On December 1, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward (Press release, Moleculin, DEC 1, 2021, View Source [SID1234596322]). With this IND now cleared, Moleculin plans to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

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The Company believes WP1122 has significant potential as both an antiviral therapy and as a cancer therapy. Moleculin recently announced its plans to initiate a Phase 1a clinical trial of WP1122 in healthy volunteers in the United Kingdom to facilitate future testing in COVID-19 patients. This new US IND sets the stage for parallel development of WP1122 as a cancer therapy. Consistent with its strategy of leveraging external funding for many of its clinical trials, Moleculin intends to seek opportunities for an investigator-initiated clinical trial of WP1122 in cancer patients in 2022.

"This IND underscores our dual pronged approach to the development of WP1122 for the treatment of both certain types of cancers and viruses. In addition to the trial in the UK designed to position WP1122 as an antiviral therapy, we can now be advancing the cancer therapy path in parallel. Along with GBM, we believe WP1122 has the potential to be well suited as a treatment for other highly glycolytic cancers such as pancreatic cancer," commented Walter Klemp, Chairman and CEO of Moleculin.

GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months1. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,2 and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.3 The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.4

1 Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207–12

2 Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, et al. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006–2010. Neuro Oncol. 2013;15 Suppl:2ii–56.

3 De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep 27.

4 Thakkar J, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, et al. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers Rev. 2014;23(10):1985–96.

On December 1, 2021 Genomic Testing Cooperative, LCA (GTC) reported that it will be presenting at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting new data on the use of their proprietary machine learning approaches in the diagnosis of acute graft-versus-host disease (aGVHD) and for the stratifying of patients with diffuse large B-cell lymphoma (DLBCL) based on outcome after treatment with the standard R-CHOP (Press release, Genomic Testing Cooperative, DEC 1, 2021, View Source [SID1234596340]). GTC will also present studies on their liquid biopsy and its reliability in detecting cytogenetic abnormalities in myeloid neoplasms and in monitoring minimal residual disease after stem cell transplant. These studies were performed in collaboration with multiple academic institutions that contributed clinical data. GTC is the only diagnostic company that offers molecular testing based on cooperative (Co-Op) business model. By working with other members of the Co-Op, the company is able to develop and validate tests in efficient ways reducing the cost of testing and innovation. GTC shares the intellectual property rights of three of the four innovative tests with John Theurer Cancer Center and Hackensack Meridian Health, both members of the Co-Op. Dr. Andre Goy, Chairman and Chief Physician Officer at John Theurer Cancer Center, Chairman of Oncology at Hackensack Meridian School of Medicine and Professor of Medicine at Georgetown University said "being a part of the cooperative group at GTC has been extremely productive and enabled John Theurer Cancer Center to offer state-of-the-art precision medicine, not only for selecting therapy but for developing cutting edge approaches for monitoring patients".

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The presented work reflects the current GTC innovation strategy in improving cancer care. GTC uses RNA data and targeted transcriptome generated by next generation sequencing (NGS) along with new machine learning approaches to predict the presence of aGVHD and for stratifying patients with DLBCL. These are examples of how genomics can improve patient care. aGVHD remains a major cause of morbidity and mortality in patients after hematopoietic stem cell transplant. Proper and early diagnosis of this serious complication of transplant will trigger prophylaxis therapy and treatment that may improve outcome. Similarly predicting patients with DLBCL who will not respond well to the current standard R-CHOP therapy will help in selecting different therapeutic approaches and new clinical trials.

GTC is developing new indications in liquid biopsy testing and extensively exploring new technology to improve patient care. ASH (Free ASH Whitepaper) presentations show that their liquid biopsy can reliably predict cytogenetic abnormalities in patient with hematologic neoplasms and can be used for diagnosis and management of patients with myeloid neoplasm. Another presentation shows that liquid biopsy is reliable in monitoring patients after hematopoietic stem cell transplant. Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC stated "GTC was established as a co-op business to improve patient and democratizing genomics through efficient innovation and collaboration". He added "Advances in genomics and machine learning are opening new opportunities in medicine to improve outcome in cancer care. Our new studies that are presented at ASH (Free ASH Whitepaper) are examples of how a cooperative business model can deliver".

