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Rakovina Therapeutics Closes Previously Announced Over-subscribed Private Placement

On July 26, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV) (the "Company"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private placement (the "Private Placement") for gross proceeds to the Company of $2 million (Press release, Rakovina Therapeutics, JUL 27, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-closes-previously-announced-over-subscribed-private-placement [SID1234645110]).

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In connection with the Private Placement, the Company issued 19,950,000 units (each, a "Unit") at a purchase price of $0.10 per Unit. Each Unit is comprised of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange (the "TSXV") is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.

According to Executive Chairman Jeffrey Bacha, the funds will be used to further the company’s Artificial Intelligence (AI) fueled drug candidate research. Bacha said, "We are continuing activities under our AI collaboration to screen billions of drug candidates against DNA-damage response targets. We anticipate having initial output from this effort in the form of recommended molecular structures for validation in our laboratories at the University of British Columbia in early fall, which puts us on track to have initial data from validating in vivo models later this year."

Defects on our natural DNA-damage response mechanism are involved in the formation and growth of approximately three out of every four cancers. First generation DDR-inhibitors, called PARP-inhibitors, currently generate approximately $3 billion in annual sales and have provided significant benefit to patients diagnosed with certain types of breast, ovarian, and prostate cancer. Rakovina Therapeutics’ goal is to advance one or more next-generation DDR drug candidates into human clinical trials in collaboration with pharmaceutical partners.

In connection with the Private Placement, the Company paid a cash finder’s fee to Hampton Securities Limited totaling $1,200 and issued 12,000 finder’s warrants (each, a "Finder’s Warrant"). Each Finder’s Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance, subject to acceleration on the same terms as the Warrants issued in connection with the Private Placement.

The Private Placement is subject to the final acceptance of the TSX-V and all securities issuable in connection with the Private Placement are subject to resale restrictions for a period of four months plus one day from the date of issuance.

New MultiCenter Prospective Study Demonstrates Signatera’s Clinical Utility in Merkel Cell Carcinoma

On July 26, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in the Journal of Clinical Oncology highlighting the utility of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, for surveillance in Merkel cell carcinoma (MCC) (Press release, Natera, JUL 26, 2024, View Source [SID1234645114]).

MCC is an aggressive skin cancer with high mortality and a recurrence rate of 40% within 5 years.1 MRD testing using a viral antibody is recommended by the National Comprehensive Cancer Network (NCCN)2, but this tumor marker is only present in 52% of patients and has several known limitations3-4. There is an unmet need for improved MRD testing technologies that are applicable to all patients, regardless of their viral status.

This prospective, multicenter, observational study included 319 patients with stage I-IV MCC. Signatera was used to assess ctDNA levels at the time of enrollment, and every 3 months during the surveillance period. Key findings include:

Signatera showed a test sensitivity of approximately 95% for detecting clinically evident disease at time of enrollment.
ctDNA positivity during surveillance was associated with up to 20 times higher risk of recurrence than persistently ctDNA-negative patients.
At 12 months of surveillance, the recurrence-free probability was 9% among patients with a positive ctDNA result at any time, compared with 91% for patients who remained ctDNA-negative.
"There is a strong need for highly accurate biomarkers in merkel cell carcinoma, an incredibly aggressive and rare form of skin cancer," said Lisa Zaba, M.D., Ph.D., associate professor of dermatology, director of the MCC multi-disciplinary clinic and member of the supportive oncodermatology group at the Stanford Cancer Center. "Our study shows that a tumor-informed MRD test can inform prognosis and guide surveillance in patients with MCC, regardless of tumor viral status."

"We are encouraged by the excellent performance of Signatera in this study, where high prognostic accuracy was demonstrated, and where we can see the significant clinical utility of MRD testing for detecting recurrence in MCC patients," said Angel Rodriguez, M.D., senior medical director at Natera and co-author of the study. "We are optimistic that Signatera will become a standard monitoring tool in this highly lethal cancer type, enabling clinicians to select patients with MRD who might benefit most from adjuvant therapy and better determine who may or may not need more frequent imaging with a high degree of confidence."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 70 peer-reviewed papers.

