Mark Alles, Executive Chairman of TORL BioTherapeutics, LLC (TORL) and former Chairman and CEO of Celgene Corporation has been appointed TORL's Chairman and CEO. Mark brings more than 35 years of global biopharmaceutical experience, and will lead TORL as it advances its expanding clinical-stage antibody programs in oncology and builds additional programs through the high-value discovery pipeline established and led by TORL Scientific Founder Dennis Slamon, M.D., Ph.D..

TORL BioTherapeutics，LLC（TORL）执行董事长、Celgene Corporation前董事长兼首席执行官Mark Alles被任命为TORL董事长兼首席执行官。Mark拥有超过35年的全球生物制药经验，并将领导TORL推进其在肿瘤学中不断扩大的临床阶段抗体计划，并通过TORL科学创始人丹尼斯·斯莱蒙（DennisSlamon）博士建立和领导的高价值发现管道建立其他计划。。

Dave Licata, Co-Founder, previous CEO of TORL, and the architect of its innovative approach to drug development, continues as a Board Member and President and is appointed TORL's first fully-dedicated Chief Financial Officer. As President and CFO, Dave will lead and manage future financing, business development and partnering, fiscal operations, and continue to provide strategic and operational support for the Company's novel approach to drug development.

Dave Licata是TORL的联合创始人、前首席执行官，也是其创新药物开发方法的设计师，他继续担任董事会成员和总裁，并被任命为TORL的第一位全心投入的首席财务官。作为总裁兼首席财务官，Dave将领导和管理未来的融资、业务发展和合作、财务运营，并继续为公司的新型药物开发方法提供战略和运营支持。

Based upon the emerging and promising clinical response data and favorable safety profile demonstrated during dose finding and early expansion for TORL-1-23, the Company's first-in-class ADC targeting Claudin 6, TORL expects to begin a pivotal Phase 2 trial during the second half of 2024. This trial will be designed to facilitate review and potential approval by the FDA.

基于TORL-1-23（该公司第一个针对Claudin 6的一流ADC）在剂量发现和早期扩展过程中显示的新兴且有前景的临床反应数据和良好的安全性，TORL预计将在2024年下半年开始关键的2期试验。该试验旨在促进FDA的审查和潜在批准。

In addition to TORL-1-23 and TORL-2-307, the Company's second clinical-stage ADC designed to target Claudin 18.2 in pancreatic and gastric cancers, TORL has begun patient enrollment in Phase 1 trials for two additional new ADCs developed to address internally discovered targets overexpressed in approximately 80% of patients with colorectal cancer and in patients with small-cell-lung and liver cancers, respectively.

除了TORL-1-23和TORL-2-307之外，该公司的第二临床阶段ADC旨在针对胰腺癌和胃癌中的Claudin 18.2，TORL已经开始为另外两个新的ADC进行1期临床试验，这些ADC是为了解决大约80%的结直肠癌患者以及小细胞肺癌和肝癌患者中过度表达的内部发现靶标而开发的。

LOS ANGELES, Jan. 9, 2024 /PRNewswire/ -- TORL Biotherapeutics, LLC (TORL), established in 2019, is a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide. Today, the company announced the appointment of Mark J.

洛杉矶，2024年1月9日/PRNewswire/--TORL Biotherapeutics，LLC（TORL）成立于2019年，是一家临床阶段的生物技术公司，发现并开发新的基于抗体的免疫疗法，以改善和延长全球癌症患者的寿命。今天，该公司宣布任命Mark J。

Alles, TORL's Executive Chairman, as the company's new Chairman and CEO. Mr. Alles is the former Chairman and Chief Executive Officer of Celgene Corporation with over 35 years of biopharmaceutical experience and an outstanding record of driving innovation and growth at multiple companies focused on hematology and oncology.

TORL执行董事长Alles担任公司新任董事长兼首席执行官。Alles先生是Celgene Corporation的前董事长兼首席执行官，拥有超过35年的生物制药经验，在多家专注于血液学和肿瘤学的公司推动创新和增长方面有着杰出的记录。

Mark succeeds Dave Licata, TORL Co-Founder and previous CEO, who successfully led the Company through the initiation of five (5) phase I clinical trials testing ADCs against four (4) cancer targets and led the closing of a $158 million Series B financing in April 2023, and who will continue as a Board Member, President, and has been appointed CFO..

