产，有可能解决多种癌症类型未满足的医疗需求。”。

TLR9 agonists are a class of immunotherapy that generate both innate and adaptive immune response, which may produce more robust and durable anti-cancer immunity to help overcome resistance to standard-of-care oncology treatments. TLR9 agonists have demonstrated clinical activity in melanoma patients when administered intratumorally.

TLR9激动剂是一类产生先天性和适应性免疫应答的免疫疗法，其可以产生更强大和持久的抗癌免疫力以帮助克服对标准护理肿瘤学治疗的抗性。当肿瘤内给药时，TLR9激动剂已经在黑素瘤患者中显示出临床活性。

Tallac Therapeutic’s TRAAC platform is designed to deliver a potent and differentiated TLR9 agonist (T-CpG) for targeted immune activation via systemic administration..

Tallac Therapeutic的TRAAC平台旨在通过全身给药为靶向免疫激活提供有效且分化的TLR9激动剂（T-CpG）。。

About TAC-001 (CD22 TRAAC)

关于TAC-001（CD22 TRAAC）

TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent toll-like receptor 9 agonist (T-CpG) conjugated to an antibody against CD22, a receptor restricted to B cells, including tumor-infiltrating B cells. TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions.

TAC-001是Toll样受体激动剂-抗体缀合物（TRAAC），其由与针对CD22的抗体缀合的有效Toll样受体9激动剂（T-CpG）组成，CD22是限于B细胞的受体，包括肿瘤浸润B细胞。TAC-001旨在通过与CD22结合系统地将T-CpG递送至B细胞，导致TAC-001内化，TLR9信号传导，B细胞活化和一系列免疫反应。

Preclinical studies demonstrate that the innate and adaptive immune responses triggered by TAC-001 lead to potent anti-tumor activity. TAC-001 is being developed for the treatment of solid tumors and is currently in a Phase 1/2 Study in cancer patients (NCT05399654).

临床前研究表明，由TAC-001触发的先天性和适应性免疫应答导致有效的抗肿瘤活性。TAC-001正在开发用于治疗实体瘤，目前正在癌症患者的1/2期研究中（NCT05399654）。

About TAC-003 (Nectin-4 TRAAC)

关于TAC-003（Nectin-4 TRAAC）

TAC-003 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a T-CpG conjugated to a novel Nectin-4-targeting antibody for systemic administration and TME delivery of a potent TLR9 agonist. Nectin-4 is a cancer associated antigen over-expressed in many solid tumor types with limited expression in normal tissues.

TAC-003是Toll样受体激动剂-抗体缀合物（TRAAC），其包含与新型Nectin-4靶向抗体缀合的T-CpG，用于全身施用和TME递送有效的TLR9激动剂。Nectin-4是在许多实体瘤类型中过表达的癌症相关抗原，在正常组织中表达有限。

Additionally, Nectin-4 over-expression correlates with poor prognosis. Preclinical data demonstrate that TAC-003 triggers TLR9 signaling, induces myeloid and dendritic cell activation, phagocytosis, cytokine production and lymphocyte activation, resulting in potent single-agent anti-tumor efficacy..

另外，Nectin-4过表达与不良预后相关。临床前数据表明，TAC-003触发TLR9信号传导，诱导骨髓和树突状细胞活化，吞噬作用，细胞因子产生和淋巴细胞活化，从而产生有效的单药抗肿瘤功效。。

About Tallac Therapeutics, Inc.

关于Tallac Therapeutics，Inc。

Tallac Therapeutics is a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer. Tallac’s pipeline of immunotherapy candidates is derived from the company’s novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to deliver a potent Toll-like receptor (TLR9) agonist (T-CpG) for targeted immune activation via systemic administration.

Tallac Therapeutics是一家私营的生物制药公司，利用先天和适应性免疫的力量来对抗癌症。Tallac的免疫治疗候选药物来源于该公司的新型Toll样受体激动剂-抗体偶联物（TRAAC）平台，通过全身给药提供有效的Toll样受体（TLR9）激动剂（T-CpG）用于靶向免疫激活。

Several TRAAC molecules are in various stages of discovery and development. TAC-001, the company’s lead clinical candidate, is the first to enter the clinic and is currently in an ongoing Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors. For more information, please visit www.tallactherapeutics.com..

几种TRAAC分子处于发现和开发的不同阶段。该公司的主要临床候选人TAC-001是第一个进入临床的公司，目前正在进行晚期或转移性实体瘤患者的1/2期临床试验。欲了解更多信息，请访问www.tallactherapeutics.com。。