Following are the list and dates and times of the presentations:

1)Reliability of Liquid Biopsy and Next Generation Sequencing in Monitoring Residual Disease Post-Hematopoietic Stem Cell Transplant, Saturday, December 11, 2021: 5:30 PM-7:30 PM

2)Bone Marrow-Based Biomarkers for Predicting aGVHD Using Targeted RNA Next Generation Sequencing and Machine Learning , Sunday, December 12, 2021: 6:00 PM-8:00 PM

3)Determining Clinical Course of Diffuse Large B-Cell Lymphoma Using Targeted Transcriptome and Machine Learning Algorithms; Sunday, December 12, 2021: 6:00 PM-8:00 PM
4) Reliability of Cell-Free DNA (cfDNA) Next Generation Sequencing in Predicting Chromosomal Structural Abnormalities and Cytogenetic-Risk Stratification of Patients with Myeloid Neoplasms; Monday, December 13, 2021: 6:00 PM-8:00 PM

On December 1, 2021 SimBioSys, the technology company that predicts tumor responses to therapy, reported that new research on the accuracy and specificity of their simulation software, TumorScope, for breast cancer treatment planning during the 2021 San Antonio Breast Cancer Symposium (SABCS) (Press release, SimBioSys, DEC 1, 2021, View Source [SID1234596358]). The studies covering eight separate posters at SABCS are based on data from both internal and external validation studies of SimBioSys’ proprietary platform. The results include biophysical simulations of neoadjuvant therapy (a preliminary step to begin shrinking a tumor); biological drivers for different racial groups including African Americans vs Caucasians; prognostic responses to identify the patients who will, or will not, benefit from various chemotherapies; and characterization of the tumor’s microenvironment.

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TumorScope is a first-of-its-kind platform combining artificial intelligence with biophysical simulations to model the impact of phenomena such as drug delivery, metabolism, and spatial heterogeneity in a comprehensive model using standard-of-care data alone. The results are generated within minutes, enabling physicians to make a well-informed decision while improving patient experience and shared decision-making. In addition, the technology can support the drug development process across pre-clinical and clinical trial settings.

"Breast cancer continues to be at the forefront of the precision medicine movement, and yet clinicians have been unable to individualize care for patients. Beyond our clinical utility in treatment selection, we are excited to expand TumorScope for use in biopharma for clinical trial optimization and biomarker identification," said John Cole, Ph.D., Chief Scientific Officer at SimBioSys. "Having eight posters accepted at the SABCS speaks to the breadth of our platform. We are proud of the work and the results that our multidisciplinary R&D team has accomplished in breast cancer."

Key SimBioSys studies from the symposium include:

Virtual replication of the NeoSphere trial using SimBioSys TumorScope: Associating standard of care data with clinical outcomes in HER2 positive breast cancer patients to garnish novel insights in silico
Brief Summary: Matched analysis using SimBioSys virtual tumor bank (3000+ patient tumors) and the Neosphere trial created an in silico virtual clinical trial of 144 HER2+ breast cancer patients. TumorScope biophysical simulations were able to predict equivalent rates of pCR and disease progression to the Neosphere trial. In the near future, virtual clinical trials may curtail the need for real-world clinical trials, enabling more efficient drug discovery. (Date/time: Wednesday, 12/8, 5:00 pm – 6:30 pm CT.)
SimBioSys TumorScope: Biophysical modeling of patient-specific response to chemotherapy
Brief Summary: TumorScope constructed 3D in silico tumor models from patient’s pretreatment DCE-MRIs through the combination of a spatial model with vascular data, tumor metabolism, pharmacokinetic and pharmacodynamic models. Validation was performed across 780 breast cancer patients (n=480 with EFS data available). Tumor volumetric response predictions were calculated with an error rate 0.03% and a mean absolute deviation of 8.2% in patients that underwent neoadjuvant chemotherapy. (Date/time: Wednesday, 12/8, 7:00 am – 8:30 am CT.)
Evaluation of the prognostic accuracy of SimBioSys TumorScope in early breast cancer
Brief Summary: Blinded study conducted prospectively using retrospective data with the University of Chicago (n=141) for patients who received neoadjuvant chemotherapy for early stage breast cancer. TumorScope accurately predicted event free survival in patients, comparable to the predictive accuracy of pCR. TumorScope demonstrates utility in guiding escalation and de-escalation of treatment regimens. (Date/time: Thursday, 12/9, 5:00 pm – 6:30 pm CT.)
A transdisciplinary approach for characterizing racial differences in the biology of breast cancer by integrating imaging and -omics data
Brief Summary: Using imaging and transcriptomic data from over 500 patients, TumorScope biophysical modeling software demonstrates how multi-modal imaging and systems biology models of patient tumors shed light on metabolic features that drive differences in response between African American and Caucasian tumors. The data assists with understanding chemotherapeutic drug responses (high spatial heterogeneity of drug delivery and secretion) and improving clinical management. (Thursday, 12/9, 7:00 am – 8:30 am CT.)

