On July 8, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that the World Health Organization (WHO) has formally granted the International Non-Proprietary Name (INN) of amsulostat to its advanced clinical development asset SNT-5505 (Press release, Syntara, JUL 8, 2025, View Source [SID1234654266]).

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Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.

Amsulostat is an innovative oral therapy currently in clinical development for myelofibrosis (MF), a debilitating bone marrow disorder characterised by fibrosis that severely impacts blood cell production.

Recent interim Phase 2 clinical trial results, which demonstrated promising efficacy and an excellent safety profile in combination with ruxolitinib, underscore the potential of amsulostat as a differentiated treatment option for patients with MF who exhibit suboptimal responses to existing therapies.

The designation of an INN represents an important milestone in the drug development process, providing global recognition of amsulostat’s unique chemical identity and facilitating clearer communication among healthcare professionals and regulatory bodies worldwide.

Syntara CEO Gary Phillips said: "After very recently being awarded Fast Track Designation by the FDA, the granting of amsulostat as the INN for SNT-5505 is another important step forward, reflecting the drug’s unique mechanism of action and clinical promise. We remain focused on advancing amsulostat through clinical development to address significant unmet medical needs in myelofibrosis and other fibrotic diseases."

On July 8, 2025 Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, reported its support to CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms (Press release, Invivoscribe Technologies, JUL 8, 2025, View Source [SID1234654283]).

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Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories), have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support CERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML.

AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chimeric antigen receptor T-cells) and Chimeric Engulfment Receptor T-cells ("CER-T") therapies, which involve engineering a patient’s own T-cells to recognize and attack cancer cells, have shown promise in other hematologic malignancies and are now being explored for AML. However, because these therapies are manufactured from patient-derived cells, it’s critical to confirm that leukemic blasts are not inadvertently included in the final therapeutic product – underscoring the need for sensitive, validated assays like those offered by Invivoscribe and its global accredited regional laboratories, LabPMM.

LabPMM’s CAP/CLIA-Validated AML MRD MFC assay which was designed to quantify residual leukemic cells in patients undergoing treatment, was customized to meet two critical needs in CERo’s drug development program: (1) assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and (2) evaluating therapeutic response to CER-1236 during the trial.

Kristen Pierce, Ph.D., CERo Chief Development Officer, commented, "Invivoscribe has played an integral role in the execution of this clinical trial. Its technology and expertise have facilitated our advancement into the clinic by helping to ensure the purity of our investigational product, and now we are reaping the benefits of our collaboration as the trial is underway and we seek to assess therapeutic response."

This collaborative effort was instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML2. The designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects Invivoscribe’s commitment to driving innovation and standardization across the oncology treatment landscape – now helping bring immunotherapies to patients faster.

For more information about LabPMM’s flow cytometry and molecular testing services, please visit View Source or contact us at [email protected] and follow us on LinkedIn.

On July 8, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company’s intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies (Press release, Oncolytics Biotech, JUL 8, 2025, View Source [SID1234654284]).

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"We are no longer in the business of funding proof-of-concept studies," said Jared Kelly, Chief Executive Officer of Oncolytics. "We have meaningful clinical data in hand—not just signals. The survival benefit across multiple tumor types demands a focused approach to take pelareorep directly into registration-enabling trials. We will use our fast-track status to find the most efficient regulatory path forward this summer to advance our platform in a product technology."

Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. These results collectively represent promising efficacy for a therapeutic regimen that includes an immunotherapy in this difficult-to-treat cancer. Currently, there are no approved immunotherapies for first-line treatment of mPDAC.

Clinical results of pelareorep in first-line mPDAC studies
Company
(Study)
Description
(Patients) 1-Year Survival 2-Year Survival Notes
Oncolytics
(REO 017)
Pelareorep+ Gemcitabine
(34 patients)
45% vs. 22% 24% vs. 4%
Disease Control Rate (DCR): 83% vs. 33%
Single arm vs. gemcitabine benchmark

Oncolytics
(NCI 8601)
Paclitaxel/Carboplatin + Pelareorep
(36 patients) vs.
Paclitaxel/Carboplatin
(37 patients)
34% vs. 28% 20% vs. 6%
Randomized study vs. control arm
(excluding crossover)
Oncolytics
(REO 029)
Pelareorep+ Gemcitabine/
Nab-Paclitaxel+ Atezolizumab
(13 patients)
45% vs. 35% N/A
ORR: 62% vs. 23%
Single arm vs. gemcitabine/
nab-paclitaxel benchmark

Pelareorep’s clinical activity in HR+/HER2- metastatic breast cancer – a large indication with continued significant unmet medical need and no currently approved immunotherapies – has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). In the randomized, controlled BRACELET-1 study, pelareorep combined with paclitaxel yielded a 12.1-month median progression-free survival (PFS) compared to 6.4 months in the paclitaxel alone control arm.

"Pelareorep represents a tipping point for immunotherapy in cold tumors," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "It is delivering consistent immunologic and clinical responses in multiple tumor types. Most impressively, pelareorep activates the immune system to produce clinical benefits in cancers that are typically unresponsive to immunotherapies like mPDAC and unresectable HR+/HER2- breast cancer, creating new oncology entry points for immune-based combination therapies."

Data from more than 1,100 patients enrolled in multiple studies across several tumor types affirm that pelareorep has a favorable, well-understood safety profile. The most common treatment-related adverse events (TRAEs) are "flu-like" symptoms, such as fever, chills, headache, fatigue, myalgia, cough, anorexia, nausea, diarrhea, or vomiting, and rarely resulted in clinically significant grade ≥3 TRAEs. Adverse events are typically transient and manageable with over-the-counter medications.

Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.

The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data.

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.

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.