On March 28, 2019 ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported its lead clinical candidate, EPI-7386, for metastatic castration-resistant prostate cancer has been selected for a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2019 to be held March 29 – April 3 at the Georgia World Congress Center in Atlanta, Georgia (Press release, ESSA, MAR 28, 2019, View Source [SID1234534726]). The poster will expand on the preclinical characterization of EPI-7386 alone and in combination with current anti-androgens, as well as provide further information on the aniten class in general.

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Title:

A new generation of N-terminal domain androgen receptor inhibitors, with improved pharmaceutical properties, in castration-resistant prostate cancer models.

Authors:

Ronan Le Moigne, Nasrin R. Mawji, Adriana Banuelos, Jun Wang, Kunzhong Jian, Raymond Andersen, Marianne D. Sadar, Han-Jie Zhou, Peter Virsik. ESSA Pharmaceuticals; BC Cancer, Vancouver, BC, Canada; University of British Columbia, Vancouver, BC, Canada

Session:

Experimental and Molecular Therapeutics, Novel Targets & Pathways.

Date & Time:

Monday April 1, 2019 from 8:00am – 12:00pm

Location:

Georgia World Congress Center, Atlanta, Georgia, Exhibit Hall B

Poster Section:

14

Poster Board No:

7

Abstract No:

1292

ESSA also announced that two abstracts have been selected for poster presentations at AACR (Free AACR Whitepaper) from the laboratory of Dr. Marianne Sadar, Distinguished Scientist and Scientific Co-Founder of Essa, Michael Smith Genome Sciences Centre, BC Cancer Agency and Professor in the Department of Pathology and Laboratory Medicine at the University of British Columbia. The featured abstracts will explore the use of aniten compounds in prostate and breast cancer preclinical models.

Title:

Targeting androgen receptors and cyclin-dependent kinases 4 and 6 in breast cancer.

Authors:

Amy H. Tien, Nasrin R. Mawji, Jun Wang, Marianne D. Sadar. BC Cancer, Vancouver, BC, Canada

Session:

Endocrine-related Cancers.

Date & Time:

Monday April 1, 2019 from 8:00am – 12:00pm

Location:

Georgia World Congress Center, Atlanta, Georgia, Exhibit Hall B

Poster Section:

2

Poster Board No:

1

Abstract No:

1000

Title:

Combining all-trans retinoic acid therapy with androgen receptor N-terminal domain inhibitors for the treatment of castration-resistant prostate cancer.

Authors:

Jacky K. Leung, Marianne D. Sadar. BC Cancer, Vancouver, BC, Canada

Session:

Endocrine-related Cancers.

Date & Time:

Monday April 1, 2019 from 8:00am – 12:00pm

Location:

Georgia World Congress Center, Atlanta, Georgia, Exhibit Hall B

Poster Section:

2

Poster Board No:

24

Abstract No:

1023

On March 28, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported plans to accelerate filing of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (T-DM1) (Press release, Daiichi Sankyo, MAR 28, 2019, https://www.prnewswire.com/news-releases/daiichi-sankyo-confirms-plans-to-accelerate-bla-submission-to-us-fda-for-fam–trastuzumab-deruxtecan-ds-8201-in-her2-positive-metastatic-breast-cancer-post-t-dm1-300820754.html [SID1234534725]). Submission of the application, which was originally planned for 2020, is now scheduled for the first half of fiscal year 2019.

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"We are pleased to confirm the acceleration of the [fam-] trastuzumab deruxtecan clinical development program for this potential indication in patients with HER2 positive metastatic breast cancer pretreated with T-DM1 ahead of schedule," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Simultaneously, we are committed to our aggressive development strategy evaluating the potential of [fam-] trastuzumab deruxtecan across a spectrum of HER2 expressing cancers including breast, gastric, lung and colorectal."

[Fam-] trastuzumab deruxtecan has been granted U.S. FDA Breakthrough Therapy for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1. The initial BLA submission of [fam-] trastuzumab deruxtecan will be based on results from the pivotal phase 2 DESTINY-Breast01 study, which will be presented at an upcoming medical conference. Final determination of exact timing of the BLA submission of [fam-] trastuzumab deruxtecan will be based on the outcome of a pre-BLA meeting with the FDA.

