Day: January 5, 2023

Global registrational trial expected to commence in the second half of 2023 BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a hematopoietic stem cell (HSC) gene therapy being developed for the treatment of the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The company expects to initiate a global registrational trial evaluating the efficacy and safety of OTL-203 compared to standard of care in the second half of 2023. “Based on data from the proof-of-concept trial, treatment with a single administration of OTL-203 has the potential to address a range of multisystemic manifestations of MPS-IH,” said Leslie Meltzer, Ph.D.,...

MINNEAPOLIS, Jan. 05, 2023 (GLOBE NEWSWIRE) — Tactile Systems Technology, Inc. (“Tactile Medical”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced the appointment of Carmen Volkart to the Company’s Board of Directors (“Board”), effective January 5, 2023. “Carmen joins our Board with more than 40 years of experience in financial and managerial positions, including extensive experience leading medical device companies,” said Bill Burke, Chairman of the Board of Tactile Medical. “We are glad to welcome Carmen to Tactile Medical and look forward to benefiting from her operating expertise and strategic insight.” Since 2018, Carmen Volkart has served as the Chief Financial Officer of NatureWorks LLC, a privately-held advanced materials company and developer of renewably...

SRF114 is designed to preferentially deplete CCR8+ Treg cells within the tumor microenvironment and has demonstrated highly specific CCR8-exclusive binding and reduced tumor growth in pre-clinical studies Initial clinical data anticipated in 2024 CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the first patient has been dosed in its Phase 1/2 clinical study investigating SRF114, a potential best-in-class, fully human, afucosylated anti-CCR8 antibody, as a monotherapy in patients with advanced solid tumors. “Helping patients fight cancer by depleting intra-tumoral regulatory T cells (Tregs) has been a key goal of many immunotherapy strategies for quite...

Figure 1: Property map showing the location of the Tarabala prospectFigure 2: Summary drilling results on the Tarabala Trend and the location of the planned RC drill holesToronto, Jan. 05, 2023 (GLOBE NEWSWIRE) — Compass Gold Corp. (TSX-V: CVB) (Compass or the Company) announced today that it has completed its previously announced private placement financing and is preparing to launch a follow-up drilling program to test previously identified mineralized sections at depth along the Tarabala Trend on its Sikasso Property in Southern Mali (Figure 1). HighlightsClosed previously announced private placement financing for gross proceeds of $700,000 Field teams to be mobilized to prepare drill pads for follow-up deeper drilling at the Tarabala prospect, including where metallic screen fire assaying reported 7 m at 14.13 g/t...

SAN JUAN, Puerto Rico, Jan. 05, 2023 (GLOBE NEWSWIRE) — Red Cat Holdings, Inc. (Nasdaq: RCAT) (“Red Cat” or the “Company”), a military technology company that integrates robotic hardware and software to provide critical situational awareness and actionable intelligence to on-the-ground warfighters and battlefield commanders, today announced an important new partnership. Opening day of the Consumer Electronics Show (CES) in Las Vegas, Nevada, brought the announcement that Teal Drones, a Red Cat subsidiary, has partnered with leading Canadian optical products manufacturer Immervision, whose latest navigation camera module is used for surveillance and unmanned systems. Immervision will provide Teal’s flagship drone with exceptional low-light capabilities – capabilities that Immervision demonstrated at CES. Teal...

BOSTON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer, today announced a clinical supply agreement with Regeneron for its anti-PD1 therapy Libtayo® (cemiplimab). The supply agreement supports the evaluation of SNS-101, a conditionally active VISTA-blocking antibody, in combination with Libtayo® in a Phase 1/2 trial in solid tumors. Sensei is on track to submit an Investigational New Drug application for SNS-101 in or before April 2023 and the trial is expected to commence in 2023 pending regulatory clearance. “We are excited for the opportunity to work with Regeneron on our planned clinical trial of SNS-101, which has demonstrated strong anti-tumor activity in combination with PD-1 inhibition...

BEIJING, Jan. 05, 2023 (GLOBE NEWSWIRE) — ZW Data Action Technologies, Inc. (Nasdaq: CNET) (“ZW Data” or the “Company”), an integrated online advertising, precision marketing, data analytics, and other value-added services company, today announced a strategic cooperation with Superwin Technology Pte. Ltd. (“Superwin”). Both parties intend to jointly establish a Web3.0 application service platform (“Platform”), through which the Company expects to provide basic computing power and blockchain services for Web3.0 application suppliers. The Company expects to bring commercial value to enterprise users and achieve efficiency in utilizing computing power resources, integrated management, and flexible scheduling, through the Platform. Superwin, headquartered in Singapore, operates data center, computing and mining...

Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG) Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 patients FDA review of application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill COVID-19 patients ongoing InflaRx’s management team to host investor and business meetings during JPM Week, January 9 – 12, 2023 in San Francisco, CaliforniaJENA, Germany, Jan. 05, 2023 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced details related to the design of its planned Phase III study with vilobelimab in ulcerative PG, a rare neutrophilic...

CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H., currently Head of Global Safety and Regulatory Sciences and Interim Head of Research & Development (R&D), has been promoted to Executive Vice President, Head of Development, following a decision to separate Research and Development into two distinct functions that will both report directly to the CEO. In addition, Biogen has initiated a search for a new Executive Vice President, Head of Research; Dr. Singhal will serve as interim head of Research until a new leader is named. “Throughout her tenure at Biogen, Priya has demonstrated excellent leadership and judgement. In this new role, Priya will focus on delivering on our development programs while working closely with a new dedicated head of Research...