On June 13, 2023 Foresight Diagnostics, the leader in ultrasensitive minimal residual disease (MRD) detection technology, reported that Mark Roschewski, MD, of the National Cancer Institute, part of the National Institutes of Health, will present pooled data from six recent clinical studies on June 14th at the 17th International Conference on Malignant Lymphoma in Lugano, Switzerland (Press release, Foresight Diagnostics, JUN 13, 2023, View Source [SID1234632679]).

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"We are thrilled to have the opportunity to share data from these impactful clinical studies at the upcoming International Conference on Malignant Lymphoma," said Jake Chabon, Ph.D., CEO and co-founder of Foresight Diagnostics. "Our goal at Foresight Diagnostics is to improve patient care by providing industry-leading MRD testing. The study being presented by Dr. Roschewski shows that our PhasED-Seq technology is on the path towards achieving that goal by providing information that physicians could potentially use to make important treatment decisions for their patients. We are grateful to Dr. Roschewski for presenting this important work and to all the authors, patients, and families who make studies like this possible."

The abstract to be presented by Dr. Roschewski is based on six pooled frontline clinical studies that used Foresight Diagnostics’ ultrasensitive PhasED-Seq technology to quantify MRD in 365 samples from 141 patients with diffuse large B-cell lymphoma (DLBCL). Samples were taken at timepoints before, during, or at the end of treatment and were profiled using PhasED-Seq at either Foresight Diagnostics’ CLIA laboratory or Stanford University. When MRD status at a variety of time points before, during, and after treatment were compared to clinical outcomes, the authors found that MRD status at the end of treatment identified patients at the highest risk of progression. Importantly, PhasED-Seq was significantly more sensitive than PET/CT imaging at the end of treatment for identifying patients who later relapsed, with PhasED-Seq correctly identifying 90% of patients who later relapse compared to 45% of patients identified by PET/CT. These results suggest that MRD measured using PhasED-Seq at the end of treatment is highly prognostic in patients with DLBCL and that ultrasensitive assays like PhasED-Seq should be considered in the revised Lugano response criteria.

Podium Presentation Information:

Abstract Number: 112
Abstract Title: MRD-Negativity After Frontline DLBCL Therapy: Pooled Analysis of 6 Clinical Trials
Presenting Author: Mark Roschewski, MD, Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD
Session Date: Wednesday, June 14, 2023, at 9:20 AM GMT (5:20 PM CEST); "Focus On…" Session – Liquid Biopsy and Minimum Residual Disease, Auditorium

On June 13, 2023 Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US (Press release, Biostar, JUN 13, 2023, View Source [SID1234632677]). This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al.

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Unmet Medical Need

With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need.

Advantage for Oral Administration

UTD2 is the world’s first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it’s not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs.

Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world."

About UTD2 and Utidelone

UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO (Free ASCO Whitepaper) annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer.

About BG02-2201 Study

BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients.

On June 13, 2023 Sirnaomics Ltd. (the "Company"; stock code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Company will present the latest developments on GalAhead, a GalNAc-RNAi therapeutic platform, and its pipeline programs, at three international industry conferences taking place in June: the Precision in Drug Discovery & Preclinical Summit, RNA Therapeutics USA, and 19th Drug Discovery Nexus (Press release, Sirnaomics, JUN 13, 2023, View Source [SID1234632676]).

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The Company’s first GalAhead-based RNAi drug candidate, STP122G, has started a Phase I clinical trial in May 2023. The start of the trial indicates that Sirnaomics’ proprietary GalNAc RNAi platform technology, GalAhead, has the potential to help patients with high unmet needs in the areas of hematologic, cardiometabolic, immunologic and rare disorders.

