On March 6, 2023 Therapeutic Solutions International (TSOI) reported plans to initiate ten patient proof-of-concept clinical trial aimed at demonstrating the ability of FloraStilbene to stimulate the immune system in advanced breast cancer patients (Press release, Therapeutics Solutions International, MAR 6, 2023, View Source [SID1234628228]).

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"Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015"

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The Company has previously been granted a patent on utilization of pterostilbene and pterostilbene compositions for synergy with cancer immunotherapy such as interleukin-21, as well as suppression of cancer derived immune inhibitory agent enzymes such as indolamine 2,3 dioxygenase2. By combining previous experiences with immune modulation, the Company announced the creation of a novel immune stimulatory adjuvant combining pterostilbene with RU-486, termed "FloraStilbene". Preclinical data, for which intellectual property has been filed, demonstrated FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.

"FloraStilbene represents a non-toxic approach to overcoming breast cancer induced immune suppression, which acts as a significant barrier to efficacy of oncology immunotherapy," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "I am eager to lead this clinical trial, which if successful, will serve as the basis for a new approach to increase efficacy of drugs such as Herceptin and checkpoint inhibitors."

"Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015," said Famela Ramos, President and Chief Executive Officer of Res Nova Bio. "We are excited to leverage these deep and broad resources to rapidly enter the clinic to address such a major unmet medical need."

"One of the guiding principles of our Company has been to bring hope to patients for which limited options exist," said Timothy Dixon, President, and Chief Executive Officer of Therapeutic Solutions International. "We strongly believe that immuno-adjuvant approaches such as FloraStilbene will greatly increase the potency of numerous existing therapies, as well as reducing various toxicities."

On March 6, 2023 VieCure, a cancer care company with a market-leading artificial intelligence, informatics, and clinical decision support platform, reported a strategic collaboration with Exact Sciences, a leading provider of cancer screening and diagnostic tests, to improve access to precision oncology diagnostics for patients and community oncologists within the United States (Press release, VieCure, MAR 6, 2023, View Source [SID1234628227]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As part of the agreement, VieCure will facilitate the integration and interpretation of Exact Sciences’ growing portfolio of diagnostic tests into the clinical workflow of its oncology care management platform at the community oncology level, starting with the Oncotype DX Breast Recurrence Score test. VieCure’s proprietary artificial intelligence (A.I.) platform, which prompts clinical rules and guidelines within its interface, will help clinicians interpret test results and provide patient-specific treatment plans.

"VieCure and Exact Sciences, together, are accelerating the adoption of precision oncology in the community cancer care setting," said Dr. Fred Ashbury, Chief Scientific Officer at VieCure. "Our goal through this collaboration is to improve clinical workflow and make it easier for community oncologists to order the right tests and generate patient-specific treatment plans."

Personalizing cancer treatment to respond to the molecular profile of an individual’s cancer is rapidly becoming the standard of care and leading to improved patient outcomes. Exact Sciences’ tests provide critical diagnostic, prognostic, and therapeutic insights to inform patient-specific treatment plans. These data are complex, considerable, and can be difficult to access and interpret in the community oncology setting. Together, VieCure and Exact Sciences aim to help overcome the potential challenges clinicians face in managing the growing amount of genomic information required to care for patients and keep current with rapidly evolving medical guidelines.

"At Exact Sciences, we know that cancer care is complex. Our growing portfolio of precision oncology tests helps doctors and patients determine the most effective treatment plan by providing actionable insights about the molecular makeup of a patient’s specific cancer," said Brian Baranick, general manager of Precision Oncology for Exact Sciences. "By streamlining the workflow, our VieCure partnership will help accelerate access to our test portfolio for community oncologists and their patients."

On March 6, 2023 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and the leader in data-driven medicine, reported the University of Arkansas for Medical Sciences (UAMS), based in Little Rock, AR, will use SOPHiA GENETICS’ platform to support their clinical oncology research (Press release, Sophia Genetics, MAR 6, 2023, View Source [SID1234628225]). Beginning this year, UAMS will implement the SOPHiA DDM platform to gain deeper insights into hematologic malignancies.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As the only health sciences university in the state of Arkansas and the state’s largest public employer, UAMS is a cornerstone of medical research and treatment for the state. SOPHiA DDM is a cloud-based platform that uses Artificial Intelligence with patented technologies and methods to synthesize next generation sequencing (NGS) data. Such synthesis is key to identifying characterizations of disease-causing mutations.

"Our mission at SOPHiA GENETICS is to democratize data-driven medicine, making it more accessible to all," said Ken Freedman, Chief Revenue Officer, SOPHiA GENETICS. "The adoption of SOPHiA DDM for UAMS – Arkansas’ only health sciences university – will benefit the entire state and larger medical community by providing the institution with more comprehensive insights from their data."

