on February 28, 2023 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company in the healthcare space, reported that Synergy Oncology, part of Synergy Laboratories, a full-service diagnostic laboratory based in Mobile, Alabama, will use SOPHiA DDM to develop a new cancer profiling solution (Press release, Sophia Genetics, FEB 28, 2023, View Source [SID1234627934]). The combination of technology from Synergy Oncology and SOPHiA GENETICS will expand Synergy’s oncology portfolio while helping to further the U.S. oncology market.

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Synergy Oncology, which specializes in the use of innovative platforms to improve patient care, will pair SOPHiA DDM for Hereditary Cancers Solution with their state-of-the-art laboratory technologies to launch Totality, a comprehensive end-to-end solution for tumor profiling that will benefit cancer research, clinical studies, and patient care.

"Our mission at SOPHiA GENETICS is to democratize data-driven medicine by increasing accessibility to synthesized, digestible data in this space," said Ken Freedman, Chief Revenue Officer, SOPHiA GENETICS. "Synergy is known to be a best-in-class facility and their use of the SOPHiA DDM is an important step in creating cancer profiling solutions that will progress research and treatments of hereditary cancers for the medical community."

"Our decision to collaborate with SOPHiA GENETICS was simple," said Joseph Cohil, Head of Synergy Oncology. "Our collaboration with SOPHiA GENETICS will accelerate Synergy’s leading hereditary cancer technology to the forefront of patient outcomes."

The use of next generation sequencing (NGS) is prevalent in the detection of biomarkers for hereditary cancers but comes with a vast and complex dataset for analysis. The SOPHiA DDM for Hereditary Cancers Solution uses Artificial Intelligence and machine learning with patented technologies to analyze raw NGS data, streamlining it for simplified interpretation, and expedited reporting. The SOPHiA DDM platform can serve as a one-stop solution for Synergy Laboratories as it looks to scale into other oncology offerings.

Synergy’s new Totality product analyzes genes from solid tumor tissue, and through the use of SOPHiA DDM for Hereditary Cancers, it provides physicians with a compact report that matches detected molecular alterations with FDA approved therapies and clinical trials. The pairing of SOPHiA DDM for Hereditary Cancers with Synergy Oncology’s technology is designed to give experts the ability to analyze and interpret findings from NGS data with confidence, turning high-quality data into valuable insights for researchers and care providers. Synergy Oncology offers the most comprehensive NGS kit of its kind, including liquid biopsy testing, hereditary testing, and myeloid malignancies.

On February 28, 2023 Median Technologies (ALMDT:PA) reported new and breakthrough results for its iBiopsy Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx1 Software as Medical Device (SaMD) to characterize malignant lung nodules in low dose CT scans (LDCT) (Press release, MEDIAN Technologies, FEB 28, 2023, View Source [SID1234627933]).

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New results released today demonstrate considerable increase of Median’s proprietary algorithms performance with a sensitivity2 of 96.5% for a specificity3 of 97.2% on end-to-end lung nodule detection and malignancy characterization. These results complement the results released previously (March 22, 2022), which were based on a cohort of 1,760 patients and showed a 94.7% sensitivity at a 93.3% specificity. New results are calculated on a much larger cohort of 9,863 patients corresponding to 195,943 nodules (vs. 16,789 lung nodules in March 2022). Consistent with previously released results, the performance corresponds to end-to-end detection and characterization at nodule level.

"On February 27, 2023 we announced the completion of the Q-Submission phase with the FDA regarding clinical protocols pre-submission, a major milestone in the roadmap of our iBiopsy LCS CADe/CADx SaMD. Our pivotal study protocols are now finalized and ready for study execution. Today, with the release of our improved performance results, we are more than ever confident for the next steps which will drive our iBiopsy LCS CADe/CADx SaMD to the FDA clearance. Our next milestone is now the execution of the pivotal studies, based on imaging and clinical data we started to collect at the end of 2022 from very prestigious clinical sites and cancer centers in the US and Europe", highlights Fredrik Brag, CEO and founder of Median. "Subsequent to this breakthrough performance, we recently filed two patents", Brag added.

Results will be presented at the European Congress of Radiology (ECR) AIX Theater, on Wednesday, 1 March, at 4:00 pm CET and on Thursday, 2 March at 1:30 pm CET. Median’s team will be available at booth #AI-35 for the duration of the technical exhibition (March 1-4).

