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JW Therapeutics and Lyell Immunopharma Announce Collaboration to Advance Solid Tumor Treatment in China

On August 10, 2020 JW Therapeutics, a clinical-stage biopharmaceutical company focused on developing, manufacturing and commercializing cell therapies for patients in China, reported entering into a development and commercialization agreement with Lyell Immunopharma to advance adoptive T cell therapy for the treatment of hepatocellular carcinoma in China and ASEAN countries (Press release, JW Therapeutics, AUG 10, 2020, View Source [SID1234638724]).

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The collaboration combines Lyell’s proprietary T cell anti-exhaustion technology, which is intended to preserve or maintain T cell function, with JW Therapeutics’ recent acquisition of Syracuse and its ARTEMIS technology platform. The companies’ complementary capabilities in developing and manufacturing cell-based products may help advance new treatment options for patients in China and other parts of Asia.

JW Therapeutics and Lyell Immunopharma intend to seek additional opportunities for collaboration in research, development, and commercialization of products in China.

Terms of the collaboration were not disclosed.

PDS Biotechnology Corporation Announces Proposed Public Offering of Common Stock

On August 10, 2020 PDS Biotechnology Corporation ("PDS Biotech" or the "Company") (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, PDS Biotechnology, AUG 10, 2020, View Source [SID1234570259]). All of the shares in the offering are to be sold by PDS Biotech. PDS Biotech intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares sold in the offering to cover over-allotments, if any. The 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.

PDS Biotech intends to use the proceeds from this offering to fund working capital and general corporate purposes.

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the offering.

This offering by PDS Biotech is being made pursuant to an effective registration statement on Form S-3 (File No. 333-240011) previously filed with the U.S. Securities and Exchange Commission ("SEC") on July 22, 2020 and declared effective on July 31, 2020, and the accompanying prospectus contained therein. The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC’s website at View Source or by contacting Oppenheimer & Co. Inc. at 85 Broad Street, 26th Floor, New York, NY 10004, Attention: Equity Syndicate Prospectus Department, by telephone at (212) 667-8055, or by email at [email protected].

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

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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.

Diffusion Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update

On August 10, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to deliver oxygen to the areas where it is needed most, reported financial results for the three and six months ended June 30, 2020 and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 10, 2020, View Source [SID1234568922]).

Highlights from the second quarter of 2020 and recent weeks include:

Initiation of an international clinical development program in hospitalized patients with COVID-19. Low oxygen levels occur as a consequence of damage to the lungs from COVID-19, often resulting in mechanical ventilation and, if that is ineffective, multiple organ failure – the leading cause of death from COVID-19. Diffusion believes that the oxygen-enhancing mechanism of action of TSC could benefit such patients.
The TSC/Covid-19 clinical development program will begin with an open-label lead-in trial which, if successful, will be followed by one or more randomized double-blinded clinical trials. The lead-in trial will test TSC in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID). Diffusion expects to begin dosing in this study in the third quarter, with data read-out in the fourth quarter of 2020. In addition to safety, the lead-in trial will collect data on possible increased oxygenation, thereby helping the Company determine TSC dosing for follow-on studies.
Following the recent successful completion of the 19-patient open-label, dose-escalation lead-in safety portion of the trial, the Company has continued pursuit of partnership efforts for its Phase 3 INTACT (INvestigating Tsc Against Cancerous Tumors) program with TSC plus standard of care (SOC) for patients newly diagnosed with inoperable glioblastoma multiforme (GBM).
The Company’s Phase 2 160-patient on-ambulance clinical trial testing TSC for the treatment of acute stroke continues, but on a limited basis because of the on-going pandemic. This program, featuring the PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC) trial, will ultimately involve a total of 23 hospitals across urban, suburban and rural areas in Los Angeles County and Central Virginia when conditions permit more robust operations.
On May 29, 2020 the Company") announced that it received written notice from the Nasdaq Listing Qualifications Staff of the NASDAQ Stock Market LLC ("Nasdaq") stating that the Company regained compliance with the applicable Nasdaq minimum bid price continued listing standard and the matter was now closed.
During the quarter, the Company sold common stock raising $10.3 million and also raised $7.6 million from the exercise of outstanding warrants, for net proceeds of $17.9 million during the reporting period.
"This is an exciting time for Diffusion as we prepare for first enrollment in our global clinical trial program using TSC for the treatment of hospitalized COVID-19 patients," said David Kalergis, chairman and chief executive officer of Diffusion. "Given the severity of the worldwide pandemic, regulatory authorities in the U.S. and Europe have put in place measures to expedite the testing of therapeutics and have been generous in their guidance in light of emerging knowledge. Protocol changes based on this guidance have been incorporated into the development program so that data from any patient, wherever located, can be included to help support planned future regulatory filings in both the U.S. and Europe.

"We also raised funds during the quarter, which will largely be used to advance our TSC clinical development plan, with an emphasis on the COVID-19 program," Mr. Kalergis continued. "At quarter-close we had more than $25 million in cash, the largest cash balance on hand since becoming a public company. In addition, to better help our investors, potential partners and the public stay informed, we are currently revamping our website to reflect the impact of our COVID-19 program on TSC’s development, with the revised website launch targeted for later this quarter."

