Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responsesNew analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumorsPre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancerSAN DIEGO and CALGARY, AB, May 23, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing i ...

Core Insights - PDS Biotechnology Corporation is advancing its lead immunotherapy program, Versamune HPV, in combination with pembrolizumab for the treatment of recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [2][8] Group 1: Clinical Trial Results - In Phase 2 trials, the median overall survival (mOS) for patients with a Combined Positive Score (CPS) ≥20 is reported at 39.3 months, while for CPS ≥1, it is 30.0 months [1][6] - The ongoing Phase 3 trial (VERSATILE-003) is currently enrolling patients, with a total of 351 patients expected to be accrued [5][6] - The VERSATILE-002 trial shows promising results, with a median follow-up of 18.4 months, indicating one of the longest follow-up periods for this patient population [6] Group 2: Presentation and Publication - Three abstracts summarizing Versamune HPV studies will be presented at the 2025 ASCO Annual Meeting, scheduled for May 30-June 3, 2025 [2][4] - The VERSATILE-002 trial results will be presented by Dr. Jared Weiss, while Dr. Katharine Price will present the ongoing VERSATILE-003 trial details [6] Group 3: Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, particularly targeting HPV16-positive cancers [8] - The company is also developing a triple combination therapy that includes PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [8]

NEEDHAM, Mass., May 22, 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 results from the Company’s positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will be presented at the 2025 American Society of Clinical Oncology (ASCO) ...

Core Insights - New data from the INSIGHT study indicates that the VeriStrat Host Immune Classifier can predict overall survival in non-small cell lung cancer patients treated with immunotherapy [1][2] - The presentation of this data will occur at the 2025 ASCO Annual Meeting, highlighting the significance of the findings [1] Group 1: Study Findings - The VeriStrat test categorizes patients' immune responses as either Hot (VeriStrat Good) or Cold (VeriStrat Poor) [2] - Statistically significant improvement in overall survival was observed in patients with a VeriStrat Poor result when treated with immunotherapy combined with chemotherapy, compared to those receiving immunotherapy alone [2] - The two-year survival rate for patients receiving the combination treatment was over three times higher than for those on immunotherapy alone [2] Group 2: Clinical Implications - The VeriStrat test may assist oncologists in evaluating treatment benefits and risks, potentially guiding decisions on treatment escalation or de-escalation [3] - Preliminary results from another ongoing study suggest that the VeriStrat test may also be applicable for other solid tumors, with data expected to be published later in 2025 [3] Group 3: Company Overview - Biodesix is a leading diagnostic solutions company focused on improving clinical care and outcomes for patients, particularly in lung disease [4] - The company offers diagnostic tests such as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance to support personalized care [4]

CG Oncology (CGON) shares have rallied 26.5% in a month. This upsurge was observed after the company, in late April, announced superior efficacy data from some cohorts of a late-stage study of its investigational candidate, cretostimogene grenadenorepvec, which is being evaluated as a monotherapy for non-muscle invasive bladder cancer (NMIBC) patients.Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as a monotherapy and in combi ...

Financial Data and Key Metrics Changes - The company ended the fiscal year with cash and cash equivalents totaling $483.8 million, an increase from $420.7 million at the end of the previous fiscal year [21] - Research and development expenses for the fiscal fourth quarter were $54 million, compared to $42.6 million in the same quarter of the previous year, reflecting increased personnel and consulting costs [22] - The net loss for the fiscal fourth quarter was $74.1 million, compared to a net loss of $55.1 million in the same quarter of the previous year [23] Business Line Data and Key Metrics Changes - The company is preparing for the potential approval and launch of RP-one, which is positioned as a first choice for advanced melanoma patients who have previously received anti PD-one therapy [6][7] - The IGNITE study data indicates that approximately one-third of patients achieve durable responses, highlighting the potential of RP-one in a high unmet need setting [6] Market Data and Key Metrics Changes - The company estimates that approximately 13,000 patients progress on or after PD-one treatment annually in the US, with about 80% eligible for RP-one [12] - The geographic distribution of patients with advanced melanoma allows for targeted launch efforts, focusing on around 350 key accounts that treat half of the melanoma population [15] Company Strategy and Development Direction - The company aims to establish RPX as a new interventional immuno-oncology treatment paradigm, expanding beyond skin cancer [8] - The commercial organization has been built out to support the launch of RP-one, with a focus on interventional radiology and oncology collaboration [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date of July 22, 2025, and the potential for RP-one to address significant unmet needs in advanced melanoma treatment [6][41] - The company is actively engaged with the FDA and has completed necessary inspections, indicating no impediments to the approval process [42] Other Important Information - The company plans to host an Investor Day on June 24, where it will discuss the current melanoma landscape and the RP-one roadmap for commercial success [20] - The company has developed a patient support hub, Replimmune Connect Plus, to enhance the treatment experience for patients and caregivers [18] Q&A Session Summary Question: What sort of medical education work are you going to be doing at ASCO ahead of the launch of RP-one? - The company will present important data at ASCO, including response rates for different lesion types and safety data, to build physician confidence in RP-one [26] Question: Can you give us some color around your expectation for the launch trajectory? - The company anticipates broad and rapid adoption of RP-one, with significant training and experience among key accounts by the time of launch [33] Question: Can you discuss the impact you're seeing from the recent regulatory changes? - The company has received breakthrough designation and is on track for the July 22 PDUFA, with consistent engagement from the FDA [41] Question: Can you talk to your expectations on the potential label for RP-one? - The company expects the label to reflect the broad population studied in the IGNITE trial, which included various anti PD-one failed presentations [52]

There are nearly 40,000 U.S. cases of cutaneous squamous cell carcinoma each year that advance to stages that are difficult to treat and life-threatening Skin Cancer Awareness Month in May shines a spotlight on the growing burden of advanced skin cancers The investigational drug is designed to be activated in the tumor microenvironment, including in cutaneous squamous cell carcinoma SCOTTSDALE, Ariz., May 20, 2025 (GLOBE NEWSWIRE) -- A common and unsightly skin cancer that can turn deadly has been undetect ...

Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti- tumor activity Highest enrollment since study launch underscores momentum and signals a positive trial trajectory Clinical data readout from Phase 1 APOLLO study expected later this year HOUSTON, May 20, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical- stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hemat ...

PRINCETON, N.J., May 20, 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 that Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech will participate in a fireside chat during the Alliance Global Partners ("A.G.P.") Virtual Annual Healthcare Company Showcase, taking place May 21, 2025. Details of the presentati ...

Repeated positive recommendation from Data Safety Monitoring Board (“DSMB”) of pivotal Phase 3 study for lead clinical candidate Bria-IMT™ in combination with checkpoint inhibitorBria-IMT has received Fast Track designation from FDA and patient enrollment has been accelerating in the pivotal Phase 3 study in metastatic breast cancerSuccessful completion of the pivotal study may lead to a Biologics License Application submission, Priority Review, Full Approval, and commercializationInterim analysis planned a ...