On September 18, 2020 BioEclipse Therapeutics, a private clinical-stage biopharmaceutical company developing first-in-class, curative immuno-oncology therapeutics, reported that its CEO and founder Pamela Contag, Ph.D., and CFO Ben Carter will participate in the Sachs 20th Annual Biotech in Europe Forum, taking place September 21–24, 2020 via a virtual platform (Press release, BioEclipse Therapeutics, SEP 18, 2020, View Source [SID1234565369]).

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Dr. Contag will host virtual one-on-one meetings with investors and potential partners to discuss BioEclipse’s business strategy and highlight recent corporate achievements, as well as anticipated milestones in its clinical program for CRX100, BioEclipse’s lead investigative candidate. Institutional investors are invited to request meeting times.

To schedule a one-on-one meeting, please contact Dr. Contag or Mr. Carter at BioEclipse Therapeutics.

CRX100 is an intravenously delivered cancer therapy designed to target and destroy multiple cancer types and to prevent disease recurrence. It only targets tumor cells, leaving healthy tissue untouched, but it has the ability to reach tumors throughout the body. This means CRX100 holds promise for metastatic disease treatment with limited toxicity. BioEclipse plans to initiate a Phase 1 clinical trial in therapy-refractory solid tumors before year end.

On September 18, 2020 BrainCool AB, a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, reported late-breaking clinical results of the Cooral System, a novel cooling device for the prevention of Oral Mucositis (OM), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, BrainCool, SEP 18, 2020, View Source [SID1234565368]).

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Data was collected from a Nordic multi-center pivotal trial led by Karolinska University Hospital, Stockholm, that enrolled 182 patients with multiple myeloma or lymphoma who were scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation. The abstract was presented at ESMO (Free ESMO Whitepaper) by Java Walladbegi, PhD, Oral Medicine, Department of Oral Medicine & Pathology, Institute of Odontology at The Sahlgrenska Academy, University of Gothenburg, Sweden. Dr. Walladbegi was project manager for the blinded, randomized investigation, which compared the efficacy of ice chips (IC) and an intra-oral cooling device (ICD; Cooral) for cryoprevention of OM.

Results from the randomized trial proved that the Cooral System was as effective as IC in terms of cryoprevention, with severe OM occurring in fewer than 10% of the cases tested. For patients with lymphoma, use of the Cooral System showed vastly improved prevention of OM and was significantly more effective when compared to the conventional method with IC [Oral Mucositis Assessment Scale (OMAS) mean total 1.77 vs 3.08; p = 0.047]. This finding is particularly notable because lymphoma patients are treated with longer courses of chemotherapy, making severe OM a life-threatening inevitability. As for patient-reported tolerability, both diagnostic groups (myeloma and lymphoma), reported a statistically significant higher degree of tolerability when Cooral was used as compared with IC [p = 0.020].

"This is a major breakthrough in patient-centered cancer care and treatment," said Martin Waleij, CEO of BrainCool. "Not only was the Cooral System shown to be safer and more feasible from the standpoint of infection control and comfort, our study shows that its use actually prevents OM occurrence. For patients faced with treatment times of up to six hours or more, that is a truly life-changing difference."

In addition to cancer care improvements, the study indicates potential economic benefits as well. Costs for patients with severe OM in conjunction with stem cell transplantation have been estimated at more than $70,000 per patient. The data presented at ESMO (Free ESMO Whitepaper) are a clear indication that most of these healthcare costs can be prevented with use of the Cooral System.

Presentation of this data at ESMO (Free ESMO Whitepaper) paves the way for market introduction of the Cooral System in the EU, following market clearance in early June 2020 as a class 2 invasive medical device. The device was CE marked for the EU / ESS markets as an invasive medical device this past June, and BrainCool is currently conducting a De Novo 510(k) process to obtain market clearance in the U.S.

The Cooral System features a disposable, thermostatically controlled intra-oral device that comprises closed conduits with continuously circulating water to evenly distribute the hypothermic medium to the oral mucosa. As the hypothermic medium gradually reaches a steady temperature, that temperature is consistently controlled and maintained in the oral mucosa, which in turn leads to reduced blood flow and exposure of tissue to chemotherapeutic agents—thus preventing soreness, erythema and painful ulcerative lesions.

"Oral Mucositis is among the most painful and debilitating adverse effects of both standard and high-dose chemotherapy within the field of oncology," said Dr. Java Walladbegi. "The data speaks for itself, and represents an important milestone in the quest to prevent this potentially lethal side-effect."

"We are opening an important new door in cancer care and treatment," adds Waleij. "Together with an anticipated scientific publication in early 2021, this ESMO (Free ESMO Whitepaper) late-breaking presentation marks the international launch of a groundbreaking improvement in cancer care that significantly improves quality of life for patients, and dramatically reduces the cost to deliver it."

