Emergent BioSolutions to Release Fourth Quarter and Full Year 2020 Financial Results and Conduct a Conference Call on February 18, 2021

On February 4, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, February 18, 2021 at 5:00 pm eastern time to discuss the financial results for the fourth quarter and full year 2020, recent business developments, financial outlook for full year 2021, and revenue guidance for the first quarter of 2021 (Press release, Emergent BioSolutions, FEB 4, 2021, View Source [SID1234574668]).

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This conference call can be accessed live by telephone or by webcast:

Webcast Information:
Visit View Source for the live webcast.
A replay of the call can be accessed from the Emergent website.

PierianDx partners with the Belgian Society of Medical Oncology (BSMO) to evaluate potential of comprehensive genomic profiling in late-stage cancer real-world setting across Belgium

On February 4, 2021 PierianDx, the global leader in clinical genomics knowledge, reported a partnership with the Belgian Society of Medical Oncology (BSMO) to study the impact of comprehensive genomic profiling (CGP) on clinical outcomes of late-stage cancer patients (Press release, PierianDx, FEB 4, 2021, View Source [SID1234574667]). As part of the study, nine sites across Belgium will use the PierianDx interpretation and reporting solution, Clinical Genomics Workspace (CGW), to help determine the best therapeutic options for treatment.

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Current approaches to precision medicine testing often mean that tests are outsourced to large international organizations or that they are run by independent regional labs, neither of which result in standardized clinical care systems or improved collective knowledge. In response to these challenges, the BSMO has established the BALLETT (Belgian Approach for Local Laboratory Extensive Tumor Testing) study to evaluate the impact of CGP.

CGP uses next-generation sequencing (NGS) to analyze hundreds of genes and biomarkers in tissue samples from biopsies or blood and detect those that are clinically relevant in driving cancer growth. Illumina will provide its CGP panel for tissue samples, TruSight Oncology 500 (TSO500), and NovaSeq 6000 and NextSeq sequencing platforms for the study. Clinical interpretation of the sequencing data will be carried out using the PierianDx Clinical Genomics Workspace (CGW) solution.

CGW provides a streamlined, standardized analysis platform in which EU drug approvals and guidelines are matched to complex genetic variants detected in patient tumor DNA and RNA, all within a GDPR-compliant environment. Using the platform, the nine participating Belgian laboratories can collaboratively review variant pathogenicity and clinical impact for their local samples while also benefiting from the knowledge of other clinical laboratory CGW users from around the world. At the same time, the nine Belgian laboratories will provide this standardized testing and analysis close to the patient’s home, where they receive cancer care, accelerating treatment initiation. As this study will also monitor the patient outcomes during and following treatment, a true indication of those longer-term clinical benefits will be derived.

Dr. Brigitte Maes of the Jessa Hospital in Belgium, Coordinator of BALLETT study said, "As part of Belgium’s broad approach to advancing precision medicine the study will generate valuable insights into the value of CGP versus currently reimbursed sequencing approaches. For example, in addition to genetic mutations that drive cancer formation, CGP will also identify cancers driven by the TMB biomarker which can guide patients towards immunotherapy treatments. This means that the study will give access to additional treatments which may not have been considered through more traditional diagnostic testing."

"Dr. Rakesh Nagarajan, Founder of PierianDx states, "We are ecstatic to be part of this groundbreaking study. The CGW platform is in use by over 25 countries to share knowledge and facilitate better treatments and patient outcomes, and now the clinicians involved in this study will benefit from this collective knowledge while incorporating European-specific data sources, which are curated and maintained by PierianDx." He adds, "Not only will this study measure the impacts of CGP but it will provide a justification, framework, and a blueprint for other clinical laboratories around the world that wish to implement similar initiatives."

Arrowhead Pharmaceuticals Reports Fiscal 2021 First Quarter Results

On February 4, 2021 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal first quarter ended December 31, 2020 (Press release, Arrowhead Research Corporation, FEB 4, 2021, View Source [SID1234574665]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 1307499.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 1307499.

