On March 4, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, reported the granting of US patent no. 11,890,350 (‘350) by the United States Patent and Trademark Office (USPTO), broadly covering its breakthrough AccuTOX technology (Press release, Defence Therapeutics, MAR 4, 2024, https://defencetherapeutics.com/defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology/?utm_source=rss&utm_medium=rss&utm_campaign=defence-therapeutics-awarded-broad-u-s-patent-covering-its-pioneering-cancer-killing-accutox-technology [SID1234640729]). The ‘350 patent, which includes valuable composition-of-matter claims covering a portfolio of therapeutically-active molecules making up the AccuTOX platform, provides Defence with potential market exclusivity until late 2042.

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The AccuTOX platform is based on the discovery that certain bile acid-peptide conjugates, in their free forms, induce cancer cell death by triggering heightened metabolic stress and the production of reactive oxygen species. The ‘350 patent demonstrates that the bile acid-peptide conjugates, when used past cytotoxic threshold concentrations, can potently induce cell death in multiple tumor cells in vitro, including lung, breast, colon, melanoma, and lymphoma cancer cells, and can dramatically reduce lymphoma tumor volumes and enhance survival in vivo in treated mice compared to controls.

Defence’s ‘350 patent was issued with broad claims encompassing a plurality of AccuTOX molecules having cytotoxic or cytostatic activity, either as a monotherapy or in combination with other therapeutics. The granted claims also cover AccuTOX molecules releasably conjugated to a variety of carrier molecules, such as cancer-specific antibodies, where AccuTOX effectively plays the role of a cytotoxic drug, thereby pioneering a potentially new class of next-generation antibody-drug conjugates (ADCs).

Stemming from the data published in the ‘350 patent, pre-clinical and GLP studies for AccuTOX, either alone or in combination with immune checkpoint inhibitors such as anti-PD-1 and anti-LAG3, were undergone, and have shown that the compound is safe and well tolerated using both rodents and canine animal models, and have also demonstrated significant solid tumor growth reductions. Subsequently, Defence has now received FDA approval to commence its Phase I clinical trial to evaluate the effect of intratumoral administration of AccuTOX as a monotherapy, as well as in combination with Opdualag (fixed IV doses), in patients with unresectable stage IIIB to IV melanoma refractory to or relapse from standard therapy.

"The rapid granting of the broad ‘350 patent by the USPTO affirms the innovative and groundbreaking potential of AccuTOX as a leading cancer therapeutic, and also importantly provides a long patent runway and period of market exclusivity for Defence to fully explore the commercial potential of the AccuTOX platform and maximize the benefit to our partners and investors," says Mr. Plouffe, CEO and president of Defence.

This patent marks the fourth granted US patent in Defence’s ever-growing patent portfolio, which currently incudes seven published patent families.

On March 4, 2024 Circio Holding ASA (OSE: CRNA) reported that the TG01 investigational new drug (IND) application filed by partner IOVaxis Therapeutics of Nantong, China, has been approved by the Chinese National Medical Products Administration (NMPA) (Press release, Circio, MAR 4, 2024, View Source [SID1234640728]). Following this acceptance by the NMPA, IOVaxis has the necessary regulatory approval to initiate TG01 clinical development in China.

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Under the parties´ agreement, IOVaxis has an exclusive option to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to the partnership announcement here and the IND-filing here. Within two weeks of the TG01 IND approval by the NMPA, IOVaxis may elect to exercise its license option and trigger a USD 3m milestone payment to Circio.

On March 4, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported it has entered into a license and collaboration agreement with Merck KGaA, Darmstadt, Germany, which operates its healthcare business as EMD Serono in the U.S. and Canada, to exclusively discover two targeted protein degraders against critical oncogenic proteins that C4T has progressed within its internal discovery pipeline (Press release, C4 Therapeutics, MAR 4, 2024, View Source [SID1234640727]).

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"We look forward to partnering with Merck KGaA, Darmstadt, Germany, and leveraging our collective strengths to advance an exciting program from C4T’s internal oncology pipeline that has the potential to transform how cancer is treated," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "This new partnership highlights C4T’s differentiated approach to targeted protein degradation science and our strong track record of designing novel targeted protein degrader medicines with desirable drug-like properties that have the potential to treat patients with unmet medical needs."

"The collaboration adds to Merck KGaA, Darmstadt, Germany’s growing portfolio of targeted protein degradation projects and accelerates our efforts to expand our presence in this highly dynamic field," said Paul Lyne, Head of Research Unit Oncology at the Healthcare business sector of Merck KGaA, Darmstadt, Germany. "We look forward to capitalizing on C4 Therapeutics’ experience in advancing degrader candidates targeting disease-causing proteins from discovery to the clinical stage, with the shared goal of improving patient outcomes."

Under the terms of the agreement, C4T and Merck KGaA, Darmstadt, Germany, will collaborate to discover two targeted protein degraders against critical oncogenic proteins. C4T will receive an upfront payment of $16 million. Merck KGaA Darmstadt, Germany, will fund C4T’s discovery research efforts. C4T has the potential to receive up to approximately $740 million in discovery, regulatory, and commercial milestone payments across the collaboration. In addition, C4T is eligible for mid-single to low-double digit tiered royalties on future sales for each program.

As part of the collaboration, C4T will utilize its proprietary TORPEDO platform to discover degraders targeting the partnership’s oncogenic proteins of interest. Merck KGaA, Darmstadt, Germany, will be responsible for clinical development and commercialization for drug candidates coming out of these programs.

On March 4, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has commenced an underwritten public offering of $250 million of shares of its common stock (Press release, BridgeBio, MAR 4, 2024, View Source [SID1234640726]). BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

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J.P. Morgan, Cantor Fitzgerald & Co. and Mizuho are acting as joint book-running managers for the proposed offering. Raymond James is acting as lead manager. 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 proposed offering.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR that was previously filed with the U.S. Securities and Exchange Commission (SEC) on May 4, 2023 and automatically became effective upon filing. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, 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]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, New York 10020, by telephone at 1-212-205-7602 or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the 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 March 4, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production (Press release, BioLineRx, MAR 4, 2024, View Source [SID1234640725]).

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In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.

"This is a very meaningful addition to our IP portfolio as we look to scale up the production of motixafortide to support both the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients as well as the numerous ongoing clinical trials underway in other indications, including metastatic pancreatic cancer and for gene therapies in sickle cell disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "When combined with the seven years of Orphan Drug Designation market exclusivity that we were granted upon FDA approval of APHEXDA beginning last September, and five years of exclusivity across all indications as a New Chemical Entity, we have a broad set of IP protections that we believe will allow us to maximize the value of this important molecule for our company and shareholders for years to come."

Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).