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Accuray Incorporated to Speak at 33rd Annual Oppenheimer Healthcare Conference

On March 8, 2023 Accuray Incorporated (NASDAQ: ARAY) reported its participation in the 33rd Annual Oppenheimer Healthcare Conference taking place March 13-15, 2023 (Press release, Accuray, MAR 8, 2023, View Source [SID1234628355]). The management team is scheduled to participate in a fireside chat on Tuesday, March 14, 2023 at 1:00pm PST / 4:00pm EST.

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A live webcast of the fireside chat can be accessed on the Accuray website at investors.accuray.com. A replay will be available on the company’s website following the event. The webcast replay of the presentation will begin about one hour after the conclusion of the live presentation and will be available for approximately 90 days.

The Oppenheimer Conference will connect institutional investors to a wide variety of public and private healthcare companies spanning all major sectors of the healthcare industry.

Citius Pharmaceuticals to Participate in the 35th Annual Roth Conference

On March 8, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported its participation in the 35th Annual Roth Conference being held March 12-14, 2023 in Dana Point, California (Press release, Citius Pharmaceuticals, MAR 8, 2023, View Source [SID1234628354]). Citius Chairman and CEO Leonard Mazur will host one-on-one meetings with institutional investors and analysts on Monday, March 13th and Tuesday, March 14th.

Nature Paper from PACT Pharma and UCLA Highlights How Patients with Cancer Respond Differently to Anti-PD-1 Therapy

On March 8, 2023 PACT Pharma, Inc., a privately held biopharmaceutical company developing transformational personalized neoantigen-specific and off-the-shelf T cell receptor (TCR)-T cell therapies for the eradication of solid tumors, reported the publication of a peer-reviewed paper in Nature in collaboration with researchers at University of California, Los Angeles (UCLA) detailing groundbreaking work characterizing and differentiating the immune responses of melanoma patients treated with anti PD-1 immunotherapy (Press release, PACT Pharma, MAR 8, 2023, View Source [SID1234628352]).

Researchers showed that patients who benefitted from anti-PD-1 treatment generated a diverse (polyclonal) repertoire of T cells that recognized a small group of immunodominant mutations in their tumor. These immune responses expanded and evolved in the tumor and in the peripheral blood throughout treatment. Patients who did not respond to anti-PD-1 therapy also harbored T cells that recognized their tumor-specific mutations, but their immune responses were less diverse (monoclonal) and did not expand during treatment. These first-of-their-kind findings not only provide critical understanding into differentiated patient responses to treatment, but also offer insight into strategies for potentially designing novel T cell therapies and diagnostics.

"These study findings are exciting as they show the unique, patient-specific manner in which T cell responses take shape and impact disease. This new insight has broad implications on how we think about T cell responses and how we might be able to manipulate these responses to achieve desired therapeutic outcomes," said Stefanie Mandl, Ph.D., chief scientific officer, PACT Pharma.

To conduct this first-of-its-kind research, the investigators utilized two of PACT’s core platform technologies:

First, the company’s ImPACT Isolation Technology was used to isolate mutation-reactive T cells from patients’ blood and tumor samples. It is important to note that blood proved equally adept in assessing tumor-specific T cell responses as tumor biopsies, underscoring the relevance of blood as a minimally invasive source for the isolation of tumor targeting TCRs and monitoring tumor-mutation specific T cell responses.
Next, investigators leveraged the company’s PACT^NV technology to generate tumor-specific TCR-T cells using CRISPR gene replacement so that they would express the mutation-reactive T cell receptors that were isolated from patients treated with PD-1 blockade therapy. The engineered T cells were then expanded to large numbers and used by investigators to functionally characterize each individual patient’s immune responses.
The study was conducted in eleven patients with metastatic melanoma. The results showed that the T cells engineered to express a specific patients’ isolated TCRs were able to guide an attack on that same patients’ tumor cells. This was true regardless of whether the patient responded to treatment or not. This shows that those patients who do not respond to anti-PD-1 therapy do have T cells that can recognize and kill their own tumor cells, they are just not doing so in a diverse and expansive enough manner. Based on this finding, these patients could benefit from personalized adoptive cell therapy in which their tumor-specific TCRs are isolated and then used to engineer large numbers of T cells capable of directing more effective immune responses against their own tumor.

