On March 28, 2019 Shuwen Biotech reported that Tasly Pharmaceutical Group has tapped Shuwen Biotech for clinical services and proprietary diagnostics for its oncology drug candidates (Press release, Shuwen Biotech, MAR 28, 2019, View Source [SID1234554004]).

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"With the shifting economic macro-environment globally, the need for cost-saving, innovative and personalized diagnostics is more than ever before. We at Shuwen aim to add value not only to committed innovators in the pharmaceutical space like Tasly, but ultimately to all patients in need of healthcare treatments," commented Jay Z. Zhang, Chairman and CEO of Shuwen Biotech.

The two companies plan to use Shuwen’s established companion diagnostic development team and CAP-accredited reference labs to drive clinical outcomes and ultimately deliver the most innovative and life-saving solutions to patients and healthcare professionals globally.

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 Queen’s University Belfast and Domainex are reported that their joint project team has successfully identified novel first-in-class small molecule inhibitors of the anti-apoptotic protein FLIP (Press release, Queen’s University Belfast, MAR 28, 2019, View Source [SID1234554005]). The team has generated data suggesting multiple therapeutic opportunities for a FLIP inhibitor in both the single agent and combination settings and is now seeking a commercial partner for further development of the novel inhibitors.

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The team is presenting the FLIP inhibitor programme at the AACR (Free AACR Whitepaper) annual meeting in Atlanta on 31 March 2019 (New Molecular Targets poster session, poster 382 /14). The poster showcases the on-target effects of the inhibitors, their drug-like properties, their potency against B Cell Lymphomas, triple negative breast cancer and KRAS and EGFR mutant non-small cell lung cancer, and their potential for combination with chemotherapy, immune oncology agents and EGFR-targeted therapeutics.

The next phase of the programme will comprise selection of a pre-clinical development candidate and completion of pre-clinical activities. Profs Dan Longley (Biology lead) and Tim Harrison (Med Chem lead) are attending the AACR (Free AACR Whitepaper) meeting and will be actively engaging in discussions with potential partners at the meeting.

This FLIP programme has been funded by the Wellcome Trust and has focussed on the identification and optimisation of novel first-in-class small molecule FLIP-FADD protein-protein interaction inhibitors. FLIP is a non-redundant inhibitor of Caspase 8 and functional FLIP allows tumour cells to evade cell death and promotes tumour growth and therapy resistance. The novel FLIP inhibitors activate Caspase 8 and have shown efficacy in a number of pre-clinical models including clinically challenging KRAS and EGFR mutant non-small cell lung cancer.

To arrange to meet the team at AACR (Free AACR Whitepaper) please contact Enda Gribbon: ([email protected])

Trevor Perrior, Chief Executive Officer of Domainex, commented: "Our medicinal chemists have been delighted to work on this exciting target and enable Prof. Dan Longley and his team to identify and optimise the FLIP inhibitors. There were several challenges that we had to solve in order to identify hits and develop a series of potential drug compounds that are potent and selective. We look forward to at least one of these compounds progressing towards the clinic for the benefit of patients. The funding secured from the Wellcome Trust is a clear endorsement of the strength of the integrated drug discovery platform of Domainex to deliver molecules with disease-modifying potential and we remain deeply committed to supporting academic translational research."

Prof. Dan Longley from the Centre for Cancer Research and Cell Biology (CCRCB) at Queen’s University Belfast, added: "Resistance to cancer therapeutics such as chemotherapy is a major clinical problem that limits the effectiveness of many current cancer treatments. Very often, this is caused by the failure of anti-cancer therapies to kill the cancer cells. FLIP is a cellular protein that cancer cells frequently express at high levels, and this increases their resistance to chemotherapy and other types of therapy used to treat cancer, such as radiotherapy. The agents that we are developing target FLIP and prevent it from causing therapy resistance. In addition, some tumour-promoting immune cells also need FLIP, so our FLIP inhibitors may also have beneficial effects in the tumour microenvironment by reactivating immune cells to attack cancer cells."

On March 28, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Dr. Cornelis Melief will give an oral presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, on March 31, 2019 (Press release, ISA Pharmaceuticals, MAR 28, 2019, View Source [SID1234534689]).

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The presentation titled "A strong HPV-specific T-cell response after chemo-immunotherapy for advanced cervical cancer is associated with prolonged survival"is scheduled for Sunday, March 31, 2019, as part of the session "Predictive Biomarkers for Immunotherapy" (12:45-2:45pm, Marcus Auditorium- Bldg A-GWCC).

The data will outline the effects of vaccination with ISA Pharmaceuticals´ therapeutic vaccine ISA101 during chemotherapy in 77 patients with advanced, recurrent or metastatic cervical cancer in a dose assessment study.

ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer. Clinical efficacy of ISA101 in combination with Regeneron’s PD-1 inhibitor cemiplimab is currently being tested in a randomized controlled Phase 2 trial in platinum refractory, HPV16-positive oropharyngeal cancer patients (NCT03669718). The results to be presented at AACR (Free AACR Whitepaper) form the basis for a planned Phase 3 trial, in which the clinical benefit of the combination of ISA101 plus cemiplimab on top of standard-of-care chemotherapy will be studied in patients with advanced HPV16-positive cervical cancer.

On March 28, 2019 ESSA Pharma Inc. (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the nomination of EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC"). EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor (Press release, ESSA, MAR 28, 2019, View Source [SID1234534727]). Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogens are inactive. Compared to ESSA’s first generation compound, ralaniten acetate, EPI-7386 is significantly more potent, metabolically stable and more effective in preclinical studies. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date. IND-enabling studies are currently underway, and ESSA expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

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As recently presented at the 2019 Genitourinary Cancers Symposium, EPI-7386 demonstrates in vitro cellular potency against the androgen receptor in a similar range to the leading antiandrogens, bicalutamide and enzalutamide. Importantly, EPI-7386 shows activity in numerous in vitro models of antiandrogen resistance driven by the AR-V7 splice variant of the androgen receptor while enzalutamide is inactive. In addition, EPI-7386 is metabolically stable in liver microsome and hepatocyte preparations and shows a favorable pharmacokinetic profile in mice, exhibiting significant exposure and a long half-life. Lastly, EPI-7386 (60 mg/kg) displayed comparable activity to enzalutamide (30 mg/kg) in a prostate cancer LNCaP xenograft mouse model in which enzalutamide mouse exposure was estimated to be twice the clinical exposure of enzalutamide in humans.

"We are excited to announce the nomination of EPI-7386 as our lead clinical candidate for the treatment of mCRPC," said David Parkinson, President and Chief Executive Officer of ESSA. "EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology. We look forward to bringing this novel drug candidate to patients with mCRPC who have no other treatment options."