Second Quarter Financial Results

Research and development expenses were $2.2 million for the second quarter of 2020, compared with $1.5 million for second quarter of 2019. The increase was attributable to a $0.6 million increase in costs associated with follow on work for our 19 patient run-in Phase 3 trial for GBM, a $0.3 million increase in expense related to our open-label Phase 1b lead-in trial for TSC in COVID-19 patients, and a $0.3 million increase in associated manufacturing costs as we ramp up the trial. These increases were offset in part by a $0.5 million decrease in costs associated with the delay in our Phase 2 stroke trial due to the COVID-19 pandemic

General and administrative expenses were $1.5 million for the second quarter of 2020, compared with $1.1 million for the second quarter of 2019. The increase was mainly due to higher professional fees, salaries and wages.

Diffusion had cash and cash equivalents of $25.6 million as of June 30, 2020, compared with $14.2 million as of December 31, 2019. During the second quarter the Company completed an offering of 11.4 million shares of common stock for net proceeds of $10.3 million. In addition, the Company received proceeds of $7.6 million from the exercise of 13.0 million warrants and the exchange and exercise of a further 5.0 million warrants. Diffusion believes its cash and cash equivalents as of June 30, 2020 are sufficient to fund operating expenses and capital expenditures, including clinical trials, into the fourth quarter of 2021.

Biofrontera AG announces subscription price for 1.00 % qualified subordinated mandatory convertible bond 2020/2021

On August 10, 2020 The Executive Board of Biofrontera AG (shares of Biofrontera AG ISIN: DE0006046113) reported that has decided on 27 July 2020, with the approval of the Supervisory Board, to issue a 1.00 % qualified subordinated mandatory convertible bond 2020/2021 (ISIN: DE000A3E4548 / WKN: A3E454). It is divided into up to 2,638,150 qualified subordinated mandatory convertible bearer bonds ("Bonds") with a nominal value of EUR 3.00 each and a total nominal value of up to EUR 7,914,450 (Press release, Biofrontera, AUG 10, 2020, View Source [SID1234568548]). The shareholders or holders of subscription rights were invited by an announcement in the Federal Gazette (Bundesanzeiger) of 29 July 2020 to exercise their subscription rights to the Bonds during normal business hours in the period from 30 July 2020 up to 13 August 2020 (included) to avoid exclusion. It was also provided that the subscription price would be published in the Federal Gazette (Bundesanzeiger) and via an electronic information medium no later than three days before the end of the subscription period.

The subscription price for each of the Bonds was set at

100 % of their nominal value of EUR 3,00.

Thus, the cash payment for each bond subscribed is EUR 3.00.

Sysmex Corporation received Insurance Coverage in Japan for Liquid Biopsy RAS Gene Mutation Testing for CRC Using High-Sensitivity Digital PCR

On August 10, 2020 Sysmex Corporation (Chairman and CEO: Hisashi letsugu) reported that it has received approval for insurance coverage for blood-based RAS gene mutation testing for colorectal cancer using the OncoBEAM RAS CRC Kit (Press release, Sysmex Inostics, AUG 10, 2020, View Source [SID1234568252]). The coverage went into effect on August 1, 2020.
With this regulatory approval, even when it is difficult to obtain in vivo diagnostics (biopsy) on a sample taken from tumor tissue, RAS gene mutation testing using the kit may be performed with a minimal physical and mental burden on patients when it is necessary, owing to the fact that it uses the patient’s blood as a sample. This will have the effect of optimizing decisions on the administration of anti-EGFR monoclonal antibody drugs. Receipt of insurance coverage will also make it possible for us to provide more patients with testing to allow physicians to select an appropriate treatment method.

Currently, at the beginning of therapy, colorectal cancer patients treated with medication undergo RAS gene mutation testing using tumor tissue, the results of which inform a decision on whether or not to administer anti-EGFR monoclonal antibody drugs. Several studies have reported that re-challenge of anti-EGFR monoclonal antibody drugs is an effective treatment method for patients with recurrent colorectal cancer after treatment by anti-EGFR monoclonal antibody drugs, and that the RAS gene mutation status may change by the time of re-challenge from what it was in initial therapy. The relevant guidance published by the Japanese Society of Medical Oncology indicates that it is desirable to assess the gene mutation status several times over time to make appropriate re-challenge decisions based on the state at the time of relapse. As such, much has been expected from a practical application of liquid biopsy, which checks the RAS gene mutation status using the patient’s blood samples when biopsy may not be performed easily.
The OncoBEAM RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. Using BEAMing technology, the kit detects RAS gene mutations with a high degree of sensitivity (mutant allele frequency of no more than 1% in approximately 30% of mutation cases thus detected). As the first colorectal cancer liquid biopsy testing in Japan that provides auxiliary test data to determine the appropriateness of anti-EGFR monoclonal antibody drugs – Cetuximab and Panitumumab (gene recombination) – for patients with colorectal cancer, this product was approved as an in vitro diagnostic reagent in July 2019 and was covered under health insurance from August 1, 2020. Please note that an insurance-covered assay service for colorectal cancer using this product is also due to start in August 2020.
Performance of RAS gene mutation testing when it is necessary and with a minimal physical and mental burden on patients for whom biopsy is challenging to perform is expected to optimize the administration of anti-EGFR monoclonal antibody drugs. On the other hand, there is a possibility that this testing may deem patients whose ctDNA is not sufficiently leaked into the blood to have wild-type RAS, even though RAS gene mutation exists in tumor tissue. For patients with lung metastasis only, it is particularly necessary to prioritize testing using tumor tissue. Sysmex will remain committed to the provision of scientific information so that medical institutions may perform testing properly.
Going forward, Sysmex will continue to contribute to the advancement of personalized medicine by working on expanding testing opportunities for patients and providing testing and diagnostic technologies with high diagnostic value.