On November 16, 2023 SHINE Technologies, an advanced nuclear technology company and largest producer of lutetium-177 in North America, reported a long-term supply agreement with Nucleus RadioPharma, the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals (Press release, Nucleus RadioPharma, NOV 16, 2023, View Source [SID1234637749]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the multi-year agreement, SHINE will provide lutetium-177, a vital component in cutting-edge medical treatments, to Nucleus RadioPharma’s radioligand therapy (RLT) offerings for targeted radiopharmaceutical treatments for neuroendocrine tumors and prostate cancer. This partnership underscores the crucial need for a reliable and consistent supply of lutetium-177, as it forms the backbone of RLT’s effectiveness. The steady availability of this radioisotope is fundamental for ensuring uninterrupted and precise cancer treatment, allowing more patients to access innovative therapies promptly. The partnership also ensures Nucleus will have an adequate supply of the radioisotope required for the use of their RLTs in clinical trials as they investigate the efficacy of targeted radiopharmaceuticals in additional cancer types.

Nucleus RadioPharma was founded to build reliable clinical and commercial supply chains for targeted radiotherapies, including radioligand therapy. Their innovative approach empowers healthcare providers to treat metastatic cancer at an earlier stage with remarkable precision, often before traditional imaging techniques can even detect the presence of cancer cells. Nucleus RadioPharma’s mission is to ensure that patients have access to potentially lifesaving radiopharmaceuticals by developing cutting-edge technologies that modernize the clinical development, manufacturing, and supply chain of these promising new treatment tools.

"Nucleus launched with the goal of addressing the scarcity of radionuclides and theranostics in production, which poses major challenges for patient care and clinical trials of new radiopharmaceuticals," said Charles S. Conroy, Chief Executive Officer of Nucleus. "We are pleased to partner with SHINE, allowing us to utilize its dependable supply of lutetium-177 to develop highly effective treatments for cancer patients. We look forward to a long and productive partnership with SHINE to transform cancer care."

Lutetium-177 is a key component for targeted radiopharmaceuticals, including those in development for the treatment of neuroendocrine tumors, prostate cancer, and other solid tumors. SHINE is at the forefront of creating non-carrier-added lutetium-177, using a breakthrough proprietary process that is more efficient, cost-effective, and environmentally friendly than existing production methods.

SHINE’s newly-opened Wisconsin facility, Cassiopeia, is the largest facility in North America dedicated to producing non-carrier-added lutetium-177. Cassiopeia is expected to produce up to 200,000 doses per year of critical medical isotopes that are often in short supply, strengthening SHINE’s position to meet increasing global demand.

"We are proud to partner with Nucleus RadioPharma to supply the high-purity lutetium-177 that powers their innovative radioligand therapy," said Harrie Buurlage, Chief Commercial Officer of Isotopes at SHINE Technologies. "This agreement demonstrates our ability to produce critical medical isotopes at commercial scale to enable new treatments that can improve patients’ lives."

The supply agreement between SHINE and Nucleus RadioPharma not only opens doors to groundbreaking therapies but also paves the way for further advancements in the fight against cancer.

On November 16, 2023 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of an offering of 2,490,000 shares of its common stock to a single investor at an offering price of $2.00 per share, for gross proceeds of approximately $5 million, before deducting underwriting discounts and offering expenses (Press release, Cel-Sci, NOV 16, 2023, View Source [SID1234637748]). All of the shares of common stock are being offered by the Company. The offering is expected to close on November 20, 2023, subject to satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the net proceeds from this offering to fund the continued development of Multikine,* for general corporate purposes, and working capital.

ThinkEquity is acting as sole book-running manager for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement, when available, and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company 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 November 16, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP) reported that after interviewing several candidates it has selected a Contract Research Organization (CRO) to perform the next set of experiments to elucidate the effectiveness of the Company’s DuraCAR cells (Press release, Regen BioPharma, NOV 16, 2023, View Source [SID1234637747]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company is preparing a series of in vitro studies to test its DuraCAR cells in both immunosuppressive and in tumor-killing experiments. The experiments to explore whether these cells have an immunosuppressive effect include mixing the DuraCAR cells with activated immune cells that are designed to kill target tumor cells and to determine if these cells suppress this killing. In addition, the same experiments will be able to determine if the DuraCAR cells have a direct effect on killing tumors cells.

"We have designed a set of sophisticated experiments that test two hypotheses" says Dr. David Koos, Chairman and CEO of the company. "We have selected a CRO with excellent credentials and we expect the results to lay a clear path forward for this program."

On November 16, 2023 HDT Bio Corp., a clinical-stage private company developing advanced RNA products to treat and prevent infectious diseases and cancer, reported its participation at the World Vaccine Congress West Coast 2023 in Santa Clara, California, from November 27 through 30, 2023 (Press release, HDT Bio, NOV 16, 2023, https://www.prnewswire.com/news-releases/hdt-bio-to-participate-in-world-vaccine-congress-west-coast-2023-301990457.html [SID1234637745]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HDT Bio’s AMPLIFY vaccine platform combines repRNA coding for an antigen target and LION formulation technology to provide a versatile solution for a range of pathologies, from infectious diseases to cancer. The platform offers increased safety and potency, simplified manufacturing, and improved temperature stability compared to traditional RNA vaccines, allowing for increased efficacy with the potential for multivalency.

