On June 20, 2022 XBiotech Inc. (NASDAQ: XBIT) reported it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer (Press release, XBiotech, JUN 20, 2022, View Source [SID1234616103]). Enrollment in the Phase II portion is commencing immediately.

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Thirty leading cancer centers across the United States are involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022 about 50,000 people will die from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy—with the aim to of reducing treatment related toxicity of chemotherapy while also blocking the tumor-associated signals that spurn growth and spread of tumors.

The key is Natrunix’s ability to specifically target the body’s response to injury. Chemotherapy and tumors both elicit an injury response from the body, and this response may counteract some of the beneficial effects of therapy while at the same time cause substantial morbidity. This injury response plays a crucial role in the growth, spread and morbidity of cancer. Natrunix targets this common pathway activated by cytotoxic therapy and paraneoplastic inflammation. Used in combination with chemotherapy, Natrunix is therefore being assessed for its ability to reduce the side effects of chemotherapy treatment and mediate anti-tumor effects.

The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of "possibly, probably, or definitely related dose limiting toxicity (DLT)" associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continued to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects.

Dr. David Park, Medical Director, Hematology, Medical Oncology, St Jude Crosson Cancer Institute, Providence OC Cancer Institute stated, "Natrunix has shown to be well-tolerated when administered concurrently with chemotherapy. We are seeing early encouraging signs that this investigational agent may have a salutary effect in patients via its action in the inflammatory pathway(s)."

The Phase II portion of the study is commencing immediately. Key endpoints in the Phase II portion will be progression-free survival, overall survival and time-to-treatment-failure. The Phase II portion is enrolling 60 subjects that will be randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Subjects will receive the treatment for up to 12 cycles and will be allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent.

About Natrunix
Natrunix is a True Human antibody that was discovered, developed and manufactured by XBiotech. True Human antibodies are derived—without modification—from individuals who possess natural immunity to certain diseases. In many individuals, the body naturally produces antibodies to block pathological inflammation associated with interleukin-1, one of the most extensively studied inflammatory pathways in medicine. Other marketed biological drugs attempt to treat diseases by blocking interleukin-1, however none specifically and exclusively target interleukin-1 alpha (IL-1a). There is also no other marketed monoclonal antibody therapy derived unaltered from a natural human immune response.

On June 20, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study (Press release, Veracyte, JUN 20, 2022, View Source [SID1234616102]). The findings were presented for the first time at the ENDO 2022 Annual Conference (Poster LBSAT255).

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"The Afirma GSC’s clinical validation study provided high-quality evidence of our test’s ability to rule out malignancy in indeterminate thyroid nodules to help these patients avoid unnecessary surgery. Our new findings show that the real-world experience supports this data, further demonstrating that the likelihood of malignancy in Afirma GSC-suspicious nodules is even greater than what was reported in the validation study," said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology and an author on the study.

In the new meta-analysis, researchers evaluated 13 independent studies and found that the Afirma GSC’s real-world ability to identify benign nodules with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, respectively). Additionally, the meta-analysis data show that the Afirma test’s real-world performance surpasses that shown in the CV study when predicting the risk of malignancy in nodules labeled suspicious (65 percent positive predictive value vs. 47 percent).

Veracyte estimates that each year approximately 565,000 people undergo fine-needle aspiration (FNA) biopsy evaluation for potentially cancerous thyroid nodules and that more than 110,000 of these patients receive indeterminate results – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to diagnostic surgery, even though 70 percent to 80 percent of the time, the nodules proved to be benign. Current American Thyroid Association guidelines include molecular testing as a recommended option to achieve definitive diagnosis for nodules classified as indeterminate following FNA biopsy.

On June 20, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that findings from a study interrogating the role of the IL-27 pathway in the development of hepatocellular carcinoma (HCC) have been published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Surface Oncology, JUN 20, 2022, View Source [SID1234616101]). The study was conducted by Cedars-Sinai Medical Center and Fox Chase Cancer Center in collaboration with Surface.

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Researchers found that IL-27 receptor signaling promoted HCC development in mice, and that IL-27 served as an immunological checkpoint that regulates natural killer (NK) cell and innate immune cell activation. The study also demonstrated that pharmacological neutralization of IL-27 using an antibody developed by Surface led to increased NK and innate immune cell activation and reduced HCC development. The study incorporated observations on the effect of IL-27 on several models of HCC development, including a model of non-alcoholic steatohepatitis (NASH), a known risk factor for the development of liver cancer, which is increasing in prevalence.

