INmune Bio Inc. Announces New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models

On April 16, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage biotechnology company focused on developing therapies that harness the patient’s innate immune system, reported new preclinical data for INB03 (XPro1595 for oncology). The data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego on April 17-22.

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The poster, titled, "Soluble TNF blockade overcomes tyrosine kinase inhibitors resistance in HER2-positive breast cancer," details how INB03 ("XPro"), a first-in-class dominant-negative soluble TNF (sTNF) inhibitor, significantly enhances the anti-tumor activity of the tyrosine kinase inhibitors (TKIs) lapatinib and tucatinib while reducing metastatic spread to the brain, lungs, and liver in HER2-positive breast cancer models. It was authored by collaborators from the Instituto de Biología y Medicina Experimental (IBYME-CONICET) in Buenos Aires, Argentina.

Key Scientific Findings:

Overcoming Resistance in Vitro: The combination of INB03 (10 µg/mL) with either lapatinib (1 µM) or tucatinib (10 µM) produced statistically superior inhibition of cell proliferation and migration in both HER2+ JIMT-1 and brain-metastatic JIMT-1 Br3-luc cell lines compared to TKIs alone (p < 0.05 to p < 0.0001).
Enhanced Tumor Control In Vivo: In female nude mice bearing JIMT-1 or JIMT-1 Br3-luc tumors, INB03 + TKI combinations markedly slowed tumor growth compared to TKIs alone.
Reduction of Metastatic Spread: The addition of INB03 significantly reduced the incidence of metastases to brain, lung, and liver (quantified by ex-vivo IVIS luminescence imaging). Notably, it further enhanced tucatinib’s effect on lung metastases (p < 0.05 to p < 0.0001).
Mechanism of Action: These results support prior research showing that selective sTNF neutralization with INB03 down-regulates MUC4, a protein that shields the HER2 molecule and prevents therapies from binding effectively.
"These results build on our prior work showing that selective sTNF neutralization with INB03 down-regulates MUC4, restoring sensitivity to HER2-targeted therapies," said Roxana Schillaci, Ph.D., lead investigator. "The ability of INB03 to overcome TKI resistance and limit metastatic dissemination, including to the brain, highlights its potential to address key unmet needs in advanced HER2-positive breast cancer."

David Moss, CEO of INmune Bio, added, "INB03 continues to demonstrate broad therapeutic potential across solid tumors by targeting the soluble TNF pathway. These AACR (Free AACR Whitepaper) data reinforce our confidence in advancing INB03 combinations in the clinic for patients who have developed resistance to standard TKIs or who are at high risk for brain metastases."

The poster will be available for viewing during the AACR (Free AACR Whitepaper) 2026 meeting on April 21st.

About XPro (INB03)

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio’s website.

(Press release, INmune Bio, APR 16, 2026, View Source [SID1234664458])

Mabwell Establishes a Licensing and Commercialization Agreement for Denosumab Biosimilars in Malaysian Market

On April 16, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that it has established a licensing and commercialization agreement with a strategic business partner ("the partner") in Malaysia for its Denosumab biosimilar products MAILISHU (a biosimilar of Prolia) and MAIWEIJIAN (a biosimilar of Xgeva) ("the products"). Under the agreement, the partner is responsible for the registration and commercialization of the products in Malaysia, while Mabwell is responsible for the development, production and commercial supply for the products.

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Malaysia has a population of approximately 35.97 million, with a GDP at a leading level in Southeast Asia. As a full member of PIC/S, Malaysia boasts the most mature and well-regulated pharmaceutical regulatory framework in the ASEAN region. In terms of the pharmaceutical market, Malaysia’s market size stood at approximately USD 3.4 billion in 2025, maintaining a compound annual growth rate of about 6%, indicating big market potential.

Mr. Huiguo Hu, Board Member, Senior Vice President and Board Secretary of Mabwell, said, "We are delighted to see that we have reached a collaboration on denosumab in another ASEAN country. Malaysia has an internationally aligned regulatory environment, strong regional recognition and significant space for development. This collaboration will further deepen Mabwell’s presence in the ASEAN market. We look forward to rapidly advancing the product’s local registration and commercialization with our partner’s strong commercial capabilities, bring high-quality, affordable treatment options to more patients in the region."

(Press release, Mabwell Biotech, APR 16, 2026, View Source [SID1234664443])

Radiopharm Theranostics Completes Enrollment in U.S. Phase 2b Imaging Trial of RAD 101 for Diagnosis of Brain Metastases

On April 16, 2026 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical needs, reported that the final patient has been dosed in the U.S. Phase 2b imaging trial (NCT06777433) evaluating RAD 101 in individuals with confirmed recurrent brain metastases from solid tumors of different origins.

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"Dosing the final patient in our most advanced diagnostic program represents an important milestone for Radiopharm and underscores the continued momentum of our radiopharmaceutical pipeline," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The interim results we have seen to date, demonstrating a high level of concordance with MRI, reinforce our confidence in RAD 101’s potential to address a critical unmet need in the accurate detection of recurrent brain metastases. As we look ahead to the full data readout in June, we are focused on advancing this important program into U.S. pivotal trial and initiating constructive dialogue with the FDA to define the optimal regulatory pathway. We believe RAD 101 has the potential to meaningfully improve clinical decision-making for patients and physicians navigating this challenging disease."

