Sona Engages Clinical Trial Clinic for First-in-Human Early Feasibility Study of its THT Cancer Therapy

On June 16, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, reported that it has entered into a clinical trial agreement for an early feasibility study clinical trial of its Targeted Hyperthermia Therapy ("THT") (Press release, Sona Nanotech, JUN 16, 2025, View Source [SID1234653923]). Sona has engaged Bradford Hill Investigacion Clinica ("Bradford Hill") in Santiago, Chile for a study of Sona’s THT treatment for up to ten patients with advanced melanoma.

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The study’s principal investigator and Bradford Hill executive director, Dr. Carlos Rojas, commented, "With extensive experience in conducting clinical trials in melanoma for tier-one global pharmaceutical companies, we are excited to partner with Sona Nanotech to assess the potential for their novel cancer treatment with patients in Chile."

Sona CMO, Dr. Carman Giacomantonio, commented, "As an early feasibility study, the primary data to be gathered from this study are for the safety and tolerability of THT in human subjects. We will also look to assess preliminary efficacy as determined by whether each patient’s immune system is engaged by Sona’s THT treatment. Indicators of success will include findings of tumor cell death in tumors treated with THT and evidence of associated enhanced immunity in these patients."

The study is designed to assess safety, tolerability, and preliminary efficacy and will include two treatments of Sona’s THT, one week apart, for patients with advanced melanoma who are on but have failed to respond to a standard of care immunotherapy protocol. The study is subject to final ethics committee approval, and enrollment of the first patients is anticipated by the end of June with interim results this summer and final results expected this fall.

Sona Nanotech believes that its THT treatment may provide benefits over current standard of care immunotherapy treatments alone which have shown limited response rates and can have undesirable side effects.

Northwest Biotherapeutics Announces Upcoming Presentation On Next Generation Dendritic Cells for Enhanced Anti-Tumor Treatments

On June 16, 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 16, 2025, View Source [SID1234653922]). 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.

NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6

On June 16, 2025 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors (Press release, NextCure, JUN 16, 2025, View Source [SID1234653921]). SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025.

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SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models.

SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration.

The partnership also includes a license for NextCure to access Simcere Zaiming’s proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC.

"We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors," said Michael Richman, NextCure’s president and CEO. "We look forward to initiating clinical development of SIM0505 in the United States."

"We are very pleased to collaborate with NextCure on the global development of SIM0505," said Renhong Tang, PhD, CEO of Simcere Zaiming. "SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure’s recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide."

Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory.

NanoCell Secures Seed-Extension Financing from The Institute for Follicular Lymphoma Innovation to Advance Lead Clinical Candidate for B Cell Malignancies

On June 16, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a biotechnology company developing a non-viral, DNA-based in vivo gene therapy platform, reported the successful closing of a seed-extension financing round, with participation from The Institute for Follicular Lymphoma Innovation ("IFLI"), a leading non-profit organization dedicated exclusively to funding innovative follicular lymphoma research and development (Press release, NanoCell Therapeutics, JUN 16, 2025, View Source [SID1234653920]).

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The funding will accelerate IND-enabling development of NanoCell’s lead clinical candidate, NCTX-01, a dual-CAR CD19/CD22 in vivo CAR-T therapy for B cell malignancies. NanoCell will use the capital to further evaluate NCTX-01’s safety, efficacy and durability in treating aggressive forms of lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma.

"IFLI’s support enables us to accelerate NCTX-01 through preclinical development to clinical development," said Maurits Geerlings, MD, President & Chief Executive Officer of NanoCell. "This partnership provides crucial resources to generate the preclinical data package needed for regulatory discussions. IFLI shares our belief that non-viral in vivo approaches have transformative potential to address significant unmet medical needs for patients who currently have limited treatment options.

"NanoCell’s innovative platform offers a novel approach to treating both follicular lymphoma and diffuse large B-cell lymphoma and could potentially overcome many of the current barriers that limit patient access to CAR-T therapies," said Michel Azoulay, MD, MBA, Chief Medical Officer at IFLI. "Supporting this program aligns with IFLI’s mission to accelerate innovative therapies that can make a meaningful difference in the lives of patients."

Immuneering to Provide Updates from Phase 2a Clinical Trial of IMM-1-104 in First-Line Pancreatic Cancer Patients on Tuesday, June 17, 2025

On June 16, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025 (Press release, Immuneering, JUN 16, 2025, View Source [SID1234653919]). The company is excited to provide updates from its ongoing Phase 2a clinical trial of IMM-1-104 in first-line pancreatic cancer patients.

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The conference call will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.