On April 25, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead gene therapy obecabatagene autoleucel (obe-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T therapy that is being investigated in the ongoing FELIX Phase 2 study of adult relapsed / refractory B-Acute Lymphocytic Leukemia (ALL) (Press release, Autolus, APR 25, 2022, View Source [SID1234612917]).

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The FDA grants RMAT designation to drug candidates in recognition of the therapy’s potential to address significant unmet medical needs in patients with serious or life-threatening conditions. RMAT designation provides important benefits in the drug development process, designed to facilitate and expedite development and regulatory review.

"RMAT designation is an important regulatory milestone for obe-cel and highlights its potential to address the unmet medical need for adult patients with relapsed and refractory B-ALL," said Dr. Christian Itin, Chief Executive Officer of Autolus. "RMAT designation from FDA, PRIME designation from EMA and ILAP designation from MHRA facilitate regulatory interactions with key health authorities and supports our drive to bring this innovative therapy to patients as quickly as possible."

obe-cel has previously been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

On April 25, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its first quarter 2022 financial results and operational highlights before open of U.S. markets on Thursday, May 5, 2022 (Press release, Autolus, APR 25, 2022, View Source [SID1234612915]).

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Management will host a conference call and webcast at 8:30 am ET/1:30 pm BST to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 3245616. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 3245616.

On April 25, 2022 Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported the publication of a new peer-reviewed publication in the journal Cancers showing that the chimeric PD1-41BB receptor augments antigen-specific activity of T cell receptor-modified T cells (TCR-T cells) while retaining a favorable safety profile (Press release, MediGene, APR 25, 2022, View Source [SID1234612914]). The data suggests that the PD1-41BB switch receptor is a promising tool to overcome PD-1/PD-L1 inhibition in the tumor microenvironment of solid cancer without the negative side-effects associated with the use of systemic PD-1/PD-L1 checkpoint inhibitor antibodies.

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The inhibitory PD-1/PD-L1 checkpoint axis is a negative influence on T cell efficacy, fitness and persistence. Systemic use of anti-checkpoint antibodies benefits clinical outcomes in some patients but is often associated with drug-related immunotoxicities. Medigene developed the PD1-41BB chimeric receptor, which is exclusively expressed in the therapeutically active TCR-T cells to switch inhibitory PD-1/PD-L1 interactions into positive signals that enhance antigen-specific TCR-T cell function.

The publication describes how Medigene isolated the HLA-A2-restricted, PRAME-specific T cell receptor (TCR) "TCR-4" from blood from healthy donors (tapping a non-tolerized T cell repertoire) and how TCR-T cells expressing TCR-4 and the PD1-41BB switch receptor show improved effector functions, a favorable safety profile in vitro, reject tumors in vivo and have a poly-cytokine profile upon antigen-specific activation.

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer of Medigene: "We are proud of the high quality of this TCR that we identified and subsequently characterized using our proprietary high-throughput TCR screening technology. Also, after more than 40 years in T cell research, I am deeply impressed by how much our PD1-41BB switch receptor enhances the functional properties of TCR-T cells. BioNTech has also recognized the potential in our technologies and purchased the "TCR-4" program as well as received licenses to the PD1-41BB switch receptor. We believe that these and other approaches which we are developing will be the key to obtaining greater efficacy in TCR-T immunotherapies against solid cancers."

The Cancers publication is titled "T-Cells Expressing a Highly Potent PRAME-Specific T-Cell Receptor in Combination with a Chimeric PD1-41BB Co-Stimulatory Receptor Show a Favorable Preclinical Safety Profile and Strong Anti-Tumor Reactivity" and has recently been published online: View Source

On April 25, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the Company’s participation in Bloom Burton & Co.’s Healthcare Investor Conference 2022 (Press release, Theratechnologies, APR 25, 2022, View Source [SID1234612913]).

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Theratechnologies Presentation Details:

Date: Tuesday, May 3, 2022
Presentation Time: 1:30PM ET
Location: Metro Toronto Convention Centre, Track B

The conference which features 66 of Canada’s premier publicly-traded and venture-backed private companies together with the most promising pre-venture companies in the healthcare industry. Investors have the opportunity to obtain corporate updates from presenting companies and participate in Bloom Burton’s 1-on-1 meeting system with company management. Only registered attendees can participate in the event. Register HERE to attend the event.

On April 25, 2022 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") reported that Dr. Henry Ji, Chairman and CEO of Sorrento and Executive Chairman of Scilex Holding Company ("Scilex"), will participate in the B. Riley Virtual Neuro & Opthalmology Healthcare Conference at 10:00AM ET on April 27, 2022 (Press release, Sorrento Therapeutics, APR 25, 2022, View Source [SID1234612912]). Live audio of the event can be accessed by visiting the "Events" page of Sorrento’s website at sorrentotherapeutics.com. Dr. Henry Ji will present on the Neuroscience programs and pipeline for Sorrento and Scilex.

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B. Riley 2022 Virtual Neuro & Opthalmology Healthcare Conference
Presentation will be available on April 27-28, 2022
Presentation Time: 10:00AM – 10:30AM ET or 7:00AM – 7:30AM PT
Webcast Link: View Source
An updated corporate presentation will also be available at www.sorrentotherapeutics.com

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("VCKA"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock is expected to be listed on Nasdaq under the ticker symbol "SCLX". The boards of directors of each of VCKA, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of VCKA’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

A corporate presentation describing Scilex’s development plans can be found at www.scilexholding.com.