Hematologic malignancies such as leukemia, lymphoma, or plasma cell myeloma can move fast. Clinical researchers need to be able to move quickly as well. Having the ability to synthesize NGS data in-house builds local expertise and allows for faster data turnaround, a benefit to both clinical researchers and patients.

Hematological tumors represent the fourth most frequent cancer type in the developed world.1 The SOPHiA DDM for Blood Cancers solution is designed to accelerate and streamline the analyses of blood cancers and positively impact disease management.

"We’re excited to bring this technology to the state of Arkansas," said Philippe Menu, Chief Medical Officer, SOPHiA GENETICS. "One person in the U.S. is diagnosed with leukemia, lymphoma, or myeloma roughly every three minutes2. The SOPHiA DDM for Blood Cancers solution will put increased data at the fingertips of clinical researchers."

For more information on SOPHiA GENETICS, visit SOPHiAGENETICS.COM, or connect on Twitter, LinkedIn, Facebook, and Instagram.

On March 6, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that it will host a virtual Research and Development (R&D) Day on Wednesday, March 22, 2023 at 4:30 pm ET/1:30 pm PT (Press release, Kezar Life Sciences, MAR 6, 2023, View Source [SID1234628224]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Kezar’s R&D Day will provide an extensive overview of the Company’s pipeline, reviewing next steps on zetomipzomib, including the trial design for the Phase 2b portion of the lupus nephritis development program, as well as on its Protein Secretion Inhibition platform. The event will also highlight the recently announced autoimmune hepatitis (AIH) PORTOLA study, including a presentation on the unmet need in AIH and treatment landscape from key opinion leader Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine and Executive Director of the Autoimmune Hepatitis Association.

Presenters:

John Fowler, Chief Executive Officer, Co-Founder
Noreen Roth Henig, M.D., Chief Medical Officer
Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine, and Executive Director of the Autoimmune Hepatitis Association
Neel Anand, D. Phil. (Ph.D.), Senior Vice President, Research and Drug Discovery
To register for this event, please visit the Events & Presentations page of Kezar’s website. On the day of the event, a live webcast and conference call will be accessible from the Events & Presentations page of Kezar’s website. Additionally, a replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About KZR-261 and the Inhibition of Protein Secretion

KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.

Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.

On March 6, 2023 Freenome, a privately held biotech company, reported a subject population analysis from PREEMPT CRC, a study for the detection of colorectal cancer (CRC) at the Western Colorectal Cancer Consortium Conference in Portland, Oregon (Press release, Freenome, MAR 6, 2023, View Source [SID1234628223]).

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According to the American Cancer Society, colorectal cancer is the second-leading cause of cancer-related death. Despite evidence that CRC screening reduces cancer incidence and mortality, screening rates continue to remain below recommended guidelines.

Freenome is in the final stages of development of its blood-based screening test for colorectal cancer. The test uses Freenome’s multiomics platform, which combines tumor and non-tumor signals with machine learning to detect cancer in the earliest, most treatable stages using a standard blood draw. The test is intended to offer an accessible and convenient option for CRC screening.

PREEMPT CRC is the largest prospective study for CRC using a blood-based screening test in the average-risk population and is Freenome’s clinical validation study for the use of its test.

The study’s focus was to enroll subjects that reflected the demographics of the intended use population for a colorectal cancer screening test: average-risk adults between the ages of 45 and 85 across urban and rural communities in the United States. The study enrolled subjects between May 2020 and March 2022. Several mitigations for the impact of COVID-19 were developed and incorporated into overall study plans.

To ensure representation, Freenome integrated forward-thinking enrollment strategies into its clinical study design. The company offered options of virtual enrollment, electronic consenting and mobile phlebotomy that enabled home blood draws for participants who were not geographically close or able to visit a hospital or other study site.

"Our tests are designed for everyone, which means our clinical studies need to demonstrate that representation," said Lance Baldo, M.D. and chief medical officer for Freenome. "Screening saves lives, and our goal is to make screening for CRC easier and more convenient for everyone."

Analysis of results demonstrate enrollment strategies were effective in recruiting an intended-use population. For example, of the study’s participants, 25% enrolled virtually and 7% used the mobile phlebotomy team. Additionally, racial diversity was above historical clinical study participation[1] with approximately 11% Black, 11% Hispanic or Latino and 7% Asian participants.

"From the onset, we wanted this study to be representative of the people of the United States. Making participation convenient was key to drive enrollment, especially during a pandemic. The results of our efforts show it’s possible to have meaningful diversity in clinical trials," said Aasma Shaukat, M.D., study co-lead, professor of medicine and director of outcomes research for the Division of Gastroenterology and Hepatology at NYU Langone Health.

For more information about PREEMPT CRC, visit Freenome’s clinical studies webpage.