On January 13, 2020 Genome & Company (KONEX: 314130) is reported that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications (Press release, Genome & Company, JAN 13, 2020, View Source;company-announces-a-clinical-trial-collaboration-and-supply-agreement-with-merck-kgaa-darmstadt-germany-and-pfizer-300985435.html [SID1234553121]).

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Under the terms of this agreement, Genome & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.

The combination trial is designed to be a first-in-human (FIH) study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

"GEN-001 has been developed as the backbone of Genome & Company’s immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck KGaA, Darmstadt, Germany and Pfizer on this phase 1/1b clinical trial for this combination of GEN-001 and avelumab. We are excited to investigate how the preclinical data of this combination will be translated to humans. We look forward to initiating this clinical trial in the coming months," said Dr. Jisoo Pae, CEO of Genome & Company.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

About GEN-001

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

On January 13, 2020 Imaging Endpoints reported that the U.S. Patent and Trademark Office has issued Patent No. 10,332,634 – "Systems And Methods For Reliably Diagnosing Breast Cancer Using Quantitative Textural Analysis" to Imaging Endpoints and its inventor, Chief Medical Officer Ron Korn, M.D., PhD (Press release, Imaging Endpoints, JAN 13, 2020, View Source [SID1234553120]).

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This breakthrough radiomic evaluation tool allows for rapid diagnosis of the nature of a patient’s breast abnormalities from standard mammography images. The technology enables a real-time evaluation that is otherwise available only through an invasive biopsy and avoids the time involved in obtaining and processing the biopsied tissue.

Imaging Endpoints is honored and excited to share with the market this patented technology that could provide patients and physicians the advantage of faster, less invasive information that is critical to treatment decisions and patient outcomes.

Imaging Endpoints is a pioneer and global leader in the non-invasive interrogation of tumors and diseased tissues by analyzing diagnostic images to identify imaging patterns linked to tumor biology. In cancer patients, image analysis provides a non-invasive, low-risk approach to assessing tumor biology prior to therapy and an objective pathway for monitoring treatment responses. The method of using signals detected on image data to characterize tumor biology is based on underlying tumor biology, growth kinetics and other drivers of oncologic transformation which may have novel expression patterns on standard of care radiological images. When used alone or in combination with other factors, a unique imaging phenotype may be developed to characterize lesions using both qualitative and quantitative approaches. Thus insights into the biologic processes of tumors may be measured, derived, inferred or predicted with the discovery of imaging phenotypes. This coupled with imaging’s ability to provide a comprehensive and real-time assessment of the entire tumor and its micro-environment make quantitative imaging an attractive tool for rapid assessment and prognosis.

The Breast Imaging Reporting and Data System (BI-RADS) was established by the American College of Radiology to assign mammogram screenings into discrete categories of perceived severity. A follow-up biopsy is typically recommended for BI-RADS category 4 and higher. However, biopsies ultimately confirm that many BI-RADS 4 designations are benign. Consequently, many women undergo painful and expensive biopsies only to find that the tumor is benign due to the rate of false positives.

Ronald Korn, M.D., PhD commented: "A reliable imaging signature for differentiating between malignant and non-malignant BI-RADS 4 mammographic lesions has remained elusive until now. The Imaging Endpoints invention provides a biomarker signature for determining whether a lesion identified in a breast image is malignant. The signature is derived from processing mammography data using a Quantitative Textural Analysis platform (TexRAD); generating respective histograms and related quantitative metrics, and performing logistical regression to yield a model predictive signature. Imaging Endpoints believes that its technology offers a real-time advantage with rapid results, however additional studies are needed to further validate the correlation of the signature with pathologic variables."

Imaging Endpoints currently offers imaging CRO services for the use of its advanced imaging technologies in clinical trials, and is actively seeking partners to commercialize its technologies for routine patient care.

On January 13, 2020 Contextual Genomics, a leading cancer genomics company, and Lab Genomics, a personalized medicine company providing state of the art molecular genetic testing in Southern California, reported that they have signed an agreement enabling Lab Genomics to offer Contextual Genomics’ quality assured Next Generation Sequencing (NGS) based ctDNA cancer genomic testing to patients in Southern California and other parts of the United States (Press release, Contextual Genomics, JAN 13, 2020, View Source [SID1234553119]).

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Under the terms of their agreement, Lab Genomics will offer the FOLLOW IT panel, a test detecting cell-free circulating tumour DNA in plasma to patients diagnosed with cancer. The FOLLOW IT panel is a multiplex, NGS genomic assay designed for rapid deployment into labs around the world. The FOLLOW IT assay evaluates the mutation status of cell-free circulating tumour, identifying the somatic mutations that have the greatest potential to impact treatment decisions.

Michael Ball, Contextual Genomics’ Chief Executive Officer, said "We are pleased to announce this important relationship with Lab Genomics. The availability of quality-assured cost-effective rapid turnaround time ctDNA testing as a result of this partnership will be of tremendous benefit to many patients suffering from solid tumour cancers, avoiding the need for more invasive tissue biopsies. We look forward to working with Lab Genomics to bring this more precise personalized care to cancer patients within their territory."

"At Lab Genomics, our mission is to deliver a suite of unmatched molecular diagnostic services to our customers, to provide preventive, predictive, personalized services," said Leena Dalal, Founder of Lab Genomics. "This partnership with Contextual Genomics, adding FOLLOW IT liquid biopsy cancer testing for our customers, provides a critical less invasive alternative testing option for cancer patients where tissue biopsy is difficult or not available. We look forward to continuing to support the best quality of life possible for all patients and FOLLOW IT will be an important part of our oncology offering."

