On January 12, 2022 GenomOncology reported that GenomOncology (GO) Pathology Workbench has been selected by Labcorp’s OmniSeq to support the analysis and reporting of OmniSeq INSIGHT℠, a comprehensive genomic and immune profiling test for solid tumors (Press release, GenomOncology, JAN 12, 2022, View Source [SID1234598644]).

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!

OmniSeq INSIGHT combines genomic and immune profiling to comprehensively characterize a patient’s tumor to identify potential treatment and clinical trial options. OmniSeq INSIGHT examines the full coding region of 523 genes by next generation sequencing for mutations, copy number alterations, fusions microsatellite instability (MSI), tumor mutation burden (TMB), and expression of 64 immune genes in the tumor microenvironment. The test also includes PD-L1 by immunohistochemistry.

"Our partnership with GenomOncology has advanced our ability to efficiently classify variants, match therapies and identify trials located within 200 miles of the patient’s home," says Shengle Zhang, MD, Laboratory Director of OmniSeq. "This highly customized laboratory information system supports OmniSeq’s competitive turnaround time of matched precision medicine options to ordering clinicians for their cancer patients."

To streamline variant review, interpretation, and case reporting, OmniSeq implemented the highly customized GO Pathology Workbench. Central to the GO Pathology Workbench’s function is a proprietary, algorithmically-driven database of evidence and guideline-based therapeutic options and clinical trials. The results are displayed in the comprehensive OmniSeq INSIGHT test report.

"The adaptability and versatility of the GO Pathology Workbench enabled us to efficiently customize the workbench to accommodate the unique features of the OmniSeq INSIGHT test. By providing the knowledge and evidence needed for effective variant interpretation, GO Pathology Workbench provides a tool to support OmniSeq INSIGHT’s swift turnaround time," said Matt Stachowiak, PhD, Director of Product Management at GenomOncology.

In June 2021, Labcorp (NYSE: LH), a leading global life sciences company, acquired OmniSeq. OmniSeq INSIGHT is available to U.S.-based clinicians exclusively through Labcorp, and across Canada through Dynacare, a Labcorp company. The test is also available to global biopharmaceutical companies exclusively through Labcorp Drug Development. For more information about OmniSeq INSIGHT, visit oncology.labcorp.com/omniseq.

On January 12, 2022 Samsung Biologics (KRX: 207940.KS) reported its sustainable growth plan for this year at the 2022 Annual JP Morgan Healthcare Conference, which is held virtually from January 10th to 13th with leaders from major pharmaceutical and biopharmaceutical companies and key investors (Press release, Samsung BioLogics, JAN 12, 2022, View Source [SID1234598643]). During the main track presentation today, John Rim, President and CEO of Samsung Biologics, addressed the company’s vision for 2022 and business goals including three core pillars of multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint.

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!

"For Samsung Biologics, 2022 will be a year where we will be able to take a great leap forward for sustainable growth and endeavor to maximize our capabilities as a leading CDMO," said John Rim, CEO of Samsung Biologics during his presentation at the conference. "Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities in overseas, Samsung Biologics will be able to accelerate the build-up of its core success drivers as the next growth engine of the industry."

As part of its growth plan, Samsung Biologics is planning to start the construction of a new facility, Plant 5 this year where it will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site. This will be additional to the mRNA vaccine drug substance (DS) manufacturing suite the company is currently adding to its existing facility in Songdo, which is expected to be ready for cGMP operations within the earlier part of this year.

The company is further venturing into securing additional sites within Songdo for the construction of Plant 6 and Open Innovation Center, and also overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in close proximity to its global clients.

Samsung Biologics’ Plant 4 is currently under stable construction to be partially operational by the end of this year and the company is steadily securing pre-sales of clients. Upon the full completion of Plant 4 in 2023, the company is expected to hold a total of 620,000L of capacity, reaffirming its position as the world’s largest CDMO.

Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with all Plants 1, 2, and 3 in stable operations, marking record-high financial results in two consecutive quarters. The company successfully laid a robust foundation in the mRNA business area through signing strategic partnership agreements for the manufacturing of mRNA vaccines. Samsung Biologics also launched its newest CDO process platform, S-CellerateTM, which offers an expedited process for the development and commercialization of monoclonal antibodies.

In light of the increasing importance of actions towards sustainability, Samsung Biologics issued its first annual sustainability report, consolidating the company’s policies for an enhanced ESG management system. The company was recently added to the DOW Jones Sustainability World Index (DJSI) in recognition of its commitment to ESG matters.

"The strategic roadmap and milestones outlined today illustrate the key success drivers for our growth this year as well as lay a strong groundwork for sustainable growth opportunities ahead of us," Rim added. "With our continued investment in capacity, portfolio, and global footprint, we will evolve as the top biopharmaceutical company and offer diversified services as the next growth engine of the industry."

On January 12, 2022 Deep Lens and Hematology-Oncology Associates of Central New York (HOA CNY) reported that they have entered into a collaboration to expand the clinical trial program and improve trial matching capabilities for the upstate New York-based practice (Press release, Deep Lens, JAN 12, 2022, View Source [SID1234598642]). Deep Lens is a digital healthcare company that utilizes proprietary artificial intelligence-based technology solutions and other services to help improve efficiencies related to clinical trial recruitment and enrollment. Hematology-Oncology Associates of CNY (HOA CNY) is a private comprehensive cancer center that has been serving patients in four locations across Central New York since 1982. This partnership will expand HOA CNY’s clinical research program by increasing the breadth of trials available to patients and it will accelerate the trial matching process, enabling patients the ability to get into trials faster.

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!

"Clinical research has been a number one priority for our practice since our doors opened almost 40 years ago. We’ve worked hard to build and expand our clinical trial program so that all of our patients have every possible option to receive access to the newest therapies in development," said Steven Duffy, MD at HOA CNY. "We’re delighted to partner with Deep Lens – the adoption of their progressive technology and other support services will help improve the speed and accuracy of matching patients to trials and will allow our staff the ability to focus more of their time on patient care."

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; however, fewer than 1 in 30 patients participate in a clinical trial. Limited trial site resources make it time-consuming to identify eligible patients, especially as trial protocols increase in complexity. The Deep Lens technology and other services support care teams by automating the identification of potentially eligible patients at the time of diagnosis and matching them to relevant trials in real-time.

"HOA CNY is an exceptional community-based oncology practice that already has deep relationships with leading institutions and organizations that provide them the ability to conduct and participate in clinical research," said Tyrone Richardson, vice president, provider sales for Deep Lens. "Deep Lens’ technology will add to the already-robust HOA CNY research program by bringing more trials to the practice and improving efficiencies related to the matching and enrollment process. We are thrilled to help HOA CNY support its patient community by improving access to new therapies."

Deep Lens’ VIPER will pre-screen all patients from HOA CNY’s EMR (OncoEMR) and integrate molecular data feeds from Caris Life Sciences, Guardant Health, Foundation Medicine as well as all pathology feeds to automatically identify qualified patients for clinical trials. Deep Lens’ pre-screening and clinical trial matching solution is provided at no cost to oncology practices.

Deep Lens is working with a significant number of community oncology practices representing every region in the U.S. It is estimated that approximately 85 percent of cancer patients are diagnosed and treated at local, community-based oncology practices. Deep Lens is committed to expanding important oncology research by making trials more accessible to a larger and more diverse population within these local community settings.

On January 12, 2022 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer have been updated for 2022 and include two important changes involving neratinib (NERLYNX) (Press release, Puma Biotechnology, JAN 12, 2022, View Source [SID1234598641]).

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 first update added NERLYNX to the body of the guidelines for the treatment of adjuvant HER2-positive Breast Cancer (BINV-L) under the heading Useful in Certain Circumstances, with a recommendation for considering extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence.

The second update involved the inclusion of dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L). This update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.