The European Congress of Radiology (ECR) organized by the European Society of Radiology (ESR) is the premier European event in radiology and the second largest in the world. The congress conveys more than 20,000 with a split of more than 10,000 professional delegates (radiologists, technologists etc.), and ~8,000 industry participants (imaging modalities, PACS etc.). Radiology professionals from Europe and beyond attend to gather knowledge through educational courses, to see the latest innovations presented by technical exhibitors, and to discover groundbreaking research from scientific paper presentations. More about the ECR: View Source

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of AI/ML tech-based Software as Medical Devices (SaMD), to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NAFLD/NASH)

Forward-looking statements: This press release contains express or implied information and statements that may be considered forward-looking information and statements about Median Technologies. They are not historical facts. Such information and statements include financial projections that are based on certain assumptions and assessments made by Median Technologies’ management in light of its experience and perception of historical trends, current economic and industry conditions, expected future developments and other factors it deems relevant. These forward-looking statements include statements that generally use conditional verbs and contain words such as "expects", "anticipates", "believes", "intends", "plans" or "estimates" and variations and conjugations thereof and words of similar import. Although Median Technologies’ management believes that the forward-looking statements and information are reasonable, Median Technologies’ shareholders and other investors are cautioned that the realization of these expectations is inherently subject to various known and unknown risks and uncertainties that are difficult to predict and generally beyond the control of Median Technologies. These risks could cause actual results and developments to differ materially from those expressed, implied or projected in the forward-looking statements. This press release contains only summary information and should be read in conjunction with the public information filed by Median Technologies with the AMF and that are available on Median Technologies’ website. Other than as required by applicable law, Median Technologies is issuing this press release as of the date hereof and does not undertake to update or revise any forward-looking information or statements.

On February 28, 2023 Xencor, Inc. (the "Company") reported that it has entered into a Sales Agreement (the "Sales Agreement") with SVB Securities LLC (the "Sales Agent"), pursuant to which the Company may issue and sell through the Sales Agent up to $200 million of shares of common stock, $0.01 par value per share, of the Company (the "Common Stock"), subject to the limitations set forth in Section 5(c) (the "Placement Shares") of the Sales Agreement (Filing, 8-K, Xencor, FEB 28, 2023, View Source [SID1234627931]).

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The Common Stock sold in the offering will be issued pursuant to a sales agreement prospectus filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023 and the accompanying base prospectus dated February 27, 2023 forming part of the Company’s shelf registration statement on Form S-3ASR (Registration No. 333-270030) filed with the SEC on February 27, 2023.

Subject to the terms and conditions of the Sales Agreement, the Sales Agent will use its commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal laws, rules, and regulations and the rules of the Nasdaq Global Market ("Nasdaq"), to such sell Placement Shares up to the number or amount specified in and otherwise in accordance with the terms of the Sales Agreement.

The Company is not obligated to make any sales of Placement Shares under the Sales Agreement. The Company or the Sales Agent may, upon notice to the other party in writing, suspend any sale of Placement Shares, subject to the limitations set forth in the Sales Agreement. The offering of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of the Common Stock under the Sales Agreement having an aggregate gross sales price equal to $200 million and (ii) the termination of the Sales Agreement by the Company and the Sales Agent as permitted therein.

The Company made certain customary representations, warranties and covenants concerning the Company and the registration statement in the Sales Agreement and also agreed to indemnify the Sales Agent against certain liabilities, including liabilities under the Securities Act.

The Company intends to use the net proceeds from any sales of the Common Stock to or through the Sales Agent for general corporate purposes, which may include research and development, capital expenditures, working capital, and general administrative expenses. The Company may also use a portion of the net proceeds to acquire or invest in businesses, products and technologies that are complementary to its own, although it has no current plans, commitments or agreements to do so.

The compensation to the Sales Agent will be an amount not to exceed 3.0% of the gross proceeds of any shares sold under the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Sales Agreement, copy of which is attached hereto as Exhibit 10.1 and the terms of which are incorporated herein by reference.

On February 28, 2023 VBI Vaccines presenting its corporate presentation (Presentation, VBI Vaccines, FEB 28, 2023, View Source [SID1234627930]).

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On February 28, 2023 TriSalus Life Sciences Inc., ("TriSalus" or the "company"), an oncology company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors, reported that it will participate in a series of events at the Society of Interventional Radiology (SIR) 2023 Annual Scientific Meeting, held March 4-9, 2023, at the Phoenix Convention Center (Press release, TriSalus Life Sciences, FEB 28, 2023, View Source [SID1234627929]).

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At this year’s conference, new data from Phase 1/1b of the company’s Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trial program will be presented. The PERIO-01 and PERIO-02 trials are studying an investigational toll-like receptor 9 agonist, SD-101, delivered intravascularly by the TriNav Infusion System ("TriNav") using the company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration. The studies are evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases, hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

In addition to several data presentations, the company is hosting numerous educational opportunities for interventional radiologists to learn more about the company’s FDA-cleared TriNav Infusion System, including multiple in-booth presentations, a lunch symposium and an evening networking reception. The TriNav Infusion System utilizes the PEDD method of administration with SmartValve technology to overcome intratumoral pressure and improve delivery of therapeutic agents during outpatient interventional radiology procedures.

The details of these additional activities are highlighted below. Oral abstract presentations listed below are part of the SIR 2023 CME-accredited scientific program and are not TriSalus-sponsored activities.

