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Qurient Announces U.S. FDA Clearance of IND Application for Q901, a Novel Cancer Therapy

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.

Samyang Biopharm USA Announces Appointment of Eun-Ju Ryu as New President

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]).

"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."

AngioDynamics to Present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

On February 8, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference at 10:00 a.m. ET on Tuesday, February 15, 2022 (Press release, AngioDynamics, FEB 8, 2022, View Source [SID1234607856]).

BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

Beyond Air® Announces Participation at Upcoming Investor Conferences in March 2022

On February 8, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to participate in two upcoming investor conferences in March 2022 (Press release, Beyond Air, FEB 8, 2022, View Source [SID1234607855]).

Details for Upcoming Conference Presentations:

Event: 34th Annual Roth Conference
Date and Time: March 13-15, 2022
Location: Dana Point, California

Event: Oppenheimer 32nd Annual Healthcare Conference
Date and Time: March 15-16, 2022
Location: Virtual presentation is scheduled for Wednesday, March 16th at 10:00 AM ET
Please contact your representative at either Roth or Oppenheimer to schedule a one-on-one meeting with Beyond Air during the respective conference.

Synthetic Biologics Announces VCN Biosciences’ VCN-01 Receives Orphan Drug Designation for Retinoblastoma from the U.S. FDA

On February 8, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that VCN Biosciences, S.L.’s (VCN) VCN-01 received Orphan Drug Designation for retinoblastoma from the U.S. Food & Drug Administration (FDA) (Press release, Synthetic Biologics, FEB 8, 2022, View Source [SID1234607854]). This announcement follows Synthetic Biologics’ recent announcement that it had entered a definitive agreement to acquire VCN, which is subject to conditions that must be met prior to closing. VCN is developing a new oncolytic adenovirus (OV) platform designed to trigger tumor cell death and promote immune cell infiltration into tumors.

The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, diagnose or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of application fees, reduced annual product fees, clinical protocol assistance and potential qualification for expedited development programs.

Steven Shallcross, Chief Executive Officer and Chief Financial Officer of Synthetic Biologics, commented, "We are pleased to report that VCN’s VCN-01 was granted Orphan Drug Designation for retinoblastoma by the FDA. We believe VCN-01 may represent a novel rescue therapy for patients who fail standard therapy, or may be used as an adjunct to chemotherapy, to provide improved outcomes for these patients. We are highly encouraged by the preliminary clinical data thus far and look forward to conducting a pivotal Phase 2/3 trial in these patients following our expected completion of the acquisition."