Steven Reed, Ph.D., Chief Executive Officer of HDT Bio will moderate a panel entitled, "SupeRNAtural: Realizing the potential of RNA therapeutics for ID & Cancer," on Wednesday, November 29, at 10:15 a.m. PT in Hall B. Panel participants include Zelanna Goldberg, M.D., Chief Medical Officer of Replicate Bioscience, Inc., Robert Shoemaker, Ph.D., Co-Chief of Chemopreventive Agent Development at the National Cancer Institute, and Joshua DiNapoli, Ph.D., Global Project Head mRNA Platform of Sanofi. The panel will discuss the wide variety of RNA molecules used to inhibit infectious diseases and cancer, along with common challenges within the field.

Dr. Steven Reed will also deliver a presentation entitled, "AMPLIFY Vaccine Platform: repRNA + LION," as part of the Cancer and Immunotherapy portion of the conference on Wednesday, November 29, at 1:05 p.m. PT. HDT Bio’s AMPLIFY platform is designed to enhance flexibility of manufacturing, improve stability during storage, while increasing cellular immune responses.

Additionally, Darrick Carter, Ph.D., Co-Founder and Senior Advisor of HDT Bio, will deliver a presentation entitled, "JO – opening tumor junctions to treat cancer" as part of the Immune Profiling session, on Wednesday, November 29, at 3:30 p.m. PT.

"The World Vaccine Congress West Coast 2023 has evolved into an impactful and influential platform, seamlessly integrating advancements in cancer and infectious disease research, bringing together innovative minds in the field of vaccines and immunology. At HDT Bio, we’re dedicated to pioneering solutions for infectious diseases and cancer, and we believe that the future of preventive healthcare lies in the potential of RNA technologies." commented Dr. Steven Reed, CEO of HDT Bio. "We look forward to sharing our insights, exchange ideas, and collaborate with the brilliant minds gathered at this conference, as well as highlighting the advances of our AMPLIFY vaccine platform, and our ACCESS junction opener technology designed to improve tumor penetrance."

On November 16, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), reported that the companies have entered into a new agreement for the supply of generators to produce actinium-225, a medical isotope used to treat cancer in clinical trials (Press release, Fusion Pharmaceuticals, NOV 16, 2023, View Source [SID1234637744]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, BWXT Medical will provide Fusion with a preferential supply of radium-225 and access to generator technology, enabling Fusion to produce actinium-225 (actinium-227 free) on site at the Company’s good manufacturing practice (GMP) manufacturing facility. In addition, the Companies have expanded their existing actinium-225 supply agreement, supporting Fusion’s advancing pipeline of targeted alpha therapies.

Actinium-225 is an alpha-emitting isotope used in Fusion’s targeted alpha therapies (TATs) that combine the isotope with specific tumor targeting vectors to kill cancer cells while minimizing the impact to healthy tissues. Radium-225 is the parent isotope that undergoes decay to form actinium-225. BWXT’s proprietary generator technology allows for the on-demand isolation of high purity actinium-225 from the radium supplied from BWXT. Generators, which will be shipped to Fusion’s GMP production facility, have been used successfully to produce other types of medical isotopes because they are simple to use and do not require investment in high-cost cyclotrons and associated infrastructure and staffing needs.

Fusion Chief Executive Officer John Valliant, Ph.D., said, "Since our inception, Fusion has made proactive investments to secure actinium-225 supply, creating a robust and diversified supply chain. Our collaboration with BWXT Medical, an established leader in medical isotope manufacturing and supply with proven ability to produce and deliver high purity actinium, is a critical component of our strategy, and we are excited to expand our relationship. Supply of radium-225 and access to BWXT’s generator technology allows Fusion to be one of the first radiopharmaceutical development companies to have onsite production of actinium-225, providing us superior flexibility in our manufacturing schedules and increased capacity to support our clinical pipeline. The addition of the actinium generator technology to our previously announced partnerships for actinium-225 supply is timely as we prepare to advance into a Phase 3 clinical trial our lead program, FPI-2265, which is positioned to be the first actinium-based radiopharmaceutical for prostate specific membrane antigen (PSMA) to market."

BWXT Medical President and Chief Executive Officer Jonathan Cirtain, Ph. D. said, "We’re proud to be expanding our relationship with Fusion, a leading developer of targeted alpha therapies. Our company’s significant investments in infrastructure and intellectual property are demonstrating results for our customers around the world. BWXT Medical’s innovative actinium-225 generator technology will have significant benefits for both clinical and future commercial supply. We look forward to continuing our respective efforts as Fusion’s clinical programs advance, and BWXT Medical helps meet the increasing global demand for actinium."

In January 2023, Fusion and BWXT Medical announced that the companies entered into a preferred partner agreement for the supply of actinium-225. Under that agreement, BWXT Medical provides predetermined amounts of Fusion’s actinium supply needs at volume-based pricing. The agreement was expanded to include future sources of actinium-225.