On June 5, 2024 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of its new digital PCR (dPCR) Custom Assay Design Tool for copy number variation (CNV) analysis for use on its digital PCR platform QIAcuity and several other enhancements in its GeneGlobe Design and Analysis Hub, a comprehensive research platform that integrates pre-designed assays with a database of more than 10,000 biological entities including genes, miRNAs, and pathways (Press release, Qiagen, JUN 5, 2024, View Source [SID1234644137]). The new advancements aim to support customers with a wide range of assay customization options, from simple to complex and validated multiplex assays, while further improving the user experience.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Genetic research is moving fast, and new target genes are rapidly evolving that are not covered by standard or pre-designed assays. To keep pace and close the need gap, the new digital PCR Custom Assay Design Tool has been developed as an interface on the GeneGlobe platform. It enables customers to design and order assays for use on QIAGEN’s digital PCR platform QIAcuity outside of QIAGEN’s comprehensive catalog of over 200 wet-lab validated assays for copy number variations profiling in translational cancer research. Copy number variations (CNVs) are a type of genetic variation where specific segments of the DNA are copied more or fewer times than normal in the genome, potentially affecting susceptibility to diseases and response to treatment.

"As certain copy number variations are associated with cancer, studying them can improve the understanding of how these variations can affect health and the responsiveness to treatments. It is therefore crucial for advancing precision medicine," explained Nitin Sood, Senior Vice President, Head of the Life Science Business Area at QIAGEN. "Our new digital PCR Custom Assay Design Tool in GeneGlobe provides researchers with an innovative and user-friendly tool to design customized assays for QIAcuity tailored to their specific needs, streamlining research and accelerating scientific discovery."

Additional enhancements of GeneGlobe have been launched recently or are currently in development. These include more user-friendly design pages that simplify product selection and a new tool for creating, saving and editing target gene lists, supporting researchers in creating their own panels, even collaboratively. Thanks to a software update, pathway maps from QIAGEN’s Ingenuity Pathway Analysis are now rendered faster. QIAGEN is working on improving the searchability of pathways and pathway relationships and plans to expand the interactivity of pathway diagrams, facilitating the import of selected genes into the GeneGlobe Custom Panel Design tools.

QIAGEN is building a strong pipeline for customization and plans to expand the dPCR Custom Assay Design Tool capabilities to microbial and somatic mutation assays later in 2024. When customers seek higher-order multiplexing or more complex assays, QIAGEN Genomic Services offers expert custom assay design support and assays are made available in GeneGlobe.

About GeneGlobe

QIAGEN’s proprietary research platform GeneGlobe provides researchers with easy access to an extensive range of molecular biology tools, pre-designed assays and customizable design services. The platform streamlines the process of identifying, selecting, and customizing assays, panels and pathway maps tailored to specific research needs while continuously updating its content to ensure researchers stay up to date with the latest advancements in their respective fields.

Learn more about QIAGEN’s GeneGlobe Design and Analysis Hub and the latest advancements at View Source

About QIAcuity

QIAGEN’s digital PCR platform QIAcuity uses nanoplates to disperse a sample over thousands of tiny partitions and then reads the reaction in each one simultaneously to quantify even the faintest signals from DNA and RNA. This enables specific, sensitive, and rapid detection of small copy number changes up to 5-plex.

The highly versatile QIAcuity systems integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six and are available in one, four and eight-plate versions. While the one-plate version processes up to 384 samples in an eight-hour shift, the eight-plate version processes up to 1,248 samples in the same time period. At the end of 2023, more than 2,000 cumulative instrument placements had been made.

On June 5, 2024 Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that it has completed enrollment in the pivotal Precision-T Phase 3 clinical study (Press release, Orca Bio, JUN 5, 2024, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-completion-of-patient-enrollment-for-the-precision-t-phase-3-study-of-orca-t [SID1234644135]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A randomized, open-label multicenter study, Precision-T (NCT05316701) is evaluating the safety and efficacy of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to a standard of care allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Orca-T is a donor-derived product designed to replace a patient’s diseased blood and immune system with a healthy one.

