On April 29, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company with a presence in seven of the top ten cancers in the United States, reported that six abstracts for its genomic tests in lung, prostate and thyroid cancers will be presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held virtually June 4-8, 2021 (Press release, Veracyte, APR 29, 2021, View Source [SID1234578815]).

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The accepted abstracts include pivotal clinical validation data for Veracyte’s Percepta Nasal Swab. This first-of-its-kind, non-invasive test will help physicians determine which patients with lung nodules found on CT scans are at low risk for cancer and can be safely directed to routine monitoring without fear of missing a cancer and which patients should undergo further, including potentially more-aggressive, clinical work-up. Veracyte plans to introduce the nasal swab-based genomic test in the second half of 2021, as part of the company’s comprehensive lung cancer portfolio.

"We are thrilled with the compelling data that will be presented at ASCO (Free ASCO Whitepaper), which reflect our tests’ ability to positively impact patient care in a range of major cancers," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We are particularly excited about the opportunity in lung cancer, where early detection can save lives, but where distinguishing between cancerous and benign lung nodules is often challenging and can lead to missed cancers or unnecessary procedures. We believe our Percepta Nasal Swab test is going to be a game-changer for patients being evaluated for lung cancer."

Among other Veracyte highlights, researchers will share prospective validation data for the Decipher Prostate test, demonstrating the genomic test’s ability to predict aggressive prostate cancers among African American men as compared to the use of clinical factors alone.

Below are details of the Veracyte abstracts accepted for presentation at ASCO (Free ASCO Whitepaper). All posters will be available to meeting registrants on demand beginning June 4, 2021, at 9:00 a.m. EDT.

Title:

Early candidate nasal swab classifiers developed using machine learning and whole transcriptome sequencing may improve early lung cancer detection.

(Title of poster to be presented: A validated nasal swab classifier developed using machine learning and whole transcriptome sequencing may improve early lung cancer detection.)

Abstract #:

8551

First Author:

Peter Mazzone, M.D., M.P.H., Cleveland Clinic

Title:

A prospective Validation of the genomic classifier defines high-metastasis risk in a subset of African American men with early localized prostate cancer: VanDAAM study. (oral presentation)

Abstract #:

5005

First Author:

Kosj Yamoah, M.D., Ph.D., Moffitt Cancer Center

Time:

June 8, 2021, 8:00-11:00 a.m. EDT

Title:

The impact of Percepta Genomic Sequencing Classifier (GSC) on clinical decision making in patients with a high- risk lung nodule. (poster presentation)

Abstract #:

8549

First Author:

Sonali Sethi, M.D., Cleveland Clinic

Title:

Validation of the Decipher Genomic Classifier (GC) in SAKK 09/10: A Phase III Randomized Trial of Dose-Escalated Salvage Radiotherapy (SRT) after Radical Prostatectomy (RP). (poster presentation)

Abstract #:

5010

First Author:

Alan Dal Pra, M.D., University of Miami Health System

Title:

NTRK, RET, BRAF, and ALK Fusions in Thyroid Fine-Needle Aspirates (FNAs). (poster presentation)

Abstract #:

6083

First Author:

Lori J. Wirth, M.D., Massachusetts General Hospital

Title:

Detection of actionable molecular alterations through combined DNA/RNA molecular profiling of biopsies collected in early stage lung cancer at time of diagnosis. (online abstract)

Abstract #:

e20546

First Author:

Joshua Babiarz, Ph.D., Veracyte

On April 29, 2021 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that management will host a conference call and webcast to discuss its first quarter 2021 financial results and provide a business update on Thursday, May 6, 2021 at 7:30 a.m. ET (Press release, Epizyme, APR 29, 2021, View Source [SID1234578833]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4139845. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call.

On April 29, 2021 Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd., a subsidiary of Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer, fibrotic diseases and viral infections, reported that the company has entered into a partnership agreement with Walvax Biotechnology (Walvax) for the co-development of its anti-influenza siRNA therapeutic product candidate STP702 (Press release, Sirnaomics, APR 29, 2021, View Source [SID1234578846]). Sirnaomics will out-license to Walvax the exclusive development and commercialization rights for territories including mainland China, Taiwan, Hong Kong and Macao. Based on the agreement, the company will receive an initial payment of ~US$6.4 million for this asset, with additional milestone payments and royalty sharing based on product sales.