"I would like to take the opportunity to thank all the patients, families, and caregivers for their trust in our clinical trial. The investigators and the Clinical Center did an amazing job in the recruitment process, and our congratulations go to BAMF HEALTH for leading the table of the top recruiters," added Mr. Canevari.

RAD 101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases.

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. RAD 101 received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.

(Press release, Radiopharm Theranostics, APR 16, 2026, View Source [SID1234664459])

Wobble Genomics to Present Novel mRNA Sequencing Research at AACR 2026

On April 15, 2026 Wobble Genomics reported it will present new data at the AACR (Free AACR Whitepaper) Annual Meeting 2026, highlighting its approach to sequencing full-length mRNA from blood to support antibody-drug conjugate (ADC) therapy selection in breast cancer.

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Poster: Sequencing Full-Length mRNA in Whole Blood of Breast Cancer Patients for ADC Therapy Selection
Session: Liquid Biopsies: Circulating Nucleic Acids 3
Date: April 20, 2026 | 2:00–5:00 PM
Location: Poster Section 45 | Board #4 | Poster #3843

This research demonstrates the potential of liquid biopsy to enable more precise, non-invasive treatment selection, helping match patients to the most effective therapies while reducing reliance on invasive tissue biopsies.

"This work represents an important step toward making precision oncology more accessible and actionable through blood-based testing," said Richard Kuo, CEO of Wobble Genomics. "By capturing full-length mRNA directly from blood, we can generate richer biological insights to better inform therapy selection, particularly for complex treatments such as antibody-drug conjugates."

Wobble Genomics welcomes engagement with researchers, clinicians, and partners working at the forefront of translational science and therapeutic development during the conference.

(Press release, Wobble Genomics, APR 15, 2026, View Source [SID1234664412])

Sonire Therapeutics Closes $18 Million Series A Financing to Advance Breakthrough HIFU Therapy for Pancreatic Cancer, Expands U.S. Clinical Development

On April 15, 2026 Sonire Therapeutics, a U.S. based clinical-stage medical device company, reported $18M in Series A financing. The round was led by Santé Ventures with participation from Fast Track Initiative (FTI), Nomura SPARX Investment (Japan Growth Capital Investment Corporation), and SBI Investment, as well as other Japanese investors. The proceeds will accelerate clinical development, support U.S. regulatory progress following the company’s 2024 FDA Breakthrough Device Designation, and advance global commercialization efforts for its innovative non-invasive cancer treatment.

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Sonire’s proprietary High-Intensity Focused Ultrasound (HIFU) therapy system combines real-time imaging guidance with patented technologies, including a noise-cancellation system, cavitation bubble visualization, and a robot-assisted positioning platform, along with advanced capabilities such as rapid multi-focus scanning, to enable precise, effective thermal ablation of tumors. Unlike conventional ultrasound-guided HIFU systems, Sonire’s solution provides clear real-time visualization of the treatment site, requires no anesthesia, and can be performed on an outpatient basis in approximately 20 minutes. Additionally, this system requires only one physician to administer treatment, which lowers the cost and staff burden for hospitals.

"We are grateful for the strong support from our investors, which validates the transformative potential of our sonic technology," said Tohru Satoh, President and CEO of Sonire Therapeutics. "This funding enables us to complete our landmark SUNRISE-I randomized controlled trial in Japan, which will be the world’s first of its kind for HIFU in pancreatic cancer, while preparing for U.S. clinical and regulatory milestones. Our goal is to deliver a new standard of care that gives patients more time and better quality of life, without the burdens of invasive procedures or anesthesia."

Pancreatic cancer remains one of the most lethal diseases, with a 5-year survival rate of only 12%. Existing treatments are limited, and to date, there is the still high unmet medical needs due to a lack of established standard local therapy options. Sonire’s approach is designed to prolong overall survival when combined with chemotherapy while offering a safer, more patient-friendly alternative to surgery or radiation.

Foundational work from an academic-led study using a prototype HIFU system (MoonShot-2) demonstrated a 66% disease control rate in patients with advanced or refractory pancreatic and biliary tract cancers in a sonodynamic therapy (SDT) setting. These findings have informed the development of Sonire’s current system. The SUNRISE-I study (HIFU with chemotherapy vs. chemotherapy alone) is ongoing across seven leading Japanese hospitals with Sonire’s current system. The company holds 25 issued patents and 22 pending.

"Sonire has engineered a genuine leap forward in next generation HIFU by solving the core challenges of visualization, precision, and workflow that so far have limited the field," noted Dennis McWilliams, Managing Director for Santé. "Santé is excited to lead this round to expand Sonire’s corporate footprint to the United States and build upon their solid clinical foundation in Japan."

"Sonire’s differentiated approach is well positioned to bring meaningful benefit to patients globally. We look forward to continuing our support of the team as they advance U.S. clinical development" noted Koji Yasuda, Principal at Fast Track Initiative (FTI)

(Press release, SONIRE Therapeutics, APR 15, 2026, View Source [SID1234664413])