SHANGHAI and WARREN, N.J., May 23, 2024 /PRNewswire/ -- Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) ('LAE201')in patients with metastatic castration-resistant prostate cancer (mCRPC) following standard of care (SOC) treatment..

上海和新泽西州沃伦（WARREN，N.J.），2024年5月23日/PRNewswire/-Laekna，Inc.（2105.HK），一家科学驱动的临床阶段生物技术公司，宣布该公司已获得美国食品和药物管理局（U.S.Food and Drugs Administration）的批准，用于LAE002（一种AKT抑制剂afuresertib）加LAE001（CYP17A1/CYP11B2双重抑制剂）（'LAE201'）治疗转移性去势抵抗性前列腺癌（mCRPC）患者的III期临床试验方案，遵循标准护理（SOC）治疗。。

Laekna initiated a Phase II clinical trial of the multi-region clinical trial of the study of LAE201 in the U.S. in June 2021, and South Korea in September 2022. The trial is an open-label, dose-escalation and dose expansion study to assess the efficacy and safety of the combination candidate.

Laekna于2021年6月在美国和2022年9月在韩国启动了LAE201研究的多区域临床试验的II期临床试验。该试验是一项开放标签，剂量递增和剂量扩展研究，用于评估联合候选药物的疗效和安全性。

The study demonstrated promising treatment benefit for mCRPC patients. As of Nov 21, 2023, 40 patients who progressed on 1–3 lines of standard treatments, including at least 1 line of abiraterone, or the second generation of AR antagonists, had been enrolled in the recommended phase II dose group. The median rPFS was 8.1 months.

该研究表明mCRPC患者有希望获得治疗益处。截至2023年11月21日，40名接受1-3线标准治疗（包括至少1线阿比特龙或第二代AR拮抗剂）的患者已被纳入推荐的II期剂量组。中位rPFS为8.1个月。

This is a significant improvement compared to the median rPFS of 2 to 4 months of mCRPC patients under the standard treatments historically[1]. The combination therapy was generally tolerable with manageable treatment emergent adverse events and recoverable after routine treatments..

与历史上标准治疗下2至4个月mCRPC患者的中位RPF相比，这是一个显着的改善（1）。联合治疗通常是可耐受的，具有可控的治疗紧急不良事件，并且在常规治疗后可恢复。。

'Since the Phase II data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following Phase III pivotal trial design has been discussed with the U.S. FDA and the approval for the protocol has been received this month,' said Dr.

“由于LAE002（afuresertib）加LAE001联合治疗的II期数据显示mCRPC患者具有令人鼓舞的抗肿瘤活性和安全性，因此已与美国FDA讨论了以下III期关键试验设计，并于本月获得了该方案的批准，”Dr。

Yong Yue, Chief Medical Officer of Laekna. 'The approval marks a significant milestone for Laekna. The mCRPC post 1-3 lines of SOC are difficult-to-treat late stage cancer with poor outcomes. It is an unmet medical need worldwide.We look forward to bringing this precision therapy to mCRPC patients who are in need of novel treatment options.'.

Laekna首席医疗官Yong Yue说该批准标志着莱克纳的一个重要里程碑。mCRPC后1-3行SOC难以治疗晚期癌症，预后不佳。这是全世界尚未满足的医疗需求。我们期待着将这种精确疗法带给需要新治疗选择的mCRPC患者。”。

[1] R. de Wit, et al., 2019;Rhian Sian Davies et al., 2016

[1]R.de Wit等人，2019年；Rhian Sian Davies等人，2016年

About afuresertib

关于afureserib

Afuresertib(LAE002) is one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally.

Afuresertib（LAE002）是全球抗癌治疗关键阶段临床开发中仅有的两种AKT抑制剂之一。

Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). Afuresertib has demonstrated several advantages compared to other AKT inhibitors, including higher efficacy, better potency, more significant tumor inhibition exposure and a better safety profile, based on public data.

Afuresertib是一种有效的AKT抑制剂，可抑制所有三种AKT亚型（AKT1，AKT2和AKT3）。与其他AKT抑制剂相比，Afuresertib具有几个优点，包括更高的疗效，更好的效力，更显着的肿瘤抑制暴露和更好的安全性，基于公共数据。

Capivasertib is the first approved AKT inhibitor from AstraZeneca, which FDA approved for HR+/HER2- breast cancer in November 2023..

