On September 8, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based circulating cell-free tumor DNA (ctDNA) analysis for oncology, reported the publication of a clinical study investigating the utility of cfDNA-based markers using the highly sensitive OncoBEAM RAS assay, an enhanced digital PCR test optimized for high sensitivity blood-based mutation detection, as a prognostic tool in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Sysmex Inostics, SEP 8, 2020, View Source [SID1234568256]).

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Pancreatic cancer is the fourth leading cause of cancer related death worldwide. Moreover, PDAC accounts for 90% of all pancreatic cancers with an overall 5-year survival of less than 8%, the lowest survival rate of all cancers. Patients diagnosed with PDAC suffer from a poor prognosis which is attributed to diagnosis at an advanced stage, due to late onset of symptoms and lack of reliable biomarkers for early detection. Moreover, most patients with late stage disease exhibit resistance to available therapy modalities.

The primary initiating genetic event for PDAC is a KRAS mutation, occurring in 94% of pancreatic ductal tumors. KRAS mutational status is typically analyzed in tumor tissue but obtaining biopsy specimens from pancreatic lesions – especially during chemotherapy treatment – may be difficult and requires invasive procedures. Tumor tissue for biomarker testing is only available at diagnosis and is not feasible to access during treatment. CfDNA-based liquid biopsy analysis of KRAS mutations using OncoBEAM technology represents a minimally-invasive tool to measure levels of circulating KRAS mutations to assist in the prognosis determination and management of PDAC patients.

The study published by investigators at the University of Córdoba, Spain indicates that the dynamics of circulating RAS mutations may better correlate with patient outcomes and survival compared with CA19-9 protein blood-based marker testing. CA19-9 is usually found in higher concentrations in pancreatic cancer, however, it is not a tumor specific biomarker and can be elevated for reasons unrelated to cancer. In this comparative analysis, a significant correlation was found between the increase in RAS mutation levels detected in plasma by the OncoBEAM RAS test (r = 0.65, p = 0.02), but not in CA19-9 (r = 0.09, p = 0.78) and survival time. Overall, greater increases in levels circulating KRAS mutation during patient monitoring predicted shorter survival time, with researchers noting that KRAS mutant cfDNA shows great promise as real-time biomarker of tumor response.

Lead author Dr. Toledano-Fonseca of Maimónides Biomedical Research Institute of Córdoba (IMIBIC), said, "Remarkably, sensitive plasma KRAS mutation testing using OncoBEAM alongside of CA19-9 and fragmentation analysis greatly helped prognosis stratification of metastatic PDAC patients. Our results support KRAS MAF as a valuable complementary tool for monitoring the response to chemotherapy treatment in metastatic PDAC patients."

The publication, titled "Circulating Cell-Free DNA-Based Liquid Biopsy Markers for the Non-Invasive Prognosis and Monitoring of Metastatic Pancreatic Cancer" was published in Cancers, July 1, 2020, by Marta Toledano-Fonseca et al.: View Source

On September 8, 2020 Don Hayden, Chairman and CEO of WindMIL Therapeutics, reported that it will present at Citi’s 15th Annual BioPharma Virtual Conference on September 8, 2020 at 4:05 pm EDT (Press release, WindMIL Therapeutics, SEP 8, 2020, View Source [SID1234568096]).

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On September 8, 2020 Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, reported that it has closed on an initial $3 million in a Series B-1 financing with total approved capital of up to $6 million in the raise (Press release, Nanospectra Biosciences, SEP 8, 2020, View Source [SID1234565071]). The equity round was led by Sirtex Medical as a strategic investor with additional participation from existing and new investors. Sirtex is a leading U.S. based provider of targeted liver cancer therapies via their proprietary SIR-Spheres Y-90 microspheres with global operations. Kevin P. Smith, Sirtex’s General Counsel and Executive Vice President, Business Development, will join the Nanospectra Board of Directors.

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AuroLase, Nanospectra’s lead product, is the first and only ultra-focal ablation therapy designed to maximize treatment efficacy while minimizing side effects typically associated with surgery, radiation and alternative focal therapies. Proceeds from the financing will be used to further develop AuroLase, including full completion of the ongoing pivotal study for prostate cancer tissue ablation, filing of a 510(k) with the U.S. Food and Drug Administration (FDA) for marketing clearance, and preparing for commercialization. In addition, Sirtex and Nanospectra have agreed to exclusively negotiate for a defined period of time for access to AuroLase in certain geographies outside of the U.S.

