On July 8, 2025 IRIC and IRICoR reported the start of a Phase 1 clinical trial of its small molecule therapy for solid tumors licensed to Ipsen (Press release, Université de Montréal, JUL 8, 2025, View Source [SID1234654289]). This marks a major milestone in the strategic collaboration between the partners, which began in May 2020 with a research and option agreement followed by a licensing agreement in February 2023.

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The small molecule clinical candidate, now known as IPN01195, is a RAF inhibitor, an important target in a signaling pathway involved in cancer cell growth and proliferation. It was originally discovered and developed by the teams of Professors Marc Therrien and Anne Marinier at the Université de Montréal’s Institute for Research in Immunology and Cancer (IRIC) and has shown promising activity in preclinical models of various solid tumors.

"We are extremely proud to see our novel small molecule therapy reaching this important clinical milestone. This is another example of the efficiency and innovative approach of IRIC’s collaborative drug discovery research model," said Dr. Anne Marinier, Director of the Drug Discovery Unit at IRIC. "This marks a major step forward for our multidisciplinary teams of biologists and chemists, but more importantly, it brings us closer to delivering a potential new treatment option for patients facing advanced cancers," said Dr. Marc Therrien, Principal Investigator, Intracellular Signalling Research Unit and Chief Executive Officer, IRIC. "We are delighted by the commitment and progress of our partner Ipsen, and we look forward to the continued development of this promising therapy," concluded Dr. Marinier.

"The initiation of this clinical trial marks a major validation of our business development efforts," said Elizabeth Douville, CEO, IRICoR. "It demonstrates our ability to translate novel science into programs that attract world-class partners and progress into the clinic. With additional first-in-class and best-in-class molecules targeting key cancer pathways in our pipeline, we are actively exploring new strategic collaborations and raising capital to accelerate development. This is an exciting inflection point for IRICoR as we continue to deliver both scientific and commercial value," added Elizabeth Douville.

Under the terms of the agreement, the Université de Montréal granted Ipsen exclusive rights to develop and commercialize the compound globally. The University and IRICoR are eligible to receive development and commercial milestone payments, as well as royalties on net sales.

On July 8, 2025 LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, reported that it has entered into a share and warrant purchase agreement (the "Purchase Agreement") with an institutional investor for the issuance and sale of 16,987,542 ordinary shares of the Company, par value US$0.0002 per share, at US$0.883 per share, and 16,987,542 warrants, each entitling the institutional investor to purchase one ordinary share at an exercise price of US$1.079 at any time and from time to time during a 36-month period, in a private placement of US$15 million exempt from registration pursuant to Regulation S under the Securities Act of 1933, as amended (Press release, LakeShore Biopharma, JUL 8, 2025, View Source [SID1234654288]). The closing of the private placement is expected to take place as soon as possible upon agreement by the parties to the Purchase Agreement, subject to customary conditions precedent stipulated thereunder.

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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 of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 8, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM) (Press release, Plus Therapeutics, JUL 8, 2025, View Source [SID1234654287]). The dose optimization trial builds on promising results from the Company’s completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the FDA’s Project Optimus to identify the optimal dosing regimen that maximizes efficacy and safety.

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"Based on the promising, recently completed Phase 1 single-dose escalation study and lack of FDA approved therapies for LM, we expect trial enrollment to proceed rapidly in accordance with the trial protocol," said Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio. "Furthermore, assuming REYOBIQ continues its attractive safety profile, we expect that we will enroll all required patients and doses in Cohort 1 by the end of this year."

Patients and family members interested in enrolling in the ReSPECT-LM Dose Optimization Trial can learn more here.

ReSPECT-LM Dose Optimization Trial
The study aims to optimize treatment dosing for maximum efficacy and safety, with the primary objectives of determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer, and to identify both the maximum tolerated dose and minimum effective dose. Previously announced details of the study, including primary, secondary, and exploratory endpoints, can be found here.

