On October 5, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a new study demonstrating DecisionDx-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM) (Press release, Castle Biosciences, OCT 5, 2023, View Source [SID1234635703]). The study is available online in Anticancer Research.

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"Nearly 90% of patients receive a negative result after undergoing the sentinel lymph node biopsy (SLNB) procedure,1-2 indicating there is a significant need for more precise methods to identify which patients can safely forego the surgery and still experience good outcomes," said Michael Tassavor, M.D., study author, board-certified dermatologist and fellowship-trained Mohs surgeon currently practicing in New Jersey. "By providing an accurate prediction of a patient’s likelihood of having a positive SLN, DecisionDx-Melanoma test results can inform important conversations between clinicians and patients and provide added confidence in decisions to proceed without the surgery if a patient’s risk is low."

The study evaluated the performance of two tools used to identify patients at low and high risk of SLN positivity:

Castle’s DecisionDx-Melanoma test, which uses advanced algorithms to integrate a patient’s clinical and pathologic factors with his/her tumor biology to provide a personalized prediction of the risk of SLN positivity, and melanoma recurrence and metastasis.
The MSKCC nomogram, which uses logistic regression and only clinical and pathologic factors to predict a patient’s SLN positivity risk.
Patients from previously published multicenter cohorts with T1-T2 tumors who had undergone the SLNB procedure (n=465) were analyzed using both DecisionDx-Melanoma and the MSKCC nomogram. Following current National Comprehensive Cancer Network (NCCN) guidelines, a risk prediction of less than 5% in the study was considered low risk for SLN positivity, where patients could safely forego the SLNB procedure. A true-to-false-negative ratio was evaluated using this 5% risk threshold. A 5% threshold represents 19 truly negative nodes for one positive SLN missed (19:1 ratio; 1/20 [5%]), meaning that for every 100 patients who avoided SLNB based on NCCN criteria, 5 would have had a missed positive SLN.

The DecisionDx-Melanoma test resulted in a 36:1 true-to-false-negative ratio (108/3), meaning that for every 100 patients who avoided SLNB based on the test’s results, only 2.7 would have had a positive SLN. This is well below the 5% low-risk threshold established by NCCN. DecisionDx-Melanoma’s performance was better than that of the MSKCC nomogram, which resulted in a 9:1 true-to-false-negative ratio, suggesting that for every 100 patients avoiding SLNB using the MSKCC nomogram, 10 would have had a positive SLN. DecisionDx-Melanoma also demonstrated better accuracy in predicting SLN positivity, including higher sensitivity (95% vs. 81%) and negative predictive value (97% vs. 90%) than the MSKCC nomogram.

Importantly, in patients with T1 tumors, for whom the decision to perform SLNB is least clear, using the DecisionDx-Melanoma test to help guide decision-making could have reduced the number of SLNBs by 43.7%, compared with standard NCCN SLNB guidance using American Joint Committee on Cancer staging, while maintaining a low false-negative rate.

DecisionDx-Melanoma has been validated to identify patients who have less than a 5% risk of a positive SLN, indicating that these patients may consider avoiding the SLNB surgical procedure.3-4 The results of this study support these findings and demonstrate that DecisionDx-Melanoma outperforms the MSKCC nomogram in identifying patients at low risk of SLN positivity. The study provides further evidence that using DecisionDx-Melanoma to help guide decisions regarding the SLNB procedure could improve patient selection, reduce unnecessary surgical procedures and ultimately improve the care of patients with melanoma.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2023, DecisionDx-Melanoma has been ordered more than 137,200 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On October 5, 2023 CEL-SCI Corporation (NYSE American: CVM) reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer (Press release, Cel-Sci, OCT 5, 2023, View Source [SID1234635702]).

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At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.

A statistical validation of outcomes in the new target population, based on the Phase 3 study data, was recently concluded and will be presented at the Conference of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) which takes place October 20-24, 2023 in Madrid, Spain.