Joyce O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas Texas, said, "Oncologists should be aware of an important recent update to the NCCN guidelines that now include adjuvant neratinib to be used in certain circumstances, i.e., high-risk HR+, HER2+ early-stage breast cancer patients. These high-risk patients need access to every available treatment option proven to decrease their risk of recurrence, and the new NCCN guidelines update supports neratinib in this context."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The NCCN guidelines are utilized by many institutions, practices and clinicians who treat breast cancer patients. These updates help to increase the awareness of neratinib within the guidelines and should further support neratinib as an appropriate option to reduce the risk of recurrence for patients battling HER2-positive breast cancer."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.

On January 12, 2022 Agendia, Inc., a commercial-focused company specializing in precision breast cancer oncology, reported that it is offering breast cancer patients in Brazil early access to its Digital MammaPrint platform (Press release, Agendia, JAN 12, 2022, View Source [SID1234598640]). With this, the company is expanding its offering in Brazil with the aim of making important findings from cancer tests accessible to the global breast cancer community. Brazil is the first country to use Digital MammaPrint to analyze samples, offering physicians and their patients the opportunity to benefit from genomic data from digitized images of breast cancer tumors. Results for the individual tumors are now provided by the new AI platform, which enables faster treatment decisions thanks to shorter processing times.

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!

Agendia offers Brazilian doctors and their patients early access to Digital MammaPrint test results. In doing so, Agendia aims to reach a patient population that includes the more than 66,000 women in Brazil who were newly diagnosed with breast cancer in 2020 alone, and give her the opportunity for earlier and faster intervention throughout the treatment continuum. 1

"Integrating AI into the MammaPrint solution for early-stage breast cancer patients has the potential to uniquely accelerate the use of genomic testing and diagnostics in the management of this disease, and can impact the outcomes of women with breast cancer around the world around the globe," said Mark Straley, Chief Executive Officer at Agendia. "The stratification of breast cancer through AI analysis of a tumor tissue image trained on extensive proprietary clinical data has the potential to transform breast cancer treatment worldwide. Agendia’s extensive expertise in breast cancer functional genomics enables us to

Agendia’s Digital MammaPrint is powered by the cloud-based Paige platform – a partnership the two companies announced in November 2020 . This is the first product of this collaboration, which was initially aimed at developing digital tests for planning early treatment. Genomic testing is essential in determining the risk of recurrence and tumor biology so that physicians and their patients can make important decisions about the way forward.

"The introduction of Digital MammaPrint to doctors and patients in Brazil is an important step in increasing access to high-quality, AI-powered diagnostic tests," said David Klimstra, MD, Founder and Chief Medical Officer at Paige. "As part of our collaboration with Agendia, we will pursue our shared goal of translating pathology data into clear and actionable clinical insights for better patient outcomes."

On a global scale, the availability of Digital MammaPrint data opens up new diagnostic opportunities for affected women with breast cancer who do not have access to genomic testing or sophisticated laboratory infrastructure.

"For breast cancer patients around the world who do not have direct local access to genomic testing for their cancer, the data obtained from such imaging could have far-reaching implications. Introducing a digital AI-powered platform to interpret the genomic profile of a given tumor can offer significant clinical benefit, with the added benefit of preserving valuable tumor tissue for future use. We use an innovative platform to do pioneering work," commented William Audeh, MD, Agendia’s Chief Medical Officer. "Ultimately, the aim is to give patients access to important information about their cancer. With the help of digital technology, our tool can provide you with this information even faster. The quicker MammaPrint data gets into the hands of doctors, the greater the benefit for patients as treatment decisions can be made earlier."

Agendia’s MammaPrint is a 70-gene prognostic test that stratifies a given patient’s risk of recurrence and provides a prognostic marker that, in conjunction with other clinicopathological factors, forms the basis for determining risk. MammaPrint supports decisions on preoperative systemic therapy, adjuvant chemotherapy and adjuvant endocrine therapy. The digital possibilities of the test are intended to provide doctors and patients with clear and reliable information for making critical decisions throughout the entire cancer treatment process.