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.

On July 13, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the second quarter 2022 after market close on Thursday, August 4, 2022 (Press release, Guardant Health, JUL 13, 2022, View Source [SID1234616657]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On July 13, 2022 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the Half-Year report on its liquidity contract with Gilbert Dupont (Press release, Nanobiotix, JUL 13, 2022, View Source [SID1234616656]).

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As of June 30, 2022, the following resources appeared on the liquidity account:

– Number of shares: 25,706
– Cash balance: € 60,051.07

During the 1st Half of 2022, a total of:

As of December 31, 2021, the following resources appeared on the liquidity account:

– Number of shares: 15,456
– Cash balance: € 97,415.97

Upon signing of the liquidity contract the following assets were made available:

– Number of shares: 0
– Cash balance: € 300,000.00

The implementation of this half-year report is carried out in accordance with AMF Decision N°2021-01 of June 22nd 2021 renewing the implementation of liquidity contracts for shares as an accepted market practice.

On July 13, 2022 Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, reported a collaboration to advance the discovery of novel spatial biomarkers in solid tumors (Press release, Nucleai, JUL 13, 2022, View Source [SID1234616655]). The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials.

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Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities (H&E, IHC, Multiplex) and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022.

"Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging," says Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai. "This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy."

Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook.

"We are delighted to announce a partnership with Nucleai," said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. "Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine."