On April 8, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its collaborators from The University of Texas MD Anderson Cancer Center ("MD Anderson") presented positive preclinical data for the combination of the TUSC2 gene with an anti-PD1 antibody, pembrolizumab, for the treatment of lung cancer in a poster presented at the American Association of Cancer Research Meeting 2019 (Press release, Genprex, APR 8, 2019, View Source [SID1234535051]). The TUSC2 gene is a tumor suppressor gene, the active agent in Genprex’s Oncoprex immunogene therapy.

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The poster, entitled "Development of an improved humanized patient-derived xenograft, Hu-PDX, mouse model for evaluation of antitumor immune response in lung cancer" showed that TUSC2 combined with checkpoint blockade was more effective than checkpoint blockade alone in increasing the survival of mice with human immune cells (humanized mice) that had metastatic lung cancer. The TUSC2 treatment with the checkpoint inhibitor pembrolizumab slowed tumor growth significantly. Pembrolizumab previously had no effect on tumor growth in non-humanized mice. The data also demonstrated the Hu-PDX model as an improved platform for evaluation of immunotherapy.

"This sophisticated model gets one step closer to recapitulating certain functions of the human immune response within a manageable scientific animal model and allows us to further test our hypotheses of how a more complex immune system could interact with aggressive cancers when primed by drugs, such as Oncoprex, in humans," said Julien L. Pham, MD, MPH, President and Chief Operating Officer of Genprex. "These data further support and solidify existing preclinical data showing that Oncoprex immunogene therapy is synergistic with anti-PD1 therapy and could result in a stronger antitumor response compared to either agent alone. It also demonstrates how Oncoprex could be used in combination with other immunotherapies as a viable treatment option for late-stage non-small cell lung cancer."

Poster Presentation Details:

Date/Time: Wednesday, April 3, 2019 from 8 a.m. to 12 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B
Session: Immunomodulators and Response to Therapy
Title: Development of an improved humanized patient-derived xenograft, Hu-PDX, mouse model for evaluation of antitumor immune response in lung cancer
Authors: Ismail M. Meraz, Mourad Majidi, Feng Meng, RuPing Shao, Min Jin Ha, Shinya Neri, Bingliang Fang, Steven H. Lin, Peggy T. Tinkey, Elizabeth J. Shpall, Jeffrey Morris, Jack A. Roth. UT MD Anderson Cancer Ctr., Houston, TX

Following the AACR (Free AACR Whitepaper) annual meeting, the poster will also be made available on Genprex’s website at genprex.com.

On April 8, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its first-quarter 2019 financial results on Monday, May 6, 2019. Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update (Press release, Valeant, APR 8, 2019, View Source [SID1234535035]). All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Monday, May 6, 2019

Time:

8:00 a.m. EDT

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

0806644

Replay Dial-in:

+1 (877) 344-7529 (United States)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10129984 (replay available until May 13, 2019)

On April 8, 2019 Based on its exclusive license related to photoimmunotherapy, Rakuten Medical Inc., which is developing a cancer therapy to target cancer cells, reported that ASP-1929 received Sakigake designation under the Sakigake Designation System*, which is a Fast Track designation from the Japanese Ministry of Health, Labour, and Welfare as a treatment for head and neck cancer patients (Press release, Rakuten Aspyrian, APR 8, 2019, View Source [SID1234535068]).

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ASP-1929 qualified on all four criteria of the Sakigake Designation System: innovativeness of the product, the severity of the target condition, prominent effectiveness of the treatment, and with a plan to file the initial application first or simultaneously with others in Japan. This designation was referred for Sakigake Designation System based upon the results of analysis of a Phase I trial in Japan and a Phase I/IIa trial in the United States. The results of these studies in comparison to past data of the currently available standard treatments in a group of head and neck cancer patients suggest the potential for improved survival time.

Based on receipt of this designation, Mickey Mikitani, chairman and CEO of Rakuten Medical said, "Every day, we receive messages from many patients waiting for this treatment. To those people, I am delighted to be able to make an announcement today that brings them hope. This is a major step forward toward delivering a new treatment for head and neck cancer patients. We are aiming to get this therapy to as many patients as possible, and as soon as possible, by rigorously following the process established by the Sakigake Designation System."

ASP-1929 received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of head and neck squamous cell carcinomas (HNSCC) in the first quarter of 2018. Under the mission of Rakuten Medical, we will accelerate the development of photoimmunotherapy applying ASP-1929 to cancers of the head and neck.