About Oral Mucositis (OM)
OM is a highly significant and sometimes dose-limiting condition that has been reported as the single most-debilitating complication of cancer therapy. OM can be present in combination with a variety of debilitating symptoms that may compromise the ability of patients to maintain oral hygiene practices. For example, intractable oral pain, which may lead to an increased need for analgesics and, on occasions, opioids that are administered intravenously. OM is further associated with undernourishment, weight loss, the use of feeding tubes or total parenteral nutrition, and impaired quality of life, and it can represent a portal of entry for systemic infections that can lead to sepsis and death. Taken together, these symptoms, along with their related sequelae, can result in hospitalization and may incur increased costs for healthcare systems.

On September 18, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported new data from the ongoing Phase 1 study evaluating dubermatinib (TP-0903), an AXL kinase inhibitor, in patients with advanced solid tumors (Press release, Sumitomo Dainippon Pharma, SEP 18, 2020, View Source [SID1234565367]). These results were presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Annual Congress, being held September 19-21, 2020.

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Preliminary findings from the Phase 1a/b first-in-human, open-label, dose-escalation, safety, pharmacokinetics and pharmacodynamic study indicated dubermatinib was well tolerated with a manageable safety profile as a monotherapy or in combination with immunotherapy or tyrosine kinase inhibitor (TKI). Dubermatinib, as a single agent and as part of the combination regimens, showed preliminary signs of clinical activity in the study, with four partial responses observed.1

The study consists of two parts. The dose escalation portion of the study enrolled 45 patients with advanced solid tumors across 10 dose levels of dubermatinib monotherapy. The expansion portion of the study enrolled 132 patients across five cohorts of various solid tumor types, including combination cohorts receiving dubermatinib plus immunotherapy or dubermatinib plus TKI.1

In the dose escalation portion of the study, 5% (n=2 of 45) of patients achieved a partial response when treated with dubermatinib monotherapy (1 patient with metastatic melanoma and 1 patient with intrahepatic cholangiocarcinoma) and 29% (n=13 of 45) of patients experienced stable disease, resulting in an overall disease control rate of 33%.1

In the expansion portion of the study, 5% (n=1 of 21) of patients in Cohort A (one patient with non-small cell lung cancer treated with dubermatinib plus immunotherapy) and 5% (n=1 of 22) of patients in Cohort B (one patient with non-small cell lung cancer treated with dubermatinib plus TKI) achieved a partial response. Across cohorts, 14-48% of patients experienced stable disease and a disease control rate ranging from 14-53% was achieved. In Cohort C (patients with colorectal cancer treated with dubermatinib monotherapy), pharmacodynamic evaluation of pre- and post-treatment tumor biopsies and peripheral blood mononuclear cells correlated with clinical activity.1

The maximum tolerated dose of dubermatinib was determined to be 50 mg. The most frequently observed treatment-emergent adverse events of Grade 3 or higher at least possibly related to dubermatinib were nausea, vomiting and diarrhea.1

"These preliminary data presented at ESMO (Free ESMO Whitepaper) 2020 are encouraging as we learn more about how dubermatinib may inhibit the AXL kinase protein and sensitize cancer cells to treatment with other targeted agents in patients with advanced solid tumors," said David J. Bearss, Ph.D., Chief Scientific Officer and Global Head of Research, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We are continuing to advance this study to evaluate the potential role of dubermatinib in immune cell modulation by observing changes in the tumor immune microenvironment in patients with specific tumor types."

Below are the details for the SDP Oncology presentation:

Abstract Title

Details

Presenter

A Phase 1, First-in-human, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Dubermatinib (TP-0903) in Patients with Advanced Solid Tumors

Presentation #536MO

Friday, September 18 at 9:56 a.m. CEST

Mini-Oral Presentation

John Sarantopoulos, M.D., UT Health San Antonio

About Dubermatinib (TP-0903)

Dubermatinib is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1a/b study in patients with advanced solid tumors (NCT02729298) and an ongoing study in collaboration with the Leukemia & Lymphoma Society as part of the Beat AML Clinical Trial (NCT03013998). SDP Oncology is exploring parallel clinical development paths for dubermatinib in both solid and hematologic malignancies.

About AXL Kinase

AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.2 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.3

On September 18, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported it will present new data on its personalized molecular residual disease (MRD) test, Signatera, at the 2020 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) virtual meeting taking place September 19-21, 2020 (Press release, Natera, SEP 18, 2020, View Source [SID1234565366]).

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Natera will present four abstracts — one oral and three poster presentations — which highlight applications for detecting MRD levels and tracking tumor clonal evolution in CRC and in esophageal adenocarcinoma.

"When CRC patients present with multiple lesions, recurrence monitoring may be complicated by spatial heterogeneity between the primary tumor and the metastases," said Andrés Cervantes, M.D., Ph.D., President-Elect of ESMO (Free ESMO Whitepaper) and co-author of the tumor evolution study. "Our study leverages a tumor-informed ctDNA technology that can evaluate and account for this heterogeneity."

