On January 26, 2024 Orion reported at the 2024 ASCO (Free ASCO Whitepaper) GU Cancers Symposium a poster with additional data from the ongoing Phase II CYPIDES trial evaluating the safety and efficacy of ODM-208 (or MK-5684), an investigational, oral CYP11A1 inhibitor, in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) with and without AR-LBD mutations (Press release, Orion, JAN 26, 2024, View Source [SID1234639560]). Previously published data has focused on patients with androgen receptor gene (AR) ligand-binding-domain (LBD) mutations. The new data reports initial results in an extension cohort of mainly AR-LBD wild-type patients combined with previously reported phase 2 data (AR-LBD mutation-positive only).

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Prostate cancer continues to be regulated by steroid hormones, even in castration-resistant disease. Data from the Phase II CYPIDES trial suggest that ODM-208/MK-5684 potently inhibits all steroid-hormone biosynthesis with observed antitumor activity in a heavily pretreated mCRPC population, especially in patients with AR-LBD mutations.

In Phase II CYPIDES, at data cut-off, a total of 134 previously treated mCRPC patients received 5mg of ODM-208/MK-5684 twice a day with glucocorticoid/mineralocorticoid replacement and ongoing androgen-deprivation therapy. Of the total, 66 patients had AR-LBD mutation and 68 were AR-LBD wild-type. PSA (prostate-specific antigen) responses occurred in men without AR-LBD mutations, but were more frequent in those with such mutations. A decrease in PSA levels of 50% or more occurred in 55.6% of patients with AR- LBD mutation and in 16.7% of AR-wild-type patients. A decrease in PSA levels of 30% or more occurred in 69.8% of patients with AR-LBD mutation and in 30.0% of AR-wild-type patients. Results on other endpoints are not yet mature and will be reported later. Adverse events on ODM-208/MK-5684 were clinically manageable and the rate of serious adrenal insufficiency remained low on hormone replacement therapy (3.0%), although many patients continue on treatment and further events are possible. The new data support and are consistent with the previously reported results.

"These results support the continued importance of hormone-based treatments and potential of ODM-208/MK-5684 as a new inhibitor of AR driven growth of prostate cancer, even in heavily treated patients with advanced disease. Interestingly, the results in the patients with AR-wild-type suggest that they benefit from ODM-208/MK-5684 too, although the PSA decrease was more frequently seen in the patients with AR-LBD mutation. We look forward to having further data both in AR LBD positive and negative patients in the on-going Ph3 studies", said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Innovative Medicines and Research and Development at Orion.

About ODM-208/MK-5684

ODM-208/MK-5684 is an investigational oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. ODM-208/MK-5684 is being developed through a collaboration with MSD (tradename of Merck & Co., Inc. Rahway NJ USA). The compound is being evaluated in two pivotal Phase 3 clinical trials in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC). Patients are now enrolling in the trials, named OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650).

On January 26, 2024 Sirona Biochem Corp. (TSX-V:SBM) (FSE: ZSB) (OTC: SRBCF) (the "Company") reported a non-brokered private placement of up to 10,000,000 units of the Company at a price of $0.10 CAD per Unit (a "Unit") for gross proceeds of up to CAD$1,000,000 (the "Private Placement") (Press release, Sirona Biochem, JAN 26, 2024, View Source;utm_medium=rss&utm_campaign=sirona-biochem-initiates-private-placement [SID1234639558]). Each Unit consists of one common share and one transferable share purchase warrant, each whole warrant exercisable into one additional common share of the Company for a period of 2 years from the date of issue at a price of $0.15 per Share in year one and $0.25 per Share in year two.

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In connection with the Private Placement, the Company may pay finders’ fees of up to 10% in cash and 10% in Finder Warrants (the "Finder’s Warrants"). Each Finder Warrant will entitle the holder to purchase one Share of the Company at any time for two years from the closing date of the Private Placement at a price of CAD$0.15 per Share in year one and CAD$0.25 per Share in year two.
The company intends to use the proceeds of the private placement for general working capital purposes.
The completion of the Private Placement is subject to customary conditions, including acceptance from the Toronto Stock Exchange Venture ("TSXV"). All securities issued will be subject to a hold period in accordance with TSXV and/or other regulatory requirements.
This announcement does not constitute an offer to sell or a solicitation of an offer to buy. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws and may not be offered or sold within the United States or to, or for the benefit of, U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements.
The Company looks forward to the successful completion of this Private Placement, further fortifying its financial position to drive strategic initiatives and maintain its position at the forefront of innovative skincare solutions.

On January 26, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of high-risk patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced resectable urothelial carcinoma (Press release, Merck & Co, JAN 26, 2024, View Source [SID1234639557]). These late-breaking data are being presented for the first time today during an oral abstract session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA531).