CEL-SCI is seeking a pathway towards approval of Multikine throughout the UK. CEL-SCI’s goal is to apply for marketing authorization in the UK as soon as possible, based on the data already generated. Just two weeks ago CEL-SCI filed a similar submission with the European Medicines Agency (EMA).

"We have a comprehensive global regulatory approval strategy," stated CEL-SCI’s CEO Geert Kersten. "Having received encouraging submission guidance from Health Canada, we plan to file for a NOC/C conditional approval there. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, we hope to do the same. We are extremely excited about the results seen in the newly defined Multikine target population."

CEL-SCI’s pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.

On October 5, 2023 XNK Therapeutics AB reported that Anna-Karin Maltais, Chief Scientific Officer, will be speaking at the 2nd Annual Innate Killer Europe Summit in London on October 18 (Press release, XNK Therapeutics, OCT 5, 2023, View Source [SID1234635701]).

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The meeting is the second Innate Killer Europe Summit following last year’s first European version of the larger annual US Innate Killer Summit. The purpose of the meeting is to build community and collaboration to leverage innovative European R&D and transform the innate immune space. The summit gathers 80+ key European natural killer, natural killer T, neutrophil, gamma delta T and macrophage thought leaders to discuss how innate immunotherapies, through effective and scalable engineering, cell engager and combined modality strategies, can help bring safe, potent, and persistent innate immune therapies to patients in need.

On October 18, 2023, Dr. Maltais will present XNK and discuss how to harness autologous NK cells for personalized immunotherapy. She will discuss engineering vs non-engineering strategies, important aspects of repeat dosing as well as strategies to increase cell potency, targeting and persistence.

On October 5, 2023 Medivir AB (Nasdaq:MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that all patients in the ongoing phase 2a study in advanced hepatocellular carcinoma (HCC) has now dosed at least two treatment cycles and the treatment continues to show very promising clinical benefit (Press release, Medivir, OCT 5, 2023, View Source;lenvima-continues-to-show-promising-tumor-control-in-hcc-all-patients-have-now-dosed-at-least-two-treatment-cycles-301948293.html [SID1234635700]). The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

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The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show early and durable clinical benefit across the cohort, as measured by local review. Of the 13 patients with sustained tumor control at 3 months, 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR). The patient who has benefited the longest remains on treatment after 13.5 months, with sustained partial response.

The combination remains tolerable with no unexpected new safety events and adverse events are transient and manageable. Continued lower need for dose reductions or interruptions than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function.

"Overall, the consistent early and durable signals of clinical benefit and the favorable safety profile are very encouraging. Patients with advanced HCC, who have progressed on at least one line of treatment, are a very difficult-to-treat population with few effective treatment options. The overall response rate of 17% already at 2nd scan is very encouraging and indicates a higher share of responders than historically seen in second line treatment of HCC. We can also see that for many patients, their target lesions continue to shrink with longer follow-up," says Dr. Pia Baumann, CMO at Medivir.

Medivir plans to provide an update in connection with the company’s upcoming quarterly results presentation on Friday October 27. This will include a more comprehensive update of local review data as most of the patients will have had the opportunity to have at least three scans, with each scan scheduled to take place every 6 weeks. In addition to the data update, the company will also provide further context what these more mature data could mean for future clinical practice in second line HCC, a patient population for whom there are no approved medical treatments today.

On October 5, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-drug conjugate therapeutics for cancer, reported that management will be participating in one-on-one meetings at Bank of America’s Healthcare Trailblazers Private Company Conference on Thursday, October 26, 2023 (Press release, ProfoundBio, OCT 5, 2023, View Source [SID1234635699]).

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"We look forward to participating in the BofA conference to speak with selected potential investors in advance of our upcoming data presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2023, where we will present data on our ADC programs, including interim Phase 1 data for our lead anti-folate receptor alpha ADC program, rinatabart sesutecan." said Baiteng Zhao, PhD, CEO of ProfoundBio. "We believe our innovative ADC technology platforms have the potential to lead to highly differentiated ADC therapeutics with improved clinical outcomes, and we’re excited to share our emerging clinical data."