On November 16, 2023 Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, reported that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) (Press release, Apollomics, NOV 16, 2023, View Source [SID1234637771]).

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"The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China. Apollomics extends its full support and congratulations to Avistone on this significant achievement," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. "Our collaboration with Avistone and our ongoing global SPARTA trial with vebreltinib underscores our dedication to developing novel therapies for difficult to treat cancers and drug resistant patients worldwide."

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. It works by inhibiting the aberrant activation of the HGF/c-Met axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies. By targeting c-Met dysregulation, vebreltinib offers a potential breakthrough for patients with MET exon 14 skipping NSCLC and other cancers driven by c-Met alterations, i.e. exon14 skipping, MET amplification, MET fusions.

In pursuit of the MET exon 14 skipping NSCLC indication, Apollomics is in active discussion with the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for vebreltinib based on totality of clinical data from the global SPARTA trial and Avistone’s KUNPENG trial in China.

NSCLC accounts for approximately 85% of all lung cancer cases and remains a leading cause of cancer-related deaths worldwide. Patients with MET exon 14 skipping mutations, comprise approximately 3% to 4% of all NSCLC cases, face significant challenges due to limited treatment options.

Under the partnership agreement, Avistone holds the exclusive rights to vebreltinib in China, Hong Kong and Macau, while Apollomics retains the exclusive rights in the rest of the world, including the U.S, and partners have access to each other’s data. This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

About SPARTA

Apollomics is conducting a multi-cohort Phase 2 study of vebreltinib, SPARTA, at over 90 centers in 13 countries investigating the efficacy and safety of vebreltinib in MET exon 14 skipping non-small cell lung cancer (NSCLC). Cohorts A-1 is recruiting in first line Met exon 14 skipping NSCLC subjects and Cohort A-2 is recruiting in pretreated (> 2L) MET exon 14 skipping NSCLC subjects. In addition, Cohort C includes histology agnostic cMet amplified cancers (excluding primary CNS tumors) and Cohort C-1 includes NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR).

On November 16, 2023 BPGbio, Inc., a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, reported that researchers will present data from an ongoing phase 2 trial study of BPGbio lead candidate, BPM31510, in patients with newly diagnosed glioblastoma multiforme (GBM), at the Society for Neuro-Oncology Annual Meeting being held November 16-19, 2023 in Vancouver, Canada (Press release, BPGbio, NOV 16, 2023, View Source [SID1234637750]).

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"We are delighted to share the developments of the BPM31510 GBM trial with the neuro-oncology community," stated Seema Nagpal, MD, Clinical Professor of Neurology at Stanford Medicine and the trial’s principal investigator. "The information gathered from preclinical and clinical research has offered valuable insights into treatment for GBM, and we eagerly anticipate continuing to advance our discoveries with neoadjuvant BPM31510."

GBM is one of the most aggressive forms of brain cancer with survival times averaging only 15-18 months from diagnosis, and a five year survival rate under 10 percent. There are approximately 13,000 new cases of GBM-related tumors annually in the U.S., occurring more frequently in patients over age 60. BPM31510 as a treatment for GBM has received Orphan Drug Designation from the U.S. Food and Drug Administration.

The ongoing first-line Phase 2b trial (NCT04752813) follows a successful 104-patient Phase 1a/b clinical trial, which demonstrated both the safety and efficacy of BPM31510. The results from that trial enabled BPGbio to build a dynamic patient-based AI model to better understand the compound’s mechanism of action and predict who may be most likely to respond to the therapy. The Phase 1a/b data, which were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in 2019, helped the BPGbio team plan for a Phase 1b trial in advanced GBM patients, where BPM31510 was well tolerated.

"The initial data from our ongoing clinical development of BPM31510 suggests early promise and brings new hope to patients with some of the most aggressive and difficult-to-treat cancers of the brain and pancreas. It also validates our biology-first AI approach to making clinical development more efficient," said Niven R. Narain, Ph.D., President and CEO, BPGbio, Inc. "Our NAi Interrogative Biology platform guided our development team throughout the process, helping us optimize our clinical trials with the appropriate patient cohorts. We look forward to advancing the trial with the Stanford team and other leading medical centers."

The ongoing trial, which plans to enroll 50 patients, is a single arm dose-confirmation trial where patients are dosed with BPM31510 in combination with Vitamin K and standard chemoradiation therapy. BPGbio is planning to expand the Phase 2b trial to new clinical sites in the United States and the United Kingdom.

Presentation Summary
Abstract #: CTNI-27
Abstract Title: Trial In Progress: A phase 2 study of BPM31510 (an oxidized CoQ10-lipid conjugate nanodispersion) with vitamin K and standard chemoradiation in newly diagnosed glioblastoma
In-Person Session Name: Poster Session
In-Person Poster Session Date: Friday, November 17, 2023

About BPM31510

BPM31510 is BPGbio’s lead candidate in late-stage development for glioblastoma multiforme (GBM) and pancreatic cancer. The compound has demonstrated a tolerable safety profile and shown potential clinical benefit in both populations. The mechanism of action of BPM31510 was first validated by data from BPGbio’s NAi Interrogative Biology platform, which suggested that there is a hallmark shift in the tumor microenvironment (TME) induced by BPM31510 which modulates mitochondrial oxidative phosphorylation in highly aggressive tumors.

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]).

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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.

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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."