On May 19, 2020 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported that Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences, is scheduled to participate in a fireside chat discussion hosted by Maury Raycroft, Ph.D., Equity Analyst, at the Jefferies Virtual Healthcare Conference on Tues, June 2, 2020 at 11:00 a.m. ET (8:00 am PT) (Press release, Ideaya Biosciences, MAY 19, 2020, View Source [SID1234558301]).

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!

On May 19, 2020 ArcherDX, Inc. reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next-generation sequencing (NGS) device under development as a companion diagnostic (CDx) to detect neurotrophic receptor tyrosine kinase (NTRK) gene fusions that lead to the formation and growth of cancer (Press release, ArcherDX, MAY 19, 2020, View Source [SID1234558300]). ArcherDX’s NGS technology utilizes proprietary Anchored Multiplex PCR (AMP) chemistry that captures DNA, RNA or ctDNA from both blood and tissue samples regardless of the location of the tumor.

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!

ArcherDX is developing and pursuing regulatory clearances for its NGS diagnostic to help solve for the underutilization of targeted therapies. ArcherDX’s technology is designed to enable the use of the diagnostic in community and regional settings where the lack of infrastructure and expertise to implement sophisticated genomic analysis can limit a clinician’s ability to optimize therapy for patients through diagnosis, prognosis and therapy selection.

"NTRK gene fusions are notoriously difficult to detect in cancer.i ArcherDX’s next-generation sequencing technology uses RNA to provide sensitive NTRK fusion detection without requiring prior knowledge of fusion partners for any solid tumor,i" said Jason Myers, Ph.D., Chief Executive Officer and co-founder of ArcherDX. "Our goal is to develop products to help clinicians receive the right information at the right time to make the right treatment decision."

ArcherDX recently announced a collaboration to develop an NGS-based CDx for a TRK inhibitor.

The Breakthrough Devices Program is a voluntary program intended to expedite the review, development and assessment of certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

On May 19, 2020 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454 (Press release, Tolero Pharmaceuticals, MAY 19, 2020, View Source [SID1234558299]). Under this IND, Tolero intends to conduct a Phase 1/1b, first-in-human, open-label, dose‑escalation, safety, pharmacokinetic and pharmacodynamic study, which will evaluate oral TP‑1454 alone, and in combination with ipilimumab and nivolumab, in patients with advanced metastatic or progressive solid tumors.

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 IND submission for TP-1454 represents an important step in advancing Tolero’s pipeline of innovative oncology compounds," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "TP-1454 will be the first PKM2 activator to be tested in cancer patients, representing a novel mechanism that aims to target the underlying metabolics driving tumor growth and anti-cancer immune suppression. We look forward to building our understanding of the potential role of PKM2 activation in the treatment of solid tumors."

The primary objectives of the study are to establish the safety of oral TP-1454 administered once daily as monotherapy in patients with advanced metastatic or progressive solid tumors and as combination therapy with ipilimumab and nivolumab in patients who are eligible for standard of care treatment. In addition, the study will establish the dose of TP-1454 alone and in combination with ipilimumab and nivolumab for future studies in select tumor types. Secondary objectives include assessing the pharmacokinetic profile and antitumor activity of TP-1454 alone and in combination with ipilimumab and nivolumab and evaluating proof of mechanism of TP-1454.

About TP-1454

TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, that will be evaluated in a Phase 1/1b study in patients with advanced metastatic or progressive solid tumors. TP-1454 will be the first PKM2 activator tested in cancer patients. Pyruvate kinase is the enzyme responsible for catalyzing the last step of glycolysis. PKM2 plays a critical role in the metabolic changes observed in cancer and immune cells and establishes a metabolic advantage for tumor cells over the tumor immune microenvironment.1

On May 19, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it will report its results for the first quarter 2020 on Tuesday, 26 May 2020 (Press release, Nordic Nanovector, MAY 19, 2020, View Source [SID1234558298]). A presentation by Nordic Nanovector’s senior management team will take place via a webcast at 08:30 am CET on the same day.

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!

A link to the webcast and a presentation will be uploaded to the company’s homepage (www.nordicnanovector.com) at 07:00 am CET on Tuesday 26 May.

On May 19, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company that applies its Nucleosomics platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose a range of cancers and other diseases, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, VolitionRX, MAY 19, 2020, View Source [SID1234558297]). Volition intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the offering, to cover overallotments, if any. All shares of common stock in the offering are being offered by Volition. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NASDAQ:NHLD), is acting as sole book-running manager in connection with the offering.

Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes, including potential strategic acquisitions.

The securities described above are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227248) previously filed with and declared effective by the Securities and Exchange Commission ("SEC") on September 28, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: National Securities Corporation, 200 Vesey St., 25th Floor, New York, NY 10281, by telephone at (212) 417-3634 or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Volition has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Volition and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The offering will be made only by means of a written prospectus and prospectus supplement that form part of the registration statement.