Precision in Drug Discovery & Preclinical Summit Oral Presentation Details

Presentation Title: A Novel Therapeutic GalNAc-RNAi Platform to Downregulate Single and Multiple Genes
Presenter: Dmitry Samarsky, PhD, Sirnaomics Chief Technology Officer
Time/Date: 2:55 pm-3:20 pm ET on Tuesday, Jun 13, 2023
Location: Revere Hotel, Boston, USA
RNA Therapeutics USA Oral Presentation Details

Presentation Title: GalAhead: a novel therapeutic GalNAc-RNAi platform to downregulate single and multiple Genes
Presenter: Jim Weterings, PhD, Sirnaomics Senior Director of Technology Innovation
Time/Date: 3:10 pm-3:50 pm ET on Thursday, June 15, 2023
Location: Horton Grand Hotel; San Diego, USA
19th Drug Discovery Nexus Oral Presentation Details

Presentation Title: GalAhead: A Novel Therapeutic GalNAc-RNAi Platform to Downregulate Single and Multiple Genes
Presenter: Jack Wei, PhD, Sirnaomics Senior Director of Drug Discovery
Time/Date: 3:15 pm -3:40 pm ET on Friday, June 16, 2023
Location: Holiday Inn Express – Arena Towers; Amsterdam, Netherlands
About the GalAhead Technology

The GalAhead is a proprietary technology platform for RNAi therapeutics, developed by Sirnaomics. The GalAhead platform relies on unique RNA structures that allow the knockdown of single or multiple distinct mRNA targets, specifically two key technological components: mxRNA (miniaturized RNAi triggers) and muRNA (multi-unit RNAi triggers). mxRNAs are comprised of single ~30 nt long oligonucleotides to downregulate individual genes, while muRNA molecules are comprised of multiple oligonucleotides to silence two or more targets simultaneously. The targeted delivery technology has demonstrated specific liver hepatocyte targeting via a cell surface receptor ASGPR.

On June 13, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported that it will host an R&D Event to discuss the pipeline expansion and the evolution of its end-to-end platform on Tuesday, June 20, 2023, at 10:00 am ET (Press release, MediGene, JUN 13, 2023, View Source [SID1234632673]). A live Q&A session will follow the formal presentations and discussions.

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The company’s leadership team will be discussing the evolution of Medigene’s end-to-end platform and their exciting pipeline expansion into neoantigens with programs targeting multiple KRAS (Kirsten rat sarcoma viral oncogene homologue) mutations and HLAs (human leukocyte antigens), focused on developing differentiated, best-in-class T cell receptor-engineered T cell (TCR‑T) therapies for multiple solid tumor indications.

Attendees are invited to listen to the presentations and discussions exploring the unmet needs in the treatment of solid tumors.

Full details for the webcast and registration are as follows:

Date: June 20, 2023
Time: 10:00 am ET
Location: Virtual
Webcast registration: View Source

Following the call, an archived webcast will also be accessible on the Investors & Media section of the Medigene website View Source

On June 13, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that the Company will host a virtual KOL event, "A New Vista for Cancer Care: Exploring SNS-101’s Potential as a Transformative Treatment Option for Patients with Solid Tumors," on Tuesday, June 27, 2023 at 2:00 p.m. ET (Press release, Sensei Biotherapeutics, JUN 13, 2023, View Source [SID1234632670]).

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The event will feature James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology at the National Cancer Institute (NCI), who will provide an overview of the unmet medical need in solid tumors and the current immuno-oncology treatment landscape, and discuss the potential for Sensei’s lead candidate, SNS-101, a conditionally active VISTA-blocking antibody, to improve treatment outcomes for patients with solid tumors.

Sensei management will provide insight into the preclinical mechanism and profile of SNS-101, and present an overview of the SNS-101 clinical program, including collaborating with the NCI as a site for the Phase 1/2 SNS-101 clinical trial. Sensei recently announced that the first patient has been dosed in the trial at a starting dose of 0.3 mg/kg.

Participants may register in advance for the event online. A recording of the presentation will be made available on the Sensei website following the event.

The event will conclude with a live Q&A session. If you would like to ask a question during the live Q&A, please submit your request to [email protected].

James Gulley, M.D., Ph.D., FACP, is an internationally recognized expert in cancer immunotherapy with a strong interest in prostate cancer. Since 1998 he has authored and run a variety of clinical trials at the National Cancer Institute (NCI). These innovative, investigator-initiated studies involve the use of cancer immunotherapy to (a) initiate immune responses, (b) expand immune responses and/or (c) allow the immune responses to be effective within the tumor microenvironment. In addition to his role as the CIO Co-Director, Dr. James L. Gulley is the Acting Clinical Director, NCI.