"The findings published in Cancer Discovery, combined with previously reported translational and early clinical data, support our hypothesis that IL-27 blockade is a promising immunotherapy for patients with cancer," said Vito Palombella, Ph.D., chief scientific officer at Surface. "HCC is the most common form of liver cancer and characterized by a poor survival rate and limited treatment options. These data bolster our belief that SRF388, a first-in-class IL-27 neutralizing antibody, holds the potential to become an important treatment option for patients confronting this devastating disease."

Surface’s lead IL-27 antibody, SRF388, is currently being evaluated in multiple clinical studies, including a randomized Phase 2 trial designed to evaluate its efficacy and safety in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC. SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of HCC from the FDA.

On June 20, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that preclinical data from three of the Company’s proprietary compounds will be presented at the Extracellular Matrix Pharmacology Congress ("ECM"), being held in Copenhagen, Denmark, 23rd-25th June 2022 (Press release, Redx Pharma, JUN 20, 2022, View Source [SID1234616100]). The two presentations cover data originating from Redx collaborations with prestigious international research institutes, the Garvan Institute of Medical Research ("the Garvan"), Australia and Ghent University, Belgium.

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The first presentation will highlight preclinical data from Redx’s ongoing collaboration with the Garvan demonstrating the efficacy of targeting fibrosis associated with pancreatic cancer in mouse models with Redx’s Porcupine inhibitor, RXC004, and a Redx proprietary ROCK2 selective inhibitor. The second presentation will detail results from a research collaboration with scientists at Ghent University assessing the efficacy of RXC008, a GI-targeted ROCK inhibitor, to suppress fibrosis as measured by histopathology and magnetic resonance imaging (MRI).

Title: Investigation of novel therapeutic targets in pancreatic cancerassociated fibrosis

Day/Date: Thursday 23 June 2022, 12:45-13:30 CEST

Title: RXC008 suppresses fibrosis in a DSS model as measured by histopathology and magnetic resonance imaging

Day/Date: Saturday 25 June 2022, 13:35-13:45 CEST

The final program is available on the ECM website at: View Source

About the Extracellular Matrix Pharmacology Congress
Redx is one of eight symposium sponsors of the ECM Congress, organised by the Danish Research Foundation. The Congress will bring together experts in the fields of cancer, fibrosis and immunology to discuss new pharmacological approaches to treat chronic diseases often caused by alterations in the extracellular matrix ("ECM") structure

On June 20, 2022 Microbiotica, a leading player in discovering and developing microbiome-based therapeutics and biomarkers, reported its upcoming scientific conference attendance (Press release, Microbiotica, JUN 20, 2022, View Source [SID1234616099]).

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Microbiome Movement – Drug Development, 21-24 June 2022, Boston, US
Dr Ron Carter, Microbiotica’s CMO, will be contributing to a panel at Microbiome Movement – Drug Development, taking place in Boston, US, from 21 to 24 June. This is a key conference series for the microbiome industry, and will focus on taking a collaborative approach to close the clinical gap, discover the next generation of microbiome-based therapeutics and establish new partnerships to accelerate research.

Ron will contribute to a panel discussion entitled "Learn How to Advance Your Clinical Trial Recruitment and Progress Your Pipeline" on 22 June at 12:00 pm local time, along with speakers from Enterobiotix, Series Therapeutics, Gusto Global and Alveolus Bio.

Microbiome Connect Europe, 6-7 July 2022 – Amsterdam
Microbiotica’s Director, Cell Biology, Dr Ghaith Bakdash will be presenting on the topic of "MB097: A clinically defined consortium of bacteria with potent anti-tumour activity" at the 8th Annual Microbiome Connect: Europe 2022 conference. This conference highlights the most advanced drug development and consumer product platforms applying live microbial consortia, engineered microbes, and microbial-derived metabolites for therapeutic and health applications in patients and consumers.

Ghaith’s talk is scheduled for 9.30am local time on 7 July.

Anaerobe 2022, 28-31 July – Seattle, US
Microbiotica’s Director, Discovery Microbiology, Dr Anne Neville will be presenting at Anaerobe 2022 which takes place in Seattle from 28 to 31 July on the subject of "Anaerobic Cultivation and Strain-Banking from the Human Gastrointestinal Tract". This conference will address both the clinical and microbiological aspects of anaerobes, as related to human diseases, animal diseases, and environmental conditions.

Anne’s talk will be at 1.45pm local time on 30 July.

Immuno UK, 29-30 September – London, UK
Microbiotica’s VP Transitional Biology, Dr Mat Robinson, will be discussing "Co-Therapy Development For Immuno-Oncology" at Immuno UK, an event focussed on the design and delivery of innovative immunotherapies to transform cancer care, on 29 September at 2.20pm local time.