Mark接替TORL联合创始人兼前首席执行官Dave Licata，Dave Licata成功领导公司启动了五（5）个针对四（4）个癌症目标测试ADC的I期临床试验，并于2023年4月完成了1.58亿美元的B系列融资，他将继续担任董事会成员、总裁，并已被任命为首席财务官。。

'TORL has rapidly realized significant success in identifying novel cancer targets, developing first-in-class antibody-based therapies directed at these targets, and with the support of our world-class investors, has recently advanced multiple products into Phase 1 studies,' said Board Member and TORL's scientific founder Dennis Slamon, M.D., Ph.D., of UCLA.

董事会成员、加州大学洛杉矶分校TORL科学创始人丹尼斯·斯莱蒙（DennisSlamon）博士说：“TORL在确定新的癌症靶点、开发针对这些靶点的一流抗体疗法方面取得了巨大成功，并且在我们世界级投资者的支持下，最近将多种产品推进了第一阶段研究。”。

'We have reached a major inflection point where our opportunity to generate value for patients, our investors and our team made it both possible and important for us to build on the great work Dave has done by adding and appointing Mark Alles as Chairman and CEO. He is a highly regarded industry veteran with proven operational, financial, business development, clinical development, and commercial experience building and scaling oncology-focused companies.

“我们已经到了一个重要的转折点，在这个转折点上，我们有机会为患者、投资者和团队创造价值，这使得我们能够在戴夫（Dave）所做的伟大工作的基础上再接再厉，并任命马克·艾利斯（Mark Alles）为董事长兼首席执行官。他是一位备受推崇的行业资深人士，拥有成熟的运营、财务、业务开发、临床开发以及商业经验，拥有建立和扩展以肿瘤学为重点的公司。

I am extremely excited about what his proven level of experience and expertise will bring to TORL during its next critical phase.'.

我对他成熟的经验和专业水平将在下一个关键阶段为TORL带来什么感到非常兴奋。”。

'Since joining the TORL Board two years ago and becoming Executive Chairman in late 2022, I have had the privilege to work with Dave Licata and Dennis Slamon as they built the foundation for what has become an oncology-focused biotechnology company full of promise and potential,' said Mr. Alles. 'We are driven by a shared passion to discover, develop and commercialize breakthrough therapies for patients challenged with cancer worldwide.

艾利斯说，自从两年前加入TORL董事会并于2022年底成为执行董事长以来，我有幸与戴夫·利卡塔（DaveLicata）和丹尼斯·斯莱蒙（DennisSlamon）合作，为一家充满希望和潜力的以肿瘤学为重点的生物技术公司奠定了基础我们共同致力于为全球癌症患者发现、开发和商业化突破性疗法。

I am excited and honored to lead the Board and the company at such a pivotal time.'.

能在如此关键的时刻领导董事会和公司，我感到兴奋和荣幸。”。

'I am proud of the prolific scientific discoveries and the remarkable progress we have made in advancing high potential biologics into the clinic since launching the company only four years ago,' said Dave Licata, TORL Co-Founder, Board Member, President, and CFO. 'After co-founding TORL with Dennis with a common vision for a new approach to drug development, and leading the company as CEO, I feel immense pride in what we have achieved.

TORL联合创始人、董事会成员、总裁兼首席财务官戴夫·利卡塔（DaveLicata）说：“自四年前成立该公司以来，我为丰富的科学发现和我们在将高潜力生物制剂推向临床方面取得的显着进展感到骄傲。”在与丹尼斯（Dennis）共同创立了TORL，对药物开发的新方法有着共同的愿景，并作为首席执行官领导公司之后，我对我们取得的成就感到无比骄傲。

I am excited and eager to work even more closely with Mark as we continue to build TORL into what we believe will be a highly successful biopharmaceutical company.'.

随着我们继续将TORL打造成我们认为将成为一家非常成功的生物制药公司，我很兴奋并渴望与Mark进行更密切的合作。”。

During his 15-year tenure at Celgene, Mr. Alles executed several multi-billion-dollar company and asset acquisitions, helped to build a broad portfolio of globally marketed medicines and high-potential cancer therapeutics, and led the expansion of Celgene from a US-based organization of approximately 500 employees to a global company with more than 8,800 employees serving patients globally.