On December 1, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will host a meeting for the investment community on Wednesday, Dec. 15, 2021, from 9 a.m. to 4 p.m., Eastern time (Press release, Eli Lilly, DEC 1, 2021, View Source [SID1234596381]).

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Earlier that day, the company will announce its initial financial guidance for 2022, and at the meeting, Lilly leadership will further detail the 2022 financial guidance. A substantial portion of the meeting will cover Lilly’s research and development opportunities, with a focus on the early-phase pipeline, in the areas of diabetes, immunology, neuroscience and oncology.

In-person attendance is by invitation only and advance registration is required. Investors, media and the general public can access a live video webcast through a link that will be posted on Lilly’s website at View Source A replay of the presentation will be available on the website following the meeting.

On December 1, 2021 Physicians in the United States can now order the liquid biopsy-based Target Selector NGS Lung Panel test directly from Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services (Press release, Quest Diagnostics, DEC 1, 2021, View Source,-Expanding-its-Menu-of-Advanced-Cancer-Diagnostics [SID1234596323]). Developed by Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, the lab-developed liquid biopsy test aids genomic profiling in patients with advanced non-small cell lung cancer (NSCLC), helping physicians identify potential targeted therapies and monitor the effectiveness of treatment .

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With a physician’s order, individuals are now able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. Collected specimens will be forwarded to Biocept’s CLIA-certified, CAP-accredited laboratory in San Diego for testing.

The Target Selector NGS Lung Panel contributes to better patient outcomes by providing physicians with direction on therapeutic options for those battling NSCLC. Healthcare providers may perform genomic profiling of tissue to aid their selection and response monitoring of gene-targeted NSCLC therapies. However, patients are not always able to have a tissue biopsy, which can take weeks to produce a result and may be limited by the quality and quantity of tissue that can be collected. Liquid biopsies identify genetic material from tumor cells that are shed and circulate in the blood stream, complementing insights from tissue biopsies and reducing dependence on tissue.

The addition of this blood-based panel to Quest’s advanced diagnostic testing menu enables Quest to provide actionable insights in an easier and less invasive manner, supplementing its services in tissue biopsy.

"By providing Biocept’s Target Selector NGS Lung Panel test under our advanced diagnostics portfolio, Quest will enable more physicians and patients to receive insights necessary to provide the appropriate treatment for NSCLC," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Our relationship with Biocept is the latest example of how Quest’s scale and expertise helps innovators reach larger markets and serve patients most in need."

"Our collaboration with Quest Diagnostics reflects our shared commitment to excellence in oncology diagnostics and allows us to serve more patients nationwide and expand our customer base, with the goal of improving care for those with lung cancer," said Michael Nall, President and CEO, Biocept. "The Target Selector NGS Lung Panel provides critical information to aid in the creation of more personalized treatment plans for patients with NSCLC and help oncologists get the answers they need to provide the best care possible."

Biocept’s multi-gene, tumor-specific NGS Lung Panel allows physicians and researchers to use a simple blood sample to analyze actionable biomarkers associated with specific solid tumor types. It combines Biocept’s liquid biopsy biomarker testing expertise with next generation sequencing and decision support resources. The biomarkers included in the Target Selector NGS Lung Panel are those that physicians frequently rely upon when making treatment decisions for their patients diagnosed with NSCLC. The assay is targeted and actionable—the majority of the biomarkers investigated are based on National Comprehensive Cancer Network guidelines and/or FDA-approved therapies.

Quest Diagnostics is the world’s leading provider of cancer diagnostics, providing physicians and health systems a single source solution via the most comprehensive capabilities in anatomic pathology and molecular diagnostics. Quest’s innovative test menu includes various options for screening, diagnosis, treatment and monitoring recurrence. The company provides a range of pathology services through its AmeriPath and Dermpath specialty businesses.