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At the trial’s first pre-specified interim analysis, after a median follow-up of 22.3 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in one of the study’s dual primary endpoints of disease-free survival (DFS), reducing the risk of disease recurrence or death by 31% (HR=0.69 [95% CI, 0.54-0.87]; p=0.001) versus observation in these patients after surgery. Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for KEYTRUDA and 14.0 months (95% CI, 9.7-20.20) for observation, an improvement of 15 months. These DFS results were consistent regardless of patients’ PD-L1 expression status. The trial’s other dual primary endpoint of overall survival (OS) did not reach statistical significance at the time of this interim analysis and will continue to be followed as data mature (HR=0.98 [95% CI, 0.76-1.26]; p=0.88). After a median follow-up of 36.9 months, median OS was 50.9 months (95% CI, 43.8-NE) for KEYTRUDA versus 55.8 months (95% CI, 53.3-NE) for observation.

"Even after undergoing radical surgery with the goal of removing all cancerous tumors, up to half of patients with muscle-invasive bladder cancer still experience high rates of cancer recurrence," said Dr. Andrea Apolo, principal investigator and chief of the Bladder Cancer Section, Genitourinary Malignancies Branch, National Cancer Institute (NCI), part of the National Institutes of Health. "In this trial, adjuvant pembrolizumab [KEYTRUDA] reduced the risk of disease recurrence or death from any cause by 31% versus observation, demonstrating the potential of using pembrolizumab [KEYTRUDA] after surgery for high-risk patients with persistent muscle-invasive or locally advanced urothelial carcinoma who have high tumor stage, lymph node involvement or positive margins at surgery to help prevent their cancer from returning."

"These Phase 3 data mark the first time KEYTRUDA has shown a clinically meaningful improvement in DFS as adjuvant therapy in urothelial carcinoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Results from this pivotal study support KEYTRUDA as a potential new adjuvant option for these patients and demonstrate the expanding role of KEYTRUDA into earlier stages of resectable muscle-invasive bladder cancer."

Merck has an extensive clinical development program evaluating KEYTRUDA as monotherapy and in combination with other anti-cancer therapies across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Phase 3 studies in muscle-invasive bladder cancer include the KEYNOTE-866 trial, as well as the Phase 3 KEYNOTE-B15 and Phase 3 KEYNOTE-905 trials, which are being conducted in collaboration with Pfizer (formerly Seagen) and Astellas.

Study design and additional data from AMBASSADOR/KEYNOTE-123

AMBASSADOR (A031501)/KEYNOTE-123 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT03244384) evaluating KEYTRUDA versus observation for the adjuvant treatment of patients with localized MIUC and locally advanced resectable urothelial carcinoma. The dual primary endpoints are OS and DFS, and secondary endpoints include OS and DFS in PD-L1 positive and negative patients and safety. The trial enrolled 702 patients who were randomized to receive KEYTRUDA (200 mg intravenously every three weeks for up to 18 cycles) or undergo observation.

17.4% of patients receiving KEYTRUDA withdrew from the trial without event versus 27.2% from the observation arm. Seventy-six patients (22%) in the observation arm received an immune checkpoint inhibitor following a DFS event.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Grade ≥3 adverse events occurred in 48.4% of patients receiving KEYTRUDA versus 31.8% of patients under observation.

This trial was sponsored by the U.S. NCI, part of the National Institutes of Health. Alliance for Clinical Trials in Oncology designed and led the trial with funding from the NCI and participation from all the National Clinical Trials Network Groups. Merck provided funding and support through a Cooperative Research and Development Agreement between Merck and NCI.

About bladder cancer

It is estimated that approximately 83,000 people in the U.S. will be diagnosed with bladder cancer in 2024. Globally, there were approximately 573,000 new cases in 2020. Muscle-invasive bladder cancer is bladder cancer that has spread into the deep muscle of the bladder wall, and locally advanced urothelial cancer is cancer that begins in the urothelial cells and has spread from where it started to nearby tissue or lymph nodes. Muscle-invasive bladder cancer accounts for 20-25% of patients with newly diagnosed bladder cancer. Despite surgery, up to 50% of patients with muscle-invasive bladder cancer experience recurrence.

On January 26, 2024 Iovance Biotherapeutics presented its corporate presentation (Presentation, Iovance Biotherapeutics, JAN 26, 2024, View Source [SID1234639556]).

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On January 26, 2024 ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) and healthy aging research, reported that its Chief Executive Officer, Rob Fried, and Chief Financial Officer, Brianna Gerber, will be participating in the Lytham Partners 2024 Investor Select Conference (Press release, ChromaDex, JAN 26, 2024, View Source [SID1234639554]).

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Mr. Fried and Mrs. Gerber will participate in virtual one-on-one meetings throughout the event on Thursday, February 1, 2024.

To arrange a meeting with the ChromaDex management team, please contact Lytham Partners at 1×[email protected] or register for the event at View Source

For additional information on ChromaDex, visit www.chromadex.com, and for details on investor relations, please visit www.investors.chromadex.com.