On June 28, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, reported that it has commenced an underwritten public offering of $75.0 million of shares of its common stock (Press release, Black Diamond Therapeutics, JUN 28, 2023, View Source [SID1234632955]). Black Diamond also intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares in the proposed offering are to be sold by Black Diamond. 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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Piper Sandler is acting as sole book-running manager for the proposed offering. Wedbush PacGrow is acting as the lead manager for the proposed offering.

The shares are being offered by Black Diamond pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on November 14, 2022 and declared effective by the SEC on November 22, 2022 (File No. 333-268341). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement relating to the offering may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

The final terms of the 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 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On June 27, 2023, Arcus Biosciences, Inc. ("Arcus") and Gilead Sciences, Inc. ("Gilead") reported to have entered into a Second Amended and Restated Common Stock Purchase Agreement (the "A&R Purchase Agreement"), which amends and restates in its entirety the Amended & Restated Common Stock Purchase Agreement entered into between Arcus and Gilead on January 31, 2021 (the "2021 SPA") (Filing, 8-K, Arcus Biosciences, JUN 28, 2023, View Source [SID1234632953]). Pursuant to the A&R Purchase Agreement, Gilead will purchase from Arcus 1,010,000 shares of Arcus common stock at a purchase price of $19.26 per share, subject to customary closing conditions. All other terms of the 2021 SPA, including Gilead’s option to purchase additional shares from Arcus, up to a maximum of 35% of Arcus’s then-outstanding common stock, from time to time until July 13, 2025, remain unchanged.

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The foregoing is only a brief description of the material terms of the A&R Purchase Agreement and does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the agreement, which will be filed as an exhibit to Arcus’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023.

On June 27, 2023 Disruptive Pharma reported the company is initiating the development of MMC sorafenib as its first proprietary product based on the mesoporous magnesium carbonate (MMC) platform (Press release, Disruptive Pharma, JUN 27, 2023, View Source [SID1234649943]). Sorafenib is a cornerstone in the treatment of patients suffering from hepatocellular- and renal cell carcinomas. While highly efficacious, currently approved formulations also exhibit undesirable side effects. With Disruptive Pharma’s MMC platform we could demonstrate bioequivalence using significantly reduced quantities of the active pharmaceutical ingredient (API). In our upcoming clinical program, we aim to translate the sorafenib dose reduction advantage into intra-patient variability and potentially other patient benefits.

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Mesoporous magnesium carbonate (MMC) is Disruptive Pharma’s proprietary drug delivery platform for amorphous stabilization and solubility enhancement. MMC leverages a uniformly porous structure to stabilize small molecule APIs into an amorphous state. Its unique properties make MMC an ideal carrier for APIs and its template-free synthesis allows for facilitated production scale-up.

On June 27, 2023 Cambrian Bio, a clinical-stage biotechnology company focused on treating and preventing chronic diseases of aging, reported the launch of its new pipeline company, Telos Biotech (Press release, Cambrian Biopharma, JUN 27, 2023, View Source [SID1234649818]). The organization will develop Telovance , a novel recombinant protein delivered intracellularly during the ex-vivo manufacturing of CAR-T cells.

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Rapid telomere shortening naturally occurs during the ex-vivo cell expansion portion of cell therapies, a medical procedure in which an organ, cells, or tissue are taken from a living body for a treatment or procedure, and then returned to the living body. During this process, critically shortened telomeres have emerged as a key barrier to successful CAR-T cell immunotherapy. Ultimately, the cells are unable to fully eliminate malignancy and provide durable and persistent protection against recurrent disease. By safely lengthening telomeres during the ex-vivo manufacturing process, Telos can rewind the cellular biological clock and unlock the potential of cell immunotherapy. With these findings, Telos has engineered Telovance , a recombinant protein that can be easily incorporated into the cell therapy manufacturing process. Telos has a patent portfolio directed to this technology.

