On February 8, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ET140203 and ECT204 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Eureka Therapeutics, FEB 8, 2022, View Source [SID1234607861]).

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Eureka is currently recruiting patients in three Phase I/II clinical trials to investigate the safety and potential efficacy of ARTEMIS T cells that have been engineered to target specific liver cancer antigens. The ARYA-1 and ARYA-2 studies use ET140203 ARTEMIS T cells to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells. The ARYA-3 study uses ECT204 T cells to target the Glypican 3 (GPC3) protein expressed on the surface of liver cancer cells.

"We are pleased to have received ODD for ET140203 and ECT204 just months after receiving FDA Fast Track Designation (FTD) for the treatment of hepatoblastoma (HB) and HCC in pediatric patients, and Rare Pediatric Disease Designation (RPDD) for the treatment of HB," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "These designations for Eureka’s clinical candidates underscore the significant unmet medical need for more effective liver cancer treatment options. We are committed to working closely with regulators, clinical investigators, patients and their families to advance these programs in the clinics."

Under the Orphan Drug Act, orphan drug status provides incentives, including tax credits, grants and waiver of certain administrative fees for clinical trials, and seven years of market exclusivity following drug approval.

ABOUT ET140203

ET140203 is an investigational therapy during which a patient’s T cells are collected, engineered to express Eureka’s proprietary ARTEMIS cell receptor and infused back into the patient. Engineered ET140203 T cells express a TCR-mimic antibody to target an alpha fetoprotein (AFP)-peptide/HLA-A2 complex on liver cancer cells. In addition, ET140203 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients.

ET140203 is currently being investigated in two of Eureka’s ongoing clinical studies, ARYA-1 and ARYA-2: The ARYA-1 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with AFP-positive HCC; the ARYA-2 study is an open-label, dose escalation, multi-center Phase I/II clinical trial in pediatric subjects who are AFP-positive and have relapsed/refractory hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and HCC.

ABOUT ECT204

ECT204 is an investigational ARTEMIS T-cell therapy targeting Glypican 3 (GPC3), a promising HCC antigen found in more than 70% of HCC cells. ECT204 ARTEMIS T cells also incorporate Eureka’s proprietary tumor infiltration technology demonstrating enhanced ability to infiltrate solid tumors in animal models, potentially leading to improved efficacy in patients. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.

Additional information about the above studies may be found at www.clinicaltrials.gov, using Identifier NCT: NCT04502082, NCT04634357 and NCT04864054.

On February 8, 2022 Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, reported that it has entered into a data sharing agreement with Pfizer, a leader in innovative IBD research (Press release, Pfizer, FEB 8, 2022, View Source [SID1234607860]). The agreement aims to accelerate successful, efficient development of potential new treatments for patients suffering from IBD worldwide by standardizing endoscopic interpretation.

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As part of the agreement, Pfizer will grant access to one of its IBD clinical trial databases, allowing Iterative Scopes to enrich its disease severity scoring algorithms.

Polina Golland, PhD, AI Chair of the Iterative Scopes Scientific Advisory Board and Professor, EECS & PI, MIT CSAIL at the Massachusetts Institute of Technology, said, "This agreement will enable Iterative Scopes to push our AI methods for IBD scoring to the next level by providing the team with a rich set of data. This new data will support development of next generation AI tools based on recent innovations in machine learning to improve the comprehensive interpretation of endoscopy videos and the accuracy of quantitative endoscopy scoring."

Currently, disease severity scoring systems, such as the Mayo Endoscopic Score (MES), are used to meet inclusion criteria in IBD clinical trials and to measure primary and secondary endpoints. These metrics are highly subjective and dependent on physician experience and intuition. Moreover, they present patient recruitment and workflow challenges. Iterative Scopes’ computational algorithms resolve these challenges when integrated with existing colonoscopy imagery to determine clinical trial eligibility. The company’s computational software automates interpretation of colonoscopy videos, enabling clinical trial investigators to arrive at standardized MES scores for individual patients.

"We are excited to harness machine learning and computer vision to ultimately aid physicians and help them improve clinical outcomes for IBD patients earlier and with greater success," said Jean-Pierre Schott, PhD, SVP of Engineering at Iterative Scopes. "This agreement will leverage certain Pfizer patient research along with the Iterative Scopes technological advancements to assess colon health faster and with greater granularity, and possibly improve the quality of life for thousands of patients."