CEL-SCI Announces Pricing of $10.8 Million Offering

On July 26, 2024 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a cancer immunotherapy company, reported the pricing of a best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price) (Press release, Cel-Sci, JUL 26, 2024, View Source [SID1234645113]). All of the shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be $10,845,000. The offering is expected to close on July 29, 2024, subject to satisfaction of customary closing conditions.

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

ThinkEquity is acting as sole placement agent 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 will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

CStone Announces European Commission Approval of Sugemalimab (Cejemly®) as First-Line Treatment for Non-Small Cell Lung Cancer

On July 26, 2024 CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, reported that the European Commission (EC) has approved sugemalimab (Brand name: Cejemly) in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations (Press release, CStone Pharmaceauticals, JUL 26, 2024, View Source [SID1234645112]). Sugemalimab has become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe in combination with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC, making CStone the first innovative biopharmaceutical company to successfully bring a China domestic anti-PD-L1 mAb to the international market.

The EC approval is primarily based on the results of the GEMSTONE-302, a multicenter, randomized, double-blind phase 3 study. The study demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival and overall survival compared to placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC. The study results have been published in The Lancet Oncology and Nature Cancer, and have been presented at multiple international academic conferences. Additionally, long-term treatment and survival data from the GEMSTONE-302 study will be presented in a poster session (#1318P) at the 2024 ESMO (Free ESMO Whitepaper) Annual Meeting.

Dr. Jason Yang, CEO, President of R&D and Executive Director of the Board at CStone, said, "We are extremely excited by today’s announcement, which represents a major milestone in CStone’s journey towards becoming a leading global company dedicated to eradicating cancer. Sugemalimab has not only become CStone’s first independently-developed product to receive overseas marketing authorization but it is also the world’s first anti-PD-L1 mAb to receive regulatory approval in Europe in combination with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC. This achievement reflects the international regulatory authorities’ recognition of our high-quality R&D and manufacturing standards, and it infuses new momentum into our globalization strategy. We are humbled by level of interest in sugemalimab commercial partnership from companies around the world which only signifies the large unmet need in this class for newer and better drugs. We are actively engaging with potential partners in Western Europe, Latin America, the Middle East and Africa, Southeast Asia, and Canada and we expect to announce the completion of these deals soon."

Dr. Yang recalled, "In early May 2023, CStone regained the development and commercialization rights for sugemalimab outside Greater China. Since then, the entire company acted swiftly, with all departments working in coordination to thoroughly review regulatory and submission documents, assess their completeness, perform gap analyses, screened and replaced numerous suppliers, and completed the applicant transfer and submission dossier updates. Within just over a month of fully taking over the MAA, the EMA issued a critical Day 120 List containing 194 outstanding questions. After analyzing a vast amount of data, our team submitted a detailed response to the EMA within the required timeframe. By Day 180, nearly 90% of the responses issues has accepted by EMA’s Reviewers resolved, and the remaining ones were further clarified and eventually agreed by the EMA. During the review period, we also successfully passed the EMA’s routine GMP inspection of the manufacturing plant, and GCP inspections of two study centers and a CRO, which lasted a total of three weeks. Subsequently, at the end of May this year, we received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of sugemalimab. I truly believe that this journey, marked by numerous challenges, reflects the CStone team’s resilience and innovative spirit."

Dr. Jason Yang emphasized, "The international approval and commercialization of sugemalimab mark a significant milestone in CStone’s Pipeline 1.0 strategy, demonstrating our success in developing best-in-class immuno-oncology drugs for monotherapy and as a foundation for combination therapies. In Pipeline 2.0, we have global rights for a range of highly promising candidates, either in international multicenter clinical trials or approaching the clinical stage, with the potential to be first-in-class or best-in-class. Additionally, we are actively exploring the combination of sugemalimab with other treatment modalities, such as antibody-drug conjugates (ADCs) and bi-/tri-specific antibodies, to enhance its clinical value as a backbone of cancer immunotherapy."

