On May 28, 2021 NEC Corporation (NEC; TOKYO: 6701) reported the development of an AI technology for supporting doctors to detect neoplasia in Barrett’s esophagus during endoscopic procedures (Press release, NEC, MAY 28, 2021, View Source [SID1234583277]). This is the world’s first technology of its kind to comply with the requirements for CE mark labeling, a European safety, health and environmental protection standard (*1), and is being released as WISE VISION Endoscopy, where it will soon be available in Europe to help doctors in the detection of Barrett’s neoplasia (*2).

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This software is connected to endoscopy processors and automatically notifies users of potential Barrett’s neoplasia from images captured during endoscopic procedures.

Barrett’s esophagus is a pre-cancerous condition in which the inner lining of the esophagus is replaced by a lining that resembles that of the stomach. Patients with Barrett’s esophagus have 30-40 fold higher risk of developing cancer of the esophagus as compared to the normal population (*3).

However, if this cancer can be detected at an early stage, then it can be removed through the endoscope and a patient can be cured.

To help resolve this issue, NEC collaborated with Professor Pradeep Bhandari (Portsmouth, UK), Chair of the European Society of Gastrointestinal Endoscopy (ESGE) Research Committee, in development of this new technology to support doctors to detect Barrett’s neoplasia during examination. In developing this solution, NEC applied its face recognition technology that has been highly evaluated (*4) by the National Institute of Standards and Technology (NIST) in the United States, and belongs to NEC’s portfolio of cutting-edge AI technologies, "NEC the WISE."

"I am delighted that NEC, as one of the world’s leaders in AI technology, has entered the field of endoscopy and developed WISE VISION Endoscopy to detect and help manage Gastrointestinal neoplasia," said Professor Pradeep Bhandari, Chair of the ESGE Research Committee.

On May 28, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported that filed a lawsuit against Natera, Inc. for false advertising, unfair competition, and unlawful trade practices, relating to misleading statements Natera has made about its own products and the performance of Guardant Health’s new oncology test, Guardant Reveal (Press release, Guardant Health, MAY 28, 2021, View Source [SID1234583276]).

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Guardant Health asked the federal court in San Francisco, California for an injunction preventing Natera from continuing to make these false or misleading statements and requiring Natera to take corrective actions.

Guardant Health’s recent introduction of Guardant Reveal, the first blood-only liquid biopsy test to detect residual and recurrent disease in early-stage cancer survivors, represents an important medical breakthrough for the 1.5 million early-stage colorectal cancer survivors in the U.S.1 Colorectal cancer is the second leading cause of cancer death in the U.S.2 The Guardant Reveal test detects circulating tumor DNA (ctDNA) from a simple blood draw and is performed after surgery to identify patients with residual disease who may benefit most from adjuvant therapy and surveillance. The test can also detect recurrence months earlier than current standard-of-care methods, such as carcinoembryonic antigen tests or imaging.3-8 Guardant Health’s method for ctDNA detection is vastly different from Natera’s Signatera assay, which requires a tissue-biopsy.9

The complaint alleges that Natera is misleading healthcare providers about the performance of the Guardant Reveal test by suggesting the test is inaccurate and/or insensitive, and inferior to Signatera. As a direct result, colorectal cancer patients are missing opportunities for minimal residual disease (MRD) detection and recurrence monitoring, and the attendant benefits of guided treatment decisions.

"Guardant Health believes it is vital that clinicians receive accurate and truthful information, as this impacts potentially life-saving patient treatment decisions. We also believe that companies in the cancer diagnostics business must have patient care as their central mission and should not misrepresent medical science. When they do, we believe that immediate corrective action is required," said John Saia, Senior Vice President, General Counsel and Corporate Secretary at Guardant Health.

On May 28, 2021 Alkermes plc (Nasdaq: ALKS) reported that it will host a webcast and conference call at 4:00 p.m. ET (9:00 p.m. BST) on Friday, June 4, 2021 to review data updates presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the company’s ARTISTRY-1 and ARTISTRY-2 clinical trials evaluating immuno-oncology candidate nemvaleukin alfa (nemvaleukin) (Press release, Alkermes, MAY 28, 2021, View Source [SID1234583275]). The company will provide an overview of the data being presented followed by a roundtable discussion with expert oncologists and ARTISTRY clinical program investigators, Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal; and Omid Hamid, M.D., Chief of Research and Immunotherapy, The Angeles Clinic and Research Institute.

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Investor and Analyst Webcast with Expert Oncologists
Date and Time: Friday, June 4, 2021, at 4:00 p.m. ET (9:00 p.m. BST)
Dial-in: +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers.
Investors and analysts can also view slides and listen to the live audio webcast of the presentation on the Investors section of Alkermes’ website at www.alkermes.com. A replay of the webcast will be archived on the company’s website for 30 days following the presentation.

