4D-150 Clinical Activity and Tolerability - 4D-150 demonstrates robust and durable clinical activity across all studied populations, including recently diagnosed patients with wet AMD[7] - 4D-150 exhibits a tolerability profile comparable to approved anti-VEGF agents[8] 4D-150 Injection-Free Rates in Wet AMD - In the severe wet AMD population, 44% of patients were injection-free through 52 weeks, with 48% requiring >1 injection and 8% requiring 1 injection, resulting in an 83% treatment burden reduction[13] - In the broad wet AMD population (including recently diagnosed), 70% of patients were injection-free through 52 weeks, with 20% requiring >1 injection and 10% requiring 1 injection, resulting in an 89% treatment burden reduction[16] - In the recently diagnosed wet AMD population, 87% of patients were injection-free through 52 weeks, with 13% requiring 1 injection, resulting in a 98% treatment burden reduction[19] 4D-150 Intraocular Inflammation (IOI) Profile - 4D-150 development is enabled by a favorable IOI profile, with IOI rates of 2-3%[22] 4FRONT Phase 3 Program Design - The 4FRONT Phase 3 program in treatment-naïve wet AMD is designed to maximize the probabilities of clinical, regulatory, and commercial success[10, 24, 35] - The 4FRONT-1 Phase 3 study's primary endpoint is BCVA noninferiority of 4D-150 3E10 vg/eye to Aflibercept 2mg Q8 weeks[33]

Core Insights - Oncolytics Biotech Inc. has reported compelling clinical data for its oncolytic virus immunotherapy, pelareorep, showing a significant two-year survival benefit of 21.9% in metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to a historical benchmark of 9.2% [1][2] - The company is shifting its strategy to focus on advancing pelareorep into registration-enabling trials, leveraging its fast-track status to expedite the regulatory process [2][7] - Pelareorep has demonstrated a favorable safety profile across over 1,100 patients, with common treatment-related adverse events being manageable and transient [6][8] Clinical Data Summary - In mPDAC trials, pelareorep combined with chemotherapy showed a 2-year overall survival rate of 21.9% versus 9.2% from historical data, with a 62% objective response rate (ORR) in a single-arm study [2][3] - In HR+/HER2- metastatic breast cancer, pelareorep has shown a median overall survival benefit of over 10 months compared to standard chemotherapy, with specific studies indicating mOS of 21.0 months versus 10.8 months [5][6] - The disease control rate (DCR) for pelareorep in combination with gemcitabine was reported at 83%, significantly higher than the 33% benchmark [3] Regulatory and Developmental Status - Pelareorep has received Fast Track designations from the FDA for both metastatic breast cancer and mPDAC, indicating its potential as a significant therapeutic option [7][9] - The company is planning combination clinical trials with pelareorep in various solid tumors as it moves towards registrational studies [9]

Company Overview - Calidi Biotherapeutics Inc. is a clinical-stage immuno-oncology company focused on developing innovative cancer treatments through the precise delivery of genetic medicines to both primary tumors and metastatic sites [3][4] - The company utilizes proprietary stem cell-based platforms that can carry oncolytic viruses, aiming to enhance the efficacy and safety of cancer therapies [4] Industry Context - An estimated 20 million people are diagnosed with cancer annually, with nearly 10 million deaths each year worldwide, and these figures are projected to rise significantly [2] - The American Cancer Society anticipates that by 2050, 35 million people will be diagnosed with cancer each year, highlighting the urgent need for new and effective cancer drugs [2] Technology and Innovation - Calidi's platform employs engineered viruses to target cancer sites in the body, delivering potent genetic medicines that could potentially revolutionize cancer treatment [3] - The dual approach of using allogeneic stem cells and oncolytic viruses aims to treat or prevent metastatic disease, addressing significant unmet needs in oncology [4]

Premier research journal article provides validation for BiomX’s phage therapy platform, showcasing first-in-human Phase 1b/2a trial results for antibiotic-resistant P. aeruginosa infectionsNew, updated data demonstrates a further bacteria reduction of 2.7 log₁₀ (approximately 500-fold) compared to placebo, with no emergent resistance and preservation of a healthy microbiomeBiomX is advancing its Phase 2b trial of BX004 with topline results expected Q1 2026 NESS ZIONA, Israel, July 08, 2025 (GLOBE NEWSWIRE) ...