About DESTINY-Breast01
DESTINY-Breast01 is a pivotal phase 2, open-label, global, multicenter, two-part study evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with T-DM1. The primary endpoint of the study is objective response rate. Secondary objectives include duration of response, disease control rate, clinical benefit rate, progression-free survival and overall survival. The first part of the study includes a pharmacokinetic stage and a dose-finding stage to identify the recommended dose of [fam-] trastuzumab deruxtecan to be evaluated in the second part of the study. The second part of the study enrolled patients into one of two cohorts: patients resistant or refractory to T-DM1 (part 2a) and patients who discontinued treatment with T-DM1 for reasons other than resistant or refractory disease (part 2b).

Enrollment into DESTINY-Breast01 was completed in September 2018, with approximately 230 patients at more than 100 sites in North America, Europe, Japan and other countries in Asia. For more information about this study, visit ClinicalTrials.gov.

Unmet Need in HER2 Positive Breast Cancer
Breast cancer is the most common cancer and the most common cause of cancer mortality in women worldwide; there were an estimated 2.1 million new cases of female breast cancer diagnosed in 2018.1 Approximately one in five breast cancers (20 percent) are HER2 positive (IHC3+ or IHC2+/ISH+).2,3 HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells that is associated with aggressive disease and poorer prognosis.4,5 To be considered HER2 positive, tumor cancer cells are usually tested first by immunohistochemistry (IHC) and reported as: 0, IHC 1+, IHC 2+ or IHC 3+. A finding of IHC 3+ is considered HER2 positive, and a finding of IHC 2+ is borderline and typically is confirmed by a positive fluorescent in situ hybridization (FISH) test.3,4

Several unmet treatment needs remain today in HER2 positive metastatic breast cancer. Many HER2 positive breast cancers eventually advance to the point where no currently approved HER2 targeting therapy continues to control the disease, and there is no established standard of care after treatment with trastuzumab, pertuzumab and T-DM1.6

About [Fam-] Trastuzumab Deruxtecan
[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia including five pivotal studies. [Fam-] trastuzumab deruxtecan is in pivotal phase 3 development in previously treated HER2 low expressing metastatic breast cancer versus investigator’s choice (DESTINY-Breast04); phase 3 development in HER2 positive metastatic breast cancer versus ado-trastuzumab emtansine (T-DM1) (DESTINY-Breast03); and phase 3 development in HER2 positive metastatic breast cancer versus investigator’s choice post T-DM1 (DESTINY-Breast02). [Fam-] trastuzumab deruxtecan also is in pivotal phase 2 clinical development for HER2 positive metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01); pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01); phase 2 development for HER2 expressing advanced colorectal cancer; phase 2 development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC; and, phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancer.

[Fam-] trastuzumab deruxtecan has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1, and Fast Track designation for the treatment of patients with HER2 positive unresectable and/or metastatic breast cancer who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). [Fam-] trastuzumab deruxtecan has received SAKIGAKE Designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On March 28, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer (Press release, Daiichi Sankyo, MAR 28, 2019, https://www.prnewswire.com/news-releases/daiichi-sankyo-and-astrazeneca-announce-global-development-and-commercialization-collaboration-for-daiichi-sankyos-her2-targeting-antibody-drug-conjugate-fam–trastuzumab-deruxtecan-ds-8201-300820766.html [SID1234534724]).

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Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and the supply of [fam-] trastuzumab deruxtecan.

As announced separately by Daiichi Sankyo, a Biologics License Application (BLA) submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (T-DM1) will be accelerated to the first half of fiscal year 2019.

Designed using Daiichi Sankyo’s DXd proprietary ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload compared to the way chemotherapy is commonly delivered.

"[Fam-] trastuzumab deruxtecan is the flagship asset in our oncology pipeline created by our relentless pursuit of science and technology, the most important strengths of our company," said George Nakayama, Representative Director, Chairman and CEO of Daiichi Sankyo Company, Limited. "Through the strategic collaboration with AstraZeneca, a company with a wealth of global experience and expertise in oncology, we will combine our respective skill sets to maximize the value of [fam-] trastuzumab deruxtecan, and accelerate the establishment of our global oncology business. By aiming to provide new treatment options across a wide range of cancers as soon as possible, we will maximize our contribution to patients with cancer and their families around the world."

"We believe that [fam-] trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2 positive breast and gastric cancers," said Pascal Soriot, Chief Executive Officer, AstraZeneca. "In addition, [fam-] trastuzumab deruxtecan has the potential to redefine breast cancer treatment as the first therapy for HER2 low expressing tumors. It also has the potential to treat other HER2 mutated or HER2 overexpressing tumors, including lung and colorectal cancers. We are proud to be working with Daiichi Sankyo, a long-term collaborator of AstraZeneca in other disease areas."

