Weekly Quick Hits (BioHealth Capital Region) – Week of May 29, 2023

By Sarah Ellinwood
June 2, 2023

Funding, Awards and Collaborations

BCWorld Healthcare and ReGelTec Enter Exclusive Distribution Agreement for Hydrafil™ in the South Korean Market

ReGelTec has entered into an agreement with BCWorld Healthcare Co., Ltd. (BCWH) that provides BCWP exclusive rights to distribute the HYDRAFIL™ System for the treatment of Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD) in the South Korean market. The agreement includes an investment by BCWH in ReGelTec. BCWH will also fund a clinical study in South Korea to support regulatory approval from the Ministry of Food and Drug Safety (MFDS) with ReGelTec providing HYDRAFIL™ Systems for the study. The companies have already started planning regulatory strategies for approval and expect the trial to begin in 2024.

Maryland Tech Council, Mount St. Mary’s University Partner to Offer Continuing Education to Tech & Life Sciences Professionals

The Maryland Tech Council (MTC) and Mount St. Mary’s University (MSMU) announced a partnership to provide MTC’s members with continuing education opportunities needed to advance their careers. With this partnership, MTC’s over 700 members will be eligible for 20 percent tuition savings on courses in the university’s Division of Continuing Studies. Fields of study include data science, logistics and supply chain management, business administration, biotechnology, project management, cybersecurity, and more. Courses can count toward undergraduate degrees, post-baccalaureate certificates, and graduate degrees.

University of Maryland School of Medicine Receives One of the Largest Gifts in Its History to Establish Kahlert Institute for Addiction Medicine

With an urgent mission to address the alarming rise in drug overdose deaths, the University of Maryland School of Medicine (UMSOM) announced plans to open the new Kahlert Institute for Addiction Medicine. It will be funded with a $10 million gift from the Maryland-based Kahlert Foundation with an additional $10 million provided by the University of Maryland, Baltimore (UMB) and $5 million from UMSOM to renovate research facilities on campus. UMSOM has committed to raise an additional $5 million in philanthropic donations for the Kahlert Institute.

Innovent Enters into Clinical Trial Collaboration with Merck KGaA, Darmstadt, Germany Investigating Combination Therapy of IBI351 (KRASG12C Inhibitor) and Cetuximab (ERBITUX®)for KRASG12C-mutated NSCLC in China

Innovent Biologics (HKEX: 01801) entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany for the combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX®) as a potential frontline treatment for NSCLC patients harboring KRASG12C mutation in a Phase 1b clinical trial in China. Under the agreement, Innovent will conduct a Phase 1b study to evaluate the anti-tumor activity and safety of the combination therapy of IBI351(GFH925) with cetuximab in Chinese patients with advanced or metastatic NSCLC harboring KRASG12C mutation. Merck KGaA, Darmstadt, Germany will provide clinical drug supplies of cetuximab in this multi-center trial in China. Cetuximab as a monotherapy or as a combination therapy has not been approved in any country for patients with advanced NSCLC.

In the Clinic

Precigen Receives IND Clearance to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab for Recurrent or Metastatic Cervical Cancer

Precigen (Nasdaq: PGEN) announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase 2 study of the first-in-class PRGN-2009 Off-the-Shelf (OTS) AdenoVerse™ immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer. The Phase 2 randomized, open-label, two-arm, multicenter study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab versus pembrolizumab monotherapy in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. The study will enroll approximately 46 patients who previously have been treated with pembrolizumab for recurrent or metastatic disease.

Ascentage Pharma’s Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

Ascentage Pharma (6855.HK) announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended olverembatinib (HQP1351), Ascentage Pharma’s lead novel drug candidate, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.

This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs).

ReAlta Life Sciences Shares Proof of Mechanism Data from the Phase 1b Inhaled LPS Trial of RLS-0071, Demonstrating Powerful Inhibition of Lung Neutrophils and Inflammatory Cytokines

ReAlta Life Sciences (“ReAlta”) announced exciting new proof-of-mechanism data from the company’s Phase 1b Inhaled LPS clinical trial of RLS-0071 presented at the American Thoracic Society International Conference on May 23, 2023. RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for HIE and other rare diseases.

Findings from the Phase 1b Inhaled LPS trial demonstrated that treatment with RLS-0071 was safe and well-tolerated. Thirty subjects were randomized into three cohorts (10 subjects per cohort) that first inhaled lipopolysaccharide (LPS) and then received three administrations of RLS-0071 at 10 mg/kg (low dose), a 120 mg/kg loading dose followed by two administrations of 40 mg/kg (high dose) or placebo at 1 hour, 8 hours and 16 hours timepoints after the initial LPS inhalation.

YS Biopharma’s PIKA Rabies Vaccine Receives Phase 3 Clinical Trial Approval From Philippines FDA

YS Biopharma (NASDAQ: YS) announced that its PIKA Rabies Vaccine (the “Vaccine”) was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines. The Phase 3 clinical trial, which is planned to commence later in 2023, is a multi-center, multi-country study designed to evaluate the safety and immunogenicity of the company’s PIKA Rabies Vaccine. The study will include approximately 4,500 subjects in the Philippines, Singapore, and Pakistan. 

Sirnaomics Doses First Patient in Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Treatment

Sirnaomics has dosed the first participant in a Phase I clinical trial of STP122G for anticoagulation treatment. STP122G is part of the Group’s GalAhead™ Factor XI RNAi therapeutic program, which has applications across a broad range of disease indications such as the potential prevention and treatment of stroke after atrial fibrillation, cancer patients after immunotherapy, and improving total knee replacement recovery.

The phase I, single-center, randomized, double-blind, sequential cohort study is designed to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of a single ascending dose of STP122G when administered subcutaneously to healthy participants. The safety and tolerability will be compared among five different doses of STP122G (25 mg, 50 mg, 100 mg, 200 mg, 400 mg) to select one for future studies. The study plans to recruit 40 total participants.

Sensei Biotherapeutics Doses First Patient in Phase 1/2 Clinical Trial of SNS-101, a Conditionally Active VISTA-blocking Antibody, for the Treatment of Advanced Solid Tumors

Sensei Biotherapeutics (Nasdaq: SNSE) announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced solid tumors. SNS-101 is a conditionally active, human monoclonal IgG1 antibody, designed to selectively block the immune checkpoint VISTA in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1. The multi-center Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors.

People on the Move

DELFI Diagnostics Hires David Morgenstern, PhD, as Vice President of Clinical Development

Morgenstern joins DELFI from Roche Diagnostics, where he spent more than a decade in clinical development roles focused on oncology screening and diagnostic products, most recently as Global Head of Clinical Development for Oncology and Genetics.

Prior to Roche, Dave led Clinical Affairs at Endocyte, a clinical-stage pharmaceutical company acquired by Novartis in 2018, focusing on both therapeutic and companion diagnostic clinical evidence generation. Before that, he managed multiple clinical studies at Merck. He received a PhD in Microbiology and Immunology from Indiana University.

Distinguished Cardiac Surgeon Abbas Ardehali, MD, Joins Medcura’s Board of Directors

Ardehali is a professor of surgery and medicine in the division of cardiothoracic surgery at the David Geffen School of Medicine at UCLA. Ardehali also serves as director of the UCLA Heart and Lung Transplant program.