在他在Celgene的15年任期内，Alles先生执行了数十亿美元的公司和资产收购，帮助建立了全球上市药物和高潜力癌症治疗药物的广泛组合，并领导Celgene从一家总部位于美国的约500名员工的组织扩展到一家全球公司，该公司拥有8800多名员工，为全球患者提供服务。

As Chairman and CEO of Celgene, he led the company's acquisition by Bristol Myers Squibb for $74B in late 2019. He has served on the Boards of several biopharmaceutical companies and industry groups, including Board Chair of Turning Point Therapeutics (acquired by Bristol Myers Squibb for $4.1B in 2022), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Biotechnology Innovation Organization (BIO).

作为Celgene的董事长兼首席执行官，他于2019年末领导了百时美施贵宝（Bristol-Myers Squibb）以740亿美元收购该公司。他曾在多家生物制药公司和行业集团的董事会任职，包括转折点治疗公司（Bristol-Myers Squibb于2022年以41亿美元收购）、美国药物研究与制造商（PhRMA）、欧洲制药工业与协会联合会（EFPIA）和生物技术创新组织（BIO）的董事会主席。

He previously served on the Boards of Antengene Corporation and Syros Pharmaceuticals, and currently serves on the Boards of BioMarin Pharmaceutical and Wugen, Inc. Prior to joining Celgene in 2004, Mr. Alles was Vice President of the U.S. Oncology business unit at Aventis Pharmaceuticals. He began his industry career at Bayer and Centocor after serving as a Captain in the United States Marine Corps..

他曾在Antengene Corporation和Syros Pharmaceuticals的董事会任职，目前在BioMarin Pharmaceuticals和Wugen，Inc.的董事会任职。在2004年加入Celgene之前，Alles先生是Aventis Pharmaceuticals美国肿瘤业务部门的副总裁。在美国海军陆战队担任队长后，他在拜耳和Centocor开始了他的行业生涯。。

About the TORL123-001 (TRIO-049) Clinical StudyTORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL123-001 (TRIO-049), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-1-23.  Further details including current study sites can be found at https://clinicaltrials.gov/show/NCT05103683.

关于TORL123-001（TRIO-049）临床研究TORLBIO目前正在招募患者参加其第一阶段研究TORL123-001（TRIO-049）的扩展部分，评估TORL123-23的安全性，药代动力学，生物标志物和抗肿瘤活性。包括当前研究地点在内的更多详细信息，请访问https://clinicaltrials.gov/show/NCT05103683.

Key study findings to date for this Claudin 6 targeting ADC include:

迄今为止，针对这种Claudin 6靶向ADC的关键研究结果包括：

TORL-1-23 is generally well tolerated from 0.2 to 2.4 mg/kg IV every 21 days

TORL-1-23通常每21天静脉注射0.2至2.4 mg/kg耐受性良好

With consistent use of prophylactic granulocyte colony-stimulating factor (G-CSF), current dosing regimen of 3 mg/kg every 21 days is well tolerated

通过持续使用预防性粒细胞集落刺激因子（G-CSF），目前每21天服用3 mg/kg的给药方案耐受性良好

Pharmacokinetic data indicate sustained exposure of TORL-1-23 over the 21-day dosing period with low levels of the free monomethyl auristatin E (MMAE) payload

药代动力学数据表明，在21天的给药期内，TORL-1-23持续暴露，游离单甲基auristatin E（MMAE）有效载荷水平较低

Encouraging antitumor activity has been observed in heavily pretreated population during dose finding

在剂量发现期间，在经过大量预处理的人群中观察到了令人鼓舞的抗肿瘤活性

Confirmed responses in 12/36 (33%) patients across all enrolled disease types and all nine dose levels without G-CSF (0.2 mg/kg to 3 mg/kg every 21 days)

在所有登记的疾病类型和所有9种剂量水平的无G-CSF（每21天0.2 mg/kg至3 mg/kg）的患者中，有12/36（33%）患者的确诊反应

At the two highest dose levels without G-CSF (2.4 mg/kg and 3 mg/kg every 21 days) there were confirmed responses in 7/12 (58%) patients with CDLN6+ platinum resistant/refractory ovarian cancer

在没有G-CSF的两个最高剂量水平（每21天2.4 mg/kg和3 mg/kg）下，7/12（58%）CDLN6+铂类耐药/难治性卵巢癌患者确诊有反应

In preparation for a planned phase 2 study that could allow for regulatory approval, expansion cohorts of patients with pretreated ovarian, lung, and other CLDN6+ cancers have been initiated to further guide dose selection

为了准备一项可能获得监管部门批准的计划中的2期研究，已经开始扩大卵巢癌、肺癌和其他CLDN6+癌症患者的队列，以进一步指导剂量选择

About TORL2307MAB-001 (TRIO-051) Clinical StudyTORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307MAB-001 (TRIO-051), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307MAB.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05159440.

