Two weeks after its gastric cancer drug failed to hit endpoints in a mid-stage trial, Singapore-based ASLAN Pharmaceuticals is cutting staff and initiating a corporate restructuring and strategic prioritization of its clinical development programs.
This morning the company said it will cut its headcount by 30 percent, which will lower operational costs by about 50 percent. The savings will be used to focus its resources on its lead clinical programs -- varlitinib in biliary tract cancer (BTC), ASLAN003 in acute myeloid leukemia (AML) and ASLAN004 in atopic dermatitis, the company said. Along with the 30 percent company layoffs, ASLAN said Chief Medical Officer Bertil Lindmark will retire and return to Europe. Chih-Yi Hsieh, currently vice president of medical and general manager of Taiwan operations, will assume the role of acting CMO. Mark McHale, the company’s chief operating officer will assume the role of chief development officer and head of research and development.
Carl Firth, ASLAN’s chief executive officer, said the company remains committed to using its capital to support the development of its three key assets, varlitinib, ASLAN003 and ASLAN004. Each of the three assets have potential to be “critical value-drivers,” Firth added.
“We are approaching several significant milestones in 2019 and beyond, so it is important we complete key studies over the next two years. Restructuring the organization has involved some tough decisions. It is difficult to lose outstanding members of the team who have contributed to ASLAN over the years and have tackled some of the most challenging obstacles to advancing new treatments for cancer,” Firth said in a statement.
The move came after Varlitinib, the company’s first-line therapy for HER1/HER2 co-expressing cancer tumors failed to meet endpoints. Varlitinib (ASLAN001), a highly potent, oral, reversible, small molecule pan-HER inhibitor, combined with mFOLFOX6 shrunk tumors by an average of 22 percent compared to 12.5 percent shrinkage by mFOLFOX6 alone, but that did not reach statistical significance.
ASLAN said it will focus on the late-stage development of varlitinib as a potential novel treatment for first- and second-line biliary tract cancer. Phase Ib results of a study of varlitinib as a first-line treatment for BTC which demonstrated that varlitinib increased objective response rate compared to standard of care. The clinical development of ASLAN003 in AML and ASLAN004 in atopic dermatitis remains on track. ASLAN expects to complete the first part of the Phase II study of ASLAN003 in AML and the Phase I SAD study of ASLAN004 in the first half of 2019.
ASLAN isn’t the only company initiating a restructuring. Also announced today, California-based Aduro Biotech said it will institute a “strategic reset” to focus on its core strengths of the discovery and development of novel product candidates in the stimulator of interferon genes (STING) and a proliferation-inducing ligand (APRIL) pathways. As a result of the strategic reset, Aduro has reduced its current workforce by approximately 37 percent and redirected resources to its lead programs.
“We are committed to maintaining a leadership role in the STING and APRIL pathways, and generating multiple clinical data readouts over the next several years. The strategic reset will also allow us to explore new partnership opportunities for our deprioritized programs, including pLADD, ADU-1604 (anti-CTLA-4) and ADU-1805 (anti-SIRPα). While this was a difficult decision, I want to thank the employees who are leaving for their contributions to Aduro,” Stephen T. Isaacs, chairman, president and CEO of Aduro said in a statement.
在其胃癌药物在中期试验中未能达到终点两周后，新加坡 ASLAN 制药公司正在裁员，并启动其临床开发项目的企业重组和战略优先次序。
今天上午，该公司表示将裁员30%，这将降低运营成本约50%。该公司表示，节省的资金将用于集中其主要临床项目——胆道癌 varlitnib 、急性髓系白血病 ASLAN003和特应性皮炎 ASLAN004。随着30%的公司裁员， ASLAN 说首席医疗官 BertilLindmark 将退休并返回欧洲。现任台湾运营副总裁兼总经理谢志毅将担任代理 CMO 职务。公司首席运营官 Mark McHale 将担任首席开发官和研发主管。
ASLAN 首席执行官卡尔•弗斯( Carl Firth )表示，该公司仍致力于利用资本支持其三大关键资产 varlitnib 、 ASLAN003和 ASLAN004的发展。Firth 补充说，这三种资产都有可能成为“关键的价值驱动因素”。
“我们正接近2019年及以后的几个重要里程碑，因此我们必须在未来两年完成关键研究。重组组织涉及到一些艰难的决定。Firth 在一份声明中表示：“很难失去这些年来为 ASLAN 做出贡献的优秀团队成员，并克服了一些最具挑战性的障碍，以推进癌症的新治疗。”
此前，公司用于 HER1/ HER2共表达肿瘤的一线治疗药物 Varlitinib 未能达到终点。Varlitinib （ ASLAN001）是一种高效、口服、可逆的小分子泛HER 抑制剂，与 mFOLFOX6联合使用，使肿瘤缩小了22%，而单 mFOLFOX6就收缩了12.5%，但没有达到统计学显著性。
ASLAN 说，它将专注于 varlitinib 的后期开发，作为一种潜在的新的治疗一线和二线胆道癌症的方法。第一期治疗 BTC 的 varlitnib 研究的 Ib 期结果表明， varlitnib 比护理标准提高了客观反应率。ASLAN003在 AML 和 ASLAN004中在特应性皮炎中的临床进展仍在进行中。ASLAN 预计于2019年上半年完成 ASLAN003 AML Ⅱ期研究和 ASLAN004Ⅰ期 SAD 研究的第一部分。
ASLAN 不是唯一发起重组的公司。总部位于加州的 Aduro Biotech 公司今天也宣布，将进行“战略重组”，重点关注其在干扰素基因刺激器（ STING ）和诱导增殖配体（ APRIL ）通路中发现和开发新产品候选物的核心优势。由于战略重设， Aduro 将其现有员工减少了约37%，并将资源重新用于其领导计划。
“我们致力于在 STING 和 APRIL 途径中保持领先地位，并在未来几年内产生多个临床数据的读出。战略重设还将使我们能够探索新的伙伴关系的机会，我们的腐化方案，包括 pLADD ， ADU-1604（反 CTLA-4）和 ADU-1805（反 SIRPα）。Aduro 董事长、总裁兼首席执行官斯蒂芬· T ·艾萨克斯( Stephen T . Isaacs )在一份声明中表示：“尽管这是一个艰难的决定，但我要感谢即将离职的员工为 Aduro 做出的贡献。”