Capivasertib是阿斯利康（AstraZeneca）批准的第一种AKT抑制剂，FDA于2023年11月批准用于HR+/HER2乳腺癌。。

With the promising efficacy data from our afuresertib Phase Ib study for HR+/HER2- breast cancer, which was presented in SABCS 2023, Laekna has initiated the Phase III pivotal study. We also continue to develop our clinical trials for the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/PD-L1 drug-resistant solid tumors to address the unmet medical needs.

根据我们在SABCS 2023中提出的针对HR+/HER2乳腺癌的afuresertib Ib期研究的有希望的疗效数据，Laekna启动了III期关键研究。我们还继续开发治疗乳腺癌，前列腺癌，卵巢癌和PD-1/PD-L1耐药实体瘤的临床试验，以满足未满足的医疗需求。

In several clinical trials, the combination of afuresertib with other therapeutics exhibits favorable efficacy results..

在几项临床试验中，阿呋塞米与其他疗法的组合显示出良好的疗效结果。。

About LAE001

关于LAE001

LAE001 is an androgen synthesis inhibitor that inhibits both CYP17A1 and CYP11B2. Laekna in-licensed LAE001 from Novartis in 2017. According to Frost & Sullivan, LAE001 is the only dual CYP17A1/CYP11B2 inhibitor in clinical trials for the treatment of prostate cancer globally.

LAE001是一种雄激素合成抑制剂，可抑制CYP17A1和CYP11B2。Laekna于2017年从诺华获得LAE001许可。根据Frost＆Sullivan的说法，LAE001是全球治疗前列腺癌临床试验中唯一的双重CYP17A1/CYP11B2抑制剂。

As a dual CYP17A1/CYP11B2 inhibitor, LAE001 can block both androgen and aldosterone synthesis and potentially be administrated without prednisone, the short-term high dose or long-term exposure of which can lead to a variety of adverse events.

作为双重CYP17A1/CYP11B2抑制剂，LAE001可以阻断雄激素和醛固酮的合成，并且可能在没有泼尼松的情况下给药，泼尼松的短期高剂量或长期暴露可能导致各种不良事件。

About Laekna

关于Laekna

Stock Code: 2105.HK

股票代码：2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer, metabolic diseases and liver fibrosis patients worldwide.

Laekna成立于2016年，是一家科学驱动的临床阶段生物技术公司，致力于为全球癌症，代谢疾病和肝纤维化患者带来新疗法。

As of December 31, 2023, we have initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 for the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/ PD-L1 drug-resistant solid tumors to address the unmet medical needs. Among these six clinical trials, three are multi-regional clinical trials (MRCTs).

截至2023年12月31日，我们已经启动了六项针对afuresertib（LAE002），LAE001和LAE005的临床试验，用于治疗乳腺癌，前列腺癌，卵巢癌和PD-1/PD-L1耐药实体瘤，以解决未满足的医疗需求。在这六项临床试验中，三项是多区域临床试验（MRCT）。

Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally..

Afuresertib是一种有效的AKT抑制剂，可抑制所有三种AKT亚型（AKT1，AKT2和AKT3），也是全球抗癌治疗关键阶段临床开发中仅有的两种AKT抑制剂之一。。

Laekna's internal drug discovery platform has discovered 14 drug candidates. LAE102 is our internally discovered antibody against ActRIIA. We've obtained IND approvals from the FDA and the CDE in relation to obesity. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass.

Laekna的内部药物发现平台已经发现了14种候选药物。LAE102是我们内部发现的抗ActRIIA抗体。我们已经获得了FDA和CDE关于肥胖的IND批准。阻断激活素-ActRII途径可以促进肌肉再生并减少脂肪量。

Laekna team has accumulated tremendous experience and deep know-how in this specific field and is developing more drug candidates (LAE103 and LAE123) to maximize the value of targeting ActRII receptors. .

Laekna团队在这一特定领域积累了丰富的经验和深厚的专业知识，并正在开发更多候选药物（LAE103和LAE123），以最大程度地发挥靶向ActRII受体的价值。。

Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the 'Hong Kong Stock Exchange') on June 29, 2023, with the stock code 2105.HK.

Laekna，Inc.于2023年6月29日在香港联合交易所有限公司（“香港联合交易所”）主板上市，股票代码2105.HK。