Chugai Files for FoundationOne Liquid CDx Aiming to Provide Blood-based Comprehensive Genomic Profiling for Solid Tumors

On March 31, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has submitted the regulatory application for FoundationOne Liquid CDx (overseas product name) to the Ministry of Health, Labour and Welfare (MHLW), as a liquid biopsy (LB) test that provides a comprehensive genomic profiling (CGP) for solid tumors (Press release, Chugai, MAR 31, 2020, View Source [SID1234556025]).

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"Since the national health insurance coverage for genomic testing has started in June 2019, cancer genomic medicine has become widely and increasingly recognized in our society as a new approach in cancer treatment. However, there is an increasing need for blood-based genomic testing in some patients who are unable to undergo invasive tumor biopsy," said Chugai’s President and COO, Dr. Osamu Okuda. "FoundationOne Liquid CDx is a new tool that can help a physician determine treatment options by conducting comprehensive genomic profiling based on genomic alterations in a wider range of patients. We will continue our efforts to obtain approval for the product as soon as possible, and contribute to precision medicine."

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx is a next-generation sequencing based in vitro diagnostic device for advanced cancer patients with solid tumors. It is to identify genomic alterations in oncogenes through detection of blood circulating tumor DNA (ctDNA). In the U.S., Foundation Medicine received Breakthrough Device designation from the U.S. Food and Drug Administration for the LB test in April 2018.

As a leading company in the field of oncology, Chugai is committed to realize precision medicine in oncology and contribute to patients and healthcare professionals through improving access to CGP.

Epigenomics AG successfully completes capital increase

On March 31, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has fully placed the new shares from the capital increase resolved on March 30, 2020 of up to EUR 3,602,154.00 at a price of EUR 1.11 per new share (Press release, Epigenomics, MAR 31, 2020, View Source [SID1234556024]). Accordingly, the Company’s share capital will be increased from currently EUR 43,527,692.00 by EUR 3,602,154.00 to EUR 47,129,846.00 by issuing up to 3,602,154 new registered no par value shares of the Company against cash contributions.

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The new shares were fully subscribed by institutional investors from Germany and the U.S.A. by way of a private placement with the exclusion of the shareholders’ subscription rights and carry full dividend rights as of January 1, 2019.

The gross proceeds from the capital increase amount to approximately EUR 4.0 million.

Subject to the registration of the entry of the capital increase in the commercial register and any delays caused by the COVID 19 pandemic, the Company assumes that the admission of the new shares to the regulated market (Prime Standard) of the Frankfurt Stock Exchange will probably take place on or around April 3, 2020.

Epigenomics AG intends to use the net proceeds from the capital increase primarily to finance its ongoing operations.

Diverse Biotech announces collaboration with Duke University on glioblastoma research

On March 30, 2020 Diverse Biotech, Inc. www.diversebiotech.com reported it has signed an initial partnership agreement with The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center to study its potential new therapeutic candidates in glioblastoma (Press release, Diverse Biotech, MAR 30, 2020, View Source [SID1234576456]). The research will be performed in animal models of the disease to evaluate the efficacy and tissue distribution of Diverse Biotech’s new drug compounds.

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"We are honored to be partnering with this world-renowned center for the study and treatment of brain cancer. Glioblastoma is a disease with a large unmet patient need. Our team at Diverse Biotech wants to develop and study new drugs that could change the standard of care in this disease," said Stella Vnook, Diverse Biotech’s Chief Executive Officer.

"We are excited to be collaborating with Diverse Biotech and to evaluate their cannabidiol compounds in our GBM models. One of the main goals of our lab is to find new therapies that might improve the outcomes for patients living with this disease. Preclinical testing of novel agents is the first step in this process," said Steve Keir, DrPH, MPH, MMCI, Research Professor and Director of Translational Research at The Preston Robert Tisch Brain Tumor Center, Duke University.

Vaccitech to Present at Solebury Trout Virtual Investor Conference

On March 30, 2020 Vaccitech Ltd, a clinical stage biopharmaceutical company developing immunotherapies to treat infectious diseases and cancer, reported that its Chief Executive Officer, Bill Enright, will present an update on the Company’s progress at the upcoming Solebury Trout Virtual Investor Conference (Press release, Vaccitech, MAR 30, 2020, View Source [SID1234556135]). The presentation will include recent encouraging Phase 2 efficacy data for Vaccitech’s prostate cancer therapeutic combined with an anti-PD-1 checkpoint inhibitor in metastatic castration resistant prostate cancer patients. The presentation will also outline ongoing COVID-19 vaccine efforts using Vaccitech’s proprietary ChAdOx1 vector.

