On April 21, 2020 ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, reported that they have signed a two-part agreement, kicking off a multi-year program. Premier Applied Sciences will identify eight to 10 member institutions that will implement STRATAFIDE – in a research use only (RUO) capacity – to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests (Press release, ArcherDX, APR 21, 2020, View Source [SID1234556481]). ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.

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"Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital’s molecular diagnostic laboratory," said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. "Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 U.S. hospitals and health systems and approximately 175,000 other providers."

ArcherDX and Premier’s research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate STRATAFIDE as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.

"Our partnership with ArcherDX demonstrates the expanse of Premier’s research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings," said Stella A. Safo, M.D., MPH, Chief Clinical Transformation Officer and Vice President for Premier Applied Sciences. "We hope this research will help accelerate appropriate cancer care for hard to reach populations and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities."

On April 21, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that the Company will release its financial results for the first quarter ended March 31, 2020 after the market closes on May 5, 2020 (Press release, Nevro, APR 21, 2020, View Source [SID1234556480]).

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Investors interested in listening to the conference call may do so by dialing (833) 968-2321 in the U.S. or (778) 560-2840 internationally, using Conference ID: 8129245. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On April 21, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported pre-clinical data from a feasibility study of its visceral lesion applicator (VLA) electroporation device and APOLLO generator which were presented online at the Annual Meeting of the Society of Interventional Radiology (SIR) (Press release, OncoSec Medical, APR 21, 2020, View Source [SID1234556479]). The feasibility study demonstrated the capability of a rigid, trocar-like VLA applicator to safely deliver and electroporate DNA-based immunotherapy directly into target organs in a large animal model using a CT-guided approach and OncoSec’s new, lower voltage APOLLO generator.

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In a study titled, "Can an Intratumoral DNA-Encoded Immunotherapeutic Device Platform Currently Used in the Management of Cutaneous Lesions Be Scaled in Size to Function in the Treatment of Visceral Tumors Through Image-Guided Techniques?", investigators built upon data presented at the Annual Meeting of the Society of Interventional Oncology (SIO) demonstrating the VLA’s ability to reach deep visceral organs using laparoscopic/ultrasound and bronchoscope/steerable catheter methods in live large animal models.

In the study presented online at the Annual Meeting of the SIR, OncoSec demonstrated the ability to guide and deploy the VLA under a different guidance method and electroporate with the APOLLO generator. Using CT-guidance, investigators were able to reach high value targets including liver, lung, bone, and pancreas in a live large animal model. Additionally, TAVO was safely delivered and electroporated directly into the liver. Importantly, data also showed that it had no significant effects on hemodynamics, as indicated by consistent heart rate and arterial blood pressure. Animals were survived for at least 24 hours and no adverse events were observed.

"The potential opportunities that this technology represents are very promising. Interventional radiologists are eager to find treatment solutions that extend beyond standard of care. The possibility of delivering potent immunotherapy directly to visceral tumors in radiology suites could shift the paradigm of how we treat certain tumors, particularly in the liver, lung and bone," said Dr. Daniel Simon, Board Certified Interventional Radiologist at Vascular Management Associates of New Jersey and Maryland Cardiology Associates, and scientific advisor to OncoSec, who performed these large animal studies presented at SIR.

OncoSec has developed a short mechanism of action video that illustrates the way the VLA system is designed to target and treat tumors in humans. The video can be accessed on the Company’s website via View Source

In the previous feasibility study originally reported at SIO, large live healthy animal subjects were placed under general anesthesia while investigators safely and successfully accessed and deployed the VLA in the lungs with a flexible, catheter-based applicator using a bronchoscope and a steerable catheter, and liver using ultrasound-guided laparoscopy with a rigid-trocar-based applicator. Following deployment of the VLA, electroporation was performed in the liver using the company’s proprietary APOLLO generator. No adverse effects were recorded during or after electroporation. Additionally, initial data from the APOLLO generator’s built-in feedback system embedded within the platform detected and recorded trends in impedance values between different tissue types, as well as between the presence and absence of DNA. The APOLLO generator was also able to indicate when the applicator tip was not effectively placed within the tissue. These data highlight the safety mechanisms as well as the future possibility of differentiating between healthy tissue and a local tumor. Data from both SIR and SIO can be accessed via the two respective posters at View Source

"This study of our VLA device demonstrates the feasibility of reaching critical tissue targets, delivering a drug — in this case our lead product, TAVO, and electroporating in a large-animal model," said John Rodriguez, Vice President, Product Engineering at OncoSec. "We are very encouraged by these data, as they support our belief that electroporation combined with delivering drug intratumorally may be possible in tumors located within internal organs. These results allow us to move forward with a preclinical safety study in the near term, followed by the potential filing of an Investigational New Drug application and initiation of a phase 1 human clinical trial using the VLA platform in combination with TAVO."

On April 21, 2020 Envisagenics, a company developing therapeutics for RNA splicing errors that often lead to genetic disorders including cancer, reported that it has entered into a research program agreement with the Lung Cancer Initiative (LCI) at Johnson & Johnson (Press release, Envisagenics, APR 21, 2020, View Source;johnson-301044463.html [SID1234556478]). Through this initiative, Envisagenics will build predictive models for lung cancer progression and risk. The Envisagenics team will leverage its expertise in splicing and RNA-sequencing to analyze LCI’s data using Envisagenics’ SpliceCore software platform.

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"Lung cancer is the leading cause of cancer-related deaths globally, and it is difficult to treat in later stages," said Maria Luisa Pineda, Ph.D., co-founder and Chief Executive Officer of Envisagenics. "That is why it is so important for Envisagenics to identify early determinants of lung cancer risk. Envisagenics hopes to identify RNA splicing events that can predict lung cancer, and in the future, develop new therapies for patients."

Martin Akerman, Ph.D., co-founder and Chief Technology Officer of Envisagenics, commented, "Tumor cells can literally cut-and-paste RNAs to produce unique cancerous proteins. Detecting these RNA splicing events early could mean better prognoses for lung cancer patients. SpliceCore can extract these biological insights because it can scan through millions of potential RNA splicing events from 1,000 patient samples in two hours."

On April 21, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2020 financial results on Tuesday, May 5, 2020, after the close of the U.S. financial markets (Press release, Clovis Oncology, APR 21, 2020, View Source [SID1234556477]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss fourth quarter and full year 2019 results on Tuesday, May 5 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: U.S. participants (866) 393-4306, International participants (734) 385-2616, conference ID: 1140127.