On July 13, 2022 Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, reported the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track Designations to Alpheus Medical’s CV-01 delivery of sonodynamic therapy (SDT) as a potential treatment for patients with recurrent glioblastoma, the most common primary brain cancer, and other malignant gliomas (Press release, Alpheus Medical, JUL 13, 2022, View Source [SID1234616662]). Northwell Health’s North Shore University Hospital in Long Island, New York, is currently enrolling patients in the multi-center Phase 1 clinical trial. The First-in-Human trial will evaluate the safety, optimal dosage, and efficacy of Alpheus’ SDT platform in patients with recurrent high-grade glioma.

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"The diffuse nature of glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat. There are very few effective options, leading to poor patient outcomes, and a universally fatal disease," commented Michael Schulder, MD, Director of the Brain Tumor Center and Primary Investigator (PI) for the clinical trial at Northwell Health’s Institute for Neurology and Neurosurgery. "Alpheus’ sonodynamic therapy enables non-invasive, diffuse treatment across the hemisphere. It has the potential to change the landscape of high-grade glioma therapy and we are excited to be part of this important study."

Alpheus Medical’s proprietary, investigational SDT treatment is an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound. The SDT is administered in an outpatient setting and does not require imaging. The multi-center trial (NCT05362409) is designed to study the safety and optimal application of Alpheus’ SDT treatment, as well as efficacy, and is planned to enroll up to 33 patients.

"The FDA Fast Track and Orphan Drug Designations are significant milestones and highlight the importance of innovation within the field of brain cancer," stated Dr. Vijay Agarwal, CEO and founder of Alpheus Medical and a practicing brain tumor surgeon. "Built on a very successful pre-clinical program, we believe our proprietary SDT platform is a game changer and has the potential to significantly advance the treatment of gliomas."

The FDA Orphan Drug and Fast Track programs are designed to facilitate the development of important new therapies and to provide patients with serious and rare conditions access to treatment more quickly. Orphan Drug status is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. It provides development incentives and post-approval marketing exclusivity for seven years. The Fast Track designation enables early and frequent communication between FDA and product sponsor throughout the development and review process.

On July 13, 2022 miR Scientific, LLC reported the miR Sentinel Prostate Cancer Test is now commercially available in the United States, Puerto Rico and select international markets (Press release, miR Scientific, JUL 13, 2022, View Source [SID1234616661]). miR Sentinel is a novel, urine-based, molecular test that analyzes small non-coding RNA using a proprietary biostatistical algorithm. The miR Sentinel Test assesses the risk of aggressive prostate cancer and is intended to aid in the clinical management of men >45 years of age at risk for prostate cancer.

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The results of a recent clinical study performed at multiple sites within the US and Puerto Rico were presented at the 2022 American Urological Association’s Annual Meeting. In the study cohort of ~1100 men, the miR Sentinel Test was shown to identify molecular evidence of prostate cancer in at-risk men with 98.5% sensitivity and distinguish clinically non-significant (nominally No Pathological Evidence of Prostate Cancer and Grade Group 1), from clinically significant prostate cancer (nominally Grade Groups 2-5) with a prognostic sensitivity of 83% 2.

"We believe that the miR Sentinel Test offers patients and providers a non-invasive means of accurately assessing a man’s prostate cancer risk, which could potentially reduce unnecessary biopsies and biopsy-related complications in men with low-risk of clinically significant prostate cancer, while prioritizing diagnostic and treatment resources to those men that potentially harbor clinically significant prostate cancer," said Sam Salman, Chairman and CEO of miR Scientific. "This aligns with miR Scientific’s vision to revolutionize prostate cancer disease management by improving accessibility and accuracy of the tools used to assess each man’s personal risk of aggressive disease."