Iterative Scopes was founded in 2017 as a spin out of the Massachusetts Institute of Technology (MIT) by Dr. Jonathan Ng, a physician-entrepreneur, who developed the company’s foundational concepts while he was in school at MIT and Harvard. In December 2021, the company and its investors closed a $150 million Series B financing, which attracted a roster of A-list venture capitalists, big pharmaceutical companies’ venture arms, and individual leaders in healthcare.

On February 8, 2022 BostonGene Corporation reported expanded capabilities of the BostonGene Tumor Portrait TM Test that enable healthcare providers and insurance companies to determine eligibility and predict response for immunotherapy treatment and manage the total cost of care for cancer patients (Press release, BostonGene, FEB 8, 2022, View Source [SID1234607859]). A sophisticated analysis of the tumor and tumor microenvironment (TME), the BostonGene Tumor Portrait TM Test, reveals critical drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.

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The BostonGene Tumor PortraitTM Test is highly predictive of response to immunotherapy and stratifies patients into responders and non-responders. This information will aid physicians with therapy selection, decrease unnecessary adverse events, and allow healthcare systems to reduce expenditures significantly. For patients classified as non-responders to immunotherapy, the BostonGene Tumor PortraitTM Test provides other potential therapy options, utilizing existing guidelines to equip the treating physician in selecting the ideal therapy route.

The BostonGene Tumor PortraitTM Test is based on results from its landmark research study published in the June 2021 edition of Cancer Cell. The manuscript, "Conserved pan-cancer microenvironment subtypes predict response to immunotherapy," details a transcriptomic-based tumor classification platform that identifies distinct TME subtypes, predicting prognosis and response to immune checkpoint blockade. The study, supported by BostonGene’s 80 granted and 70 pending U.S. and international patents on cancer immunity, represents the importance of innovative multi-platform analytics to improve patient outcomes. The BostonGene Tumor PortraitTM Test builds on the understanding that matching patients to therapy options based on genomic and transcriptomic characteristics can produce better outcomes and adds a unique feature of therapy response prediction to assist in selecting the right therapy for each patient. Presently, there is a challenge between identifying candidates for a particular class of drugs and the low response rate to selected therapies. This is a costly burden on the healthcare system and may cause unnecessary adverse events to patients.

"Immuno-oncology focuses on data-informed, more precise methods to select the best choice of treatments for patients the first time, minimizing side effects and costly trial and error," says Mark Poznansky, MD, Ph.D., Professor of Medicine, Harvard Medical School, Director of Vaccine and Immunotherapy Center, Massachusetts General Hospital and an academic research collaborator with BostonGene. "Technologies that can help predict treatment response create an opportunity to improve patient outcomes and reduce the cost of overall care."

"Oncologists can choose from several hundred unique FDA-approved drugs," says Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Despite these options, cures are rare, and most patients with advanced disease will have limited response to single agents. Correctly identifying and selecting the best drug, or combination of drugs for each patient with the BostonGene test has the potential to increase cures for all cancer patients dramatically."

On February 8, 2022 Qurient Co. Ltd. (KRX: 115180), a clinical stage biotech company, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for Q901, a small molecule oncology drug candidate targeting cyclin dependent kinase 7 (CDK7) (Press release, Qurient Therapeutics, FEB 8, 2022, View Source [SID1234607858]).

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The company plans to enroll up to 70 patients with advanced solid tumors in a Phase 1/2 clinical study taking place in the United States. The goal of the study will be to determine the maximum tolerated dose, dose-limiting toxicities, and the recommended Phase 2 dose of Q901.

"IND clearance for Q901 is an important step forward in developing this novel drug candidate that may provide a new alternative treatment to patients with relapsed or refractory malignancies," says Kiyean Nam, Ph.D., CEO of Qurient. "We look forward to initiating the clinical study for Q901 and presenting additional nonclinical efficacy data of Q901 in various cancer models at an upcoming scientific meeting."

Q901 is a highly selective CDK7 inhibitor that has been shown in in vitro studies to only inhibit CDK7 in the human kinome. CDK7 is a master regulator of cell cycle checkpoints and an essential component of transcription machinery. Additional data from preclinical studies has demonstrated that selective inhibition of CDK7 specifically kills cancer cells with aberrant cell division cycle or transcriptional regulation. Nonclinical pharmacology studies of Q901 have demonstrated that the selective inhibition of CDK7 exerts tumor growth inhibition in a number of murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers.

Qurient licensed the CDK7 inhibitor program at lead stage from Lead Discovery Center (LDC) and the Max-Planck Society and further optimized the program, completed the IND-enabling studies, and submitted the IND application.

"We are thrilled about the second CDK-selective inhibitor from the LDC pipeline to reach cancer patients. The nomination of Q901 for clinical development emphasizes the translational competence of LDC and represents an extremely important milestone," adds Bert Klebl, CEO and CSO of the LDC. "Starting out with an early-stage and BMBF grant funded academic collaboration with two academic partners, and strongly supported by additional financing from the Max-Planck Foundation, LDC has launched this journey to identify and generate mono-specific CDK7 inhibitors. After an initial animal proof-of-concept, the CDK7 assets were licensed to our strategic collaboration partner, Qurient. We respectfully appreciate our ongoing partnership with Qurient, who are now moving the second joint program, after Q702, forward to clinical trials. While licensing these projects and jointly starting the spin-off, QLi5, we have since built a sustainable and strong partnership with Qurient, with more to come, focusing on the translation of innovative biology and drug discovery programs from LDC’s academic network."

"Qurient has proven to be the ideal partner for this project, and we are more than happy about the results of this strategic partnership," says Jörn Erselius, Managing Director at Max-Planck Innovation GmbH.

The CDK7 inhibitor project and other projects have been supported in part by private sponsors and charities, especially Max-Planck-Foundation, which supports many Max Planck research projects and researchers, including the most recent Nobel Laureates at Max Planck.

On February 8, 2022 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Holdings Corp. (View Source), reported that Eun-Ju Ryu has been appointed President of Samyang Biopharm USA, end of Jan. 2022 (Press release, Samyang Biopharmaceuticals, FEB 8, 2022, View Source [SID1234607857]).

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"Eun-Ju’s proven leadership capabilities are exceptional and I am confident that she is the right leader for Samyang Biopharm USA as the company continues its transition into a fully-integrated, global company delivering on the promise of an emerging pipeline," said Dr. Young Joon Lee, Head of Biopharm Group,, Samyang Holdings Corp. "During her impressive career, she has led key elements of business development, commercial and R&D in select therapeutic areas including oncology and rare disease. This experience will help Samyang Biopharm USA reach the next level of growth and achievement."

Ms. Ryu brings over 30 years of experience in the biopharmaceutical industry to her leadership position at Samyang Biopharm USA. Prior to this appointment she held a series of escalating management positions in various companies, including 12 years at Pfizer Inc. (USA) and 6 years at Pfizer Korea. Her career started as a Regulatory manager, then expanded roles in Clinical Trial Management team, Business Development and Global marketing. After she served as a Head of Oncology and Specialty Business Unit at Pfizer Korea, she moved to New York headquarter as a Japan Asia regional commercial lead in 2006. Once moved to the US, she was leading Global Marketing and Portfolio Maximization and Acquisition in various therapeutic areas including Oncology, Rare Disease, Anti-Infectives, and Neuroscience. She was awarded by the Minister of Health and Welfare for her contribution in US-Korea collaboration. Her continuous community service has been recognized by the County Community leadership award. She also worked as a CEO of Korean Community Center and a Chief Business Development Officer in Diagnostic Company. Eun Ju Ryu received her Bachelor’s degree in Pharmacy at Ewha Womans University, Master’s in Clinical Pharmacy at Sookmyung Women’s University, and MBA degree at New York University in the US. Eun-Ju joins as President of Samyang Biopharm USA in end of Jan. 2022.

"I am excited to become President of Samyang Biopharm USA as the company continues to build its pipeline in select oncology indications with the ultimate goal of providing life-changing medicines for patients," said Ms. Eun-Ju Ryu, President of Samyang Biopharm USA. "It is an honor to lead this team of committed scientists and business leaders who are dedicated to changing the lives of patients and making our vision a reality. As the company builds upon its initial success and expands its portfolio with promising new research programs, I believe we are in a position to drive substantial growth over the long term."