On April 28, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported that clinical data for lifileucel alone and in combination with pembrolizumab for advanced melanoma will be highlighted at the upcoming ASCO (Free ASCO Whitepaper) 2021 Annual Meeting, to be held June 4-8, 2021 (Press release, Iovance Biotherapeutics, APR 28, 2021, View Source [SID1234578619]). The abstract titles are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ET

Title: Safety and efficacy of lifileucel (LN-144), an autologous, tumor infiltrating lymphocyte cell therapy in combination with pembrolizumab for immune checkpoint inhibitor naïve patients with advanced melanoma.
Authors: Sajeve Samuel Thomas, et al.
Session Title: Melanoma/Skin Cancers
Session Type: ePoster Session
Abstract Number: 9537
ePoster Viewing: on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET

On April 28, 2021 Galera Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, Galera Therapeutics, APR 28, 2021, View Source [SID1234578638]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.