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Genialis and Oncologie Collaborate on Precision Medicine Initiative in Gastric Cancer

On January 22, 2020 Genialis, a leader in applied data science for the development of precision medicines, reported a collaborative partnership with Oncologie, an international, clinical-stage biopharma developing next-generation immunotherapies for cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]). Initial activities will focus on the use of Genialis’ Expressions software platform and analytics IP with Oncologie’s clinical and translational expertise to refine patient stratification methodologies.

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"We are incredibly excited to work with Genialis on this cutting-edge, precision medicine project. To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," says Oncologie CEO Laura Benjamin.

Early work between the two companies has thus far focused on modeling gene expression signatures predictive of treatment for gastric cancer. The patent-pending enhanced methodology will further Oncologie’s clinical development plans to expand beyond gastric cancer to other tumor microenvironment phenotypes.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets. Data from historical literature, public population studies, first in human trials, et cetera, can be leveraged to answer significant questions on how to make safe and effective treatments more readily available to patients fighting debilitating and deadly diseases," says Genialis CEO Rafael Rosengarten. "Our work in data science requires a great deal of artistry in addition to technology. And benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special. Right from the start, we knew we shared a vision and a commitment to the process."

This week Genialis will present its work on predictive models for patient stratification at the Precision Medicine World Conference in Santa Clara, CA on January 22.

Mustang Bio to Present at the Phacilitate Leaders World & World Stem Cell Summit 2020

On January 22, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Knut Niss, Ph.D., Chief Technology Officer, will deliver a presentation titled "Non-viral vector platform: an update and review" at the Phacilitate Leaders World & World Stem Cell Summit 2020, at 2:35 PM EST today (Press release, Mustang Bio, JAN 22, 2020, View Source [SID1234553418]). The conference is being held January 21 – 24, 2020, at the Hyatt Regency Hotel in Miami, Florida.

For additional information on the meeting, please visit: View Source

PharmaCyte Biotech Successfully Completes All Release Tests on Clinical Trial Product

On January 22, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that both batches of the company’s manufactured clinical trial product have undergone and passed all 10 of the necessary "release tests" required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 22, 2020, View Source [SID1234553417]).

PharmaCyte’s partner, Austrianova Singapore (Austrianova), is now completing and signing the paperwork to issue PharmaCyte a Certificate of Analysis for each batch of the company’s clinical trial product. Austrianova will also be turning over all of the completed batch records to PharmaCyte for both production runs that tested the company’s clinical trial product for the "functionality" of the encapsulated cells and the "safety" of the clinical trial product. These tests will provide essential data for PharmaCyte to complete its Investigational New Drug application (IND) to the FDA to request approval for our planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "After completing the production of our clinical trial product, it is extremely good news to learn that our capsules and the live cells inside are functioning and safe to put inside patients in our upcoming planned clinical trial in locally advanced, inoperable pancreatic cancer. There were 20 tests in total over both batches, and our clinical trial product passed all of them. This proves that our years of hard work and working through each challenging hurdle was well worth it. We now eagerly await the two Certificates of Analysis and the records from both batches from Austrianova so that we can begin to compile and enter that data into our IND application."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

Arrowhead Pharmaceuticals to Webcast Fiscal 2020 First Quarter Results

On January 22, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on February 5, 2020, at 4:30 p.m. EST to discuss its financial results for the fiscal first quarter ended December 31, 2019 (Press release, Arrowhead Pharmaceuticals, JAN 22, 2020, View Source [SID1234553416]).

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6694317.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6694317.

PharmaMar and Jazz Pharmaceuticals Announce the U.S. License Agreement for Lurbinectedin is Effective with the Expiration of the HSR Waiting Period

On January 22, 2020 PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended "HSR", with respect to the exclusive license agreement for lurbinectedin in the United States expired as of January 21, 2020 at 11:59 p.m. ET (Press release, PharmaMar, JAN 22, 2020, View Source [SID1234553415]).

As previously announced, on 19 December 2019, PharmaMar and Jazz Pharmaceuticals signed an exclusive license agreement for U.S. rights to lurbinectedin, the effectiveness of which was subject to the expiration or early termination of the applicable HSR waiting period. With the expiration of the HSR waiting period, the agreement became effective, and PharmaMar will receive the initial upfront payment of $200 million in the forthcoming days.

Under the terms of the agreement, PharmaMar is also eligible to receive, in the following months, potential regulatory milestone payments of up to $250 million upon the achievement of accelerated and/or full regulatory approval of lurbinectedin by FDA within certain timelines.

PharmaMar is also eligible to receive up to $550 million in potential commercial milestone payments, as well as incremental tiered royalties on future net sales of lurbinectedin ranging from the high teens up to 30%.

PharmaMar retains production rights for lurbinectedin and will supply the product to Jazz.

In December 2019, PharmaMar submitted an NDA to FDA for accelerated approval of lurbinectedin for relapsed SCLC, based on data from its Phase 2 basket trial, following positive interactions with FDA.

About Lurbinectedin
Lurbinectedin (PM1183) is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.