Nemvaleukin Poster Presentations at ASCO (Free ASCO Whitepaper)

Abstract: 2513
Title: ARTISTRY-1: Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Presenter: Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal, Madrid, Spain
Presentation Date/Time: The on-demand poster discussion session will take place on June 4, 2021 at 9:00 a.m. ET.

Abstract: 2552
Title: Selection of the Recommended Phase 2 Dose (RP2D) for Subcutaneous Nemvaleukin Alfa: ARTISTRY-2
Presenter: Omid Hamid, M.D., Chief of Research and Immuno-Oncology, The Angeles Clinic and Research Institute
Presentation Date: The poster presentation will be available on-demand to attendees beginning June 4, 2021.

About Nemvaleukin alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin alfa as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

On May 28, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, MAY 28, 2021, View Source [SID1234583274]):

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Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 10:00 a.m. ET
Goldman Sachs 42nd Annual Healthcare Conference on Wednesday, June 9, 2021 at 8:00 a.m. ET
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at View Source A replay of each webcast will be archived on Moderna’s website for 30 days following the presentation.

On May 28, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the publication of its Interim Report for the period January – March 2021 (Press release, Allarity Therapeutics, MAY 28, 2021, View Source [SID1234583273]). The report is available as an attached document and on the company’s website.

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Steve Carchedi, CEO of Allarity Therapeutics, stated, "2021 has already been a year full of significant events for Allarity. We have initiated our IXEMPRA Phase 2 trial in Europe, and we made progress on multiple fronts in our effort to achieve U.S. marketing approval for dovitinib together with its DRP companion diagnostic, and we remain committed to filing the New Drug Application (NDA) for dovitinib later this year with the U.S. FDA. Moreover, we expanded our preclinical testing of stenoparib’s antiviral properties to include both the British and South African variant of Coronavirus. On the financial side, we have ceased to rely on convertible notes as our main source of funding. Instead, we have announced two new financing events, one a rights issue and one a U.S. $20M investment, the largest in our Company’s history, which is conditional on our company transforming into a U.S. company and listing on the U.S. Nasdaq Stock Market. I look forward to our achievement of further strategic milestones during the remainder of this year."

Summary of the Interim Report

Consolidated group revenue amounted to 0 MDKK (0 MDKK).
Consolidated group loss before depreciation amounted to -15.8 MDKK (-17.3 MDKK).
Consolidated group loss before net financials amounted to -16.0 MDKK (-17.6 MDKK).
Consolidated net result amounted to -17.6 MDKK (-15.4 MDKK).
Consolidated earnings per share (EPS) amounted to -0.08 DKK (-0.12 DKK).

2020 numbers in brackets.

Highlights during Q1 2021

January

On January 26, Allarity Therapeutics announced that it would test its PARP inhibitor, stenoparib, as a potential therapy for new highly infectious Strain B.1.1.7 of Coronavirus in preclinical studies.

February

On February 11, the Company announced that it had drawn down a fourth tranche under its convertible note agreement with Negma Group LTD and Park Partners GP.
On February 24, the Company provided an update on the pre-clinical testing of stenoparib’s antiviral activity against new variants of Coronavirus.
March

On March 3, the Company published that it had initiated a Phase 2 trial of IXEMPRA in Europe for the treatment of metastatic breast cancer.
On March 9, the Company announced positive data from a preclinical study of dovitinib in osteosarcoma.
On March 23, the Company announced plans of fully guaranteed rights issue of approximately SEK 100 million.
On March 31, the Company published its annual report for 2020.
On March 31, the Company published a notice to convene the Annual General Meeting to be held on Thursday 15 April 2021 at 15:00 (CEST).

Highlights after the period

April

On April 2, the Company submitted a PreMarket Approval (PMA) application to the U.S. FDA for the DRP companion diagnostic for dovitinib.
On April 15, the Company published the minutes of the Annual General Meeting 2021.
On April 29, the Company announced that a Dovitinib-DRP e-Poster will be presented at the European Association for Cancer Research (EACR) 2021 Virtual Congress to be held from 9-12 June 2021.

May

On May 19, the Company announced that it would conduct a Rights Issue of new shares, and it had published a prospectus regarding the Rights Issue.
On May 21, the Company announced that it had secured an investment from 3i Fund for recapitalization, transition to listing on U.S. Nasdaq, and advancing the company’s pipeline of priority oncology therapeutics.
The report is available on: View Source

Online webcast/conference call

Allarity Therapeutics will host a live webcast on 28 May 2021, at 5:00 p.m. CEST to discuss the company’s first-quarter 2021 results and provide a business and financial update.

Attendees are encouraged to pre-register in order to be able to watch the presentation slides using this link: View Source