On June 11, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company pioneering next-generation oncology therapeutics, reported the publication of transformative preclinical research in the journal Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) that underscores the powerful potential of its lead asset, paxalisib, in reshaping the treatment landscape for triple-negative breast cancer (TNBC), one of the most aggressive and treatment-resistant cancer subtypes (Press release, Kazia Therapeutics, JUN 11, 2025, View Source [SID1234653823]).

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The preclinical program was conducted by Professor Sudha Rao at the renowned QIMR Berghofer Medical Research Institute, revealing how paxalisib can reprogram the tumor microenvironment and enhance immune response, showing substantial synergy with immune checkpoint inhibitors. The data provide strong scientific and translational rationale for continued development of paxalisib as part of immunotherapy-based regimens.

Key Findings

Dual targeting of PI3K and mTOR but not PI3K alone inhibits cancer cell proliferation and migration in vitro.
Paxalisib remodels the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation
The combination of paxalisib with KEYTRUDA (pembrolizumab) demonstrated synergistic antitumor activity in advanced breast cancer, resulting in robust tumor regression and prolonged survival in preclinical models
The data validate a mechanistic rationale for ongoing clinical exploration of paxalisib in combination with checkpoint inhibitors and PARP inhibitors
"This landmark study offers a mechanistic and translational foundation for our newly launched Phase 1b clinical trial of paxalisib in advanced breast cancer," said Dr. John Friend, CEO of Kazia. "It not only extends the therapeutic potential of paxalisib beyond brain cancers but also positions it at the forefront of innovative immunotherapy combinations in solid tumors."

The publication, "Combination of the PI3K/mTOR inhibitor paxalisib with immune checkpoint inhibitors enhances antitumor activity in preclinical models of triple-negative breast cancer," is available online at View Source

Clinical Milestone
Kazia recently announced that the first patient has been dosed in the Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy in advanced breast cancer, marking a critical step toward clinical translation of these findings.

For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC

On June 11, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen (Press release, Intensity Therapeutics, JUN 11, 2025, View Source [SID1234653822]).

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The INVINCIBLE-4 Study is a randomized, open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer ("TNBC") who undergo standard of care neoadjuvant immunochemotherapy ("SOC") treatment and SOC alone. The primary endpoint is pathological complete response ("pCR"), i.e., the absence of live cancer in the primary tumor and affected lymph nodes. Patients are being randomized one-to-one to receive either a regimen of two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e., the Keynote-522 regimen), or SOC alone. The study is recruiting patients in Switzerland and France and is expected to enroll 54 patients.

"We are encouraged to see high levels of tumor necrosis from the MRI scans and evidence of tumor inflammation after two INT230-6 injections and before initiation of the SOC in our first patients," said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. "We are encouraged that these patients achieved such a good response to INT230-6 prior to their beginning the Standard immune-chemo regimen and look forward to continuing enrollment in the study."

"We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation. TNBC Patients who have no live cancer in their tumor or nodes at the time of surgery have a significantly improved event-free survival advantage compared to those who do not have a pathological complete response. TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result. We look forward to seeing the pathological complete response data being generated by our partners at SAKK and Unicancer," said Lewis H. Bender, President and CEO of Intensity.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer in the Presurgical Setting

Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 Worldwide diagnosed each year, the majority of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

On June 11, 2025 TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, reported the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008 (Press release, TC Biopharm, JUN 11, 2025, View Source [SID1234653821]).

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The response was achieved after the patient’s second dose of 250,000,000 gamma delta t-cells, two weeks after treatment began, in total the patient received approximately 500,000,000 gamma delta t-cells over two weeks. The patient received 2 of a possible 4 infusions of TCB008 and continues to be monitored under the care of Dr. Hugues de Lavallade at Guy’s and St. Thomas’ NHS Foundation Trust and remains in remission state two months after treatment.

This data readout represents a major milestone in TC BioPharm’s mission to develop innovative cell therapies that target and eradicate malignant cells with precision and durability. Over 1 million patients are diagnosed with blood cancers globally each year. Patients who initially achieve remission can retain a molecular burden of disease that results in relapse. Multiple factors, including previous treatments, limit treatment options for relapsed patients.

‘This patient experienced molecular relapse while continuing low-intensity chemotherapy," said Dr. Hugues de Lavallade, consultant hematologist at Guy’s and St. Thomas’ NHS Foundation Trust. "NPM1 transcript levels detected the rising MRD on repeated samples, and chemotherapy was stopped. After two doses of the IMP, given post-lymphodepletion, the patient has now achieved a complete molecular response with no detectable NPM1 transcripts."

