On March 14, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a third-party study published on March 6, 2025 in JAMA Oncology titled "Neoadjuvant Nivolumab Plus Chemotherapy Followed by Response-Stratified Chemoradiation Therapy in HPV-Negative Head and Neck Cancer: The DEPEND Phase 2 Non-randomized Clinical Trial" provided data that support Multikine’s use as a neoadjuvant treatment in patients with tumors having low PD-L1 expression in its upcoming confirmatory head and neck cancer Registration Trial (Press release, Cel-Sci, MAR 14, 2025, View Source [SID1234651156]).

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"With these latest findings published in JAMA, industry is taking notice. We believe there is growing interest in Multikine as an advanced clinical stage asset that can prolong life for about 70% of head and neck cancer patients whose tumors have low PD-L1 expression," stated CEL-SCI’s CEO Geert Kersten.

The DEPEND study evaluated nivolumab as a neoadjuvant immunotherapy in human papilloma virus (HPV)–negative locoregionally advanced head and neck cancer. Nivolumab is already an FDA approved treatment for recurrent metastatic squamous cell carcinoma of the head and neck. The authors of the JAMA publication stated: "Taken together the DEPEND results further support the importance of PD-L1 expression as a predictive biomarker with immunotherapy trials in curative intent setting and may be an important selection criterion in subsequent trials".

The findings of the DEPEND study are very important and timely. They are similar to the findings in CEL-SCI’s Phase 3 study, namely that PD-L1 inhibitors such as Opdivo work best in patients who have high levels of PD-L1, but do not work well in patients with low or zero levels of PD-L1. Conversely, Multikine, which has a very different mechanism of action, worked best in patients who have low to zero levels of PD-L1. This underscores the potential of Multikine to address a critical unmet need amongst newly diagnosed head and neck cancer patients whose tumors have low PD-L1 expression, representing about 70% of this patient population.

The DEPEND Phase 2 data also confirm the independent findings reviewed by the FDA’s recent Oncologic Advisory Committee meeting (September 2024) on the use of checkpoint inhibitors including blockbuster drugs nivolumab and pembrolizumab, which appear to not work well in patients with low PD-L1 expression. To CEL-SCI’s knowledge, Multikine is the only oncology drug with solid data showing overall survival benefit when used as a neoadjuvant treatment in newly diagnosed locally advanced head and neck cancer patients whose tumors have low PD-L1 expression.

Multikine is an investigational cancer immunotherapy (treatment) given to newly diagnosed head and neck cancer patients before the primary standard of care treatment. CEL-SCI’s confirmatory Registration Trial, which has received the FDA’s go-ahead, will enroll patients with previously untreated resectable disease, stage 3 and 4 head and neck cancer who have low PD-L1 tumor expression and no lymph node involvement. During CEL-SCI’s completed Phase 3 clinical trial, the 5-year survival rate of this target patient population increased to 73% when patients were treated with Multikine before standard of care vs 45% for control patients who received only the standard of care treatments.

On March 14, 2025 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the publication of the study "Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study" in JU Open Plus this week (Press release, PhotoCure, MAR 14, 2025, View Source [SID1234651155]). The research objective was to assess if blue light cystoscopy (BLC) aided TURBT has an impact on the clinical outcomes of patients with NMIBC*. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort. These results are in line with prior results from multiple randomized controlled clinical trials.

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The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System.

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Outcomes data for BRAVO was measured at a 3-year time point in a predominately high-risk patient population. Median age at diagnosis was 71 years. Median follow-up was 3.7 years.

Study results include:

Risk of recurrence at 3-years was significantly reduced following BLC vs. WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of recurrence is in line with prior results from multiple randomized controlled clinical trials. A positive trend for reduction in risk of progression was also observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not statistically significant due to a low number of patients progressing on the study.
The study indicates that use of BLC can drive treatment decisions that lead to improved outcomes. Specifically highlighted in the study was that BLC patients were significantly more likely to receive intravesical BCG therapy (61% vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data supports reasoning that using BLC enhances a clinician’s ability to decide on the appropriate bladder cancer therapy based on precision risk stratification and a more complete TURBT.
The Veterans’ Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

"Bladder cancer detection plays an important role in preventing cancer recurrence and optimizing appropriate treatment pathways, as previous research has shown that WLC alone may not comprehensively detect all NMIBCs. In this propensity-score matched cohort study, we found that the use of BLC vs. WLC alone was associated with significantly decreased 38% risk of recurrence. Our results are in line with the recent Cochrane review of nearly 3,000 patients across 15 randomized trials, where the authors found that that BLC may reduce the risk of bladder cancer recurrence by 34%. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence", said Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, and one of the study authors.

