ERYTECH Reports Cash Balance at End of Q1 2021 and Announces the Details of its 2021 Q1 conference call

On April 28, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its cash position at the end of the first quarter 2021 and that it will host its 2021 first quarter conference call and webcast on Wednesday, May 5, 2021, at 2:30 PM CEST/8:30 AM EST to discuss operational highlights (Press release, ERYtech Pharma, APR 28, 2021, View Source [SID1234578655]).

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Alkermes Announces Two Abstracts Accepted for Presentation at 2021 American Society of Clinical Oncology Annual Meeting

On April 28, 2021 Alkermes plc (Nasdaq: ALKS) reported the acceptance of two abstracts related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually June 4-8, 2021 (Press release, Alkermes, APR 28, 2021, View Source [SID1234578677]). New data from the phase 1/2 ARTISTRY-1 clinical trial evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA) will be shared in a poster discussion session. In addition, data supporting the recommended phase 2 dose (RP2D) for nemvaleukin administered subcutaneously from the phase 1/2 ARTISTRY-2 clinical trial will be shared in a separate poster.

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Details of the presentations are as follows:
Abstract: 2513
Title: ARTISTRY-1: Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors
Presenter: Valentina Boni, M.D., Ph.D., Medical Oncologist and Principal Investigator, START Madrid at Centro Integral Oncológico Clara Campal
Presentation Date/Time: The on-demand poster discussion session will take place on June 4, 2021 from 9:00 – 10:00 a.m. ET.

Abstract: 2552
Title: Selection of the recommended phase 2 dose (RP2D) for subcutaneous nemvaleukin alfa: ARTISTRY-2
Presenter: Omid Hamid, M.D., Chief of Research and Immunotherapy, The Angeles Clinic and Research Institute
Presentation Date: The poster presentation will be available on-demand to attendees beginning June 4, 2021.

About Nemvaleukin alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin alfa as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3 and ARTISTRY-6.

ESSA Pharma Announces Clinical Collaboration Agreement with Bayer to Evaluate the Combination of EPI-7386 and Darolutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

On April 28, 2021 ESSA Pharma Inc. (Nasdaq: EPIX) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the Company has entered into a clinical trial collaboration and supply agreement with Bayer to evaluate ESSA’s lead product candidate, EPI-7386, a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Bayer’s androgen receptor inhibitor, darolutamide, in patients with metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, APR 28, 2021, View Source [SID1234578694]).

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Under the terms of the agreement, Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386. The clinical study is expected to start in 2021.

"We are delighted to collaborate with Bayer to explore the potential clinical role of EPI-7386 in combination with Bayer’s darolutamide in patients with metastatic castration-resistant prostate cancer, who have progressed on androgen deprivation therapy," said Dr. David R. Parkinson, Chief Executive Officer, ESSA Pharma Inc. "Combining our two therapies will simultaneously target both ends of the androgen receptor, and potentially allow for a more potent approach to suppressing androgen activity. We look forward to investigating the combination of these therapies and their potential role together in the treatment of prostate cancer."

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in Q3 of 2020 following FDA allowance of the IND and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

Race Initiates Heart Safety Preclinical Study for Bisantrene

On April 28, 2021 Race Oncology Limited ("Race") reported that it has entered into a collaborative preclinical research program with The University of Newcastle to investigate the heart safety Bisantrene offers over current anthracycline therapeutics (Press release, Race Oncology, APR 28, 2021, View Source [SID1234579463]). Eminent cardiotoxicity researchers, Associate Professors Aaron Sverdlov and Doan Ngo of the University of Newcastle, will lead the project.

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While Bisantrene’s heart safety has been demonstrated in more than 40 clinical trials, exactly how it avoids causing cardiotoxicity is unknown. Advances in molecular biology since the 1980s now allow the underlying mechanism of action to be determined. The aim of this project is to explore Bisantrene’s low cardiotoxicity at the molecular level. Bisantrene has recently been identified as a targeted inhibitor of the Fatso/Fat mass and obesity-associated protein (FTO)1. The possible role of FTO inhibition in Bisantrene’s lack of cardiotoxicity will be a primary focus of this research project.

Pillar 2 of Race’s Three Pillar strategy (ASX Announcement: 30 Nov 2020) is focused on the potential for Bisantrene to act as an anthracycline replacement, which are commonly used in the treatment of breast cancer. Anthracyclines are a class of chemotherapeutics known to be effective, but also cardiotoxic. The results of this study will support Phase IIb human trials of a Bisantrene in anthracycline naïve breast cancer patients. These trials are currently being explored for feasibility in Europe, with a potential for initiation in 2022.

"This is an exciting development for Race and we are looking forward to collaborating with Assistant Professors Sverdlov and Ngo on this important project. Understanding how Bisantrene works at a molecular level to avoid damage to the heart will aid all our clinical plans."

Chief Scientific Officer, Dr Daniel Tillett
This preclinical study is to start immediately with result to be reported over the coming 12 months.

About Associate Professors Aaron Sverdlov and Doan Ngo
Associate Professors Sverdlov and Ngo lead the dedicated Australian-first, bench-to- bedside "Cancer and the Heart" clinical and research program at University of Newcastle, Hunter Medical Research Institute, Hunter New England Local Health District and Calvary Mater Newcastle Hospitals. This program incorporates basic mechanistic discovery studies looking at mechanisms of cardiotoxicity, drug discovery studies, translational human research, clinical research and clinical inpatient and outpatient service delivery.

In recognition of this important initiative, A/Prof Aaron Sverdlov was awarded the 2018 Ministerial Award for Rising Stars in Cardiovascular Research. A/Prof Doan Ngo, a co- lead of the program was awarded NSW Health EMC Fellowship in Cardio-Oncology (2018-2021) and the highly prestigious National Heart Foundation Future Leader Fellowship (2021-2025) for the cardio-oncology program of work.

Both A/Profs Aaron Sverdlov and Doan Ngo have been invited to establish and co-chair the National Cardio-Oncology Working Group under the auspices of the Australian Cardiovascular Alliance (ACvA). The aim of the group is to coordinate clinical and research activities in the field of Cardio-Oncology in Australia and act as a scientific and advocacy body to improve the quality of cardiovascular care for our cancer patients.

Associate Professor Sverdlov has over 50 peer-reviewed publications and 4 book chapters (including chapters on Oxidative Stress in Heart Failure in the textbook "Heart Failure: A Companion to Braunwald’s Heart Disease") with over 1100 citations and has had more than 80 presentations at international and national meetings. He received over 30 competitive grants, with >20 in the last 5 years (total >$2.5M AUD).

Associate Professor Ngo is an academic pharmacist and a successful basic and translational scientist with multiple important contributions in the cardiovascular and metabolic field. She has more than 55 publications, of which more than 40 were published in the last 5 years

INmune Bio, Inc. to Report First Quarter 2021 Financial Results and Provide a Corporate Update on Wednesday, May 5

On April 28, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on Wednesday, May 5, 2021 at 4:30 PM Eastern Time to discuss results for its first quarter ended March 31, 2021 and to provide a corporate update (Press release, INmune Bio, APR 28, 2021, View Source [SID1234578620]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching an operator.

Date: May 5, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through Wednesday, May 12, 2021 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13718747.