On April 15, 2026 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OPN-6602, a dual EP300/CBP inhibitor, for the treatment of multiple myeloma (MM). The Fast Track designation applies to patients with relapsed/refractory MM who have received at least four prior lines of therapy.

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OPN-6602 is an oral, small molecule inhibitor of EP300 and CREB-binding protein (CBP) currently in a Phase 1 clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary clinical activity in patients with relapsed and/or refractory MM.

Multiple myeloma is a hematologic malignancy marked by the uncontrolled proliferation of plasma cells in the bone marrow, often leading to bone damage, kidney dysfunction and immune suppression. Despite therapeutic advances, most patients ultimately relapse or become refractory to available therapies, highlighting an unmet need for novel treatment options.

"Opna Bio has been a pioneer in the EP300/CBP inhibitor space and OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties. We are encouraged by the progress of the study to date and look forward to reporting emerging clinical data at an upcoming scientific congress," said Reinaldo Diaz, chief executive officer of Opna Bio.

The FDA’s Fast Track designation is designed to facilitate development and expedite review of therapies addressing serious conditions with unmet need. It offers benefits including more frequent FDA interactions, potential eligibility for accelerated approval and priority review, and rolling NDA submission. OPN-6602 was previously granted Orphan Drug Designation by the FDA in January 2025.

(Press release, Opna Bio, APR 15, 2026, View Source [SID1234664415])

On April 15, 2026 Nucleai, a leader in AI-powered spatial biology analytics, and Sirona Dx, a Technical CRO, specialized in spatial biology and single-cell services, reported a strategic partnership to deliver a fully integrated and scalable spatial proteomics solution for pharmaceutical and biotechnology companies.

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Spatial proteomics platforms are generating increasingly rich and complex tissue data, yet a significant portion of that data’s biological value remains unrealized. Critical insights, including novel spatial biomarkers, treatment response signatures, and patient stratification patterns, are often under extracted due to sub-optimal assay development and fragmentation across assay development, imaging, and analytics. As multiplex imaging technologies advance, the gap between data generation and actionable insight continues to widen, leaving substantial value unrealized.

This partnership introduces a premium, fully integrated offering for pharma sponsors, delivered as a single engagement unified across the entire workflow. Sirona Dx leads assay design, development, and validation to ensure high-quality image generation, while Nucleai delivers AI-powered spatial analytics from feature extraction through biomarker discovery and biological interpretation. Together, the companies provide a seamless end-to-end solution in which highest quality tissue data is connected directly to actionable biological insight.

"Until now, pharma teams haven’t had a seamless way to translate spatial proteomics data into actionable biological insight," said Avi Veidman, CEO of Nucleai. "Together with Sirona Dx, we’re delivering a single, integrated path from tissue data to meaningful biological insight — enabling more confident biomarker decisions and ultimately improving the probability of clinical success."

"Pharma sponsors are investing heavily in spatial biology and need solutions that match both the quality and complexity of their data," said Nasry Yassa, CEO of Sirona Dx. "Our partnership with Nucleai augments our capabilities to deliver fully integrated insight, providing a more seamless and effective model for supporting drug development programs."

The joint offering supports applications across oncology, immunology, and neuroscience, including biomarker discovery and validation, patient stratification, mechanism of action studies, and clinical trial biomarker programs.

The partnership, combining best-in-class experimental and analytical capabilities, is timed perfectly to meet growing demand from pharma sponsors for integrated spatial biology solutions.

(Press release, Nucleai, APR 15, 2026, View Source [SID1234664414])

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])

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])

On April 15, 2026 Verismo Therapeutics, a clinical-stage CAR T cell therapy company pioneering a novel multi-chain KIR-CAR platform technology, reported a $28 million investment from its parent company, HLB Innovation (KOSDAQ: 024850). The investment comes ahead of a significant clinical milestone: the first-ever presentation of KIR-CAR clinical data, which will be featured in the Late-Breaking Clinical Trials plenary session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA, on April 20, 2026.

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The funding will support ongoing Phase 1 clinical trials of Verismo’s two KIR-CAR programs currently in the clinic: SynKIR-110 in patients with advanced mesothelin-expressing solid tumors (STAR-101, NCT05568680) and SynKIR-310 in patients with relapsed/refractory B cell non-Hodgkin lymphomas (CELESTIAL-301, NCT06544265).

Selection for an AACR (Free AACR Whitepaper) Late-Breaking Clinical Trials plenary session is among the most prestigious distinctions in oncology research. The upcoming STAR-101 presentation marks Verismo’s first-ever presentation of clinical data on a KIR-CAR candidate.

"This investment from HLB Innovation comes at a pivotal moment for Verismo and for the KIR-CAR platform," said Bryan Kim, CEO and Co-Founder of Verismo Therapeutics. "This funding ensures we have the resources to fully capitalize on that momentum — advancing our solid tumor and blood cancer programs toward the data readouts that will define the potential for multi-chain KIR-CAR cell therapy to provide durable results over current single-chain CAR Ts."

The following data readouts will be presented at the upcoming AACR (Free AACR Whitepaper) 2026, reflecting the breadth of Verismo’s novel KIR-CAR platform:

Late-Breaking Clinical Trials Plenary Session — April 20, 2026: Initial results of a first-in-human dose-escalation study of KIR-CAR in patients with advanced mesothelin-expressing solid tumors
Poster Presentation — April 21, 2026: Novel SynKIR-310 outperforms CD3-based second-generation CD28 or 41BB co-stimulated CAR T in B cell non-Hodgkin lymphoma xenograft mice and shows early clinical signal
Late-Breaking Poster Presentation — April 20, 2026: Natural killer cell-based signaling in EGFR-targeted KIR-CAR T overcomes CD3-based CAR T functional deficits to eliminate resistant glioblastomas in vivo

(Press release, Verismo Therapeutics, APR 15, 2026, View Source [SID1234664411])