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Medigene AG: Medigene presents first results for automated manufacturing of T cell receptor engineered T cells

On February 23, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard) is an early-stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors. Prof. Dr. Dolores Schendel Medigene, Chief Scientific Officer, reporte that it has been invited to present at the CAR-TCR Summit in London on February 23, 2023, on the topic "Implementing Automation & Innovation to Improve Manufacturing of TCR-T Cells" (Press release, MediGene, FEB 23, 2023, https://www.pressetext.com/news/20230223024 [SID1234627652]).

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The presentation will focus on how Medigene is innovating its manufacturing capabilities to address the challenges of cost-effective and timely cell therapy manufacturing, by transitioning from a multi-modular to an enclosed automated system. Medigene selected the CliniMACSTM Prodigy System, a single automated, closed device that will simplify processes, decrease the risk of contamination, and reduce production and staffing time, ultimately reducing costs to manufacture individual patient TCR-T drug products.

Prof. Schendel will discuss how the new automated system is being assessed against Medigene’s existing validated multi-modular system using manufacturing benchmarks from the successful production of MDG1011 (MDG1011, a PRAME HLA-A2 TCR-T therapy) for its phase 1 trial (NCT03503968) in AML, MDS and MM blood cancers. Using the multi-modular system, appropriate cell levels were produced in 92% of patients despite patients being elderly and heavily pre-treated.

Initial results from the validation process of the new automated system demonstrate that it delivers high viabilities of manufactured cells using enriched CD8 T cells, improved rates of TCR transduction compared to the multi-modular system, and strong functional activities of the drug products after antigen stimulation. These results match or exceed the established multi-modular benchmarks and suggest that a successful transition to fully automated production of TCR-T cells is possible.

"We are very pleased with the successful results of our first steps in transitioning to a fully closed automated system," says Dolores Schendel, Chief Scientific Officer of Medigene. "This validates our overall approach to continuously improving our end-to-end technology platform. We expect these manufacturing innovations will eventually result in tangible benefits through more convenient and more cost-effective treatment for patients."

For more details, please find the presentation on Medigene’s website: View Source

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Bexion Pharmaceuticals, Inc. Announces Publication of Pediatric Phase 1 (KOURAGE) Results

On February 23, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, reported results from their clinical trial entitled, "An open-label multi-center phase 1 safety study of BXQ-350 in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors (KOURAGE)" have been published in the Volume 8, Issue 12, December, 2022, e12450 issue of Heliyon (Press release, Bexion, FEB 23, 2023, View Source [SID1234627638]).

Highlights of this study included:

A review of the Phase 1 dose escalation study of BXQ-350 in pediatric solid tumors including CNS.
BXQ-350 is a well-tolerated intravenous drug and achieved the Maximum Planned Dose.
"Results from this pediatric phase 1 study reinforces the excellent safety profile we observed in our adult phase 1 study of BXQ-350 in advanced solid tumors and recurrent high-grade glioma," stated Scott Shively, President and CEO. "Our safety and maximum planned dose objectives were met in this study, enabling Bexion to open a pediatric phase 1 study in newly diagnosed diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG), advancing our commitment to pediatric cancer research."

Accutar Biotechnology Announces First Patient Dosed in China with AC0176 in Phase 1 Study in Prostate Cancer

On February 23, 2023 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported the dosing of the first patient in China in a Phase 1 study of AC0176, an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity (Press release, Accutar Biotechnology, FEB 23, 2023, View Source [SID1234627650]).

"The initiation of this study marks the second program from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0176 Phase 1 study in the US and the IND clearance by the China National Medical Products Administration (NMPA) last year," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "Prostate cancer is one of the most common cancers among men in China, and the increase in its incidence and death ranks highest in China. We look forward to accelerating the development of AC0176 globally to bring transformative medicines to patients worldwide."

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with metastatic Castration Resistant Prostate Cancer (mCRPC). Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05673109).

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. AR is a hormonal transcription factor, and plays important roles during prostate cancer onset and progression. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

SELLAS Life Sciences Announces Proposed Underwritten Public Offering

On February 23, 2023 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock (Press release, Sellas Life Sciences, FEB 23, 2023, View Source [SID1234627649]). All of the securities in the offering will be sold by SELLAS.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by email at [email protected].

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

Termination of a Material Definitive Agreement

On February 23, 2023 Pliant Pharmaceuticals, Inc. (the "Company") received notice from Novartis Institutes for BioMedical Research, Inc. ("Novartis") that Novartis has elected to exercise its right to terminate the Collaboration and License Agreement by and between the Company and Novartis, dated October 17, 2019 (the "Collaboration Agreement"), as amended by Amendment No. 1 to the Collaboration and License Agreement between the Company and Novartis, dated as of November 15, 2022 ("Amendment No. 1") (Filing, 8-K, Pliant Therapeutics, FEB 23, 2023, View Source [SID1234627648]). Novartis informed the Company of its decision, as part of its new strategy focusing on a limited number of therapeutic areas, to divest clinical NASH assets and, as a result, to discontinue the development of PLN-1474, a small molecule selective inhibitor of integrin αvß1, being developed for the treatment of liver fibrosis associated with NASH. The termination will take effect on April 18, 2023.

The Collaboration Agreement provided for an early research program for up to three additional integrin targets (the "Research Targets"). The research term, as amended by Amendment No. 1, is scheduled to conclude in the first quarter of 2023. During the research term, the Company collaborated with Novartis to biologically validate certain Research Targets and identify and synthesize potential research compounds for each Research Target in accordance with the applicable research plan. In the second quarter of 2022, the Company successfully validated one of the Research Targets and synthesized multiple potential development candidates.

Pursuant to the Collaboration Agreement, the Company received an upfront, non-refundable license fee of $50.0 million and was eligible to receive contingent payments of up to $416.0 million, of which $29.0 million has been received by the Company. Effective upon the termination of the Collaboration Agreement, all rights and licenses granted thereunder, including development candidates targeting the validated Research Target, PLN-1474 and the related IND, will revert back to the Company. The payment obligations of Novartis with respect to future milestones, royalties and research and development funding will also terminate.

The foregoing description of the terms of the Collaboration Agreement and Amendment No. 1 are qualified in their entirety by reference to (i) the Collaboration Agreement, which is filed as Exhibit 10.15 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on May 11, 2020 and (ii) Amendment No. 1, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.