Core Perspective - Sona Nanotech Inc has initiated its first-in-human clinical trial for its THT therapy aimed at late-stage melanoma patients, marking a significant transition from preclinical to clinical testing [1][2][6] Company Developments - The first patient has been dosed in Santiago, Chile, which is a critical milestone for the company [2][3] - The therapy is classified as a device rather than a drug, designed to enhance tumor visibility to the immune system, potentially leading to tumor shrinkage and improved survival rates [2][4] Clinical Trial Details - The clinical trial will begin with an early feasibility study to assess safety, tolerability, and practical usage of the device, alongside efficacy data [4] - The protocol includes patient check-ins on days 1, 7, 14, 21, and 28, with initial results expected by the end of summer [5] Patient Impact - The therapy aims to help patients who have exhausted other treatment options, focusing on making tumors recognizable to the immune system for potential elimination [6]

Median Overall Survival (OS) of 13.9 months in triple negative breast cancer (TNBC) exceeds Trodelvy (11.8 months) and doubles control (6.9 months)OS of 17.3 months in HR+ metastatic breast cancer surpasses Trodelvy (14.4 months) and control (11.2 months)No treatment related discontinuations reported PHILADELPHIA and VANCOUVER, British Columbia, July 11, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology ...

Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Bria-IMT regimen demonstrated a median overall survival (OS) of 13.9 months in triple-negative breast cancer (TNBC) patients, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4]. - In hormone receptor-positive (HR+) metastatic breast cancer, the median OS for Bria-IMT was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [3][4]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [6]. Comparison with Established Treatments - Bria-IMT's performance outperformed established benchmarks like Trodelvy in both TNBC and HR+ patient subtypes, indicating its potential clinical impact [2][5]. - The median OS for Bria-IMT in TNBC patients is higher than that reported in the treatment arm of the ASCENT study for TNBC patients, and it is twice that reported in the physician's choice arm [5]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2].

Metastatic Colorectal Cancer Cohort in NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage DesignPRINCETON, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced patient recruitment has been completed in Stage 1 of a clinical trial of the Company’s PDS01AD ...

Core Insights - OS Therapies is making significant progress in its clinical-stage oncology programs, particularly with the OST-HER2 immunotherapy for recurrent, pulmonary metastatic osteosarcoma, with an End of Phase 2 Meeting scheduled with the FDA on August 27, 2025 [2][7] - The company has confirmed a Scientific Advice Meeting with the European Medicines Agency regarding the OST-HER2 program, which is a critical step for obtaining a centralized marketing authorization in Europe [3][7] - All patients in the Phase 1 clinical study of OST-504 have completed treatment, with updated clinical data expected in the second half of 2025 [4][7] Regulatory Updates - The FDA has granted an End of Phase 2 Meeting to review clinical data for OST-HER2, with the company aiming to align with the FDA for a rolling review Biologics Licensing Application under the Accelerated Approval Program [2][7] - A Scientific Advice Meeting with the EMA is confirmed, which is essential for the Centralized Procedure for marketing authorization across European Member States [3] - The company plans to pursue a Conditional Marketing Authorization in the UK through the MHRA's Innovative Licensing and Access Pathway, contingent on a successful meeting on July 31, 2025 [3] Clinical Development - The OST-HER2 program utilizes a HER2-bioengineered form of Listeria monocytogenes to stimulate an immune response against HER2-expressing cancer cells [5] - The company has completed a Phase 1 clinical study of OST-504, a prostate cancer-specific immunotherapy, with data expected to be reported later in 2025 [4][8] - OST-HER2 has received various designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track designation from the FDA [9] Strategic Focus - The company aims to obtain regulatory approval for OST-HER2 before the expiration of the rare pediatric disease priority review voucher program, which could provide significant non-dilutive funding [5] - OS Therapies intends to focus capital on the OST-HER2 approval while advancing other clinical programs without significant capital deployment [5] - The company is also advancing its next-generation Antibody Drug Conjugate platform, known as tunable ADC, which features tailored antibody-linker-payload candidates [10]

NEEDHAM, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the Company was added to multiple Russell indexes as part of the 2025 Russell US Indexes annual reconstitution, which became effective at the open of the U.S. equity markets on June 30, 2025. Candel was added to the Russell 2500 Value® Index ...

[IMAGES BELOW] Complete resolution maintained at 6 months in first patient treated with BriaCell’s Bria-OTS in Phase 1/2a studyNo treatment limited toxicities observedPatient remains on study with stable disease elsewhere PHILADELPHIA and VANCOUVER, British Columbia, July 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announc ...

52% of BriaCell’s most-recent 25-patient cohort* have surpassed the one-year survival milestone, exceeding current standard of care in similar patients11 patients remain alive as of recent contact, including one patient at 38.3 months and another at 30.3 months Survival benefit observed in heavily pre-treated patients, including those who failed treatment with checkpoint inhibitors (CPIs) and antibody-drug conjugates (ADCs) PHILADELPHIA and VANCOUVER, British Columbia, July 08, 2025 (GLOBE NEWSWIRE) -- Bri ...

DNase I Oncology Platform - The company is focused on advancing its proprietary DNase I technology platform to address multiple high-value cancer indications[2, 5] - DNase I targets Neutrophil Extracellular Traps (NETs) to improve immunotherapies and chemotherapies[2, 5] - DNase I digests both double and single-stranded DNA, as well as DNA:RNA hybrids, exposing cancer cells to the immune system and reducing therapy resistance[6] - Systemic administration of DNase I improves the efficacy of PD-1 blockade, resulting in the lowest tumor volume growth compared to either DNase I or anti-PD-1 alone[19] Pipeline and Clinical Development - The company's lead program, XBIO-015, combines systemic DNase I with chemotherapy for pancreatic carcinoma[7] - A Phase 1 study is planned, featuring dose escalation and expansion in subjects with locally advanced or metastatic solid tumors, with pancreatic cancer and other solid tumor indications[2, 40] - The company believes that an ORR greater than 50% or PFS greater than 9 months would be a meaningful improvement to the current standard of care for pancreatic cancer[45] Market Opportunity - The company is initially targeting pancreatic carcinoma, a multi-billion-dollar indication with significant unmet need, with a projected market of $48 billion by 2025[2, 39] - Approximately 62,000 people are diagnosed with pancreatic cancer annually, and approximately 50,000 die from it annually[39] - There were approximately 19 million new solid tumor cases in the U S in 2022, leading to approximately 6 million solid tumor-related deaths[46] Collaboration and Intellectual Property - The company is collaborating with VolitionRX to develop proprietary adoptive cell therapies potentially targeting multiple solid cancer types[2, 58] - VolitionRX is expected to fund the research program, with both parties sharing proceeds from commercialization or licensing of any resulting products[60] - The company has an IP portfolio covering the co-administration of Systemic DNase I with ICIs, radiation, and chemo, as well as DNase I for pancreatic cancer and DNase I-secreting CAR T cells[62, 64]

Asia Pacific Equity Research July 2025 Asia Deep Dive: Akeso & Innovent China Healthcare Research Yang HuangAC, PhD (852) 2800 3812 yang.huang@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking (Hong Kong) Limited Eric Zhao, CFA (86-21) 6106 6256 eric.zhao@jpmorgan.com SAC Registration Number: S1730524050001 J.P. Morgan Securities (China) Company Limited Derek Choi, CPA (852) 2800-8744 derek.c.choi@jpmorgan.com J.P. Morgan Securities (Asia Pacific) Limited/ J.P. Morgan Broking ( ...