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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.

Samsung Biologics Reports First Quarter 2021 Financial Results

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]).

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.

Medivir AB – Interim Report January – March 2021

On April 28, 2021 Medivir AB reported that Interim Report January – March 2021 (Press release, Medivir, APR 28, 2021, View Source;interim-report-january–march-2021-301278700.html [SID1234578697]).

Financing secured to bring the MIV-818 study into the next phase

January – March

Financial summary for the quarter

Net turnover amounted to SEK 9.9 (7.3) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -7.2 (-20.7) million. Basic and diluted earnings per share amounted to SEK -0.18 (-0.96) and SEK -0.18 (-0.96) respectively.
Cash flow from operating activities amounted to SEK -1.5 (-16.6) million.
Liquid assets and short-term investments at the end of the period amounted to SEK 269.3 (116.6) million.
Significant events during the quarter

In January the company signed an exclusive license agreement with IGM Biosciences, Inc. for birinapant. Medivir received a payment of USD 1 million after signing, which is to be followed by an additional USD 1.5 million when IGM includes birinapant in phase I clinical trials. In addition, the agreement entitles Medivir to milestone payments and royalties.
A rights issue of class B shares with preferential rights for existing shareholders was completed in early February. Through the rights issue, which was oversubscribed to 93.5 percent, Medivir received approximately SEK 170 million before transaction costs.
The Board of Directors decided to exercise the over-allotment option of SEK 25 million, directed to the specialist investor HealthInvest.
An Extraordinary General Meeting on March 11, 2021, decided on a directed new share issue of approximately SEK 28 million to Linc AB.
In February 2021 a licensing agreement with Ubiquigent was signed for the preclinical research program USP7.
In March, the last patient was included in the first part of the phase Ib study with MIV-818.
In March 2021, it was announced that Yilmaz Mahshid will leave his position as CEO of Medivir at the Annual General Meeting on May 5, for personal reasons. The recruitment process for a new CEO has begun.
Medivir’s Nomination Committee proposes the re-election of Uli Hacksell, Lennart Hansson, An van Es Johansson and Bengt Westermark as board members. The Nomination Committee proposes the election of Yilmaz Mahshid as new board member and that Uli Hacksell is elected Chairman of the Board.
Bengt Julander and Helena Levander have declined re-election.
Significant events after the end of the quarter

On April 16, it was announced that Magnus Christensen had been appointed interim CEO of Medivir. He will take up his new role in connection with Medivir’s Annual General Meeting on May 5, 2021.
On April 19, it was announced that the overall results from the first part of the phase Ib study with MIV-818 were positive with a good safety and tolerability profile. Thus, the starting dose for the second part of the phase Ib study could be determined.

Conference call for investors, analysts and the media
The Interim Report January – March 2021 will be presented by Medivir’s President & CEO, Yilmaz Mahshid.

The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir’s website after completion of the conference.

BioInvent International AB: Interim report January-March 2021

On April 28, 2021 BioInvent reported to make strong clinical and financial progress in Q1 2021 (Press release, BioInvent, APR 28, 2021, View Source [SID1234578699]). Positive interim results from the Phase 1/2a study of BI-1206 in B-cell non-Hodgkin’s lymphoma (NHL) are very encouraging. Our financial position was reinforced with a directed share issue, providing funding to continue the transformation of BioInvent with the expansion of our clinical programs and broadening our institutional shareholder base." – Martin Welschof, CEO BioInvent.

Events in the quarter
PROJECT UPDATES

(R) BioInvent Phase 1/2a data suggest BI-1206 restores activity of rituximab in relapsed non-Hodgkin’s lymphoma patients.
BioInvent enrolled first patient in a Phase 1/2a trial of the first-in-class anti-TNFR2 antibody BI-1808 for the treatment of patients with solid tumors and CTCL.
BioInvent and Transgene enrolled first patient in Phase 1/2a trial of novel oncolytic virus BT-001 in solid tumors.
(R) BioInvent streamlined agreement with CRUK on anti-FcγRllB antibody, BI-1206, ahead of Phase 1/2 data. In exchange for a one-off payment of GBP 2.5 million, the revised deal simplifies and reduces BioInvent’s obligations to CRUK.
BioInvent presented proof-of-concept data on anti-FcyRIIB antibody BI-1607 at AACR (Free AACR Whitepaper) Annual Meeting 2021.
FINANCING

(R) BioInvent successfully carried out a directed share issue of approximately SEK 962 million (USD 116 million).
Events after the period

BioInvent received IND approval for Phase 1/2a trial of anti-TNFR2 antibody BI-1808.
Financial information
FIRST QUARTER 2021

Net sales SEK 6.2 (16.7) million.
Loss after tax SEK -79.8 (-32.6) million.
Loss after tax per share before and after dilution SEK -1.94 (-1.63).
Cash flow from operating activities and investment activities SEK -51.5 (-35.4) million.
Liquid funds as of March 31, 2021: SEK 1,577.1 (117.1) million.

The information was submitted for publication at 08:00 a.m. CEST on April 28, 2021.

Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study

On April 28, 2021 Amgen (NASDAQ:AMGN) reported that it agreed last night with the FDA’s proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS at 960 mg once daily versus a lower daily dose of the drug (Press release, Amgen, APR 28, 2021, View Source [SID1234578701]). Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.

Amgen anticipates the results from the study in late 2022 and does not expect any impact on the timelines of the ongoing priority review of LUMAKRAS.