Cue Biopharma’s Therapeutic Immuno-STAT Biologics to be Featured in Oxford University Presentation at the 67th Biophysical Society Annual Meeting

On February 16, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported that the company’s therapeutic Immuno-STAT (Selective Targeting and Alteration of T cells) platform and biologics will be featured in a poster at the 67th Biophysical Society Annual Meeting, taking place February 18-22, 2023 in San Diego, CA (Press release, Cue Biopharma, FEB 16, 2023, View Source [SID1234627339]). The research is part of a strategic research collaboration that Cue Biopharma initiated with Dr. Michael Dustin’s laboratory at the University of Oxford in May 2020 to determine the molecular mechanisms underlying the activity of the company’s interleukin 2 (IL-2) based CUE-100 series of biologics.

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"The data continue to support the differentiated mechanism of action of Cue Biopharma’s Immuno-STAT CUE-100 series of biologics, by uniquely mimicking the natural process of immune synapse formation," said Jesusa Capera-Aragones, Ph.D., post-doctoral researcher, Dustin laboratory of the Kennedy Institute at the University of Oxford. "By simultaneously presenting a targeted antigen and the immunostimulatory molecule IL-2, Cue Biopharma’s biologics enable the specific and simultaneous engagement of IL-2 and T cell receptors, as it would occur in nature. This promotes the selective activation of disease-specific "killer" T cells, while maximizing T cell activation and minimizing off-target binding, potentially translating in a larger therapeutic window reducing toxicities seen with other IL-2-based therapies.

Dr. Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, added "We are very pleased with the research and collaboration with Dr. Dustin’s laboratory of the Kennedy Institute at the University of Oxford. The data continue to validate the platform design and support the results we are seeing as part of our Phase 1 clinical study of our lead CUE-100 candidate, CUE-101, in human papilloma virus (HPV)+ head and neck cancer, that shows activation of HPV+ specific "killer" T cells in patients. We look forward to sharing clinical progress and continue to provide clinical validation of the platform, with potential to treat a large number of cancers."

Presentation Details

Abstract title: Understanding the Spatial and Functional Link Between the IL-2R and TCR at the Immunological Synapse
Presenter: Jesusa Capera-Aragones, Ph.D., from the Kennedy Institute at the University of Oxford
Poster Session: Membrane Receptors and Signal Transduction Track A: Novel Engineered Cell Therapies and Concepts
Poster Board Number: B231
Date and Time: February 22, 2023, 10:30 a.m. PST
Location: Exhibit Hall BC
Program Number: 2481-Pos

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-major histocompatibility complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells. The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo) and reinfused.

Prothena to Report Fourth Quarter and Full Year 2022 Financial Results on February 23, 2023

On February 16, 2023 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that it will report its fourth quarter and full year 2022 financial results on Thursday, February 23, 2023 after the close of the U.S. financial markets (Press release, Prothena, FEB 16, 2023, View Source [SID1234627338]). The announcement will be followed by a live audio conference call at 4:30 PM ET.

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The conference call will be made available on the Company’s website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for at least 90 days.

To access the call via dial-in, please dial +1 (888) 350-3870 (U.S. and Canada toll free) or +1 (646) 960-0308 (international) five minutes prior to the start time and refer to conference ID number 92750. A replay of the call will be available until March 2, 2023, via dial-in at (800) 770-2030 (U.S. toll free) or +00 1 647 362-9199 (international), Conference ID Number 92750.

KURA ONCOLOGY TO REPORT FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

On February 16, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will report fourth quarter and full year 2022 financial results after U.S. financial markets close on Thursday, February 23, 2023 (Press release, Kura Oncology, FEB 16, 2023, View Source [SID1234627337]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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To participate in the teleconference, domestic callers should dial 1-877-407-4018 and international callers should dial 1-201-689-8471. A live webcast of the call can be accessed using this weblink: View Source;tp_key=5fdc524c8f. A replay of the webcast will be available online from the investor relations section of the company website at www.kuraoncology.com.

VBL THERAPEUTICS ANNOUNCES AGREEMENT TO SELL MANUFACTURING FACILITY AND CERTAIN RELATED ASSETS FOR $7.1 MILLION IN CASH

On February 16, 2023 VBL Therapeutics (Nasdaq: VBLT), a biotechnology company developing targeted medicines for immune-inflammatory diseases, reported that it has entered into an agreement to monetize its manufacturing facility in Modiin, Israel and certain related assets, for $7.1 million in cash (Press release, VBL Therapeutics, FEB 16, 2023, View Source [SID1234627336]). VBL also has the right to sell certain equipment excluded from the agreement for additional cash consideration. The asset sale is subject to customary closing conditions and expected to close on or about March 9, 2023.

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"We are pleased to announce this agreement to monetize our manufacturing facility and strengthen our cash position," said Dror Harats, M.D., Chief Executive Officer of VBL. "As part of our previously announced strategic process, we have been seeking ways to unlock value from our assets and the monetization of our state-of-the-art facility was one of our key priorities to maximize shareholder value."

Theratechnologies Announces Path to Resume TH1902 Clinical Development

On February 16, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported an update on the plan to amend and optimize the protocol of its Phase 1 oncology clinical trial with the goal of a timely re-submission to the United States Food and Drug Administration (FDA) (Press release, Theratechnologies, FEB 16, 2023, View Source [SID1234627335]).

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Following a voluntary pause in the study’s enrollment on December 1, 2022, the Company formed a Scientific Advisory Committee (SAC) to help determine the best developmental path forward for TH1902. In addition to the study’s principal investigator, the SAC includes several medical oncologists from across the U.S., who are leading experts in the end-to-end lifecycle of oncology drug development:

Erika Hamilton, MD, director of Breast Cancer and Gynecologic Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology;
Daniel Petrylak, MD, professor of medicine in Medical Oncology and Urology and chief, Genitourinary Oncology at Yale School of Medicine; and
Anthony Tolcher, MD, medical oncologist at Texas Oncology-San Antonio Medical Center.
The Company will continue to seek advice and input from Mace Rothenberg, MD, who is currently a scientific advisor to Theratechnologies.

"We are eager to resume patient enrollment with a revised protocol for TH1902 and have pulled together some of the best scientists in the field of oncology drug development to ensure an optimal amendment," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. "Their expert advice will be critical to examining different dosing strategies and patient selection to ultimately improve the chances of success of TH1902."

Theratechnologies is currently analyzing data and preparing responses to questions received from the FDA. This work is well underway and will be considered by the SAC as part of their meeting, which is scheduled for the latter half of March when the analyses are expected to be ready. Once expert advice is considered, the Company intends to promptly amend the protocol and re-submit to the FDA.

Consistent with the Company’s 2023 objective of generating positive adjusted EBITDA1 by fiscal year end, any new investments in TH1902 will be stage gated. Once the Phase 1 clinical trial has resumed, Theratechnologies will also evaluate potential partnerships for TH1902.

1 This is a non-IFRS measure. See "Non-IFRS and Non-U.S. GAAP Measure" below.

About SORT1+ Technology and TH1902

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

TH1902 is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. TH1902 is currently being evaluated in a Phase 1 clinical trial, although patient recruitment has recently been voluntarily paused.