"We are thrilled to welcome Sirtex Medical as a strategic investor due to their shared commitment and understanding of the clinical and patient benefits of minimally-invasive oncology therapies," said David Jorden, CEO of Nanospectra. "With established global operational capabilities and distribution, they are well positioned to advise on our commercialization efforts in both the U.S. and other geographies. We look forward to Sirtex’s active engagement as we proceed with our clinical programs."

The AuroLase pivotal study for the focal ablation of prostate tissue via nanoparticle directed near infrared irradiation is approved by the FDA under the original Investigational Device Exemption (IDE) and follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites. The ongoing pivotal study will enroll up to 60 patients at up to eight clinical trial sites throughout the U.S. and the combined dataset from both studies will constitute the clinical package Nanospectra will submit to the FDA.

"Nanospectra’s AuroLase is a perfect complement to our technology approach and corporate strategic focus on minimally-invasive therapies," said Kevin R. Smith, CEO of Sirtex Medical. "We look forward to collaborating with Nanospectra to explore and develop innovative therapies to meet unmet medical needs in patients with various cancer conditions."

On September 8, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that the first patient has been dosed in the Phase 1/2 clinical trial of NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3, important oncogenic drivers and major drug resistance pathways in many hard-to-treat cancers (Press release, Kitov Pharmaceuticals , SEP 8, 2020, View Source [SID1234565050]).

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"The dosing of the first patient in this important study represents a significant milestone for Kitov," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "Based on the encouraging pre-clinical data generated by NT219 as both monotherapy and in combination with several anti-cancer drugs, we believe that this promising drug candidate has the potential to be a safe and effective therapy for multiple hard-to-treat cancers. We are satisfied with the progress of the study and anticipate full enrollment in this first part of the study as planned, with top line data from the first part of the study expected in the second half of 2021."

The Phase 1/2 trial is evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the recommended dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose level of NT219, a second cohort of patients, with recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be administered weekly with NT219, dose escalated, in combination with cetuximab.

Upon completion of the monotherapy and combination therapy Phase 1 portions of the trial and establishment of the recommended Phase 2 dose for NT219, Kitov plans to commence an expansion Phase 2 component of the study at that dose in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The trial will also include exploratory evaluations of different potential biomarkers in patient tumors and serum. Further Phase 2 arms in patients with different malignancies, as a monotherapy or in combination with other cancer therapies, will be considered based on the exploratory evaluations and the data generated during the Phase 1 portions of the trial. The study is anticipated to be conducted at multiple medical centers in North America.

On September 8, 2020 Pierre Fabre reported that The National Institute for Health and Care Excellence has published the outcome of an appraisal of Braftovi (encorafinib), turning down NHS funding for the drug as a treatment for some patients with advanced colorectal cancer (Press release, Pierre Fabre, SEP 8, 2020, View Source [SID1234564992]).

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In preliminary guidelines, the Institute said it is not recommending NHS use of Braftovi in combination with cetuximab for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment.

Treatment for BRAF V600E mutation-positive metastatic colorectal cancer after previous systemic treatment includes combination chemotherapy, usually FOLFIRI (5 fluorouracil, folinic acid and irinotecan) followed by trifluridine-tipiracil then best supportive care.

Braftovi plus cetuximab is the first colorectal cancer treatment that targets the BRAF V600E mutation, and could be used as second or third-line treatment.

However, while clinical trial evidence shows that the regimen increases how survival compared with FOLFIRI plus cetuximab or irinotecan plus cetuximab, these drug combinations are not used in NHS clinical practice, NICE said.

When evidence from other clinical trials is used to indirectly compare Braftovi plus cetuximab with FOLFIRI, and with trifluridine-tipiracil, "the assumptions used make the results unreliable".

Also, while Braftovi plus cetuximab meets NICE’s criteria for being a life-extending treatment at the end of life, the cost-effectiveness estimates are higher than what is normally considered value for money for the NHS, and "so it cannot be recommended for routine use", the Institute concluded.