Core Insights - BriaCell Therapeutics Corp. has reported updated survival data from its ongoing Phase 2 clinical study of Bria-IMT in patients with metastatic breast cancer, indicating a robust survival signal and well-tolerated profile for the treatment [1][4]. Patient Survival Data - The Phase 2 study included 54 heavily pre-treated metastatic breast cancer patients, with a median of 6 prior treatment lines [7]. - The most recent cohort of 25 patients achieved a one-year survival rate of 52%, with 11 patients remaining alive, including one at 38.3 months and another at 30.3 months [6][7]. - Survival rates in this cohort exceed current standard of care therapies for similar patient populations [6]. Expert Commentary - Experts have highlighted the potential of Bria-IMT to improve survival and tolerability for late-stage patients, especially those who have progressed despite treatment with checkpoint inhibitors and antibody-drug conjugates [4][6]. - The ongoing investigation in a Phase 3 randomized clinical trial aims to further assess the efficacy of Bria-IMT in combination with checkpoint inhibitors [4]. Comparative Analysis - Bria-IMT plus checkpoint inhibitors showed a 52% one-year survival rate compared to approximately 38-40% for other studies with fewer prior treatment lines [5][6]. - The study indicates that Bria-IMT may provide significant benefits for patients who have failed multiple lines of therapy, including those treated with ENHERTU and TRODELVY [6][7]. Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing novel immunotherapies aimed at transforming cancer care [8].

Core Viewpoint - Medicus Pharma Ltd. has submitted a request for a Type C meeting with the FDA to discuss the fast-tracking of its clinical development program for treating Basal Cell Carcinoma (BCC) using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA) [1][2] Group 1: Clinical Development Program - The Type C meeting aims to align on the clinical pathway and seek FDA feedback on the D-MNA product development [2] - The clinical study SKNJCT-003 is a randomized, double-blind, placebo-controlled trial enrolling up to 60 subjects with BCC, evaluating two dose levels of D-MNA against a placebo [2][5] - The high-dose of 200μg D-MNA is the maximum dose used in the previous Phase 1 safety study, which was completed in March 2021 [3][5] Group 2: Study Design and Objectives - The company seeks FDA agreement on several key topics, including the appropriateness of selected doses, primary endpoints, patient population definitions, study design, and safety assessments for future studies [4] - The Phase 1 study (SKNJCT-001) met its primary objective of safety and tolerability, with no serious adverse events reported and six participants achieving complete responses [5][10] Group 3: Ongoing and Future Studies - The Phase 2 clinical study (SKNJCT-003) is currently underway at nine clinical sites in the U.S., with an interim analysis showing over 60% clinical clearance [6] - The number of participants in SKNJCT-003 has been increased to 90, and the company is expanding clinical trial sites to Europe [6] - A separate clinical study (SKNJCT-004) is being conducted in the UAE, aiming to randomize 36 patients across four sites [7] Group 4: Strategic Acquisitions - In June 2025, the company announced a definitive agreement to acquire Antev Limited, a UK-based biotech company developing Teverelix for advanced prostate cancer [8][11]

Dosing of the first patient in Phase 2b marks an important transition of the RESOLVE trial from a Phase 2a open-label study to a Phase 2b placebo-controlled study. This is a critical step required prior to proceeding to pivotal clinical trials necessary for regulatory approvalEupraxia plans to enroll a minimum of 60 patients in the Phase 2b portion of the RESOLVE study in up to 25 sites globally, assessing tissue health measured by biopsy (EoEHSS and PEC scores), symptom scores (SDI and DSQ), and safety, ov ...

Microbix to Develop New Products using NCIPD Organism CollectionMISSISSAUGA, Ontario and SOFIA, Bulgaria, July 08, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and the National Center for Infectious and Parasitic Diseases of Bulgaria (“NCIPD”), announce an agreement whereby NCIPD will supply a portfolio of pathogen seedstocks for production of Microbix quality assessment products (“QAPs™”). Following detailed di ...

BrainStorm to Continue with Planned Phase 3b Trial and Remains Committed to Advancing Access for People Living with ALSNEW YORK, July 8, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today acknowledged that the U.S. Food and Drug Administration's (FDA) consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potentia ...

Core Insights - Larimar Therapeutics is advancing its lead compound, nomlabofusp, as a potential treatment for Friedreich's ataxia, with a Biologics License Application (BLA) submission planned for Q2 2026 seeking accelerated approval [1][2] Company Overview - Larimar Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, with nomlabofusp being its lead compound targeting Friedreich's ataxia [3] Research Findings - Two peer-reviewed articles have been published that provide evidence of nomlabofusp's mechanism of action, demonstrating its ability to increase frataxin (FXN) levels in relevant tissues after administration [2][6] - The data from these studies support the potential use of skin FXN concentrations as a reasonably likely surrogate endpoint for the FDA's consideration in the accelerated approval process [1][2] Future Plans - The company is focused on executing near-term catalysts to advance nomlabofusp as the first potential disease-modifying therapy for patients with Friedreich's ataxia [2]