ON-SITE TRISALUS SPOKESPERSONS

Mary Szela, MBA, CEO and President
Steven C. Katz, MD, FACS, Chief Medical Officer
Jennifer L. Stevens, JD, Chief Regulatory Officer
Bryan F. Cox, PhD, Chief of Research
David B. Jaroch, PhD, Senior Principal Scientist
Alexander Y. Kim, MD, Consultant, Director of Interventional Oncology Clinical Strategies

CONFERENCE ACTIVITIES

Sunday, March 5 – Wednesday, March 8

TriNav Exhibition; Location: Exhibit Hall, Booth #1023

Visit Booth #1023 to learn more about the TriNav Infusion System and its ability to improve tumor response and enhance therapeutic delivery.

Two in-booth presentations, led by practicing interventional radiologists, will also be taking place:

The Tumor Microenvironment – Understanding the Barriers to Effective Treatment (March 5, 2:30pm-3:00pm MST)
Ripal Gandhi, MD, Miami Cardiac and Vascular Institute and Miami Cancer Institute
The Benefits of PEDD – Real World Experience with TriNav (March 6, 10:00am- 10:30am MST)
A. Michael Devane, MD, FSIR, Prisma Health Upstate/University of South Carolina School of Medicine Greenville
Sunday, March 5

SIR Foundation Research Gala, 6:30pm-10:30pm MST; Location: Scottsdale Resort at McCormick Ranch

TriSalus is proud to be a bronze sponsor of the SIR Foundation’s annual gala, a premier fundraising event focused on advancing research progress in interventional radiology.

Monday, March 6

Oral Abstract Presentation, 3:00pm-3:09pm MST; Location: Room 227ABC

Abstract Title: The Effects of a Pressure-Enabled Drug Delivery Microcatheter on Radiotracer Distribution Compared to a Standard Microcatheter in Radioembolization, an Interim Analysis

Learn more from TriSalus research collaborators at Massachusetts General Hospital about differences in delivery between the Pressure-Enabled Drug Delivery (PEDD) microcatheter and a standard microcatheter in pre-radioembolization mapping procedures.

Oral Abstract Presentation, 4:12pm-4:21pm MST; Location: Room 225AB

Abstract Title: Hepatic Arterial Infusion of the Class C TLR9 Agonist SD-101 in Pressure Enabled Regional Immuno-Oncology (PERIO) Phase 1/1b Trials for Liver Tumors

The PERIO-01 and PERIO-02 clinical trials are studying investigational SD-101 delivered by the PEDD method of administration in uveal melanoma with liver metastases, advanced hepatocellular carcinoma, and advanced intrahepatic cholangiocarcinoma. Hear Rahul Sheth, MD, Associate Professor of Interventional Radiology, MD Anderson Cancer Center, discuss data from the trials, co-authored by TriSalus colleagues Bryan Cox, PhD, Steven Katz, MD, Ann-Marie Hulstine, and Zoe Nguyen.

Hands-on Workshop – Interventional Oncology: Embolization, 8:30am-10:00am MST; Location: Expo Halls 4-5

During this interactive workshop, attendees will have the opportunity to understand the unique features of the TriNav Infusion System that distinguish it from conventional delivery methods.

Tuesday, March 7

Lunch Symposium with TriSalus Life Sciences, 12:00pm-1:00pm MST; Location: Room 128AB

Alex Kim, MD; Resmi A. Charalel, MD, MPH, Assistant Professor of Radiology and Population Health Sciences at Weill Cornell Medicine; and David Jaroch, PhD, will discuss current evidence for PEDD. The symposium will discuss intratumoral pressure and vascular resistance and include a review of PEDD data featuring case studies.

Educational Interactive Symposium with TriSalus Life Sciences, 6:00pm-8:00pm MST; Location: Sheraton Phoenix Downtown, Room: Valley of the Sun D

Join TriSalus for an interactive exchange including two demonstrations on drug delivery barriers and the Pressure-Enabled Drug Delivery (PEDD) approach. (Media can RSVP for this event by emailing [email protected]).

Wednesday, March 8

Oral Abstract Presentation, 3:36pm-3:45pm MST; Location: Room 222AB

Abstract Title: Pancreatic Retrograde Venous Infusion (PRVI) Significantly Enhances Delivery of NearIR Labelled SD-101 TLR9 Agonist to Targeted Regions of the Porcine Pancreas

David Jaroch, PhD, will discuss pre-clinical data from a study examining Pancreatic Retrograde Venous Infusion (PRVI), a trans-venous approach for the regional treatment of pancreatic tumors, using investigational drug SD-101. Co-authors of the study include Steven Katz, MD, and Bryan Cox, PhD.

Oral Abstract Presentation, 4:21pm-4:30pm MST; Location: Room 222AB

Abstract Title: Pancreatic Venous Anatomy for Trans-portal Treatment of Pancreatic Cancers Using Pressure-Enabled Drug Delivery (PEDD)

Michael Kwong, BA, medical student at the University of Colorado Anschutz Medical Campus, will be presenting clinical data to inform the use of the PEDD method in treating pancreatic cancers.