On February 16, 2022 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, and THREAD, a leading technology and service provider enabling electronic clinical outcome assessments (eCOAs) and decentralized clinical trials (DCTs), reported a new combined offering to give pharmaceutical companies a comprehensive and simultaneous view of clinical research participants, followed by data and detailed analysis across the care continuum (Press release, EVERSANA, FEB 16, 2022, View Source;real-world-data-rwd-driven-evidence-and-commercialization-solution-301483355.html [SID1234608853]).

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The new solution combines EVERSANA’s integrated commercial services, rich electronic medical record (EMR) data, and RWD-driven recruitment capabilities with THREAD’s leading decentralized clinical trial platform to aggregate and link patient-generated and secondary regulatory-grade RWD. Together in a single platform, the offering enables continuous active, passive, retrospective and prospective data collection with patient consent and identity security as central tenets. Data linkages will be performed using Datavant’s technology to ensure patient privacy and data security.

"While certainly complex to deliver, this new solution gives pharmaceutical clients the gift of simplicity. For example, we’ve reduced the data collection and security burden on sites and participants and enabled rapid go-live, consent and enrollment while reducing registry and startup costs," said Jim Lang, CEO, EVERSANA. "Our commercial services are designed to reduce burdens like these to help our clients refocus their time and energy on future innovations for patients worldwide."

"Putting all available real-world data to work is imperative to optimize the development of new treatments and our understanding of marketed therapies," said John Reites, CEO, THREAD. "By combining the power of THREAD’s technology platform with EVERSANA’s rich, diverse data sets, clinical studies can be more efficient, comprehensive and inclusive, providing researchers with a totality of evidence to inform their research."

The combined offering showcases immediate value, by supporting the capture and curation of clinical and real-world data across the full spectrum of clinical research and care. From digital recruitment to RWD collection and analysis, study participants are engaged throughout the research period. Registry data can be further enriched with other RWD assets and are deidentified and linked for analytic access across multiple sources.

"We are proud to support the digitization of evidence generation and amplify the benefit of remote evidence generation by securely connecting data across the health data ecosystem," said Travis May, Co-Founder and President, Datavant. "Connecting real-world data augments the depth of data on each patient while increasing the cost-efficiency of the entire study."

The partnership expands both companies’ position on the front line of real-world evidence innovation. Included in a growing list of industry partnerships:

EVERSANA recently announced an agreement with Janssen Research & Development, LLC (Janssen) to transform clinical data into the much-needed evolution of chronic disease care through real-word data, data science analysis and regulatory-grade studies.
THREAD recently acquired inVibe, the leading voice-powered research and insights technology solution for the life sciences and health care industries. THREAD’s addition of inVibe’s voice research technology and consulting services to its comprehensive, decentralized research platform follows the company’s acquisition of Modus Outcomes in November 2021.
Earlier in 2021, EVERSANA launched its Chronic Disease Real-World Data solution, which enables life sciences stakeholders to conduct regulatory-grade research studies, generate evidence and provide data-driven insight and proactive support to improve the chronic, comorbid patient experience.

On February 16, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a pre-clinical biotechnology company developing various products for the immuneoncology space, is pleased to reported the establishment of an agreement with Cato SMS, to advise on the submission of its clinical application to Health Canada in order to initiate a Phase I trial using AccuTOXTM against breast cancer (Press release, Defence Therapeutics, FEB 16, 2022, View Source [SID1234626247]).

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CATO SMS is a consulting firm with more than 30 years of global experience to guide clinical development of biopharma pipelines. With offices across North America, Europe, and the Middle East, CATO SMS has experience conducting trial designs in more than 25 countries. Their specialists deliver innovative regulatory consulting solutions to guide complex challenges with a proven center of excellence in oncology.

"We are very pleased to work with Cato SMS on our AccuTOXTM program. This step is central to Defence as it ensures the achievement of important milestones for our clinical program. Cato SMS will be designing the clinical protocol, pre-CTA meeting package, CTA Compilation and Submission as well as regulatory affairs for our AccuTOXTM Phase I trial" says Mr. Plouffe, the CEO of Defence.

The AccuTOXTM program consists of using a lead variant of the AccumTM molecule to trigger cell death in cancer cells. When combined with the immune-checkpoint inhibitor CTLA-4, this lead AccumTM triggered potent anti-tumoral response in several cancer models including, T-cell lymphoma, melanoma, colon and breast cancer. As such, Defence plans to use AccuTOXTM in its Phase I to treat breast cancer patients in Q4 of 2022.

According to Fortune Business InsightsTM, the Global Breast Cancer Therapeutics Market to exhibit 13.1% CAGR and hit USD 55.27 Billion till 2027.

On February 16, 2022 Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies that target signal regulatory proteins (SIRP), reported a $84 million Series B financing co-led by Westlake Village BioPartners and OrbiMed (Press release, Electra Therapeutics, FEB 16, 2022, View Source [SID1234610665]). Other participating investors include Redmile Group, Cormorant Asset Management, Cowen Healthcare Investments, RA Capital, and New Leaf Venture Partners. Electra was previously funded by its parent company, Star Therapeutics.

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Electra is building a pipeline of novel therapies targeting SIRP, a family of cell surface receptors on various immune cell types. The company is taking a first-in-class approach to engage SIRP beyond the current drug development efforts in cancer, by targeting specific SIRP proteins to deplete targeted pathological immune cells. ELA026, the company’s lead product candidate, exhibits this novel mechanism of action and is currently in Phase 1 clinical studies, including a trial in secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease. ELA026 is also advancing in other immunological diseases. In addition, the company’s pipeline includes preclinical programs in immunology and immuno-oncology.