Financial Terms
Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35 billion. Contingent payments of up to $5.55 billion include $3.8 billion for achievement of future regulatory milestones and other contingencies, as well as sales-related milestones of up to $1.75 billion. Total payments under the agreement have the potential to reach up to $6.90 billion.

Daiichi Sankyo and AstraZeneca will share equally development and commercialization costs as well as profits from [fam-] trastuzumab deruxtecan worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates. AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia.

The impact on Daiichi Sankyo’s consolidated results for the fiscal year ending March 31, 2019 is immaterial because the upfront payment will be booked in revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

About [Fam-] Trastuzumab Deruxtecan
[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia including five pivotal studies. [Fam-] trastuzumab deruxtecan is in pivotal phase 3 development in previously treated HER2 low expressing metastatic breast cancer versus investigator’s choice (DESTINY-Breast04); phase 3 development in HER2 positive metastatic breast cancer versus ado-trastuzumab emtansine (T-DM1) (DESTINY-Breast03); and phase 3 development in HER2 positive metastatic breast cancer versus investigator’s choice post T-DM1 (DESTINY-Breast02). [Fam-] trastuzumab deruxtecan also is in pivotal phase 2 clinical development for HER2 positive metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01); pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01); phase 2 development for HER2 expressing advanced colorectal cancer; phase 2 development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC; and, phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancer.

[Fam-] trastuzumab deruxtecan has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1, and Fast Track designation for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). [Fam-] trastuzumab deruxtecan has received SAKIGAKE Designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On March 28, 2019 Cytonus Therapeutics Inc., a biotechnology company developing new platforms for delivering biologics, reported that it will be presenting preclinical data for its Cargocyte technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting March 29 – April 3, at the Georgia World Congress Center in Atlanta (Press release, Cytonus Therapeutics, MAR 28, 2019, View Source [SID1234534723]).

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Cargocytes are engineered allogenic cell lines that can carry a variety of payloads like small molecule compounds, gene editing therapies, therapeutic RNAs, and powerful biologics such as immune modulating cytokines, antibodies and oncolytic viruses.

"Cytonus Therapeutics will be presenting preclinical data from our growing oncology pipeline that supports the versatility of our Cargocytes as a groundbreaking allogeneic, off-the-shelf, immune-therapy platform," said Remo Moomiaie-Qajar, M.D., president and CEO of Cytonus. "Our preclinical results in our Triple Negative Breast Cancer model experiments are impressive and exciting. We are able to demonstrate that 40 percent of our animals being treated with our Cargocyte associated IL-12 are showing no sign of disease more than 260 days post treatment where as our control animals are dying typically 25 to 30 days into the experiments. These experiments are still ongoing and our mice are doing well. We have replicated these studies multiple times and have found the pattern to exist."

Details of the presentation:

Abstract Title: Cargocytes: A novel cell therapy platform to drive anti-tumor immunity

Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41
Poster Board Number: 12
Permanent Abstract Number: LB-067
Cytonus will also be presenting at:
Association Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29-May 2, 2019 in Washington, D.C.
Bio International Convention, June 3-6, 2019 in Philadelphia

On March 28, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of new solutions designed to advance cancer research as part of its highlights at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting from March 29 to April 3, 2019, in Atlanta, Georgia (Press release, Qiagen, MAR 28, 2019, View Source [SID1234534722]). More than 30 studies being presented at AACR (Free AACR Whitepaper) 2019 cite molecular testing tools from QIAGEN’s Sample to Insight portfolio.

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These products involve:

New solution bundles for all QIAseq and QIAact DNA panels for next-generation sequencing (NGS), integrating its market-leading CLC Genomics Workbench and QIAGEN Clinical Insight-Interpret software with these assays for seamless secondary analysis and tertiary interpretation of complex genomic data. The proprietary technology driving the superior performance of QIAGEN’s NGS panels was described in a recent Nature article: View Source
QIAGEN is introducing its exoRNeasy Midi and Maxi Kits for isolation of exosomes and other extracellular vesicles from urine and other samples, as well as the miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples. These are two novel liquid biopsy workflows for cancer research designed to enable non-invasive extraction and purification of ribonucleic acid (RNA).