Cue Biopharma to Present an Updated Overview of Immuno-STAT Platform at the 2022 Festival of Biologics World Immunotherapy Congress

On March 2, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will give an oral presentation at the Festival of Biologics World Immunotherapy Congress which is being held at the Marriott Marquis in San Diego, California March 9-11, 2022 (Press release, Cue Biopharma, MAR 2, 2022, View Source [SID1234609400]).

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At the conference, Cue Biopharma’s senior vice president of clinical development, Dr. Matteo Levisetti, will present an updated overview of Cue Biopharma’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform, designed to enable selective engagement and activation of tumor-specific T cells. Dr. Levisetti will also highlight recent data from the ongoing clinical trial of CUE-101, the Company’s lead clinical candidate representative of the interleukin 2 (IL-2)-based CUE-100 series, in patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). Data demonstrates favorable tolerability throughout a range of doses and anti-tumor activity as a monotherapy in late stage (HPV+ R/M HNSCC) patients. The data provides support for proof of concept and de-risking of CUE-101 as well as subsequent programs and platform applications across the IL-2 based CUE-100 series. Additionally, Dr. Levisetti will discuss Cue Biopharma’s platform expansion via Neo-STAT and bispecific RDI-STAT, which allows for targeting multiple tumor antigens and for harnessing the protective anti-viral T cell repertoire to destroy tumors, respectively.

Presentation Details
Title: Targeting IL-2 to tumor-specific T cells via novel biologic platforms
Presenter: Dr. Matteo Levisetti, senior vice president, clinical development
Date & Time: Thursday, March 10, 2022 at 2:20 p.m. PST or 5:20 p.m. EST

"We are very pleased to have Dr. Levisetti present an updated overview of the IL-2 based CUE-100 series at the 2022 Festival of Biologics, with a particular emphasis on the promising clinical data that provides clear differentiation for our strategy focused on selective activity of IL-2 on tumor-specific T cells," said Dr. Anish Suri, president and chief scientific officer of Cue Biopharma. "IL-2 has been a validated therapeutic target with significant hurdles pertaining to lack of specificity, systemic immune activation and serious toxicities. We believe the preliminary anti-tumor activity and positive tolerability profile of CUE-101 is highly encouraging and supportive of its mechanistic advantages and superior differentiation from all other IL-2 variants in development. CUE-101 has demonstrated an impressive tolerability profile as a monotherapy and has achieved targeted engagement of tumor specific T cells without reaching a maximum tolerated dose (MTD). With its unique mechanism of action, we believe CUE-101 has the potential to change the treatment landscape and improve the lives of patients with head and neck cancer as well as a broad range of other indications."

About the Festival of Biologics
The Festival of Biologics brings together pharma & biotech, academics and research institutes, together with their partners across the value chain. Across antibodies, immunotherapy and biosimilars participants share research, create new partnerships, and tackle the clinical trials, manufacturing and commercial challenges involved in bringing new therapies to market.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (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. 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) 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.

HARPOON THERAPEUTICS RECEIVES FDA FAST TRACK DESIGNATION FOR HPN217

On March 2, 2022 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HPN217, a BCMA-targeting TriTAC, for the treatment of patients with relapsed, refractory multiple myeloma (RRMM) who have received at least four lines of therapy (Press release, Harpoon Therapeutics, MAR 2, 2022, View Source [SID1234609399]). A Phase 1/2 clinical trial is currently ongoing for HPN217 in the RRMM patient population.

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"We are pleased that HPN217 has received FDA Fast Track designation because it highlights the serious unmet medical need for patients with relapsed, refractory multiple myeloma who received multiple lines of therapy," stated Julie Eastland, President and CEO, Harpoon Therapeutics. "We are focused on selecting an initial dose to study in the expansion phase of the ongoing Phase 1/2 clinical trial in the first half of this year as we progress HPN217 forward as an innovative new treatment option for these patients."

In November 2019, Harpoon Therapeutics and AbbVie announced a licensing agreement and option to advance HPN217 and expand an existing discovery collaboration. Under the terms of the agreement, AbbVie may exercise its option to license HPN217 after completion of the Phase 1/2 clinical trial.

About Fast Track Designation

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. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions and the request can be initiated by the drug company at any time during the development process. FDA will review the request and decide based on whether or not the drug fills an unmet medical need in a serious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the sponsor is encouraged throughout the entire drug development and review process.

Leap Therapeutics to Present at Raymond James 43rd Annual Institutional Investors Conference

On March 2, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, President and Chief Executive Officer will present a corporate overview at Raymond James Institutional Investors Conference, being held in Orlando on March 6-9, 2022 (Press release, Leap Therapeutics, MAR 2, 2022, View Sourcenews-releases/news-release-details/leap-therapeutics-present-raymond-james-43rd-annual" target="_blank" title="View Sourcenews-releases/news-release-details/leap-therapeutics-present-raymond-james-43rd-annual" rel="nofollow">View Source [SID1234609398]).

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Leap Presentation Details:

Raymond James Annual Institutional Investors Conference
Date: Wednesday, March 9th, 2022
Time: 7:30 a.m. Eastern Time

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

Kezar Life Sciences to Participate in Cowen 42nd Annual Health Care Conference

On March 2, 2022 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that Noreen Roth Henig, M.D., Chief Medical Officer, will participate on the Kidney Disease/Fibrosis Panel at the Cowen 42nd Annual Health Care Conference (Press release, Kezar Life Sciences, MAR 2, 2022, View Source [SID1234609397]). The panel will be held on Wednesday, March 9, 2022, at 2:10 p.m. ET.

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A live webcast of the panel will be available on the "Events & Presentations" section of the Company’s website at View Source A replay will be available on the Kezar website for 90 days following the event.

Orion Corporation: Transfer of 38,543 own B shares on 1 March 2022

On March 2, 2022 Orion Corporation reported that has on 1 March 2022 transferred altogether 38,543 Orion Corporation B shares held by the company as a share reward for earning period 2019–2021 to the persons belonging to the Share-based Incentive Plan of the Orion Group (Press release, Orion , MAR 2, 2022, View Source [SID1234609392]). The transfer is based on the authorisation by the Annual General Meeting of 26 March 2019.

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The price per share of the transferred shares is EUR 41.3238, which is the volume weighted average quotation of the Orion Corporation B share on 1 March 2022. Accordingly, the total transaction price of the transferred shares is EUR 1,592,743.22.

After the share transfer, the total number of own B shares held by Orion Corporation is 532,771.

Orion Corporation has informed about the Share-based Incentive Plan in stock exchange release on 6 February 2019.