"Completing enrollment in our multicenter Phase 3 study of Orca-T is an important milestone toward our ultimate goal of delivering a potentially life-saving product to patients who have long had to settle for a standard of care that carries significant risks," said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. "We’re immensely grateful to the patients, their families and the trial site investigators who participated in our study, and look forward to sharing pivotal data in the near future with the broader blood cancer community."

The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). Secondary endpoints include time to moderate-to-severe chronic GvHD, graft-versus-host-disease and relapse-free survival (GRFS) and overall survival. Topline results from the study are expected in the first half of 2025. The study has enrolled 187 patients, exceeding the original target of 174 patients.

Orca-T is designed to deliver improved outcomes for patients while overcoming the limitations of standard alloHSCT, which carries the risk of serious complications and treatment-related mortality. Orca-T uses highly purified regulatory T cells with the goal of reducing the tradeoff between the risk of relapse and the risk of serious toxicity, a primary objective of the cell therapy field. Orca-T has demonstrated promising results in early single-arm trials which were recently presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting the Annual Meeting of the EBMT, the 2024 Tandem Meetings of ASTCT and CIBMTR and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

More information about the Precision-T study can be found at www.precisiontstudy.com or www.clinicaltrials.gov.

On June 5, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported that Caroline Loew, Ph.D., CEO, will present at the East Coast IDEAS Investor Conference on June 13 at 9:15 a.m. EST (Press release, Mural Oncology, JUN 5, 2024, View Source;1-investor-meetings-14th-annual-east [SID1234644128]). A webcast will be available at www.threepartadvisors.com/east-coast and ir.muraloncology.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

About IDEAS Investor Conferences

The mission of the IDEAS Conferences is to provide independent regional venues for quality companies to present their investment merits to an influential audience of investment professionals. Unlike traditional bank-sponsored events, IDEAS Investor Conferences are "SPONSORED BY INVESTORS. FOR INVESTORS" and for the benefit of regional investment communities. Conference sponsors collectively have more than $200 billion in assets under management and include: 1102 Partners, Adirondack Research and Management, Allianz Global Investors: NFJ Investment Group, Ariel Investments, Aristotle Capital Boston, Ascend Wealth Advisors, Barrow Hanley Mewhinney & Strauss, BMO Global Asset Management, Constitution Research & Management, Inc., Diamond Hill, First Wilshire Securities Management, Inc., Granahan Investment Management, Great Lakes Advisors, Greenbrier Partners Capital Management, LLC, Hodges Capital Management, Ironwood Investment Management, Keeley Teton Advisors, Luther King Capital Management, Marble Harbor Investment Counsel, North Star Investment Management, Perritt Capital Management, Punch & Associates, Shepherd Kaplan Krochuk, Westwood Holdings Group, Inc., and William Harris Investors. The IDEAS Investor Conferences are held annually and are produced by Three Part Advisors, LLC. Additional information about the events can be located at View Source

On June 5, 2024 Model Medicines, a leading human health company specializing in generative AI-driven drug discovery, reported the nomination of preclinical candidate MDL-4101, a novel-acting small molecule inhibitor of bromodomain-containing protein 4 (BRD4), for the treatment of thyroid and other cancers (Press release, Model Medicines, JUN 5, 2024, View Source [SID1234644127]). MDL-4101 demonstrates the company’s commitment to leveraging AI to discover novel therapies for aggressive cancers with high unmet medical needs. In particular, MDL-4101 was discovered and the BRD4 program [4] was launched to overcome the limitations of previous BRD4 therapeutics, which have failed to reach the pharmacy [5].

