On February 16, 2023 TriSalus Life Sciences, Inc. ("TriSalus" or the "Company"), an oncology company reported that the process of going public through a business combination transaction (the "Business Combination") with MedTech Acquisition Corporation (Nasdaq: MTAC) ("MedTech" or "MTAC"), today posted an updated investor presentation with new data regarding its ongoing Pressure-Enabled Regional Immuno-Oncology ("PERIO-01" and "PERIO-02") clinical studies for primary and metastatic liver tumors (Press release, TriSalus Life Sciences, FEB 16, 2023, View Source [SID1234627321]). The presentation is available on the investor relations section of the Company’s website.

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The PERIO-01 and -02 trials are studying an investigational drug, 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, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.

The latest data from the PERIO-01 and PERIO-02 trials, as well as multiple nonclinical studies, are supportive of the PEDD method for delivering therapeutics, including SD-101, into high-pressure liver tumors. Specifically, in uveal melanoma patients with liver metastases, when delivered via the PEDD method at a 2 or 4 mg dose, SD-101 in combination with nivolumab demonstrated decreases of circulating tumor DNA in the majority of patients, which has been associated with longer overall survival in this population. Emerging data, outlined in the Company’s investor presentation, also supports the hypothesis that SD-101 delivered via the PEDD method, can enable broad immune effects including depletion of liver myeloid derived suppressor cells ("MDSCs"). TriSalus expects data in connection with higher doses by Q2 2023, in addition to data from a separate cohort that combines SD-101 with the combination of nivolumab and ipilimumab.

As of February 2023, 42 patients have enrolled in PERIO-01 and PERIO-02 and have been treated with more than 138 infusions of SD-101. TriSalus is continuing to enroll patients in both PERIO-01 and PERIO-02 and is adding additional clinical sites in anticipation of Phase 2 programs in the second half of 2023.

"The early findings from the Phase 1 PERIO-01 and Phase 1b PERIO-02 trials build on our previous findings and reinforce our confidence in the potential of SD-101 combined with TriSalus’ proprietary PEDD approach," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "Given the aggressive nature of stage IV uveal melanoma, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma, we believe that the patient enrollment in these studies highlights the potential of SD-101 and PEDD to enable better outcomes when combined with checkpoint inhibitors. These results, which are summarized in our new investor presentation, further support our hypothesis that SD-101, delivered by PEDD, may favorably reprogram the liver tumor microenvironment and reduce or eliminate MDSCs to promote better responsiveness to checkpoint inhibition. Based on the initial data at the lower end of our SD-101 dose range in combination with checkpoint inhibition, we are eager for clinical results at higher dose levels."

About TriSalus and Its Proposed Business Combination with MedTech
TriSalus is an oncology company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors.

TriSalus’ proprietary platform approach addresses immune dysfunction in liver and pancreatic tumors by combining its drug delivery technology with immunotherapeutics. The TriSalus platform comprises the TriNav Infusion System and SD-101, a class C toll-like receptor 9 (TLR9) agonist. TriNav is an FDA-cleared device that is designed to administer established and emerging therapeutics. SD-101, the Company’s investigational TLR9 agonist, is being delivered via TriNav to selected sites, including tumors in the liver. TriNav is the latest TriSalus asset for the proprietary PEDD method of administration which has been shown to overcome intratumoral pressure through modulation of pressure and flow to increase delivery of therapeutic agents.

As previously announced on November 14, 2022, TriSalus entered into a definitive merger agreement with MedTech, a publicly traded special purpose acquisition company (the "Merger Agreement") in connection with the proposed business combination and related transactions between the parties. Upon the closing of the transaction, which is expected to occur in the second quarter of 2023, the combined company will be a publicly traded company and its common stock is expected to be listed on the NASDAQ Stock Exchange under the ticker "TLSI." The transaction is subject to the satisfaction of the necessary regulatory approvals and customary closing conditions, including the approval of MedTech’s shareholders.

On February 16, 2023 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its fourth quarter 2022 results (Press release, Targovax, FEB 16, 2023, View Source [SID1234627320]).

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Members of Targovax’s executive management team will give an online presentation to investors, analysts and the press at 10:00 CET today (details below).

FOURTH QUARTER 2022 HIGHLIGHTS
ONCOS-102
The phase 1b melanoma study was selected for oral presentation at the prestigious Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) annual meeting
The phase 1b melanoma full study results were published in the high-impact oncology journal Clinical Cancer Research
CircRNA pipeline program
Key technical proof-of-concept data were established, and IP filed for the in-house circRNA design and circAde vector
Mutant KRAS platform
The TG01 trial in multiple myeloma at Oslo University Hospital received regulatory approvals to proceed
A clinical trial collaboration was announced with Agenus and Kansas University to test TG01 in combination with PD1 checkpoint inhibitor balstilimab in pancreatic cancer
Corporate
Hubro Therapeutics acquired GM-CSF vaccine adjuvant for NOK 10m from Targovax ASA in an asset purchase agreement
POST-PERIOD HIGHLIGHTS
In February 2023, Targovax announced financing of up to NOK 300m over three years to advance its clinical cancer programs & pre-clinical circular RNA platform
Erik Digman Wiklund, CEO commented: "We are now well positioned to execute on all our R&D programs in 2023. During the year, we expect both ONCOS-102 and TG01 to progress rapidly in clinical studies at major cancer centers in the USA and Europe, teeing up important read-outs in 2024. For circRNA, we aim to establish in vivo proof-of-concept in several settings, and firmly establish Targovax as the leader in vector-delivered circRNA therapeutics – aiming to be first into the clinic with a circRNA product for cancer treatment already in 2025. To further strengthen our financial position, we are building on the momentum in the RNA field to actively pursue additional opportunities to help unlock the substantial potential value of our circRNA platform"