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Vaccitech is one of the few companies in the world that has data in humans demonstrating neutralizing antibodies against a coronavirus with its MERS (Middle Eastern Respiratory Syndrome) vaccine candidate.

Date of presentation: Tuesday, 31 Tuesday, 2020

Time: 10:00 am – 10:30 am ET

Entry into a Material Definitive Agreement

On March 30, 2020, Propanc Biopharma, Inc., a Delaware corporation (the "Company"),reported that it has entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") whereby an investor (the "Investor") purchased from the Company, 7,500,000 units (the "Units"), each consisting of (i) 1.5 shares of the Company’s common stock (the "Common Stock"), or pre-funded warrants (the "Prefunded Warrants") and (ii) 1.5 warrants to purchase one share of Common Stock ("Series A Warrants", and collectively with the Common Stock the "Units") (Filing, 8-K, Propanc, MAR 30, 2020, View Source [SID1234556122]). In addition to the Units, the Investor was issued 63,750,000 warrants to purchase one share of Common Stock (the "Series B Warrants") and an additional 63,750,000 warrants to purchase one share of Common Stock, subject to a vesting schedule (the "Series C Warrants" and, together with the Prefunded Warrants, the Series A Warrants, and the Series B Warrants, the "Warrants"). The aggregate purchase price for the Units, the Series A Warrants, the Series B Warrants and the Series C Warrants of $450,000 was paid at closing (the "Purchase Price"). The 11,250,000 shares of Common Stock underlying the Units issuable at closing of the Securities Purchase Agreement are comprised of 804,518 shares of restricted Common Stock and 10,445,482 Prefunded Warrants.

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The Securities Purchase Agreement contains such representations, warranties and covenants as are typical for a transaction of this nature.

Series A Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series A Warrants to purchase up to 11,250,000 shares of Common Stock, subject to adjustment as provided therein. The Series A Warrants have a cash exercise price of $0.20 per share. The Series A Warrants contain a provision for cashless exercise in the event there is no effective registration statement registering the shares underlying the Series A Warrants calculated based on the difference between the exercise price of the Series A Warrant and the trading price of the stock (the "Cashless Exercise").Additionally, the Series A Warrants contain a provision for a cashless conversion at the Holder’s option should the trading price of the Common Stock fall below $0.20 per share calculated based on the difference between the exercise price of the Series A Warrant and 70% of the Market Price, as defined therein (the" Alternate Cashless Exercise").

Series B Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series B Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein; provided, however, commencing on the 90th day following the effective date, the Company may reduce the number of Warrant Shares issuable upon exercise thereof by 37,500,000 upon 10 Trading Days’ prior written notice to the Holder provided that the Company issues to the Holder 3,750,000 shares of Common Stock (or, at the election of the Holder, an equivalent number of pre-funded warrants) and Series A Warrants to purchase up to 3,750,000 shares of Common Stock, which shares shall be issued pursuant to a registration statement without restrictions on resale. The Series B Warrants have a cash exercise price of $0.04 per share. The Series B Warrants contain a provision for Cashless Exercise.

Series C Warrants

Pursuant to the Securities Purchase Agreement, the Investor purchased Series C Warrants to purchase up to 63,750,000 shares of Common Stock, subject to adjustment as provided therein. The Series C Warrants have a cash exercise price of $0.20 per share, subject to the vesting schedule set forth therein, which is based on such Holder’s exercise of the Series B Warrants. The Series C Warrants contain provisions for Cashless Exercise and Alternate Cashless Exercise.

Registration Rights Agreement

In connection with the Securities Purchase Agreement, the Company and the Investor entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to register the shares of Common Stock underlying the Securities Purchase Agreement. The Registration Rights Agreement provides that the Company shall (i) use its best efforts to file with the Commission the Registration Statement within 60 days of the date of the Registration Rights Agreement; and (ii) have the Registration Statement declared effective by the Commission within 90 days of the date of the Registration Rights Agreement, or within 120 days of the date of the Registration Rights Agreement in the event of a full review by the Commission. The Registration Rights Agreement also provides that in the event of a limited or no review by the Commission, the Company shall use its best efforts to have the Registration Statement declared effective on the earlier of (i) the 90th day from the date of the Registration Rights Agreement or (ii) the fifth trading date following the Company’s receipt of notice from the Commission that the Registration Statement will not be reviewed or is no longer subject to further review and comments.

The foregoig provides only brief descriptions of the material terms of the Securities Purchase Agreement, the Registration Rights Agreement and the Warrants, and does not purport to be a complete description of the rights and obligations of the parties thereunder, and such descriptions are qualified in their entirety by reference to the full text of the forms of Securities Purchase Agreement, Registration Rights Agreement and the Warrants, respectively, filed as exhibits to this Current Report on Form 8-K, and are incorporated herein by reference.