6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On April 28, 2021 Silence Therapeutics plc, AIM: SLN and Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, reported that it has achieved another research milestone as part of its ongoing RNAi collaboration with Mallinckrodt plc ("Mallinckrodt") for complement-mediated diseases, triggering a further $2.0 million payment to Silence (Filing, 6-K, Silence Therapeutics, APR 28, 2021, View Source [SID1234578772]).

The milestone relates to pre-clinical development work on the SLN500 C3 targeting program, highlighting the successful ongoing collaboration between the two companies. Silence continues to work with Mallinckrodt to progress Investigational New Drug (IND) enabling studies for SLN501, the first nominated product candidate in the SLN500 program, this year.

The collaboration with Mallinckrodt is focused on the development and commercialization of RNAi therapeutics designed to inhibit or ‘silence’ the complement cascade, a group of proteins involved in the immune system and which play a role in the development of inflammation. Using Silence’s proprietary mRNAi GOLD platform, siRNAs engineered to inhibit each target in the collaboration will be optimized and investigated before progressing into clinical development.

In July 2019, Silence received an upfront payment of $20 million from Mallinckrodt for an exclusive worldwide license to siRNAs against one complement target, C3, and options to license siRNAs against up to two additional targets, each of which Mallinckrodt has exercised at $2 million per target. Under the terms of the agreement, Silence is responsible for preclinical activities and for executing development of each target through Phase 1, after which Mallinckrodt will assume responsibility for clinical development and global commercialization. Silence is also eligible to receive tiered double-digit royalties on net sales for each product candidate and up to $2 billion in total milestone payments across all three targets.

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Adcentrx Therapeutics Announces Completion of $50m Series A Financing Led By CBC Group To Accelerate Next-Generation Conjugate Drugs Research & Development

On April 28, 2021 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company focused on accelerating breakthroughs in antibody drug conjugate ("ADC") therapeutic development, reported the closing of $50m Series A financing to power the development of next generation ADC for improving patient treatment options (Press release, Adcentrx Therapeutics, APR 28, 2021, View Source;development-301278632.html [SID1234578768]). This round of financing was led by CBC Group ("CBC"). Zoo Capital, Boyu Capital’s venture arm, also joined this round.

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Adcentrx was founded by a veteran ADC team with extensive experience in ADC conjugation, target biology and CMC. The founder, Dr. Hui Li, was the CEO of Levena Biopharma, the ADC subsidiary of Sorrento Therapeutics. Dr. Pia Challita-Eid, head of research at Adcentrx, has led teams at Agensys, responsible for novel target and drug discovery. She has contributed to the progression of a dozen ADCs into the clinic, including recently FDA approved PADCEV (Anti-Nectin-4). Dr. Alexander Chu-Kung, head of development at Adcentrx, was a principal engineer at AbbVie, overseeing process development to commercialization ready manufacturing of ADC drugs and other biological therapies. He has led development teams preparing multiple ADC projects for commercialization.

"We are pleased with the progress we have made to date on our proprietary conjugation platform and we are looking forward to moving a set of innovative new drugs into development," said Dr. Hui Li, CEO and founder of Adcentrx. "With this round of financing, we have the ability to progress multiple discovery and development programs. CBC has shown unwavering support in our endeavor and mission of bringing innovative and effective treatments to underserved patient populations."

"We’re thrilled to work alongside industry veterans with an impressive track record of efficiently developing drugs in the ADC space," said Ms. Meng Jiang, Managing Director of CBC. "Beyond the innovative pipeline already assembled, we see additional promise in creation of their proprietary conjugation platform and how it can accelerate development of more ADC programs that offers clear efficacy and safety differentiation."

Replimune to Host Virtual Investor Event on June 3, 2021

On April 28, 2021 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that it will host an investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1 with Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo (Press release, Replimune, APR 28, 2021, View Source [SID1234578745]). The event will include presentations by Philip Astley-Sparke, Chief Executive Officer of Replimune, Robert Coffin, Ph.D., President and Chief Research & Development Officer of Replimune, and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Haematology Centre and Head of the Department of Oncology at the University of Oxford.

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The event will begin at 8:00 a.m. Eastern Time on Thursday, June 3, 2021. The webcast and slides will be accessible live under "Events & Presentations" on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

Opdivo (nivolumab) is a registered trademark of Bristol-Myers Squibb Company.

Aurinia Pharmaceuticals to Release First Quarter 2021 Financial Results on May 6, 2021

On April 28, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that it will release its first quarter 2021 financial results on Thursday, May 6, 2021, after the markets close (Press release, Aurinia Pharmaceuticals, APR 28, 2021, View Source [SID1234578737]). Aurinia’s management team will also host a conference call at 5:00 p.m. EDT to discuss the Company’s financial results and to provide a general business update.

The conference call and webcast is scheduled for May 6, 2021 at 5:00 p.m. ET. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will also be available on Aurinia’s website approximately two hours after the live call is completed.

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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.