Key figures
Amounts in NOK thousands 4Q 2022 4Q 2021 FY 2022 FY 2021
Total operating revenues 10 002 – 10 002 –
Total operating expenses -32 198 -25 523 -112 266 -95 601
Operating profit/loss -22 196 -25 523 -102 264 -95 601
Net financial items -17 -1 129 -313 -2 422
Income tax

9 10 40 52
Net profit/loss -22 204 -26 641 -102 537 -97 971
Basic and diluted EPS (NOK/share) -0.12 -0.28 -0.54 -1.10
Net change in cash -30 171 127 617 -115 667 59 360
Cash and cash equivalents start of period 96 186 54 064 181 682 122 321
Cash and cash equivalents end of period 66 015 181 682 66 015 181 682
The interim financial information has not been subject to audit

Presentation

We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to submit questions during the presentation.

Reporting material

TRVX 4Q’22 report.pdf

TRVX 4Q’22 presentation.pdf

The quarterly report and presentation are also available at the website www.targovax.com.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: [email protected]

Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: [email protected]

Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Email: [email protected]

On February 16, 2023 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer patients, reported that Company management will participate in a fireside chat at Citi’s 2023 Virtual Oncology Leadership Summit, on Thursday, February 23rd at 11:00 a.m. ET (Press release, Sensei Biotherapeutics, FEB 16, 2023, View Source [SID1234627319]).

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A webcast of Sensei’s presentation will be available in the Investors section of the Sensei website. A replay of the webcast will be on the website for approximately 90 days following the event. Registration for the live webcast is available here.

On February 16, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that new research performed in the laboratory of preeminent CD4 T cell researcher, Andrea Sant, PhD at the University of Rochester Center for Vaccine Biology and Immunology, was published in the peer-reviewed journal, Viruses (Press release, PDS Biotechnology, FEB 16, 2023, View Source [SID1234627318]). The preclinical research studied Infectimune, PDS Biotech’s novel investigational infectious disease immune activating platform, and demonstrated the technology’s potency in eliciting CD4 T cells. The studies focused on comparing Infectimune induced immune responses following primary vaccination against influenza with immune responses induced by leading vaccine adjuvants. This publication follows a recent article in Viruses highlighting the ability of Infectimune to generate a broad immune response against viruses, including SARS-CoV-2 and multiple strains of influenza.

The paper, titled, "R-DOTAP cationic lipid nanoparticles outperform squalene-based adjuvant systems in elicitation of CD4 T cells after recombinant influenza hemagglutinin vaccination," reported findings from a preclinical study investigating the ability of Infectimune (R-DOTAP) to promote CD4 T cell responses to vaccination with recombinant influenza protein. Infectimune was compared to AddaVax, which is analogous to commercial adjuvant MF59, and AddaVax combined with CpG, a commercial adjuvant, using HA-B as the influenza vaccine antigen. Results from the study concluded that Infectimune dramatically enhanced CD4 T cell responses to recombinant HA-B proteins relative to AddaVax and AddaVax plus CpG. Further, the Infectimune elicited CD4 T cells displayed abundant Interferon (IFN)-gamma and Interleukin (IL)-2 production that are critical for protective immunity. CD4 T cells are documented to present multiple functions including CD8 T cell expansion and antibody responses as well as direct anti-viral effects and potentiation of antigen presenting function to enhance protection against viral infection.

"Influenza remains challenging due to low immune responses, especially in the elderly. Thus, there is a significant opportunity to develop a flu vaccine that induces broadly protective responses to influenza," stated Dr. Gregory Conn, Chief Scientific Officer of PDS Biotech.

Dr. Sant, the senior author on the paper stated, "These results showing the potency of R-DOTAP to promote epitope-specific, cytokine-inducing CD4 T cells against a recombinant influenza antigen are exceptionally promising."

The preclinical research published in Viruses demonstrates the ability of Infectimune to significantly boost CD4 T cell activity, suggesting that Infectimune based vaccines could provide durable protection against seasonal flu and potentially emerging pandemic flu.

The research was supported by grants from the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program and funded in part by the National Institute of Allergy and Infectious Diseases.

About Infectimune

Infectimune is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

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On February 16, 2023 OPKO Health, Inc. (NASDAQ: OPK) plans to reported operating and financial results for the three months ended December 31, 2022 after the close of the U.S. financial markets on Thursday, February 23, 2023 (Press release, Opko Health, FEB 16, 2023, View Source [SID1234627317]). OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on February 23rd beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until March 2, 2023 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 3187296. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.