On December 1, 2021 Freenome, a privately held biotech company, reported a partnership with Siemens Healthineers to collaborate in multiomics and radiomic breast cancer diagnostics to identify suitable markers for early breast cancer detection through blood to augment existing imaging technologies (Press release, Freenome, DEC 1, 2021, View Source [SID1234596326]).

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The partnership leverages Freenome’s expertise in machine learning and multiomics to detect early cancer, utilizing epigenetic, proteomic, genomic, immunologic and other data types to maximize clinical accuracy for future screening tests. This collaboration will allow Freenome and Siemens Healthineers to share their technologies by connecting imaging and clinical data with molecular data to identify new suitable markers of breast cancer that are complementary to those identified using current imaging.

"With their multiomics approach in molecular diagnostics, Freenome is our partner of choice for this study," said Rangarajan Sampath, Head of the Center for Innovation in Diagnostics (CID), Siemens Healthineers. "Our collaboration in the identification and development of new biomarkers will allow us to work together toward a new patient-centric pathway to diagnose early-stage breast cancer."

By modeling Freenome’s multiomics data enabled by artificial intelligence and machine learning based methodologies, researchers seek to identify the most effective biomarkers and molecular features to improve the identification of breast cancer.

"Siemens Healthineers is an established leader in the development of imaging and diagnostic technologies, especially in breast cancer screening with more recent improvements leveraging 3D mammograms or digital breast tomosynthesis," said Mike Nolan, chief executive officer, Freenome. "This collaboration will give us even more insights on how we can incorporate unique data types to address the unmet medical needs for one of the most common cancers."

On December 1, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that it has been granted United States Patent No. 11,185,523, "Use of Bipolar Trans Carotenoids With Chemotherapy and Radiotherapy for Treatment of Cancer," by the United States Patent and Trademark Office (Press release, Diffusion Pharmaceuticals, DEC 1, 2021, View Source [SID1234596325]). This patent includes new claims related to methods of treating cancerous tumors by administering the Company’s lead product candidate, trans sodium crocetinate ("TSC"), in combination with radiation therapy and chemotherapy.

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"We believe the issuance of this patent represents another important step in our development of TSC and provides us with additional intellectual property protection to support the design and execution of our recently announced clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors," said Robert J. Cobuzzi, Jr., Ph.D., President and Chief Executive Office of Diffusion.

On December 1, 2021 Adare Pharma Solutions ("Adare"), a technology-driven contract development and manufacturing organization (CDMO), reported the acquisition of Frontida BioPharm ("Frontida"), a vertically integrated CDMO focused on oral formulations (Press release, Frontida Biopharm, DEC 1, 2021, View Source [SID1234596324]). The acquisition reinforces Adare’s commitment to transform drug delivery by providing world class solutions from product development through commercial scale manufacturing and packaging. Adare’s portfolio of offerings for its customers will expand to include new capabilities such as high potency compound handling and packaging services. The combination of the two organizations will further establish Adare as a leader in the development and manufacturing of life saving medications in complex dosage forms.

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Vivek Sharma, Chief Executive Officer of Adare, commented, "We are devoted to improving the quality of life for patients by solving the most complex formulation challenges for our customers, and we believe this acquisition will bolster our ability to achieve our mission. Frontida and Adare share a commitment to quality and innovation, and we are excited to continue growing together. The combined company will lead in the space of oral formulations, while expanding the services and technical offerings we provide to meet the needs of our customers and their patients."

Dr. Song Li, Frontida’s Chairman added, "We are very excited about the opportunities this transaction is expected to provide to both existing and new clients. Our combined resources and capabilities will result in enhanced support and talent to ensure the success of their development and commercialization programs. This transaction is also a testament to the hard work, dedication, and caring culture of the team who has helped Frontida grow, enabling continued investment into the Philadelphia area, which is a respected home for pharmaceutical development and manufacturing. We look forward to continuing our work together to provide innovative, life-enhancing products to the US and global markets."

Together, the combined company will offer an expanded suite of solutions for complex oral formulations, such as taste masking, controlled release, high potency formulation manufacturing, and bioavailability enhancement. The addition of Frontida brings Adare’s manufacturing footprint to seven sites globally and expands Adare’s integrated, end-to-end offering to its partners. The combined organization will be led by Vivek Sharma.

Adare is backed by private equity firms Thomas H. Lee Partners and Frazier Healthcare Partners. RBC Capital Markets, LLC acted as exclusive financial advisor to Adare for this transaction.

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.

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.