On March 26, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, reported progress from a phase 1 clinical trial utilizing Calidi’s CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally (Press release, Calidi Biotherapeutics, MAR 26, 2025, View Source [SID1234653216]). This trial is the first to evaluate the safety and therapeutic potential of a multiple-dose regimen of this novel virotherapy for recurrent high-grade glioma – among the most aggressive and deadly forms of brain cancer.

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Conducted by City of Hope, which has a National Cancer Institute-designated Comprehensive Cancer Center known for its pioneering research, this physician-sponsored phase 1 trial is assessing the safety and feasibility of delivering up to four weekly intracerebral doses of CLD-101. To date, 14 participants have been treated and all treatment has been well tolerated. The study is currently enrolling participants to the highest treatment schedule.

"We are optimistic about the initial results in these first 14 patients. I am especially encouraged by cohort 4 as we keep enrolling participants in this highest treatment schedule," said Dr. Jana Portnow, co-director of City of Hope’s Brain Tumor Program and the trial’s principal investigator. This clinical trial is now also open at Northwestern University Feinberg School of Medicine and Stanford University Hospitals, both globally recognized institutions in cancer research and treatment.

Dr. Karen Aboody, City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine, Division of Neurosurgery, has played a critical role in developing this approach alongside Dr. Portnow. Their collaboration secured a $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.

"We are dedicated to improving clinical outcomes of cancer patients with the use of stem cell technology to deliver oncolytic virus payloads to cancer sites," said Allan Camaisa, CEO and Chairman of Calidi. "Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."

Calidi licensed the technology from the University of Chicago, on behalf of City of Hope and University of Alabama. City of Hope has a financial interest in the technology.

Dr. Aboody, an inventor of the technology, has a financial interest in Calidi and is a paid advisory board member.

On March 26, 2025 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, reported that it has entered into definitive agreements for the purchase and sale of (i) 2,363,636 shares of its common stock to certain directors, executive officers, and certain existing stockholders of the Company (collectively, the "Insiders") at an offering price of $0.55 per share, and (ii) 1,739,087 shares of its common stock, together with common stock purchase warrants to purchase up to 1,739,087 shares of common stock (individually, a "Warrant" and collectively, the "Warrants"), to certain other existing stockholders of the Company and new investors at a combined offering price of $0.55 per share and accompanying Warrant (Press release, VolitionRX, MAR 26, 2025, View Source [SID1234651467]). Each Warrant has an exercise price per share of $0.66, and is exercisable immediately upon issuance, and expires five years from the issuance date.

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The Insiders (purchasers of 2,363,636 shares) will not receive any Warrants in the offering.

The securities will be issued and sold in the offering by the Company directly to the investors and without a placement agent. The offering is expected to close on or about March 26, 2025, subject to the satisfaction of customary closing conditions.

The aggregate gross proceeds from the offering to the Company are expected to be up to approximately $2.3 million, before deducting estimated offering expenses payable by the Company, assuming no exercise of the Warrants. The additional gross proceeds to the Company from the Warrants, if such Warrants are fully exercised, will be approximately $1.1 million. However, no assurance can be given that any of these Warrants will be exercised. Volition expects to use the net proceeds of the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-259783) that was filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021, as amended on November 4, 2021, and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and accompanying base prospectus relating to the offering that form a part of the shelf registration statement. The prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and may be obtained, when filed, on the SEC’s website located at www.sec.gov.

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 offer or 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 March 26, 2025 Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, reported that its abstract has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held April 25-30, 2025 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Bantam Pharmaceutical, MAR 26, 2025, View Source [SID1234651483]). The poster presentation will highlight solid tumor regression data from Bantam’s lead product candidate, BTM-3566. BTM-3566 is a first-in-class, small molecule cancer therapeutic which targets difficult-to-treat aggressive tumors by activating the OMA1-ATF4 Integrated Stress Response (ISR), a newly described mitochondrial homeostasis pathway. Leveraging its unique mechanism of action, BTM-3566 demonstrated robust activity as a single agent in vivo in solid tumors with low FAM210B RNA expression. Additionally, preclinical data suggest that rational combinations with BH3 mimetics could extend the therapeutic potential of BTM-3566, particularly in difficult-to-treat tumors.