"Cell therapies have delivered cures to thousands of cancer patients but face major manufacturing challenges as expanding exhausted cells from older patients can prevent people from benefitting from life-saving medicines," said James Peyer, PhD, CEO of Cambrian Bio. "We’re so excited to work with the team at UT Southwestern Medical Center to discover a safe way to extend telomeres without increasing cancer risk, meaning that all types of cell therapies may one day be made available to any patient, no matter their age or previous lines of therapy."

Telos Biotech was founded in 2020 based on the work of Drs. Jerry Shay, Professor of Cell Biology, Enzo Tedone, Senior Research Scientist, and Mohammad Sayed, Senior Research Scientist, all at UT Southwestern. The company builds on over three decades of telomere biology research by the Shay Laboratory. Telos has licensed the invention from UTSW.

"It’s been over 20 years since the first primary human cells were made to live longer through telomere maintenance. The limitations were to ensure this did not lead cells one step closer to cancer," said Mohammad Sayed, Scientific Founder, Telos. "At Telos, we believe that we have overcome those limits and are now able to safely maintain and lengthen telomeres to create a more robust and fit cell."

Telos has engaged cell therapy partners looking for functional benefits with their cells, to improve outcomes for patients. Telovance is an ancillary reagent that can be employed via our simple and easy delivery platform, a variety of manufacturing processes. To learn more please visit: www.telosbio.com.

About Telos Biotech
At Telos, our mission is to overcome cell aging and replicative lifespan limits caused by critically short telomeres. We aim to improve state-of-the-art cell and gene therapies by generating more biologically fit cells. We are developing a safe and state-of-the-art platform to overcome the manufacturing bottlenecks of cell therapies for optimal treatment outcomes. Telos empowers innovative cell therapy companies to deliver on their promise: to cure the most severe, treatment-resistant cancers and bring these therapies to the patients that need them most.

On June 27, 2023 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Nucleus RadioPharma, a full-service Contract Development and Manufacturing Organization (CDMO) dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies, reported the signing of a supply agreement for the therapeutic radioisotope actinium-225 (Ac-225) (Press release, Nucleus RadioPharma, JUN 27, 2023, View Source [SID1234636355]). Under terms of the agreement, NorthStar will supply its high purity, non-carrier added (n.c.a.) Ac-225 to Nucleus. Nucleus will use NorthStar’s Ac-225 for their customers’ radioligand pharmaceutical programs.

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Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy, which combines select molecules with therapeutic radioisotopes to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 have been constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of n.c.a. Ac225 and copper-67 (Cu-67) for advancing clinical research and commercial radiopharmaceutical therapy products. The Company will use its electron accelerator technology to produce n.c.a. Ac-225 that is free of long-lived radioactive contaminants and byproducts associated with other production methods. Such contaminants pose regulatory and waste management challenges for pharmaceutical companies, hospitals, and health systems.

"NorthStar is applying the same development expertise to rapidly advance large-scale production of n.c.a. Ac-225 that has positioned us at the forefront of U.S. radioisotope production as the only national commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99), and we previously announced successful production of Mo-99 using electron accelerator technology," said Frank Scholz, Ph.D., President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Progress on our dedicated, state-of-the-art Actinium-225 Production facility is on schedule. The electron accelerator is installed and initial production of radiochemical grade Ac-225 is planned in 2024. NorthStar expects to submit a Drug Master File to the FDA as quickly as possible, which, upon acceptance by the FDA, will allow NorthStar to provide cGMP grade Ac-225. We are very pleased to enter this Ac-225 supply agreement with Nucleus RadioPharma, and we look forward to working with them in their efforts to provide targeted alpha radioligand therapies for patients with cancer."

"Nucleus was established to address the acute manufacturing scarcity of radionuclides and theranostics, which poses significant challenges to patient care and clinical trials for new radiopharmaceuticals," said Charles S. Conroy, Chief Executive Officer of Nucleus. "We are pleased to work with NorthStar as an experienced and reliable partner in innovative, accelerator-based radioisotope production technology, and to using its n.c.a. Ac-225 to develop highly transformative treatments for patients with cancer."