On April 24, 2023 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ("LIXTE") a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported that the Spanish Sarcoma Research Group (Grupo Español de Investigación en Sarcomas, or GEIS) completed its first site initiation visit in preparation for the advanced soft tissue sarcoma (ASTS) clinical trial at Fundación Jiménez Díaz University Hospital (Madrid) (Press release, Lixte Biotechnology, APR 24, 2023, View Source [SID1234630479]).

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Fundación Jiménez Díaz University Hospital is the home base of Dr. Javier Martín-Broto, Coordinating Investigator of the clinical trial, GEIS Co-Founder, and an internationally recognized expert in sarcoma research and therapy. Three additional GEIS-associated cancer research centers, located in Valencia, Barcelona, and Madrid, Spain, are expected to be activated in the near-term, with Phase 1b patient accrual planned to begin by mid-May 2023.

The Phase 1b portion of the clinical trial to determine the recommended phase 2 dose (RP2D) is expected to be completed within approximately nine months from commencement. Subsequently, up to ten more clinical sites are expected to join the international Phase 2 portion of the study to enter up to 150 patients, randomized to standard cytotoxic chemotherapy with doxorubicin alone, versus doxorubicin plus LB-100. Given the lack of effective first-line treatments for ASTS, this trial has been designed to provide data expected to be sufficient to justify proceeding to a Phase 3 comparative study.

John S. Kovach, MD, Founder and CEO of LIXTE, said, "We are very pleased to finally have an opportunity to test whether LB-100 improves the treatment of ASTS. GEIS has been very patient, having had to wait several months for various regulatory approvals to introduce LB-100 into a European clinical trial program. The fact that this trial design is still relevant attests to the slow pace of finding better treatments for this disease."

For a more complete description of the science underlying the study developed by Dr. Martín-Broto and his colleagues, please see:

LIXTE Biotechnology Announces Approval of a Phase 1b/2 Randomized Trial of Doxorubicin +/-Lb-100 in Advanced Soft Tissue Sarcomas to be Conducted by the Spanish Sarcoma Group

The Spanish Sarcoma Group Will Lead a European Consortium to Evaluate the Ability of Lixte Biotechnology Holdings’ LB-100 to Improve First Line Therapy for Advanced Soft Tissue Sarcomas

On April 24, 2023 Onxeo, a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) and driver oncogenes, reported its consolidated results for the fiscal year ending December 31, 2022 (Press release, Onxeo, APR 24, 2023, View Source [SID1234630458]).

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Dr. Shefali Agarwal, Chairwoman of the Board of Directors and CEO, stated: "2022 was a pivotal year for our Company, with renewed governance. Thanks to the support of our two main and historical shareholders, Invus and Financière de la Montagne, we were able to refocus our R&D efforts to the United States. A first major step in this direction was the FDA clearance of the initial Investigational New Drug (IND) application for AsiDNATM, our first-in-class drug candidate, last June 30. Since then, we have initiated, in December 2022, a Phase 1b/2 trial for AsiDNATM in combination with Olaparib in recurrent ovarian, breast and metastatic castration-resistant prostate cancer. At the same time, REVOCAN study, Phase 1b/2 study is ongoing, and we observed encouraging activity from the preliminary data highlighting the potential of AsiDNATM for patients with recurrent ovarian cancer who are progressing on an initial treatment with a PARP inhibitor. This study sponsored by Gustave Roussy Cancer Campus continues to enroll patients and we look forward to obtaining additional data. Last but not least, we are finalizing the preclinical development of OX425, our new compound sourced from the PlatON platform, in order to file an IND application in the United States in the second half of 2023.

As the company is actively moving forward its R&D portfolio, the Company has received the necessary financial support, which will allow the extension of the Company’s runway to the second quarter of 2024."

On April 24, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that Janux management will participate at two upcoming investor conferences and be available for 1×1 meetings (Press release, Janux Therapeutics, APR 24, 2023, View Source [SID1234630455]). Details of the conferences are as follows:

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H.C. Wainwright BioConnect Investor Conference at NASDAQ
Date: Tuesday, May 2
Time: 8am to 5pm ET
Forum: 1×1 meetings
Location: NASDAQ World Headquarters, New York, NY

BofA Securities 2023 Health Care Conference
Dates: Tuesday, May 9 to Thursday, May 11
Forum: 1×1 meetings and corporate presentation
Presentation Time: Wednesday, May 10 at 5pm PT
Location: Encore Hotel, Las Vegas, NV

Janux’s TRACTr and TRACIr Pipeline

JANX008 is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

On April 24, 2023 MAIA Biotechnology, Inc. (NYSE: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the pricing of an underwritten public offering of 2,222,200 shares of its common stock at a public offering price of $2.25 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and other offering expenses (Press release, MAIA Biotechnology, APR 24, 2023, View Source [SID1234630454]). In addition, MAIA has granted the underwriters a 45-day option to purchase up to an additional 333,300 shares of common stock to cover over-allotments at the public offering price, less the underwriting discount.

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The Company intends to use the net proceeds to fund the ongoing clinical trials of THIO, pre-clinical development of second-generation of telomere targeting compounds, and other research and development activities, as well as for working capital and other general corporate purposes.

The offering is expected to close on April 27, 2023, subject to satisfaction of customary closing conditions.

ThinkEquity is acting as sole book-runner for the offering.

A registration statement on Form S-1 (File No. 333-269606) relating to the shares being sold was filed with the Securities and Exchange Commission ("SEC") and became effective on April 24, 2023. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

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

On April 24, 2023 Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, reported that it will present first quarter 2023 earnings results for the period ended March 31, 2023, on Tuesday, May 9, 2023 (Press release, Mallinckrodt, APR 24, 2023, View Source [SID1234630453]).

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A conference call for investors will begin at 8:30 a.m. ET. The call can be accessed as follows:

Live Call Participant Registration (including dial-in): https://register.vevent.com/register/BIbe1f9805fe5b4490acd8359f7bdd616d
Audio Only Webcast Link (live and replay):
View Source
At the Mallinckrodt website: https://ir.mallinckrodt.com/