*The Sakigake Designation System is the Japanese Fast Track designation which started as a national strategy and was announced by the Ministry of Health, Labour and Welfare on June 17, 2014. The measures included the creation of this designation system for groundbreaking drugs developed in Japan and identified in the early clinical trial phase as being likely to be remarkably effective. This would offer priority examination that would reduce the length of the approval examination period before commercialization.

On April 8, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will report its first quarter 2019 financial results after the market close on Monday, April 29, 2019 (Press release, Medpace, APR 8, 2019, View Source [SID1234535053]). The Company will host a conference call the following morning, Tuesday, April 30, 2019, at 8:30 a.m. ET to discuss these results.

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To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 8067378.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at investor.medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available from 12:00 p.m. ET on Tuesday, April 30, 2019 until 12:00 p.m. ET on Tuesday, May 14, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 8067378.

On April 8, 2019 Oncolys BioPharma Inc. (hereafter, "Oncolys") and Chugai Pharmaceutical Co., Ltd. (hereafter, "Chugai") reported the both companies have entered into an agreement that Oncolys will grant an exclusive license, with sublicensing rights, to Chugai concerning the development, manufacturing and marketing in Japan and Taiwan for "Telomelysin (OBP-301)" (hereafter, "Telomelysin") an oncolytic viral immunotherapy which is currently under development by Oncolys (Press release, Chugai, APR 8, 2019, View Source [SID1234535069]). In addition, licensing agreement that grants exclusive option rights concerning the worldwide development, manufacturing and marketing of Telomelysin, excluding Japan, Taiwan, China, Hong Kong and Macau to Chugai has also been concluded. Moreover, both companies agreed that Oncolys will newly issue common stock worth approximately 800 million yen, and Chugai will accept all the stocks. The start of this licensing agreement and the payment accompanying the issuance of new shares by third-party allotment are planned on April 24, 2019.

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Chugai shall pay 550 million yen as an upfront payment for the exclusive licensing agreement, with sublicensing rights, in Japan and Taiwan. If a certain level of efficacy has been confirmed in the clinical study of Telomelysin, and in case Chugai exercised the exclusive option rights described above, the total value of the licensing agreement which Chugai shall pay to Oncolys will be 50 billion yen or more. In addition, after the launch of Telomelysin, Chugai shall pay to Oncolys, sales royalties according to Chugai’s amount of sales of Telomelysin, apart from the total value of the licensing agreement.

The capital and business tie-up agreement described in this release is announced separately by Oncolys on April 8, 2019, in the "Notice of Capital and Business Alliance and Issuance of New Shares through Third Party Allotment."

Comments by the Management
Yasuo Urata, President & CEO, Oncolys BioPharma Inc.
"Chugai is an expert in the development of oncology drugs including antibody pharmaceuticals, and we feel that we were able to form the best partnering in developing Telomelysin, an oncolytic viral immunotherapy. Telomelysin is an oncolytic virus drug originated in Japan, and we are extremely delighted that Chugai had highly valued the clinical effects of the drug against esophageal cancer. We hope that Chugai will greatly expand the indications of Telomelysin, going forward."

Tatsuro Kosaka, President and CEO, Chugai Pharmaceutical Co., Ltd.
"Telomelysin is an oncolytic viral immunotherapy with a novel mode of action, expected to provide new value to oncology patients. We are committed to maximize the value of this new innovative drug created by Oncolys in order to deliver it to patients as quickly as possible, and also expand its indications to other types of cancer, by considering the combination with cancer immunotherapies, which could provide true value to patients and their families. We strongly believe that Chugai, as one of the shareholders of Oncolys, can contribute to increasing corporate and shareholder values of Oncolys in the medium- to long-term perspective."

Oncolys believes that the conclusion of this licensing agreement and the third-party allocation of shares will contribute to enhancing its corporate value as well as shareholder value. At this point, however, the concrete amount of impact they would have on Oncolys’ business performance of the term ending December 2019 is unclear. The impact on the consolidated financials for the fiscal year ending December 2019 of Chugai is expected to be minimal.
As written in the financial statements for the business term ended December 2018, released on February 8, 2019, Oncolys has not announced its business performance forecasts for the term ending December 2019, since the company views it difficult to calculate appropriate and reasonable numerical value due to the existence of numerous uncertain factors that impact the business performance at this point.