"While this particular study was conducted in patients with metastatic melanoma treated with anti-PD-1 therapy, it provides a framework for our core platforms to be deployed for studying the mechanism of action and related patient responses for immuno-oncology therapies, vaccines and across a range of T cell-related diseases," said Dr. Mandl. "This important advance further supports the learnings from our Phase 1 clinical trial using our same proprietary TCR-T cell technologies for the development of personalized therapies for the treatment of patients with cancer, the findings of which were also published in Nature late last year. Taken together, these studies and their respective papers offer a glimpse into the potential power of technologies that enable us to push the boundaries of analyzing TCR-T cell responses and developing personalized TCR-T cell therapeutics."

A copy of the newly published Nature article, entitled, "Neoantigen-targeted CD8+ T-cell responses with PD-1 blockade therapy," can be accessed at: View Source

A copy of the previously published Nature paper reporting the results of PACT’s Phase 1 trial can be accessed at: View Source

RedHill Biopharma Announces Definitive Agreement for Up To $6 Million Private Placement with a Single Investor

On March 8, 2023 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported agreement, with a single investor, for the issuance of convertible promissory note in the principal amount of up to $6 million, convertible into American Depositary Shares ("ADS") and warrants to purchase ADSs of the Company, pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (Press release, RedHill Biopharma, MAR 8, 2023, View Source [SID1234628351]).

Gross proceeds to the Company under the promissory note will be up to $6 million, subject to certain conditions, before costs and fees, including prepaid interest of eight (8%) percent. Advances under the promissory note are to be made in three tranches of $2 million, $1 million, and $3 million, respectively. The first tranche will be paid upon closing, and the second and third tranches will be advanced following effectiveness of a registration statement that the Company will file with the Securities and Exchange Commission covering the resale of ADSs to be acquired by the investor under the convertible promissory note and the warrants. The promissory note has a one-year term and must be converted by the end of the term. The conversion price of the promissory note is 93% of the closing price of the Company’s ADSs on the trading day immediately preceding the date of any conversion by the investor.

The number of warrants to be issued will be one-fourth of the value of each tranche divided by $0.21, today’s ADS closing price. Each warrant will have a term of three years commencing six months following closing and have an exercise price equal to $0.21.

RedHill intends to use the net proceeds from this placement for general working capital, acquisitions, research and development and general corporate purposes.

The convertible promissory note and warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the promissory note and the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About RedHill Biopharma

Telix to Showcase Additional ZIRCON Phase III Data in Kidney Cancer Imaging and Theranostic Pipeline Developments at EAU

On March 8, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported presentations from the Company’s carbonic anhydrase IX (CAIX) targeting kidney and bladder cancer programs at the 38th Annual European Association of Urology (EAU) Congress to be held in Milan from 10 – 13 March 2023 (Press release, Telix Pharmaceuticals, MAR 8, 2023, View Source [SID1234628349]).

Further data from Telix’s completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in a "Game Changing" oral session.

Game Changing sessions are reserved for Phase III trials or other developments that the EAU’s Scientific Congress Office believes will have a large impact on daily practice.

In addition, presentations will report on the potential utility of TLX250-CDx in urothelial carcinoma or bladder cancer (ZiPUP study, ClinicalTrials.gov Identifier: NCT05046665); and a preclinical evaluation of a Telix targeted radionuclide therapy candidate in combination with an immune checkpoint inhibitor.

Dr Colin Hayward, Telix Chief Medical Officer, said, "In support of Telix’s vision to drive innovation in urologic oncology, we are pleased that our programs in renal and bladder cancer will be presented at EAU 2023, the largest urological event in Europe. Notably, Professor Peter Mulders from Radboud UMC will be presenting further data from the Phase III ZIRCON study of TLX250-CDx, our investigational renal cancer imaging agent, which is generating significant interest in the medical community, following a highly positive result. We are also excited to announce two additional presentations on Telix’s CAIX-targeting candidates further exploring potential theranostic applications beyond ccRCC."

EAU presentation details are as follows:

Session: Game Changing Session
Title: 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma – results from phase 3 ZIRCON study
Date and Time: 11-Mar-2023, 10:00 AM-10:15 AM
Presenter: Prof. P.F.A. Mulders, Radboud UMC, Nijmegen, The Netherlands

Session: Clinical Trials in Progress
Title: 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP) – A phase I trial of a novel staging modality for urothelial carcinoma
Date and Time: 12-Mar-2023, 10:45 AM-12:15 PM
Presenter: Dr. D. Hayne, University of Western Australia, Australia
Abstract ID: A0520

Session: Cell biology and novel biomarkers in kidney cancer
Title: Preclinical evaluation of targeted radionuclide therapy combined with immune checkpoint inhibition
Date and Time: 13-Mar-2023, 10:45 AM-12:15 PM
Presenter: Ass. Prof. E. Oosterwijk, Radboud UMC, Nijmegen, The Netherlands
Abstract ID: A1032