"This is an encouraging patient response, and our team is invigorated by this important step forward. We believe TCB008 has the potential to become a foundational component of post-remission therapy for patients with blood cancers, helping to extend survival and improve long-term outcomes, as well as newly diagnosed patients where TCB008 can potentially be impactful as a monotherapy to avoid an arduous bone marrow transplant process" said Bryan Kobel, CEO of TC BioPharm. "Treating MRD effectively halts disease progression before it has the chance to return, and TCB008’s targeted immune activity continues to show great promise in this setting. This response to TCB008 heightens our focus on this patient population, where we believe the ability of the gamma deltas to rapidly overwhelm the cancer cells and bring about a high-grade patient response is value-enhancing and commercially impactful."

On June 11, 2025 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that Dr. Marnix Bosch, its Chief Technical Officer, will make a presentation on "Next Generation Dendritic Cell Treatments to Improve Anti-Tumor Responses" at the upcoming Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, JUN 11, 2025, View Source [SID1234653820]). Dr. Bosch will address certain factors and combinations of factors that may lead to supercharged dendritic cells with enhanced anti-tumor effects.

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The presentation will take place on Monday, June 16, at 2:50 p.m. The slides will be posted on the Company’s website after the presentation.

On June 11, 2025 Monopar Therapeutics Inc. ("Monopar," the "Company," "us" and "our") (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, in collaboration with Excel Diagnostics and Nuclear Oncology Center ("EDNOC"), a premier diagnostic medical imaging and therapeutic nuclear medicine center, reported that the physician-sponsored Expanded Access Program ("EAP") for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration ("FDA") (Press release, Monopar Therapeutics, JUN 11, 2025, View Source [SID1234653819]).

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The MNPR-101 EAP is now open for enrollment to patients with advanced solid tumors at EDNOC in Houston, Texas. EDNOC is among the first private outpatient facilities in the U.S. to be designated as a Radiopharmaceutical Therapy Center of Excellence by the Society of Nuclear Medicine and Molecular Imaging ("SNMMI"). Patients will be treated under the supervision of renowned investigator Ebrahim S. Delpassand, MD, founder and medical director of EDNOC.

"We are pleased to provide patients in the United States with access to MNPR-101-Zr and MNPR-101-Lu, which were developed to target aggressive cancers, such as triple-negative breast, pancreatic, and colorectal cancer," said Andrew Cittadine, Chief Operating Officer of Monopar. "This EAP represents continued progress in our radiopharmaceutical pipeline following last year’s initiation of Phase 1 clinical trials in Australia with MNPR-101-Zr and MNPR-101-Lu. We are grateful for the opportunity to work with Dr. Delpassand to make these therapies available to patients on a compassionate use basis," added Mr. Cittadine.

"Our team at Excel Diagnostics looks forward to providing MNPR-101-Zr and MNPR-101-Lu to patients in need," said Dr. Delpassand. "Targeting uPAR-expressing solid tumors will be another promising frontier in radioligand therapy to help patients with ‘difficult-to-treat’ cancers," continued Dr. Delpassand.

About Expanded Access to MNPR-101-Zr and MNPR-101-Lu

EAPs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product outside of clinical trials preceding FDA approval; this occurs when no comparable or satisfactory alternative treatment is available, and the patient’s situation necessitates accessing an unapproved product outside of clinical trials. Healthcare providers and cancer patients who are interested in learning more about the MNPR-101-Zr and MNPR-101-Lu EAP, including eligibility criteria, can visit www.clinicaltrials.gov using the following links: NCT06980506 and NCT06980519 for the imaging and therapy EAP, respectively.

About MNPR-101-Zr and MNPR-101-Lu

MNPR-101 is Monopar’s proprietary antibody targeting the urokinase plasminogen activator receptor ("uPAR"), which is expressed in numerous tumor types, including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to image tumors and deliver a targeted radiopharmaceutical therapy that kills cancer cells while minimizing damage to healthy tissue. MNPR-101-Zr is MNPR-101 conjugated to zirconium-89 and designed for the imaging of advanced cancers; MNPR-101-Lu is MNPR-101 conjugated to lutetium-177 and designed as an investigational treatment of advanced solid cancers.