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Poster Presentation Details
Title: Selective pharmacological activation of the mitochondrial protease OMA1 inhibits tumor growth and induces regression in tumors expressing low levels of FAM210B
Presenter: Matthew Kostura, PhD, Chief Scientific Officer, Bantam Pharmaceutical
Session: Experimental and Molecular Therapeutics
Date/Time: Monday, April 28th at 3 p.m. to 6 p.m. ET
Abstract Number: 3032

Additional meeting information can be found on the AACR (Free AACR Whitepaper) website, View Source The poster presentation will be made available under the News & Resources section of the company’s website shortly after the event.

About BTM-3566
BTM-3566 is a novel, orally available small molecule designed to target a wide range of cancers, including both hematologic and solid tumors. Its initial clinical focus is on mature B-cell lymphomas, such as mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). In preclinical studies, BTM-3566 demonstrated potent anti-cancer activity, driving significant tumor regression – and in many cases, complete tumor elimination – in models resistant to standard treatments, including CAR-T cell therapy. BTM-3566 works by disrupting the mitochondrial function in tumor cells, triggering their natural cell death process (apoptosis). With its unique mechanism of action and strong preclinical data, Bantam also plans to expand clinical development into solid tumors, broadening its potential impact for patients with limited treatment options.

Currently, Bantam is conducting an ongoing Phase 1 clinical trial in both the U.S. and Canada evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. For more information about the U.S. trial, visit ClinicalTrials.gov and search NCT06792734.

On March 26, 2025 Innovent Biologics reported annual results announcement for the year ended 31 December 2024 (Filing, 3 mnth, DEC 31, Innovent Biologics, 2024, MAR 26, 2025, View Source [SID1234651499]).

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On March 26, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. ("PeriNess"), has entered into a Clinical Study Agreement (the "Agreement") to support an exploratory clinical study of Xenetic’s systemic DNase I candidate, XBIO-015, in patients with relapsed/refractory osteosarcoma and Ewing sarcoma (Press release, Xenetic Biosciences, MAR 26, 2025, View Source [SID1234651468]).

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Prof. Ronit Elhasid, Director of Pediatric Hemato-Oncology and Bone Marrow Transplantation Department at the Dana-Dwek Children’s Hospital in the Tel-Aviv Sourasky Medical Center ("Sourasky Center"), will act as the principal investigator and co-sponsor of the study along with the Health Corporation of the Tel Aviv Medical Center, an affiliate of the Sourasky Center.

"The primary objective of this study is to explore safety and tolerability in patients with relapsed/refractory osteosarcoma or Ewing sarcoma receiving XBIO-015 in combination with relapsed chemotherapy regimens. Secondary objectives include efficacy to be evaluated by the measure of objective response rate and progression-free survival. The study has a strong translational component with a complex assessment of biomarker response. Data on DNase I efficacy in combinations with chemotherapy in experimental models has encouraged us to support the study," stated Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.

Ewing sarcoma and osteosarcoma are aggressive orphan pediatric cancers that grow in bones or soft tissues. There is a lack of effective treatment options for children with recurrent and refractory disease where the five-year survival rate is only 20 to 30 percent. Studies conducted at Tel Aviv Sourasky Medical Center between 2013 and 2024 showed that the formation of neutrophil extracellular traps (NETs) in the tumor microenvironment of pediatric sarcomas is an independent prognostic factor, with a clear association between NETs burden and poor prognosis. According to the above research, elevated levels of NETs at diagnosis predicted a poor response to neoadjuvant chemotherapy, relapse, and death from the disease. Xenetic’s proprietary recombinant DNase I is an enzyme that digests NETs in a tumor microenvironment.

James Parslow, Interim Chief Executive Officer and Chief Financial Officer of the Company stated, "As part of our overall development strategy, we aim to participate in a series of exploratory studies to evaluate XBI0-015 combinations with chemotherapy, radiotherapy and immunotherapy in various oncology indications. Our commitment to the DNase program remains steadfast and we are pleased to further expand our body of clinical data."

As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.