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."

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.

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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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.

On April 28, 2021 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported financial results for the first quarter of fiscal 2021 (Press release, Samsung BioLogics, APR 28, 2021, View Source [SID1234578696]).

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John Rim, CEO of Samsung Biologics, stated, "Our first-quarter financial performance was in line with our expectations and provides us with a strong start to the 2021 fiscal year. We have maintained a solid performance, and continue to see momentum from our expanding CDMO business globally while simultaneously making continuous advancements in our biosimilar subsidiary and new business models. As the world continues to navigate the difficult times amid COVID-19, we remain committed to supporting our clients and patients in delivering life-saving therapeutics in a timely manner."

FIRST QUARTER 2021 RESULTS

First quarter 2021 revenue was KRW 260.8 billion, an increase of 26% from KRW 207.2 billion reported for the first quarter in the previous year, attributable to the expanded sales volume at Plant 3 for its full-scale operation.

First quarter 2021 operating profit was KRW 74.3 billion, 19% higher than the prior-year period due to Plant 1 and 2’s stable operation and the gradual increase in Plant 3 operation for its early lock-in orders.

First quarter 2021 net profit reached KRW 61 billion, an increase of KRW 24.2 billion from KRW 36.8 billion in the first quarter a year ago, showing a direct reflection on improved profitability and sales at Plant 3.

FISCAL YEAR 2021 OUTLOOK

Continuing on the strong performance from the fiscal year 2020, all existing Samsung Biologics plants are at near full operation. The construction of Plant 4 remains on track with active pre-sales discussions. The US R&D Center is fully equipped and operational, and the company’s growth plans remain active.

Since there have been no disruptions to business continuity caused by the challenges amid COVID-19, the company has maintained stable business operations and is currently able to continue as planned with key strategic growth projects and long-term investments.

For more detail on performance and financials, please refer to the Earnings Release.