Dr. Yang added, "The seven-year journey of sugemalimab to becoming a first-line treatment for NSCLC in Europe and other cancers in China is a testament to the extensive expertise of numerous Chinese oncology specialists. It also reflects the dedication of patients who participated in sugemalimab clinical trials and the relentless efforts of our R&D team over the years. The remarkable results of the GEMSTONE-302 study provide definitive scientific evidence supporting the use of sugemalimab in combination with chemotherapy as a first-line standard therapy for Stage IV NSCLC. We are honored and humbled that this ‘Chinese innovative solution’ may significantly improve outcomes for lung cancer patients worldwide, offering both longer survival and a better quality of life."

Meanwhile, CStone is actively preparing to submit multiple Marketing Authorization Applications (MAAs) for additional indications, including Stage III NSCLC, first-line Gastric Cancer, first-line Esophageal Cancer, and relapsed/refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL).

Immorta Bio Files Investigational New Drug Application for First in Class Senolytic Immunotherapy SenoVax™ for Treatment of Advanced Lung Cancer

On July 26, 2024 Immorta Bio Inc, a science-based longevity company dedicated to treating "Diseases of Aging and Aging as a Disease" with personalized cellular solutions, reported the filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) (Press release, Immorta Bio, JUL 26, 2024, View Source [SID1234645111]). The IND, which was granted #30745, is to initiate a clinical trial to evaluate safety, immunogenicity, and efficacy signals of SenoVax in patients with advanced non-small cell lung cancer. The trial will recruit patients who have failed standard therapies and will comprise of three patient groups receiving increasing doses of SenoVax.

SenoVax leverages dendritic cell technology to augment the natural ability of the immune system to clear senescent cells. These cells, referred to as "zombie cells", are known to accelerate the process of aging. In the context of cancer, senescent cells have been demonstrated to surround tumors and to provide a protective element that "hides" cancers from immune attack1,2,3,4. Previous studies by Immorta Bio have shown that SenoVax can reduce growth of lung cancer in animal models and can induce immune responses that selectively kill senescent cells in the laboratory.

"To our knowledge, this is the first clinical candidate to push the immune system to attack not the cancer itself, but the cells protecting it," said Thomas Ichim, PhD, President and Chief Scientific Officer of Immorta Bio. "In contrast to cancer, which mutates in a very rapid manner, senescent cells surrounding the tumor do not mutate, thus making them a more attractive therapeutic target. While the primary aim of the study is not to investigate systemic effects, it will be of significant interest to observe any additional regenerative benefits of the SenoVax therapy, beyond its impact on tumor size reduction."

Studies suggest that reducing the number of senescent cells using small molecule approaches reduces adverse effects of the aging process, such as declines in physical5 and mental function6,7. In addition, it has been reported that reduction of senescent cells increases therapeutic efficacy of chemotherapy8, radiation therapy9, and immunotherapy10,11. Based on recent findings, the Company hypothesizes that immune mediated clearance of senescent cells is a more attractive approach as compared to small molecules since one of the natural functions of the immune system is to clear these cells.

"I am thankful for our team, and our clinical and scientific collaborators that have taken this promising laboratory technology and have advanced it into a candidate for clinical assessment," said Boris Reznik, PhD, Chairman and CEO of Immorta Bio. Our Senolytic Immunotherapy has the potential to be valuable not only as a monotherapy, but also as an adjuvant to numerous oncological treatments that are currently in the clinic."

About SenoVax

SenoVax is an autologous polyvalent cellular therapeutic that induces immune responses against senescent cells. It is produced by extracting a skin biopsy and creating autologous senescent cells in vitro using a proprietary mechanism. These "accelerated senescent" cells are used as an antigenic source to pulse patient derived dendritic cells generated ex vivo. SenoVax combines the potency of dendritic cell immunotherapy, with the novel target of killing tumor associated senescent cells. Preclinical studies have demonstrated SenoVax can reduce growth of lung cancer in animal models and can induce immune responses that selectively kill senescent cells in the laboratory.