"We are thrilled to introduce Electra and share our novel approach to targeting SIRP," said Adam Rosenthal, PhD, CEO and Co-founder of Electra. "Our team has made rapid progress advancing our lead product candidate, ELA026, from an idea to the clinic in less than 3 years, and we are excited by each of our three pipeline programs targeting numerous diseases with significant unmet need."

Proceeds from the financing will be used to continue advancing ELA026 in clinical trials for sHLH and other immunological diseases. The funding will also support advancement of an additional preclinical pipeline program targeting SIRP in immunology, as well as Electra’s immuno-oncology platform that leverages SIRP to promote targeted depletion of tumor cells.

"It is inspiring to see the rapid progress and success of Electra’s pioneering work in targeting SIRP to develop therapies for immunological diseases. ELA026 represents a novel mechanism for targeting diseases driven by aberrant myeloid and T cell activity, and has enormous potential to address life-threatening diseases like sHLH, as well as other severe inflammatory diseases," said Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners.

Electra’s Board of Directors consists of Beth Seidenberg, MD, Founding Managing Director at Westlake Village BioPartners; Carl Gordon, PhD, CFA, Managing Partner at OrbiMed; Nancy Stagliano, PhD, Executive Board Chair, and Adam Rosenthal, PhD, CEO and Co-founder of Electra. Electra’s Board observers are Amrit Nagpal, Managing Director at Redmile Group and Vijay Lathi, Managing Director at New Leaf Venture Partners.

"We are impressed by the bold vision of the Electra team which has deep insights into drug discovery and development, and we are pleased to support Electra as they translate their approach with SIRP to patients in need of innovative treatment options," said Carl Gordon, PhD, CFA, Managing Partner at OrbiMed.

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening hyperinflammatory condition for which there is no approved treatment. sHLH can be triggered by cancer, immunotherapy, infection, or an autoimmune disease. Once triggered, sHLH requires immediate intervention. Without treatment, it can rapidly progress from symptoms such as persistent fever, hepatomegaly and/or splenomegaly, and cytopenias, to multi-organ failure and death. Even with the current use of off-label treatments that have toxicity challenges and limited efficacy, sHLH remains fatal in approximately 60% of adults within 3.5 years.

On February 16, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, reported that it will report fourth quarter and full year 2021 financial results on Monday, February 28, 2022, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 16, 2022, View Source [SID1234608185]).

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Dynavax will host a conference call and live audio webcast on Monday, February 28, 2022 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4678925. A replay of the webcast will be available for 30 days following the live event.

On February 16, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported the availability of FusionPlex Dx and LiquidPlex Dx in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products (Press release, Invitae, FEB 16, 2022, View Source [SID1234608168]). Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer.

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With this announcement, Invitae provides the highest quality CE-IVD products to enable European pathologists and oncologists to efficiently provide vital information, in a timely manner, to guide cancer therapy for patients.

"This is a major step toward our mission to bring comprehensive genetic information into mainstream medicine," said Vishal Sikri, President of Oncology at Invitae. "Our best in class FusionPlex and LiquidPlex tests will enable more patients access to the right cancer therapies at the right time, which is especially critical in Europe where the majority of molecular testing is performed locally in decentralized hospital settings."

In line with ESMO (Free ESMO Whitepaper) guidelines for non-small cell lung cancer (NSCLC), Invitae’s FusionPlex Dx and LiquidPlex Dx allow comprehensive genomic profiling (CGP) and companion diagnostic (CDx) use for solid tumor neoplasms including NSCLC in tissue biopsy and where tissue is a limiting factor. The panels are intended to be used on Illumina’s Next Generation Sequencing (NGS) platforms for IVD testing.

"Increasing patient access to content on our instrument fleet through partnerships such as those with Invitae speaks to our mission to improve human health by unlocking the power of the genome," said Joydeep Goswami, Chief Strategy and Corporate Development Officer at Illumina. "We congratulate Invitae on its first CE-IVD cancer testing kits, a significant milestone."

FusionPlex Dx identifies structural variants including fusions in RNA derived from formalin-fixed, paraffin-embedded tumor specimens. FusionPlex Dx covers multiple actionable variants in a 41-gene panel to provide CGP for patients with solid malignant neoplasms. FusionPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping alterations, anaplastic lymphoma kinase (ALK) fusions, ros proto-oncogene 1, receptor tyrosine kinase (ROS1) fusions, ret proto-oncogene (RET) fusions, neurotrophic receptor tyrosine kinase 1-3 (NTRK1, NTRK2, NTRK3) fusions, and for whom treatment with a targeted therapy may be beneficial.

LiquidPlex Dx identifies substitutions and insertion-deletion mutations in cell-free circulating tumor DNA (ctDNA) isolated from plasma derived from whole blood of cancer patients (liquid biopsy). LiquidPlex Dx interrogates 29 genes to provide CGP for patients with solid malignant neoplasms. LiquidPlex Dx is intended to be used as a CDx to aid in identifying patients diagnosed with NSCLC with METex14 skipping alterations, and for whom treatment with a targeted therapy may be beneficial.

"With Invitae’s simplified workflow and reporting solutions, both tests will enable any facility with sequencing technology, combined with our solutions, to accurately profile solid tumors using tissue or blood samples for therapy selection," said Sikri. "Precision medicine has increasingly delivered better outcomes for many cancer patients over the last several years. Molecular pathology has never been more important as the fight against cancer shifts towards precision oncology and targeted therapies based on genomic testing. Yet globally, access to the exponentially increasing therapy options is not guaranteed."