关于TORL2307MAB-001（TRIO-051）临床研究TORL Bio目前正在招募患者参加其1期研究TORL2307MAB-001（TRIO-051）的扩展部分，评估TORL-2-307MAB的安全性，药代动力学，生物标志物和抗肿瘤活性。有关包括当前研究地点在内的更多详细信息，请访问https://clinicaltrials.gov/study/NCT05159440.

About TORL2307ADC-001 (TRIO-052) Clinical StudyTORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL2307ADC-001 (TRIO-052), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-2-307ADC.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05156866.

关于TORL2307ADC-001（TRIO-052）临床研究TORL Bio目前正在招募患者参加其1期研究TORL2307ADC-001（TRIO-052）的扩展部分，评估TORL-2-307ADC的安全性，药代动力学，生物标志物和抗肿瘤活性。有关包括当前研究地点在内的更多详细信息，请访问https://clinicaltrials.gov/study/NCT05156866.

About TORL3600-001 (TRIO-055) Clinical StudyTORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL3600-001 (TRIO-055), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-3-600.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT05948826.

关于TORL3600-001（TRIO-055）临床研究TORLBio目前正在招募患者参加其第一阶段研究TORL3600-001（TRIO-055）的扩展部分，评估TORL-3-600的安全性，药代动力学，生物标志物和抗肿瘤活性。包括当前研究地点在内的更多详细信息，请访问https://clinicaltrials.gov/study/NCT05948826.

About TORL 4-500-001 (TRIO-056) Clinical StudyTORL Bio is currently enrolling patients in the expansion portion of their phase 1 study, TORL4500-001 (TRIO-056), assessing the safety, pharmacokinetics, biomarkers, and antitumor activity of TORL-4-500.  Further details including current study sites can be found at https://clinicaltrials.gov/study/NCT06005740.

关于TORL 4-500-001（TRIO-056）临床研究TORL Bio目前正在招募患者参加其第一阶段研究TORL4500-001（TRIO-056）的扩展部分，评估TORL-4-500的安全性，药代动力学，生物标志物和抗肿瘤活性。包括当前研究地点在内的更多详细信息，请访问https://clinicaltrials.gov/study/NCT06005740.

About TORL BioTherapeutics, LLCTORL Biotherapeutics, LLC (TORL or Company) is a clinical-stage biopharmaceutical company developing new antibodies, both monoclonal (mABs) and drug conjugates (ADCs) with the goal of transforming the lives of patients challenged with a variety of human malignancies. Through a strategic partnership with the Slamon Research Lab at UCLA, TORL has exclusive development and commercial rights to a large program of biologics-based drugs for new, promising and novel cancer targets..

关于TORL BioTherapeutics，LLCTORL BioTherapeutics，LLC（TORL或Company）是一家临床阶段的生物制药公司，开发新的单克隆抗体（mAb）和药物偶联物（ADC），目的是改变受多种人类恶性肿瘤挑战的患者的生活。通过与加州大学洛杉矶分校Slamon研究实验室的战略合作关系，TORL拥有一项大型生物制剂药物项目的独家开发和商业权利，用于新的，有前途的和新颖的癌症靶标。。

The lead program, TORL-1-23, is a CLDN6-directed ADC for patients across multiple cancers. The Company has four (4) additional clinical-stage antibody programs. Additionally, TORL is building a broad pipeline of novel ADCs and mABs in cancers of high unmet medical need. TORL Bio is headquartered in Los Angeles, California..

lead程序TORL-1-23是针对多种癌症患者的CLDN6指导的ADC。该公司还有四（4）个额外的临床阶段抗体计划。此外，TORL正在为高度未满足医疗需求的癌症建立广泛的新型ADC和mAb管道。TORL Bio总部位于加利福尼亚州洛杉矶。。

SOURCE TORL Biotherapeutics LLC

来源TORL Biotherapeutics LLC