"The exciting long-term real-world results from the BRAVO study complement and confirm the generalizability of prior recurrence outcomes with BLC beyond the randomized controlled trial setting, reflecting a routine clinical practice patient population", said Anders Neijber, Chief Medical Officer of Photocure.

Read the full publication here: View Source

An editorial to the publication can be found here: View Source

*NMIBC: Non muscle-invasive bladder cancer

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.

About Hexvix/Cysview (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.
The following safety information is solely included to comply with U.S. regulatory requirements: Important Risk & Safety Information for Cysview (hexaminolevulinate HCl)

On March 14, 2025 iOncologi, Inc., a clinical-stage biopharmaceutical company focused on advancing immunotherapy platform technologies, reported the acquisition of TargImmune Therapeutics, a biotechnology company specializing in novel tumor targeted immunotherapies (Press release, iOncologi, MAR 14, 2025, View Source [SID1234651154]). This strategic acquisition significantly enhances iOncologi’s capabilities in developing cutting-edge immunotherapies for solid tumors.

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As part of the transaction, iOncologi, Inc. and TargImmune Therapeutics executed a share purchase agreement, resulting in iOncologi acquiring at least 99% of TargImmune’s shares, warrants, and options. Following the acquisition, TargImmune will continue to operate in Basel, Switzerland, as a wholly owned subsidiary of iOncologi, Inc. This structure ensures the seamless continuation of TargImmune’s research into novel tumor-targeted RNA therapies while benefiting from iOncologi’s expanded resources and strategic vision.

"This acquisition represents a pivotal moment for iOncologi as we continue to push the boundaries of immunotherapy for solid tumors," said Dr. Edgardo Rodriguez-Lebron, iOncologi’s recently appointed CEO. "TargImmune’s pioneering approaches perfectly align with our mission to develop transformative cancer therapies. By integrating two incredibly talented and highly experienced drug development teams, we are well-positioned to accelerate innovation and bring novel treatments to patients with limited therapeutic options."

The acquisition aligns with iOncologi’s broader strategy to expand its therapeutic pipeline, leverage next-generation RNA-based immunotherapies, and drive innovation in oncology.

On March 14, 2025 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have filed with the Securities and Exchange Commission on August 6, 2019 relating to the Collaboration Agreement For An Investigator-Initiated Clinical Trial (the "Clinical Trial Agreement") between the Company and Grupo Español de Investigación en Sarcomas ("GEIS") effective July 31, 2019 (Filing, 8-K, Lixte Biotechnology, MAR 14, 2025, View Source [SID1234651153]).

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The Clinical Trial Agreement set forth the terms under which GEIS would conduct a clinical research protocol to study the safety and/or efficacy of LB-100, the Company’s lead compound (the "Study"). The Clinical Trial Agreement was intended to support a Phase 1b/randomized Phase 2 Study of doxorubicin, the global standard for initial treatment of advanced soft tissue sarcomas versus doxorubicin plus LB-100. The Company had agreed to provide funding for the Study. The Clinical Trial Agreement was filed as Exhibit 10.1 to the previously referenced Current Report on Form 8-K.

This Study commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. The recruitment for the Phase 1b portion of the Study was completed during the quarter ended September 30, 2024, and the Company expects to have initial data on toxicity and preliminary efficacy from this portion of the Study during the quarter ending December 31, 2025.

Effective March 11, 2025, the Company and GEIS entered into Amendment No. 1 to the Clinical Trial Agreement that relieved the Company of the financial obligation to support the randomized Phase 2 portion of this Study contemplated in the Clinical Trial Agreement of approximately $3,095,000. Amendment No. 1 to the Clinical Trial Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K (the "Report") and is incorporated herein by reference. The description of Amendment No. 1 to the Clinical Trial Agreement is qualified in its entirety by reference to Exhibit 10.1 to the Report..

On March 14, 2025 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO, Dr Tim Franklin, COO, and Dr Sebastien Goudreau, CEO of the R&D subsidiary ImmuPharma Biotech will be attending the Bio-Europe Spring Conference from 17-19 March 2025, in Milan (Press release, ImmuPharma, MAR 14, 2025, View Source [SID1234651150]).

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BIO-Europe Spring is a premier partnering event in the biopharmaceutical and life sciences sector bringing together over 3,700 executives and facilitating more than 20,000 one-on-one meetings. It is an important opportunity for networking among biotech companies, pharmaceutical firms, investors, and academia.

Commenting on attendance at the Bio-Europe Spring conference, Tim McCarthy, CEO of ImmuPharma said: "Following on from positive discussions already held with a number of global BioPharma companies, we are focussed on continuing the momentum towards completing commercial deals across the portfolio."