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.

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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]).

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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]).

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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]).

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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.

On November 16, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, is presenting encouraging clinical data of the Company’s four key drugs in clinical development: ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (oral CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor), at its 2023 R&D Day taking place today (Press release, Antengene, NOV 16, 2023, View Source [SID1234637743]). The event will also include presentations and discussion with three well-known clinical experts from leading medical centers in the U.S. and Australia.

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ATG-101 (PD-L1/4-1BB bispecific antibody): Early data from the Phase I PROBE trial have shown a partial response (PR) in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [MSS], liver metastasis, and three prior lines of therapy) which is ongoing. Additionally, two patients have been on ATG-101 for 18 cycles and 17 cycles (Q3W), respectively, demonstrating durable stable disease (SD) with a good safety profile with no liver toxicities. This distinguishes ATG-101 as a safer drug compared to many molecules currently under development targeting 4-1BB. At present, Antengene is conducting the Phase I clinical trials with ATG-101 for the treatment of patients with solid tumors or B-cell non-Hodgkin’s lymphoma (B-NHL) in Mainland of China, Australia, and the U.S.

ATG-022 (Claudin 18.2 antibody-drug conjugate): Initial clinical data include a complete response (CR) and a PR in two late-stage metastatic gastric cancer patients in the Phase 1 CLINCH trial. The PR was observed in Cohort 3 (1.8 mg/kg), a dose lower than the anticipated efficacious range; while the CR was observed in Cohort 4 (2.4 mg/kg). At present, Antengene is conducting a Phase I clinical study of ATG-022 for the treatment of patients with advanced or metastatic solid tumors in Australia and Mainland of China.

ATG-037 (oral CD73 inhibitor): In the dose escalation portion of the Phase I STAMINA trial, 12 patients, all previously treated with a checkpoint inhibitor (CPI, pembrolizumab or nivolumab), have received ATG-037 in combination with pembrolizumab after at least 2 cycles of ATG-037 monotherapy, with 7 patients still under treatment. PRs were observed in two melanoma patients (with prior anti-PD-1 treatment), and in one patient with non-small cell lung cancer (NSCLC) who had also undergone treatment with chemotherapy in addition to a CPI (anti-PD-1). In Australia and Mainland of China, Antengene is currently conducting a Phase I study of ATG-037 single agent and in combination with pembrolizumab for the treatment of patients with locally advanced or metastatic solid tumors.

ATG-008 (dual mTORC1/2 inhibitor): Clinical efficacy data have shown promising results from the Phase II TORCH-2 study evaluating ATG-008 in combination with toripalimab (anti-PD-1 antibody) for relapsed/metastatic cervical cancer patients. The trial enrolled 54 late-stage metastatic cervical cancer patients (30 CPI-naïve and 17 CPI-pre-treated patients with at least one tumor assessment). For the CPI-naïve patients, the objective response rate (ORR) is 53.3%, accompanied by a disease control rate（DCR） of 86.7% and a median progression-free survival (mPFS) of 8.41 months. For the CPI-pre-treated patients, the ORR, DCR, and mPFS stands at 29.4%, 82.4%, and 4.17 months respectively. These results support the efficacy of the treatment and compare favorably with previously published benchmark data.

"We are gratified that the differentiated preclinical efficacy data and benchmark comparisons for each program are being effectively translated to the clinic and encouraged to observe preliminary responses below the projected efficacious doses, according to the preliminary clinical data of ATG-022 and ATG-101. Moreover, ATG-037 and ATG-008, have progressed to combination studies and that, to date, we have already seen promising efficacy data with well tolerated safety profile. This is very encouraging." commented Dr. Amily Zhang, Antengene’s Chief Medical Officer. "Finally, we look forward to the participation of the investigators for the three programs: ATG-101, ATG-022 and ATG-037, and believe their perspective will help enrich the discussion at the R&D Day."

"The promising, early efficacy and good overall safety signals that we are presenting today on ATG-101, ATG-022, ATG-037 and ATG-008 are very encouraging because these programs target patients with advanced disease who had received multiple prior lines of therapy and the data further demonstrate these drugs’ potential to improve the care of patients with cancer," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO."In addition, we will also present the latest preclinical data of ATG-031 (anti-CD24 monoclonal antibody), our novel first-in-class CD24-targeted drug acting on the ‘don’t eat me’ pathway. The drug is currently being evaluated in a Phase I study of ATG-031 that is led by the MD Anderson Cancer Center and participated by other three clinical trial centers across the U.S. We were founded with the mission of bringing more transformative medicines to cancer patients around the world. Everyone at Antengene has resolute dedication to our mission and these early data affirm that we are delivering."

Antengene expects that updated and detailed study results of the studies that will be presented at international scientific conferences in 2024 or later.

The English session will be held virtually at 8:30 AM, November 17, 2023, Eastern Time/ 9:30 PM, Beijing Time. The Chinese session will be held in-person at the Antengene Shanghai Office and virtually at 8:30 AM, November 17, 2023, Beijing Time. We invite all investors to join Antengene’s 2023 R&D Day. To attend the event, please follow instructions provided in the press release below:
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