In a subset analysis of men from this cohort where the findings of TRUS and MRI-guided biopsies disagreed on the presence of prostate cancer, the miR Sentinel Test was able to correctly identify 99% (71/72) of men found positive by either biopsy type while identifying all but 4 of 234 cases where prostate cancer was found by either TRUS or MRI resulting in a false negative rate of 1.7%. Additionally, 87% of men with PSA levels <3 found to have pathologic grade group 2 through 5 upon biopsy were identified by the miR Sentinel Test as having molecular evidence of intermediate or high risk of aggressive disease2. These findings suggest that the miR Sentinel Test may represent a significant improvement over the current standards of care and other tools being used to detect and classify prostate cancer.

"Accurate assessment of a man’s individual risk related to prostate cancer is one of the cornerstones of appropriate patient management. The miR Sentinel Test has the potential to provide a significant improvement over the current tools that are available to physicians," said Laurence Klotz, MD, FRCSC, CM, miR Scientific’s Chief Medical Officer, Professor of Surgery and Chair of Prostate Cancer Research, University of Toronto Sunnybrook. "The implementation of such an innovation into practice could have a dramatic impact on outcomes through appropriately guiding the need for further diagnostic workup in men with elevated risk of significant cancer and guiding treatment in those subsequently diagnosed."

The current version of the miR Sentinel Test represents a refined and clinically validated assessment developed for commercialization based on our comprehensive miR Sentinel PCC4 assay, which received FDA Breakthrough Device Designation in third quarter 2020 and the original three-test proof of concept, published in the Journal of Urology1 in September 2020.

Additional information on the miR Sentinel Prostate Cancer Test as well as information on how to access the test can be found by visiting miRSentinel.com or calling 855-55CALLMIR from the United States or +1 (855) 552-2556.

On July 13, 2022 Triastek, Inc. ("Triastek") reported a collaboration with Eli Lilly and Company ("Lilly"), a leading global pharmaceutical company, to leverage the advantages of 3D printing technology to enable precisely targeted and programmed release of drugs in specific regions of the GI tract (Press release, Eli Lilly, JUL 13, 2022, View Source [SID1234616660]).

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According to the agreement, the project will focus on the targeted release of drugs in the intestine. Triastek will focus on two aspects: Firstly, conduct an in-depth study of excipient properties and process parameters to maintain drug stability throughout the formulation development and 3D printing process, as well as during drug release. Secondly, identify a unique three-dimensional structure dosage form design, that will permit programmed release of drugs in specific parts of the intestine, with the goal of improving the bioavailability of orally administered drugs.

Triastek is a 3D printing technology platform company, and its pioneering MED technology has versatile applications in solid dosage forms development and manufacturing. With the facilitation of this collaboration by Lilly China Innovation & Partnerships, Triastek will work with Lilly to explore novel solutions to the oral delivery of drugs.

Triastek is committed to promoting the application of 3D printing technology in the pharmaceutical field. Triastek’s 1st and 2nd products (T19 and T20) have received IND clearance from the U.S. Food and Drug Administration (FDA). The company also holds 158 patent applications related to 3D printing of pharmaceuticals with comprehensive patent coverage in the world. Triastek has also established collaborations with a number of multinational pharmaceutical companies, as well as domestic pharmaceutical companies to provide technical solutions for the development of challenging formulations.

Dr. Senping Cheng, founder and CEO of Triastek, said: "the collaboration between Triastek and Lilly is a great example of applying MED technology for improving the oral delivery of drugs. We envision that the MED technology of Triastek can be used to solve the challenges in formulations leading to the development of clinically valuable products for our global partners."

On July 13, 2022 Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, reported the first patient in its Phase 1 study has been dosed with TCMCB07, the company’s melanocortin‐4 antagonist peptide candidate for the treatment of cachexia (Press release, Endevica Bio, JUL 13, 2022, View Source [SID1234616659]). The study will enroll up to 97 healthy volunteers to assess the safety of TCMCB07, with data expected in the first quarter of 2023.

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Cancer, renal failure and congestive heart failure can generate a high degree of cachexia, which can impact survival and quality of life. This Phase 1 study design in healthy volunteers allows Endevica to have flexibility in the number of indications it will study in its Phase 2 trial.