"We’re delighted to share new data at this year’s ESMO (Free ESMO Whitepaper) meeting, which shows the broad potential of our tumor-informed approach to MRD assessment," said Alexey Aleshin, M.D., M.B.A., Senior Medical Director of Oncology at Natera. "These studies demonstrate that Signatera provides clinically actionable information that can improve the management of patients with multiple different solid cancers."

Details about the abstracts are as follows:

Abstract #405MO | Mini Oral Presentation
Presenter: Fotios Loupakis, M.D., Ph.D.

Personalized circulating tumor DNA assay for the detection of minimal residual disease in CRC patients undergoing resections of metastases.

This study evaluated the prognostic value of MRD testing after surgical resection of metastases. MRD positivity correlated with inferior progression-free survival and was the most significant biomarker for prognosis in patients with oligometastatic CRC.

Abstract #420P | Poster Presentation
Presenter: Tenna V. Henriksen, M.S.

MRD detection and tracking tumor evolution using ctDNA in stage I-III colorectal cancer patients

A prospective, multicenter cohort study that analyzed the genetic heterogeneity between primary tumor, metastases, and synchronous tumors in patients with stage I-III CRC using Signatera. While primary and metastatic tumors showed at least 50 percent phylogenetic similarity, synchronous CRC tumors were observed to be genetically unrelated and required individual Signatera assays to be designed for reliable ctDNA detection.

Abstract #1491P | Poster Presentation
Presenter: Emma Ococks, M.S.

Bespoke circulating tumor DNA assay for the detection of minimal residual disease in esophageal adenocarcinoma patients

A pilot study that evaluated the ability of tumor-informed ctDNA testing to assess MRD status in patients with esophageal adenocarcinoma, a low-shedding tumor type. Postoperative assessment of MRD detected clinical relapse with a median lead time of 335 days and with 100 percent sensitivity.

Abstract #520TiP | Poster Presentation
Presenter: Pashtoon Kasi, M.D., M.S.

A multicenter study to evaluate the impact of circulating tumor DNA guided therapy (BESPOKE) in patients with Stage II and III colorectal cancer

A trial-in-progress poster presentation, describing the first real-world, prospective, multicenter study (BESPOKE) utilizing a tumor-informed ctDNA test to assess MRD status in 1000 patients with stage II and III CRC over the course of two years. The primary endpoint of this study is to examine the impact of Signatera on adjuvant treatment decisions and to determine the rates of CRC recurrence while asymptomatic.

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On September 18, 2020 BERG, a clinical-stage biotech that employs artificial intelligence (AI) to investigate diseases and develop innovative treatments, reported two major medical/clinical research developments on pancreatic ductal adenocarcinoma (PDAC) to be presented virtually at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Congress taking place from September 19-21, 2020 (Press release, Berg, SEP 18, 2020, View Source [SID1234565365]).

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The first study entitled "Project Survival: High Fidelity Longitudinal Phenotypic and Multi-omic Characterization of Pancreatic Ductal Adenocarcinoma (PDAC) for Biomarker Discovery", is the culmination of the largest existing high-fidelity characterization of pancreatic cancer from a phenotypic/adaptive multi-omic perspective. BERG’s Interrogative Biology platform was employed to identify causal relationships between existing pancreatic cancer therapies and changes in proteomic, metabolic and lipidomic responses to 253 treatment interventions and 211 progression events.

The research cohort included PDAC patients across different stages including early, locally advanced and metastatic to yield the most accurate characterization of the evolution of the disease. Throughout the course of the study, 470,000 clinical data points were gathered.

"Valid biomarkers will have a dramatically positive impact on patients suffering from pancreatic cancer," said Dr. A. James Moser, Co-Director of the Pancreas and Liver Institute at Beth Israel Deaconess Medical Center (BIDMC), and Professor of Surgery at Harvard Medical School. "The Project Survival and BPM study data cross an important threshold on the road to personalized treatment, underscoring the vital role of comprehensive and sustained research collaborations in the fight against this dreadful cancer."

The second study, Validation of Response and Survival Biomarkers in a Phase 2 Trial of BPM 31510—IV Advanced Refractory Pancreatic Ductal Adenocarcinoma (PDAC), identified two potential biomarkers predictive of response and overall survival in PDAC patients in response to BPM 31510-IV treatment.

The Interrogative Biology platform was applied to patient Buffy Coat (BC) samples being treated with BERG’s pancreatic drug cancer candidate, BPM 31510-IV, in a Phase 1 trial to identify novel markers. The biomarkers were then independently confirmed for utility between survival (OS), stable disease (SD), and progressive disease (PD) in a Phase 2 trial.

"PDAC is the most common type of pancreatic cancer and is an infamously devastating disease," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "We are fully committed to continue advancing these critical developments and leveraging our proprietary Interrogative Biology platform to identify therapeutic improvements for patients. We’re honored to present these findings at the ESMO (Free ESMO Whitepaper) 2020 Congress, and continue fostering partnerships with pioneers across the oncology field."