On June 27, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported a detailed overview of its lead candidate MDG1015, a first-in-class 3rd generation T cell receptor engineered T cell (TCR-T) therapy, at the 7th Cell and Gene Therapy In-Depth Focus Summit from June 27-28, 2024, in Beijing, China (Press release, MediGene, JUN 27, 2024, View Source [SID1234644580]). MDG1015 advances towards the clinic and targets the cancer-testisantigens (CTA) NY-ESO-1 / LAGE-1a (New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a) and is armored and enhanced by the Company’s PD1-41BB costimulatory switch protein (CSP).

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The presentation with the title "MDG1015: a 3rd Generation TCR-T Therapy Incorporating the PD1-41BB Costimulatory Switch Protein, Advancing to the Clinic" is available on Medigene’s website: View Source

"Targeting tumors expressing CTAs has shown promising clinical benefits, yet there remains a need to enhance efficacy, safety, and response durability not only in orphan indications but also in more common solid tumor types. We tackle these issues with a comprehensive strategy, starting with the development of a best-in-class TCR that is sensitive, specific, and safe (3S TCR). Further, our innovative approach not only armors and enhances the TCR-T cell functionality by combining our 3S TCRs with the PD1-41BB CSP but also places a significant emphasis on the drug product (DP) manufacturing process. This process is vital for producing effective, safe, and durable TCR-T therapies" stated Kirsty Crame, MD, VP Clinical Strategy & Development.

"Our focus on optimizing the DP composition is intended to shorten the ex-vivo manufacturing time, thereby reducing the overall vein-to-vein duration for patients. This will be achieved while upholding the highest standards of safety, efficacy, and durability."

A benefit of adding the PD1-41BB CSP to the Company´s 3S TCRs has been shown in multiple in vitro assays displaying elevated TCR-T cell proliferation, superior TCR-T cell functionality as well as quick and consistent elimination of tumor cells when compared to TCR-T cells lacking the CSP. It has been demonstrated this effect is ""gated" in that the enhancement occurs only after the 3S TCR binds to its specific target antigen. This is an important safety feature of Medigene’s 3rd generation TCR-T programs.In addition, Medigene devised an efficient 6-day manufacturing process that emphasizes enriching CD8+ T cells while preserving their stem-like properties. Research studies indicates that DPs with more stem-like characteristics demonstrate increased effectiveness and longer-lasting responses. By incorporating the PD1-41BB CSP, the necessity for CD4+ T cells within the DP is eliminated, allowing CD8+ T cells to independently produce the necessary cytokines that would have been provided by the CD4+ cells. This approach mitigates potential risks associated with CD4+ T cells, potentially enhancing both the safety and therapeutic benefits of the treatment.

Medigene’s lead TCR-T program, MDG1015, is scheduled for IND submission in the third quarter of 2024 and CTA submission in the fourth quarter of 2024. MDG1015’s clinical indications were selected due to significant unmet medical needs, the presence of the target antigen, and/or PD-L1 expression. This decision resulted in the initial focus on evaluating gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. Subject to additional financing, the first patient enrollment is anticipated by the end of 2024. Based on this timeline, the Company aims to unveil early data from the dose escalation phase in the fourth quarter of 2025.

On June 27, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported it has entered into a placement agency agreement for the purchase and sale of approximately 7,060,918 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.57 per share (or $0.569 per pre-funded warrant in lieu thereof) (Press release, TONIX Pharmaceuticals, JUN 27, 2024, View Source [SID1234644579]). The closing of the public offering is expected to take place on or about June 28, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds of the offering will be approximately $4.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is acting as the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that Tonix may file with the SEC. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

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

On June 27, 2024 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, reported that the underwriters of its previously announced public offering, which closed on June 24, 2024, have exercised an over-allotment option to purchase an additional 1,786,589 shares of the Company’s common stock at the public offering price of $4.00 per share, less underwriting discounts and commissions (Press release, Rezolute, JUN 27, 2024, View Source [SID1234644578]). After giving effect to the option closing, the total number of shares sold by the Company in the offering were 13,036,589 shares, which along with pre-funded warrants to purchase up to an aggregate of 3,750,000 shares of its voting common stock, resulted in aggregate gross proceeds to the Company of approximately $67 million before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

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In addition, the Company has entered into an agreement for a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), of 1,500,000 shares of its common stock, at a sale price of $4.00 per share.

Jefferies and Cantor served as the joint book-running managers for the public offering. BTIG, Craig-Hallum, H.C. Wainwright & Co., Jones and Maxim Group LLC are acting as co-managers for the public offering.

A registration statement on Form S-3 (File No. 333-275562) relating to the public offering was filed with the Securities and Exchange Commission (the SEC) on November 22, 2023, and was declared effective by the SEC on November 29, 2023. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC. These documents are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the public offering may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at 877-821-7388, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]

This press release is being filed pursuant and in accordance with Rule 135(c) under the Securities Act of 1933 and does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 27, 2024 Recursion Pharmaceuticals, Inc. ("Recursion") (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported that it intends to offer and sell $200.0 million of shares of its Class A common stock in an underwritten public offering (Press release, Recursion Pharmaceuticals, JUN 27, 2024, View Source [SID1234644573]). All of the shares of Class A common stock are being offered by Recursion. In addition, Recursion intends to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of Class A common stock offered. The proposed 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.

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Goldman Sachs & Co. LLC and J.P. Morgan are acting as lead book-running managers for the offering. Allen & Company LLC is acting as book-running manager for the offering.

The shares will be offered by Recursion pursuant to a registration statement on Form S-3, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on May 10, 2022. The offering is being made solely by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A copy of the preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement and accompanying prospectus relating to the offering that will be filed with the SEC.

This press release does 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 offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On June 27, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, reported that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) (Press release, Oncolytics Biotech, JUN 27, 2024, View Source [SID1234644572]). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company’s proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.

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"Aligning with the FDA on key design elements and objectives of our planned registrational trial for pelareorep marks a critical step towards bringing this innovative treatment to patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our de-risked program builds on compelling data and key learnings from two randomized studies, BRACELET-1 and IND-213, which demonstrated clinically meaningful benefit in patients receiving pelareorep and paclitaxel compared to paclitaxel alone. Additionally, translational data from the AWARE-1 study highlights pelareorep’s immune-mediated mechanism of action in breast cancer patients. We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."

Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep’s advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate objective, and in parallel, we remain on track to report survival data from the BRACELET-1 study in HR+/HER2- mBC in the second half of the year. We believe these data will further bolster our compelling data package and underscores the therapeutic potential of pelareorep. We remain committed to improving the standard of care and addressing the high unmet medical needs of these patients."