"This important milestone represents our commitment to rapidly develop TCMCB07, which could be one of the first pharmaceutical treatment interventions to meaningfully improve the effects of cachexia," said Russ Potterfield, CEO and Executive Chairman of Endevica. "If our previous animal results translate to positive human data, TCMCB07 would potentially have a strong impact on patients’ lives across multiple underlying conditions."

About Cachexia

Cachexia is a life-threatening aspect to many diseases. The symptoms of this disease include lack of appetite and a loss of muscle disproportionate to the reduction in caloric intake. People suffering from cachexia often have a more difficult time doing day-to-day tasks, fatigue, a reduced quality of life and reduced survival. In advanced cases, cachexia can lead to multi-organ failure due to high metabolic rate-induced apoptosis. According to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), cachexia is highly prevalent cross malignancies, impacting approximately half of patients with advanced cancer.

About TCMCB07

TCMCB07 is a melanocortin‐4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body’s behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass gain (e.g., a reversal of the cachectic condition) during the administration of the drug. The results have been synchronous across multiple cachexia-inducing insult classes.

On July 13, 2022 Lucence reported that it will present new data at the upcoming IASLC 2022 World Conference on Lung Cancer on August 6-9, 2022, highlighting novel applications of its ultrasensitive amplicon-based next generation sequencing technology in the detection and treatment of lung cancer (Press release, Lucence, JUL 13, 2022, View Source [SID1234616658]).

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"Liquid biopsy will continue to transform the way we diagnose, treat, and understand lung cancer," said Min-Han Tan, Founding CEO and Medical Director at Lucence. "Lucence is committed to leveraging our ultrasensitive amplicon-based liquid biopsy technology, AmpliMark, to harvest as much actionable molecular information to help patients at every stage of their journey."

Lucence recently announced the publication of a validation study for its flagship LiquidHALLMARK ctDNA Liquid Biopsy Assay. The study, published in PLOS ONE, establishes LiquidHALLMARK’s performance and identifies actionable biomarkers in 70% of lung cancer patients. In addition to showing high sensitivity of both LiquidHALLMARK and Lucence’s AmpliMark amplicon next-generation sequencing (NGS) platform, external validation with cobas EGFR Mutation Test v2 for lung cancer specimens demonstrated an overall concordance of 84.00% with a 100% concordance rate for EGFR variants above 0.4% VAF.

Abstracts to be presented in poster presentations at the conference build on Lucence’s continued innovation in liquid biopsy in the detection, treatment, and monitoring of lung cancer.

Sensitive Detection of Lung Cancer Using a Multiomic Plasma Cell-Free DNA Sequencing Assay, #2347

A novel combinatorial AmpliMARK-based test measuring ctDNA abundance, cfDNA fragmentation profiles, and cfDNA methylation demonstrated an overall sensitivity of 85% and specificity of 95% for the detection of lung cancer. 14.3% additional lung cancer cases were detected compared to ctDNA detection alone, demonstrating the utility of a multi-signal cfDNA approach for sensitive detection of lung cancer.

Retrospective Analysis of BRCA1/2 Alterations in Advanced NSCLC Using An Amplicon-based NGS Liquid Biopsy Assay, #2472

Lucence’s AmpliMark-powered LiquidHALLMARK assay detected pathogenic BRCA1/2 alterations in the plasma ctDNA of 6.7% (19/285) of metastatic NSCLC patients. BRCA-mutant NSCLC had more somatic mutations and higher plasma cfDNA concentrations compared to BRCA-wildtype NSCLC, highlighting BRCA as a potential biomarker for inclusion in lung liquid biopsy testing.

Peripheral T-Cell Receptor Repertoire Profiling in Non-small Cell Lung Cancer Using an Amplicon-Based Sequencing Assay, #2293

Characterization of NSCLC patient peripheral T-cell receptor repertoire (TCR) using Lucence’s AmpliMark platform shows differences in TCR repertoires by molecular subtypes of NSCLC and treatment status, suggesting that TCR-sequencing can complement plasma-based cfDNA sequencing in treatment selection and monitoring.