On January 13, 2020 InterVenn Biosciences reported multiple achievements in its development of AI-enabled glycoproteomics, as it looks to solving difficult challenges in various disease areas of unmet medical need (Press release, InterVenn Biosciences, JAN 13, 2020, View Source [SID1234553118]). Over the last 12 months, InterVenn has received positive interim results from its first clinical trial (V.O.C.A.L.) evaluating a new, simple blood test for the care of patients with ovarian tumors; secured partnerships with seven leading cancer research organizations, including the University of Iowa and the Parker Institute for Cancer Immunotherapy, to develop novel approaches in immuno-oncology; and made a freemium version of its proprietary, AI-powered mass spectrometry analysis software, OpenPIP, publicly available to the research community. In the coming weeks, InterVenn will complete a move to a new facility in South San Francisco, with research laboratories capable of high throughput sample processing to expand the company’s repertoire of interrogating additional indications, as well as a CLIA-CAP-accredited facility.

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"Until now, glycoproteomics has been considered simply too complex to lend itself to discovering and applying meaningful information to help patients, despite its huge promise that we have been aware of for a long time," said Aldo Carrascoso, Chief Executive Officer of InterVenn Biosciences. "We have made it our absolute priority to interface our technology with a number of key institutional and industry players to deploy and validate our array of AI- and deep machine learning-based tools to allow transitioning the powerful realm of glycoproteomics into an actionable armamentarium for patient care and drug discovery. This will enable us to massively accelerate all of our partners’, collaborators’, and alliances’ workflows."

Over the last 15 years, glycobiology has developed into an increasingly solid scientific discipline, based on the seminal work of Professors Carolyn Bertozzi (Stanford) and Carlito Lebrilla (UC Davis), both of whom helped co-found InterVenn and are serving as members of the company’s Scientific Advisory Board. InterVenn has demonstrated that combining proteomics with glycomics, along with relevant phenotypical annotations and a powerful bioinformatics approach, affords critical advances in biomarker and target discovery not realized with other technologies. InterVenn’s approach to glycoproteomics leverages the power of ultra-high-pressure- liquid-chromatography, coupled-mass-spectrometry for high-resolution, accurate-mass generation of post-translational protein modification data with the prowess of artificial intelligence and machine learning technology to streamline and expedite the processing and analysis of these data. At the same time, InterVenn’s algorithms ensure that the vagaries and variabilities inherent in any clinical study – from patient recruitment bias/variability, sample collection, sample processing, all the way to instrument measurements – are minimized, and the results are reproducible. OpenPIP, the company’s AI-enabled mass spec analysis software, dramatically reduces the time and cost of integrating and quantifying mass spectrometry data while increasing the quality of output and interpretation by eliminating observer-based bias.

InterVenn’s study investigating its leading product, a clinical decision-making tool for ovarian cancer aimed at distinguishing malignant pelvic tumors from benign ones, with neither compromising diagnostic accuracy nor subjecting women to undergoing potentially unnecessary and harmful surgery, is currently actively enrolling patients in a multicenter, international clinical trial (V.O.C.A.L.) in the U.S., Australia, and Southeast Asia, with interim results indicating that the InterVenn test performs significantly better than the currently most widely used ovarian cancer test, CA 125, in terms of both specificity and sensitivity. InterVenn expects to complete enrollment and receive preliminary data from the V.O.C.A.L. trial in late 2020.

In the fall of 2019, InterVenn added Klaus Lindpaintner, M.D., MPH, FACP, FACMG, to the team as Chief Scientific Officer and Chief Medical Officer, a role in which he will lead all of InterVenn’s global scientific operations and clinical affairs. Dr. Lindpaintner is spearheading collaborations with a number of institutional and industry partners with the promise of finding new, actionable diagnostic and therapeutic approaches for a broad spectrum of diseases. Klaus also oversees both InterVenn’s Scientific and Medical Advisory Boards, notable members of which include Giuila Kennedy, Ph.D., Chief Scientific Officer and Chief Medical Officer of Veracyte; and Tony Wyss-Coray, Ph.D., Professor of Neurology & Neurological Sciences at Stanford University School of Medicine, among other luminaries.

"We have known for some time that diseased cells exhibit different protein glycosylation patterns compared to healthy cells, but the scientific community has so far been unable to accurately, and on a real-time scale, quantify and monitor what these changes are, how they occur, and how they specifically relate to disease biology," said Dr. Lindpaintner. "With InterVenn’s technology’s powerful platform of wet- and dry-lab tools, we have reached the inflection point where technological advances meet biological complexity to reveal unprecedentedly powerful insights into pathobiology that have been elusive for so long."

To find out more about InterVenn Biosciences and how the company is leveraging artificial intelligence and mass spectrometry to the transformation of medical technology, visit View Source For all general and media inquiries about InterVenn Biosciences, please contact Andrea Vuturo at [email protected].

On January 13, 2020 Geneoscopy, Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal (GI) health, reported that its preventive screening test for colorectal cancer and precancerous adenomas earned FDA Breakthrough Device Designation (Press release, Geneoscopy, JAN 13, 2020, View Source [SID1234553116]). The agency’s Breakthrough Devices program expedites the development and prioritizes the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions to provide patients and health care providers with timely access to these technologies.

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Geneoscopy’s preliminary data indicate that its screening test could provide a more effective method for early detection of advanced adenomas, thereby facilitating the removal of precancerous lesions that have the highest propensity for malignant transformation. Geneoscopy’s device could significantly reduce morbidity associated with the second deadliest cancer in the United States by detecting advanced adenomas at a higher rate than existing screening tests and preventing the development of colorectal cancer.

"Reduction in morbidity is the best way to reduce mortality associated with colorectal cancer," said Erica Barnell, CSO of Geneoscopy. "We are excited that the FDA has recognized the potential for Geneoscopy’s test to improve the health of the more than 100 million Americans recommended for colorectal cancer screening."