On February 18, 2022 Minomic reported that it will be at the ASCO (Free ASCO Whitepaper) GU Symposium, San Francisco, where Dr Neal Shore, principal investigator, is presenting a poster on our study "MiCheck Prostate Blood Test for Aggressive Prostate Cancer Designed for the Clinical Lab Setting" (Press release, Minomic, FEB 18, 2022, View Source [SID1234608310]).

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Our poster will be displayed on Thursday Feb 17 at 11.30am Megan Henken will be there live and Doug Campbell and Brad Walsh will be joining online.

On February 18, 2022 Orion Biotechnology reported that Results from an Ongoing Phase I/II CYPIDES Trial of ODM-208 Presented at ASCO (Free ASCO Whitepaper)-GU Clinical phase I data on Orion Corporation’s ODM-208, a first-in-class oral, non-steroidal and selective inhibitor of CYP11A1, the first and rate-limiting enzyme of steroid biosynthesis, were presented today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Press release, Orion Biotechnology, FEB 18, 2022, View Source [SID1234608326]). CYPIDES phase 1 data shows that ODM-208 effectively blocked the production of all steroid hormones in men with metastatic castration-resistant prostate cancer (mCRPC) and showed promising anti-tumor activity in men progressing despite extensive prior treatment with both novel hormonal therapies (NHT’s) and taxanes. Treatment responses to ODM-208 especially occurred in men with activating androgen receptor (AR) mutations.

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ODM-208 is a complete blocker of steroid biosynthesis that suppresses the production of all steroid hormones and their precursors that may activate the androgen receptor (AR) signalling pathway. This is particularly relevant in patients with AR ligand binding domain (LBD) activating somatic point mutations, a mechanism of resistance to hormone-based therapies in metastatic castration-resistant prostate cancer (mCRPC). During treatment the patients receive hormone replacement therapy to ensure sufficient adrenal function.

In CYPIDES phase I, a total of 44 patients with median age of 70 years received ODM-208. Overall, 32% of the patients achieved a PSA (prostate specific antigen) decrease of ≥50%. Of patients with AR LBD mutation (17), 68% achieved a PSA decrease of ≥50%. Also, prolonged treatment responses were observed especially in patients with AR LBD mutation. Although tolerated by most patients, the main safety finding was adrenal insufficiency (AI). Overall, 14 (32%) patients experienced severe adrenal insufficiency despite the replacement therapy requiring further adrenal supplementation after which the ODM-208 treatment commonly continued. Non-adrenal adverse events were unremarkable.

Taru Blom (MD, PhD), Vice President, Global Development and CMO, Orion R&D comments:

"ODM-208 is a first-in-class CYP11A1-inhibitor and we are excited that this novel approach works in some of the patients who have only a few effective treatment options available. The first results of CYPIDES are encouraging, and more studies are needed to confirm the potential of ODM-208 as a treatment option for men with advanced prostate cancer. In addition, we are focusing on the safety findings of the study as well as are looking into the optimization of the adrenal balance of the patients through appropriate replacement therapy."

More information about the CYPIDES trial: www.clinicaltrials.gov, Identifier: NCT03436485

The Phase II dose expansion part of CYPIDES is ongoing.

Phase I/II clinical trial CYPIDES

The Phase I/II trial CYPIDES investigates the safety, pharmacokinetics and anti-tumor activity of ODM-208 in men with mCRPC. The Phase I started in 2018 and has recruited 44 patients. More information about the trial: www.clinicaltrials.gov, Identifier: NCT03436485

ODM-208 investigational drug

ODM-208 is a novel, oral, non-steroidal and selective inhibitor of CYP11A1 enzyme developed by Orion for the treatment of prostate cancer. CYP11A1 is the rate-limiting enzyme of the steroid biosynthesis. By inhibiting CYP11A1 enzyme activity, ODM-208 suppresses the production of all steroid hormones and their precursors that may activate AR signalling pathway. Orion is the first pharmaceutical company to develop a selective drug that works by this mechanism.

On February 18, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported that it will report financial results and provide an update on the Company’s business operations and clinical development programs pre-market on February 28, 2022 (Press release, Reata Pharmaceuticals, FEB 18, 2022, View Source [SID1234608327]).

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Conference Call Information

Reata’s management will host a conference call on February 28, 2022, at 8:30 a.m. ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using access code 052919. The webcast link is View Source

Fourth quarter and full year financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast will be accessible for at least 90 days after the event at View Source.

Exelixis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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On February 18, 2022 Recipharm, a leading global contract development and manufacturing organisation (CDMO), reported the acquisition of Arranta Bio, a prominent advanced therapy CDMO (Press release, Recipharm, FEB 18, 2022, View Source [SID1234608312]). Under the stewardship of Mark Bamforth and backed by Ampersand Capital Partners, the company has established a strong service portfolio as a leader in delivering microbiome therapeutic products and mRNA clinical production capabilities.

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The acquisition forms a cornerstone of Recipharm’s strategy to provide innovative drug developers in the Biologics market with scientifically differentiated contract development and manufacturing services for ATMPs and builds on the capabilities acquired through the recently announced GenIbet transaction and the acquisition of Vibalogics, also announced today.

Arranta Bio has established a strong microbiome platform with fermentation and purification expertise for naturally-derived and engineered bacteria consortia, complemented by services in analytics, proprietary media and cryopreservative formulations. These services maximize yields and enhance viability for live biotherapeutic products that clients are testing in the clinic against a range of infectious, inflammatory, neurological and oncological diseases.

In addition, Arranta Bio is progressing the supply of end-to-end mRNA capabilities across drug substance and drug product under one roof, providing its customers with substantial time savings in product manufacturing and a hedge against supply chain challenges.

The acquisition of Arranta establishes a robust US presence for Recipharm. It provides the company with a further platform from which to build its capabilities in new biologics modalities, leveraging Arranta’s expertise in advanced therapies to bring a high degree of diversification across multiple technologies and modalities.

Marc Funk, Chief Executive Officer at Recipharm, said: "We welcome Arranta and its team of experts who boast a strong reputation in the CDMO industry. Arranta is a leading player in its field that we are proud of bringing under the Recipharm umbrella and continue to build in line with our vision of supporting biotechs by providing process development, manufacturing expertise and bold solutions to take their programs from lab to patient.

This acquisition is another important step for us in growing our biologics business and developing a strong presence into the US. We look forward to working closely with the Arranta team, building links across the wider Recipharm organisation to make this business a huge success."

Mark Bamforth, CEO at Arranta, added: "I am convinced that Recipharm will be a great home for Arranta and our talented team and that together we can fulfil our joint vision of building the leading ATMP CDMO. We share Recipharm’s vision of focusing on ATMP customers with novel manufacturing solutions and we see a clear opportunity to accelerate to global scale in this new context."

The acquisition is expected to be completed around the end of March 2022, subject to customary regulatory filings.

Centerview Partners UK LLP acted as exclusive financial adviser, and Kirkland & Ellis LLP served as counsel to Recipharm on the transaction. Morgan Stanley & Co. LLC acted as exclusive financial adviser and Goodwin Procter LLP served as counsel to Arranta Bio.