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.

On February 28, 2023 Theratechnologies Inc. ("Theratechnologies", the "Company", or "we") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has entered into a first amendment to its credit agreement dated July 20, 2022 (the "Credit Facility") with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager (collectively, "Marathon") (Press release, Theratechnologies, FEB 28, 2023, View Source [SID1234627928]).

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The Company and Marathon agreed to amend the terms of the Credit Facility by removing the condition related to the submission to the FDA of its human factors validation study ("HFS") related to EGRIFTA SV in order to access a US$20 million second tranche of the Credit Facility, and by allowing the inclusion of a going concern note in the auditor’s report to shareholders for the fiscal year ended November 30, 2022 without triggering an event of default.

The amendment was entered into in consideration of the issuance of an aggregate of 5,000,000 common share purchase warrants (the "Warrants") to Marathon. Each Warrant entitles the holder thereof to purchase one common share of the Company at a price of US$ 1.45 per share (the "Exercise Price") until February 27, 2030. The Exercise Price of the Warrants was calculated based on the volume weighted average price of the Company’s common shares on the Nasdaq over the 30 trading days for the Company’s common shares immediately preceding the date of issuance of the Warrants, plus a 50% premium. The exercise of the Warrants may be made by paying the Exercise Price in cash or by way of a cashless exercise. The Warrants are not listed. They are transferable only to affiliates of Marathon or to other potential lenders under the terms of the Credit Facility and their affiliates. The Company has relied on the exemption of Section 602.1 of the Toronto Stock Exchange Company Manual to proceed with the issuance of the Warrants.

The Company’s access to the second tranche of US$20 million remains subject to compliance with all of the other conditions set forth in the Credit Facility, including achieving net revenues of at least US$75,000,000 in the preceding 12 months prior to the disbursement of the second tranche and the absence of any event of default under the Credit Facility. The Credit Facility provides that the second tranche must be used to repay all of the outstanding US$27.5 million convertible notes of the Company due June 30, 2023.

"We are very pleased that Marathon accepted to amend the Credit Facility to allow us to access the second tranche without requiring the filing to the FDA of the HFS related to EGRIFTA SV. Having reached this agreement with Marathon at this stage speaks to the very good work the team has made thus far on the advancement of the HFS", said Paul Lévesque, President and CEO, Theratechnologies.

As previously announced, the FDA required the Company to conduct a HFS following our submission to the FDA in March 2021 of a change being effected ("CBE") supplement to the Instructions For Use ("IFU") included in the EGRIFTA SV product labeling after we received complaints from patients relating to the reconstitution of EGRIFTA SV. The Company implemented the changes to its IFU per the timelines set forth in the regulation. The FDA subsequently responded to our CBE supplement with a complete response letter asking us to carry out a HFS to ensure that patients reconstitute EGRIFTA SV in the proper manner. We have until September 15, 2023, to resubmit a CBE supplement in response to the letter issued by the FDA. The first part of the HFS, the formative study, has now been completed and the Company filed its proposed HFS protocol with the FDA for its review prior to initiating the summative study. The Corporation has not yet received a response from the FDA on its proposed HFS protocol.

On February 28, 2023 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that the company requested Fast Track designation to US Food & Drug Administration (FDA) for its first-in-class anti-PAUF monoclonal antibody ‘PBP1510 (INN-ulenistamab)’ for pancreatic cancer treatment (Press release, Prestige BioPharma, FEB 28, 2023, View Source [SID1234627927]). FDA will review the request and decide within sixty days. In June 2022, the company was granted approval for phase 1/2a clinical trial of PBP1510 in the US by FDA. The company plans to further expedite the development through FDA’s approach

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PBP1510 has been recognized as a promising new drug for pancreatic cancer treatment. The drug targets and neutralizes PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a protein that plays a critical role in tumor growth and rapid progression of pancreatic cancer. In 2020, PBP1510 was granted Orphan Drug designation by the US FDA, the European Medicines Agency (EMA), and Korea Ministry of Food and Drug Safety. In addition, the company has applied for patent for the first-in-class antibody in 24 countries, which has been successfully registered in 10 countries as of now including the US, Korea, and Singapore

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. To receive Fast Track designation, it must be determined that a drug treats or prevents a serious condition with no current therapy or show some advantage over available therapy in a serious condition. Pancreatic cancer has the highest mortality rate among major cancers and is the third leading cause of cancer-related death in the US. The company aims to pave the express way for PBP1510 by seeking close consultation and support from FDA through Fast Track designation

Upon receiving Fast Track designation, the company will have more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval. In addition, it can have more frequent written communication from FDA on such matters as the design of the proposed clinical trials and use of biomarkers. These benefits lead to higher efficiency and stability in development. Moreover, the company is eligible for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed which is the usual case

Dr. Lisa S. Park, CEO of Prestige Biopharma, commented: "We are making all round efforts to ensure the success of our first-in-class antibody PBP1510 through patent registration, clinical studies and development, and preparation for market authorization and commercialization. In addition to the Fast Track designation request, we also plan to request for FDA’s Breakthrough Therapy designation for PBP1510, as soon as we confirm preliminary clinical evidence on significant endpoint, to secure intensive guidance on efficient drug development program and organizational commitment involving senior managers."

On February 28, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, reported that the Company has completed and closed its Phase I clinical trial evaluating safety and tolerance for Pritumumab ("PTB") as a treatment for Primary and Metastatic Brain Cancers (Press release, Nascent Biotech, FEB 28, 2023, View Source [SID1234627926]). Previous announcements shared the end of the enrollment and dosing period of the Phase I trial.

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Nascent will continue to collect and evaluate the Clinical data from the Phase I trial as it prepares to submit results to the U.S. FDA for Phase II consideration.

Completing the Phase I trial is a major milestone and Nascent is excited to move toward finalizing plans for Phase II research. Phase I reinforced the companies’ determination and excitement around this unique monoclonal antibody treatment approach and Phase I has shown that it can be given safely at high doses. This is a new pathway toward attacking one of the defining health challenges we face, with longer-term implications that transcend the brain cancer market. We look forward to the opportunity to see our unique R&D platform become a game changer for patients suffering from brain cancer.

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.