Selected Recent Events

Submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for a Phase 2b dose-finding clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia
Presented new clinical data from Phase 1/2 studies of both wholly owned cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart Association meetings and subsequently hosted key opinion leader webinars to discuss the data and plans for future development of the product candidates
Closed an agreement with Takeda to co-develop and co-commercialize ARO-AAT, which includes $300 million upfront, $740 million in potential milestone payments, a 50/50 profit sharing agreement in the U.S., and 20-25% royalty on net sales outside the U.S.
Presented new clinical data at The Liver Meeting Digital Experience, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) on ARO-AAT, Arrowhead’s candidate against liver disease associated with alpha-1 antitrypsin deficiency, showing that ARO-AAT strongly reduced the production of mutant Z-AAT protein and led to improvements in multiple biomarkers of alpha-1 liver disease

Cerus Corporation to Participate in Upcoming Virtual Investor Conferences

On February 4, 2021 Cerus Corporation (Nasdaq: CERS) reported that William ‘Obi’ Greenman, Cerus’ president and chief executive officer, and Kevin D. Green, Cerus’ chief financial officer, are scheduled to participate in two conferences (Press release, Cerus, FEB 4, 2021, View Source [SID1234574664]):

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BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Wednesday, February 17th at 1:30 P.M. ET.
The Cowen 41st Annual Health Care Conference on Monday, March 1st at 2:40 P.M. ET.
A live webcast of the events will be available on the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.

Varian Installs World’s First ProBeam® 360° Proton Therapy System at Penn Medicine Lancaster General Health

On February 4, 2021 Varian (NYSE: VAR) reported that it has started the installation of the cyclotron and gantry for its ProBeam 360° single-room proton therapy system at Penn Medicine Lancaster General Health’s Ann B. Barshinger Cancer Institute (Press release, Varian Medical Systems, FEB 4, 2021, View Source [SID1234574663]). The cyclotron and gantry are core pieces of equipment of the ProBeam 360° system.

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The Ann B. Barshinger Cancer Institute, which is part of Penn Medicine Lancaster General Health, has become the first treatment center in the world to have a ProBeam 360° system from Varian. The center is expected to treat its first patients in 2022.

"Varian is proud of our longstanding collaboration with Penn Medicine, which goes back decades and encompasses joint innovation, clinical research, training and education, and bringing new technologies to cancer patients," said Kolleen Kennedy, Chief Growth Officer and President of Proton Therapy Solutions at Varian. "We’re especially pleased to be taking this next step with them, delivering the latest innovations in proton therapy technology for the cancer patients of South Central Pennsylvania."

The cyclotron is a particle accelerator that accelerates protons to extremely fast speeds; roughly 100,000 miles per second or roughly two thirds the speed of light, to create a beam that can precisely reach tumors wherever they are in the body. The finished ProBeam 360° system will incorporate the fully rotational gantry that rotates around the patient to target tumors from virtually any angle, robotic patient positioning tools, integrated iterative cone-beam CT imaging and pencil-beam scanning for delivery of high-definition intensity-modulated proton therapy (IMPT).

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects is reduced because a proton beam deposits dose within the tumor site rather than passing all the way through the patient. Proton therapy can be used for many of the most common types of cancer.

In addition to the ProBeam 360° system, Varian will also provide its ARIA information management system and Eclipse treatment planning—software that can be used to enable a cloud-based "hub and spoke" operations model for managing key functions centrally to avoid costly duplication of resources across the larger University of Pennsylvania Health System. The Eclipse software will also incorporate RapidPlan PT— the first clinical application of machine learning in proton treatment planning. RapidPlan PT is a knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from previous cases in order to develop high-quality, personalized plans for patients.

"This is yet another key milestone in a multi-year journey that will marry the extensive research and clinical protocols we’ve developed over the past 11 years at Penn Medicine’s Roberts Proton Therapy Center with the considerable expertise at Lancaster General," said James Metz, MD, Chair of Radiation Oncology, Perelman School of Medicine.