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The nomination of MDL-4101 resulted from Model Medicines’ proprietary AI-driven drug discovery platform, GALILEO, modeling the epigenetic oncology target BRD4, a promising but difficult therapeutic target. BRD4, a member of the bromodomain and extra-terminal (BET) protein family, has emerged as a highly validated therapeutic target across a wide range of cancers. As a key regulator of oncogene expression, BRD4 has been shown to drive tumorigenesis in multiple solid and hematologic malignancies, including breast cancer, prostate cancer, leukemias, and lymphomas. Despite this broad potential, BRD4 has proven challenging to drug selectively, leading to safety and tolerability issues, and has been labeled as difficult to drug, or undruggable, due to the inability of conventional approaches to yield selective and tolerable inhibitors. To date, no selective BRD4 inhibitor has received regulatory approval, underscoring the urgent need for new modalities to effectively target this high-value protein [6-10].

Model Medicines deployed its proprietary GALILEO platform to discover and design MDL-4101 as a selective BRD4 inhibitor that could overcome the limitations of previous programs. By leveraging machine learning to explore vast chemical space and predict drug-like properties, Model Medicines successfully identified MDL-4101 as a potent, selective, and orally bioavailable BRD4 inhibitor, succeeding where traditional approaches have struggled. MDL-4101 demonstrates BRD4 binding in cell free assay [11] and robust anti-tumor activity in a preclinical model of thyroid cancer (CGTH-W-1)[12], suppressing cell proliferation and metastatic capacity. Additionally, preclinical studies have shown evidence of activity in human glioblastoma, prostate, and testicular cancers.

"The successful nomination of MDL-4101 as our first preclinical oncology candidate is a significant milestone for Model Medicines and underscores the unparalleled ability of our AI platform to solve previously intractable challenges in drug discovery," said Daniel Haders, Ph.D., CEO and founder of Model Medicines. "BRD4 is a target that has long captivated drug hunters due to its central role in cancer, but has evaded their grasp. By leveraging AI to intelligently discover and design compounds with optimal properties, we discovered a molecule in MDL-4101 that potentially unlocks the full potential of BRD4 inhibition. We believe this is just the beginning of what our AI-powered approach can achieve against undruggable targets in oncology and beyond."

Thyroid cancer is the most common endocrine malignancy and the tenth most common cancer in the world, accounting for an estimated 586,000 cases worldwide in 2020 [13]. Thyroid cancer is also the fifth most common cancer type in the US, with 44,000 cases in 2022 [13, 14]. BRD4 is found to be up-regulated across many human thyroid cancers and cancer models [15]. The most common subtypes include the differentiated thyroid cancers papillary thyroid carcinoma (PTC) and follicular thyroid carcinoma (FTC), which have good prognosis with early intervention [16]. However, treatment options for more aggressive forms, such as anaplastic thyroid carcinoma (ATC) and subtypes such as squamous cell carcinoma of the thyroid (SCCT), remain limited and challenging. Today’s reported results evaluated MDL-4101 in a BRD4-enriched human thyroid cancer model (CGTH-W-1) that was derived from a sample of metastatic SCCT, which has a five-year survival rate of only 6.4% [17]. SCCT is a very aggressive tumor with a poor prognosis. The most recommended treatment involves surgical resection with adjuvant radiotherapy and chemotherapy despite its poor reported outcomes​ [18]. Thus, there is a high unmet medical need for novel therapeutic interventions.

"The preclinical data for MDL-4101 in human thyroid cancer is highly encouraging and speaks to the immense promise of a selectivBRD4 inhibitor," said Dr. Launa Aspeslet, Senior Scientific & Clinical Advisor to Model Medicines. "By unleashing the untapped potential of BRD4 inhibition, we believe MDL-4101 could represent a transformative advance for patients with thyroid and other BRD4 related cancers who currently face a paucity of effective treatment options. We are excited to rapidly progress MDL-4101 into first-in-human studies, while exploring its potential in other cancers driven by BRD4."

Model Medicines plans to initiate Investigational New Drug (IND) enabling studies for MDL-4101, with the goal of submitting an IND application to the U.S. Food and Drug Administration (FDA) and initiating a Phase 1 clinical trial in patients in the near future.

On June 5, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Robert M. Davis, chairman and chief executive officer, and Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, are scheduled to participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 10:00 a.m. EDT (Press release, Merck & Co, JUN 5, 2024, View Source [SID1234644126]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.