On June 13, 2024 Brenus Pharma, French biotech developing its proprietary discovery platform: "Stimulated-Tumor-Cell" (STC), reported it has presented the study design of "BreAK-CRC" First-in-human of STC-1010, Brenus’ lead candidate, during ASCO (Free ASCO Whitepaper) annual meeting (31st May – 4th June 2024) – Trials in Progress poster session, in Chicago (Press release, Brenus Pharma, JUN 13, 2024, View Source [SID1234644321]).

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Poster here. | Benoit You et al. Journal of Clinical Oncology 42, TPS3635-TPS3635(2024). DOI:10.1200/JCO.2024.42.16_suppl.TPS3635
Authors information’s: here.

Based on STC-1010’ robust preclinical package in vivo, in ovo, ex vivo, BreAK-CRC study will be launched in 9 oncology early phase centers (EU, US) with expert investigators in immunotherapy:

"Cancer vaccines continue to show promising clinical results in solid tumors. STC-1010, is a new immunotherapeutic approach based on cancer vaccine mechanism of action for colorectal cancer patients. In that, "BreAK-CRC" Study is eagerly expected. CRC is still challenging as current immunotherapies were found only active in dMMR/MSI-H "hot" CRC. For the pMMR/MSS population, representing 95% of patients with CRC, there is an important medical need for drugs likely to heat up "cold" tumors and have a real impact for the patient." François Ghiringhelli (M.D,PhD) Director of early clinical unit CLIPP2 and BreAK-CRC study coordinator, Centre Georges-François Leclerc, University of Burgundy, Dijon, France.

BreAK-CRC trial protocol has been reviewed in pre-submission meeting with the French National Health Authority. The submission of the CTA through the clinical trial information system of the European union is ongoing.

The Phase I/IIA clinical trial, aims to evaluate the safety and efficacy of STC-1010 in patients with unresectable advanced or metastatic colorectal cancer, 2nd cause of cancer mortality worldwide.

The Phase I will assess the tolerability of two dose levels of STC-1010, combined with low-dose immunostimulants and standard of care chemotherapy (SoC). The Phase IIA will enroll patients to further evaluate the treatment’s efficacy, particularly focusing on 12-month non-progression rate.

Exploratory analysis will evaluate the immune response and the ctDNA dynamic.

On June 13, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") that is expected to result in gross proceeds of approximately $100 million to the Company before deducting placement agent fees and offering expenses (Press release, Replimune, JUN 13, 2024, View Source [SID1234644305]). The financing was led by a life-sciences focused institutional investor, with participation from Redmile Group, RTW Investments, Boxer Capital and other institutional investors, including a leading mutual fund.

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Pursuant to the terms of the securities purchase agreement, Replimune will issue and sell to the investors an aggregate of 5,668,937 shares of its common stock ("Common Stock") at a price of $8.82 per share of Common Stock and pre-funded warrants to purchase 5,669,578 shares of Common Stock at a price of $8.819 per pre-funded warrant. The pre-funded warrants have an exercise price of $0.001 per share. The financing is expected to close on or about June 14, 2024, subject to satisfaction of customary closing conditions.

The Company intends to use the proceeds of the PIPE financing to fully scale up for the commercialization of RP1 in skin cancers thereby creating a potential path to profitability, and for working capital and general corporate purposes.

Leerink Partners acted as sole placement agent for the PIPE financing.

The offer and sale of the foregoing securities, including the shares of common stock issuable upon exercise of the pre-funded warrants, are being made in a transaction not involving a public offering and such securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the securities purchase agreement, Replimune and the investors will enter into a registration rights agreement pursuant to which Replimune has agreed to file a registration statement with the Securities Exchange Commission (the "SEC") to register the resale by the investors of the shares of common stock and the shares of common stock issuable upon exercise of the pre-funded warrants sold in the PIPE financing. Any offering of the common stock under the resale registration statement will only be made by means of prospectus.

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

On June 13, 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 it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) (Press release, Rezolute, JUN 13, 2024, View Source [SID1234644306]). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying pre-funded warrants sold in connection with the public offering. The public offering is subject to market and other conditions, and there can be no assurance as to whether or when the public offering may be completed or as to the actual size or terms of the public offering. All of the shares in the public offering are being offered by the Company.

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Jefferies and Cantor are acting as the book-running managers for the public offering.

A shelf registration statement on Form S-3 (File No. 333-275562) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on November 29, 2023. The public offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the public offering will be filed with the SEC and, when available, may be obtained on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering, when available, may 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 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 12, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that it has commenced an underwritten public offering of up to $350,000,000 of shares of its common stock and, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Ultragenyx Pharmaceutical, JUN 12, 2024, View Source [SID1234644289]). In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $52,500,000 of shares of common stock at the public offering price, less the underwriting discount.

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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. J.P. Morgan, Goldman Sachs & Co. LLC, BofA Securities and TD Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2024. This offering is being made solely by means of a prospectus supplement and accompanying prospectus. When available, copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Securities, NC1-002-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected].

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 12, 2024 Lantern Pharma Inc., (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported that the Japan Patent Office (JPO) has issued a Certificate of Patent for patent application no. 2021-513267 / registration no. 7489966 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea) (Press release, Lantern Pharma, JUN 12, 2024, View Source [SID1234644291]). The Certificate of Patent entitled "Illudin Analogs, Uses Thereof, and Methods for Synthesizing the Same" covers molecule LP-284, including claims covering the new molecular entity. A Certificate of Patent is issued after JPO examinations have confirmed the merits of a patent request. Lantern values the broad protection this latest patent provides.

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"The addition of a JPO-issued patent for LP-284 to our intellectual property portfolio strengthens the future of this novel therapeutic for the commercial market and expands the potential for LP-284 to positively impact outcomes for patients with unmet needs in non-Hodgkin’s lymphomas," said Panna Sharma, CEO and President, Lantern Pharma. "It also supports the use of Lantern’s AI technologies to accelerate the development of novel cancer therapies."

Lantern previously received a similar patent on LP-284 from the US Patent and Trademark Office (USPTO) in April 2023, with an expiry in early 2039. Lantern anticipates receiving similar or same patent rights for LP-284 in Europe, China, Australia, Canada, and Korea.

LP-284 has already seen significant success in its progress in the United States. In 2023, the FDA cleared an investigational new drug (IND) application for LP-284, and Lantern Pharma began enrolling patients for a first-in-human Phase 1 clinical trial evaluating LP-284 in patients with relapsed or refractory non-Hodgkin’s Lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL) as well as other select solid tumors and sarcomas. In mid-March 2024, Lantern announced that the first two patients had been dosed in the Phase 1 clinical trial.

MCL accounts for up to ~5,800 cases of NHL in Japan each year. In the U.S. and Europe, MCL and DHL are diagnosed in a combined ~9,000 patients each year. Nearly all patients diagnosed with MCL will relapse after treatment and LP-284 represents a potential improved novel therapeutic option for treatment of relapsed or recurrent NHL.

LP-284 has also been granted an Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of HGBL, and another for the treatment of MCL. LP-284 is the second drug candidate from Lantern Pharma to receive such designation from the FDA. LP-184— a novel therapeutic in clinical development for the potential treatment of malignant gliomas, pancreatic cancer, and atypical teratoid rhabdoid tumors (ATRT)— has also been granted an ODD by the FDA, along with a Rare Pediatric Disease Designation.