On February 23, 2023 Cantargia AB’s ("Cantargia") reported its full year report for 2022 is now available on the company’s web page www.cantargia.com/en/investors/financial-reports (Press release, Cantargia, FEB 23, 2023, View Source [SID1234627653]).

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Significant events in the fourth quarter

A milestone was reached in the CAPAFOUR and CESTAFOUR trials when enough patients had been enrolled to end recruitment. Cantargia announced that clinical development of nadunolimab will focus on randomized studies. The CIRIFOUR trial was also stopped.
New results showing the effect of nadunolimab on various tumor-promoting molecules were presented at the SITC (Free SITC Whitepaper) conference.
New positive efficacy data for CAN10 in several models of systemic sclerosis were reported at an oral presentation at the ACR Convergence conference.
Significant events after the end of the period

The TRIFOUR trial advanced to the randomized stage following promising early safety and efficacy of nadunolimab in triple-negative breast cancer (TNBC).
The GLP toxicity study for CAN10 was successfully completed and an application to start a clinical trial is planned to be submitted.
Patrik Renblad was recruited as new Chief Financial Officer (CFO).
Financial information

January – December 2022

Net sales: SEK 0 M (0)
Operating loss: SEK -381.5 M (-370.3)
Loss after tax: SEK -371.8 M (-366.5)
Loss per share: before and after dilution, SEK -2.90 (-3.66)
Equity/assets ratio: 82 (89) per cent
Cash and cash equivalents: SEK 189.6 M (247.3)
Short-term investments: SEK 237.1 M (312.1)
Fourth quarter 2022

Net sales: SEK 0 M (0)
Operating loss: SEK -89.7 M (-105.8)
Loss after tax: SEK -90.6 M (-104.2)
Loss per share: before and after dilution, SEK -0.54 (-1.04)
In conjunction to the report, Cantargia invites investors, analysts, and media to an audiocast with teleconference (in English) on February 23, at 3:00 p.m. CET, where Göran Forsberg, CEO, and Bengt Jöndell, CFO, will present Cantargia and comment on the Year-end report for January-December 2022, followed by a Q&A-session.

If you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions. Webcast: View Source

If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.

View Source

The webcast will also be available on demand on Cantargia’s corporate website: View Source

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on February 23, 2023.

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

— end of press release —

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]).

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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."

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]).

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"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.

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.

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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.