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While the medical and scientific communities are continuing the fight against the Covid-19 pandemic, there needs to be continued attention towards other viruses, such as Influenza, which cause severe epidemics worldwide. Along with its resistant strains, new pathogenic viruses continue to be discovered, creating an ongoing need for new anti-influenza treatments. RNA interference (RNAi) is a cellular gene-silencing phenomenon, in which sequence-specific degradation of target mRNA is achieved by means of complementary short interfering RNA (siRNA) molecules. This advanced therapeutic approach, using siRNA technology as a targeted inhibitor, affords a tractable strategy to combat influenza pathogenesis. SiRNAs are easy to design, and can be directed against multiple strains of the influenza virus by targeting their conserved gene regions. The newly established partnership between Sirnaomics and Walvax will specifically focus on development of the siRNA-based anti-influenza therapeutic candidate STP702.

"Establishing this partnership with Walvax exemplifies our continued execution for development strategy," said Patrick Lu, PhD, President and CEO of Sirnaomics, and Chairman of Sirnaomics Suzhou. "The out-licensing of our antiviral siRNA candidate, especially to an internationally well-recognized biopharma company like Walvax Bio that specializes in development of vaccine and therapeutics against various viral infections, marks a major milestone in Sirnaomics’ growth. I look forward to seeing the Sirnaomics and Walvax teams working together to develop a novel siRNA therapeutic to combat potential influenza epidemics of the future."

"We believe our siRNA technology has extremely broad therapeutic potential and we are excited to combine Walvax’s deep vaccine expertise with our siRNA platform technology to unlock additional value outside of our core oncology and fibrosis therapeutic focus," said Allan Shaw, Chief Financial Officer at Sirnaomics. "This alliance provides the latest validation of Sirnaomics technology platform and furthers our strategy to evaluate its potential in a wide range of new disease areas."

About STP702
Sirnaomics team has been working diligently on finding a better alternative for prophylaxis and therapeutic treatment of Influenza A. In silico design and in vitro screening (H1N1 in a P2- and H7N9 in a P3-environment) led to the identification of potent siRNA sequences targeting the most conserved regions of Influenza viral genes, and these siRNAs exhibited a broad anti-influenza activity. Through rational pairing of these potent siRNA oligos, a specific combination of two siRNA sequences can further improve efficacy by demonstrating synergistic antiviral activity while also broadening the potential coverage of Influenza strains. The most critical technical advancements are the nanoparticle-enhanced siRNA delivery (STP702) in the viral-challenged mouse models, resulting in more potent anti-influenza activity than the marketed chemo drugs: Ribavirin and Tamiflu.

These results are the first demonstration of a synergistic therapeutic effect from combining siRNAs in a single delivery system. They also demonstrate the utility of nanoparticle mediated delivery of siRNAs through IP administration and suggest that these siRNAs may act as a broad anti-Influenza therapeutic – offering a rapid response to newly emerging viral outbreaks where existing therapeutics and vaccines are ineffective. Finally, mutations in select gene segments within the virus can confer resistance to existing therapeutics, while the use of STP702 containing siRNAs against two distinct gene segments within the influenza viruses should greatly reduce the ability of the virus to escape therapeutic pressure and reduce this additional threat.

On April 29, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP) (the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it has entered into definitive agreements with several health-care focused institutional and accredited investors for the purchase and sale of 1,034,483 units ("Units"), each Unit consisting of four ordinary shares in the form of American Depositary Shares (each an "ADS") and three warrants, each to purchase one ordinary share (each a "Warrant"), in a registered direct offering to specified categories of investors, described below (Press release, ERYtech Pharma, APR 29, 2021, View Source [SID1234578753]). The subscription price for one Unit is $29.00 (€24.03), corresponding to $7.25 (€6.01) per ADS and associated 0.75 warrant. Each ADS represents the right to receive one ordinary share, €0.10 nominal value, of the Company. The Warrants have an exercise price of €7.50 ($9.05) per share, will be immediately exercisable upon issuance and will expire two years from the issuance date. The closing of the offering is expected to occur on or about May 4, 2021, subject to satisfaction of customary closing conditions.

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On April 29, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the acceptance of an abstract discussing its pancreatic adenocarcinoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place virtually from June 4 – 8, 2021 (Press release, Oncolytics Biotech, APR 29, 2021, View Source [SID1234578773]). Details on the abstract and a corresponding poster presentation are shown below.

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Title: Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma
Presentation Type: Electronic poster
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4144

The abstract will be published on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 5:00 p.m. ET on May 19, 2021. The corresponding poster will be made available on the meeting website at 9:00 a.m. ET on June 4, 2021.