The dose optimization study builds on encouraging results from the Company’s previously announced Phase 1 trial, which showed a single dose of REYOBIQ delivered up to an average absorbed dose of >250 Gy to the cranial subarachnoid space. It also demonstrated that 5 of 7 patients achieving an over 80% reduction in LM tumor cells in the cerebrospinal fluid survived at least one year post-treatment. Additional details can be found here.

The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial.

The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

About Cancer Prevention & Research Institute of Texas (CPRIT)
The Cancer Prevention & Research Institute of Texas (CPRIT) is a $6 billion cancer research and prevention initiative legislated in Texas. CPRIT accepts applications and award grants for a wide variety of innovative cancer-related research and product development and for the delivery of evidence-based cancer prevention programs and services by public and private entities located in Texas. CPRIT is the largest state cancer research investment in the history of the United States and the second largest cancer research and prevention program in the world with a three-part mission, established by the Texas Legislature, to invest in the research prowess of Texas universities and research organizations; create and expand life science infrastructure across the state; and expedite innovation in research and enhance the potential of breakthroughs in prevention and cures.

On July 8, 2025 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the "Company"), a clinical stage pharmaceutical company, reported the closing of a registered direct offering with accredited investors for the purchase and sale of approximately $1.5 million of shares of Common Stock (or Pre-Funded Warrants) (Press release, Lixte Biotechnology, JUL 8, 2025, View Source [SID1234654286]).

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The offering consisted of the sale of an aggregate of 974,026 shares of Common Stock (or Pre-funded Warrants in lieu thereof). The public offering price per share of Common Stock was $1.54 (or $1.53999 for each Pre-Funded Warrant, which is equal to the offering price per share of Common Stock sold in the offering minus an exercise price of $0.00001). The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until exercised in full.

Aggregate gross proceeds to the Company were approximately $1.5 million. The transaction closed on July 8, 2025. The Company expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital.

Spartan Capital Securities, LLC acted as exclusive placement agent for the offering. TroyGould PC acted as counsel to the Company. Kaufman & Canoles, P.C. acted as counsel to Spartan Capital Securities, LLC.

The registered direct offering was made pursuant to an effective shelf registration statement on Form S-3 (No. 333-278874) previously filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on May 2, 2024. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting Spartan Capital Securities, LLC, Attention: Prospectus Department, 45 Broadway, 19th Floor, New York, NY 10006, by e-mail at [email protected]. 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 July 8, 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 informed the Company that Bnei Zion Medical Center has commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer (Press release, Xenetic Biosciences, JUL 8, 2025, View Source [SID1234654285]).

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Dr. Abed Agbabrya, head of Oncology at the Bnei Zion Hospital, will act as the principal investigator and all work will be conducted at The Fund for Medical Research, Development of Infrastructure and Health services – Bnei Zion Medical Center in Israel.

Dr. Dmitry Genkin, Xenetic Chairman stated, "We are very pleased with the update provided by PeriNess and for the start of patient dosing in this exploratory study. We remain committed to advancing our systemic recombinant human DNase I technology into the clinical stage. The ability of DNase I to degrade neutrophil extracellular traps (NETs) in the pancreatic cancer tumor microenvironment holds promise to improve clinical responses in a critically underserved patient population. We look forward to further exploring the full potential of DNase I."

PeriNess has informed the Company that the exploratory study is evaluating the safety, biomarker response, pharmacokinetics (PK) and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer. All patients will receive intravenous infusions of DNase I on Days 1 and 8 of consecutive 14-day cycles. Safety will be continuously evaluated until the end of the study. DNase I pharmacokinetics will be evaluated on Days 1 and 2 of the first FOLFIRINOX cycle and Days 1 and 2 of the third FOLFIRINOX cycle. Neutrophil extracellular traps biomarkers will be evaluated on Day 1 of the first FOLFIRINOX cycle and every 4 weeks thereafter. Clinical activity will be evaluated by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Progression-Free Survival (PFS).

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.