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 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 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, reported poster presentations at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place January 25-27, 2024, in San Francisco, CA (Press release, Aadi Bioscience, JAN 26, 2024, View Source [SID1234639568]).

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Abstract and poster presentation details are below:

Title: "Analysis of inactivating alterations in TSC1 and TSC2 in advanced genitourinary (GU) cancers from a real-world patient population in the Foundation Medicine genomic database"
Session Title: Poster Session B: Urothelial Carcinoma
Date/Time: January 26, 2024 – 11:30 – 1:00 pm; 5:45 – 6:45 pm PST
Presenting Author: Gopa Iyer, MD
Key Findings:

In a large real-world database of patients with advanced cancer, 1,828 (4.0%) of the 46,068 patients with GU cancers had at least one inactivating alteration in TSC1 or TSC2
TSC1 and/or TSC2 inactivating alterations were present in 9.2% of patients with bladder cancer, 6.4% of patients with kidney cancer, and 0.6% of patients with prostate cancer
GU cancers with TSC1 and/or TSC2 inactivating alterations were frequently microsatellite stable and of low tumor mutational burden (TMB)
The PRECISION 1 study (NCT05103358) is currently enrolling patients with solid tumors harboring TSC1 and/or TSC2 inactivating alterations
Aadi is also presenting an encore Trials-in-Progress (TiP) poster from the ongoing PRECISION 1 study.

Title: "PRECISION 1: A phase 2, multicenter, open-label tumor-agnostic trial of nab-sirolimus for malignant solid tumors harboring pathogenic inactivating alterations in TSC1 and TSC2"
Session Title: Trials in Progress Poster Session C: Renal Cell Cancer: Adrenal, Penile, Urethral and Testicular Cancers
Date/Time: January 27, 2024 – 7:00 – 8:00 am; 11:30 am – 1:00 pm PST
Presenting Author: Gopa Iyer, MD

More information can be found on the ASCO (Free ASCO Whitepaper) GU meeting website.

On January 26, 2024 Flare Therapeutics Inc., a biotechnology company targeting transcription factors (TF) to discover precision medicines for cancer and other diseases, reported a poster presentation outlining the Phase 1 clinical trial design of FX-909, a highly potent and selective inhibitor of PPARG, at the 2024 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium taking place from January 25-27, 2024 in San Francisco, CA (Press release, Flare Therapeutics, JAN 26, 2024, View Source [SID1234639569]).

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"FlareTx has built a robust body of preclinical evidence that supports investigation of FX-909 in clinical trials in patients," said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Flare Therapeutics. "Results shown to date reveal that FX-909 eradicates tumors in urothelial cancer (UC) animal models at low oral doses. Our scientists have also leveraged high PPARG expression as a defining feature of luminal muscle-invasive UC (MIUC) to identify genetically defined populations and select the patients that may be more likely to benefit from a treatment like FX-909. In addition, we recently shared novel translational data correlating increased PPARG expression with an immunosuppressive tumor microenvironment (TME) and shorter real-world progression-free survival to anti-PD1 treatment."

PPARG drives luminal cell identity and accounts for two-thirds of all advanced cases of UC. Targeting PPARG offers a novel approach to treating advanced UC that could pave the way to improved clinical outcomes in patients with a luminal subtype. Treatment of genetically defined UC xenografts with FX-909 has shown an 84% tumor growth inhibition at a dose expected to be equivalent to a 50 mg dose in humans – the starting dose in the Phase 1 clinical study.

FX-909-CLINPRO-1 (NCT05929235) is a first-in-human, multicenter, open-label Phase 1 study designed to assess the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FX-909 given orally to patients with advanced solid malignancies. Exploratory objectives include the evaluation of patient selection biomarkers from tissue and blood samples and association with clinical outcomes. In the US, approximately 10 sites are planned for Phase 1A and 12-15 sites for Phase 1B.

"While advanced bladder cancer and MIUC remain lethal diseases, we are starting to see a real renaissance in providing new treatment options, thanks to increasing knowledge of the underlying molecular pathways involved," said Gopa Iyer, Genitourinary Oncologist & Early Drug Development Specialist, Memorial Sloane Kettering Cancer Center. "FlareTx’s novel mechanism of action offers the possibility of a much needed second line option for patients who demonstrate disease progression following standard-of-care platinum chemotherapy, immune checkpoint inhibition, and/or ADC-based therapies."

Details for the presentation are as follows:

Poster Title: A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 in Patients with Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Abstract Number: TPS709
Presenter: Gopa Iyer MD, Memorial Sloane Kettering Cancer Center
Date, Time: Session B: Urothelial Carcinoma – Friday, January 26, 2024, 11:30 AM-1:00 PM PT; 5:45 PM-6:45 PM PT
Location: Moscone West Conference Center, San Francisco, California Posters, Exhibits, and Food Room

About FX-909
Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors. Preclinical data for FX-909 has demonstrated robust anti-tumor activity, excellent PK/PD correlation, durable efficacy, and a favorable safety profile in mouse models of UC (PPARG-amp and RXRA-mut) at very low oral doses.

About the FX-909 Phase 1 Study
The ongoing Phase 1 study is a first-in-human, dose-escalation and -expansion study of FX-909 in patients with advanced solid malignancies, including advanced urothelial carcinoma. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of FX-909. FX-909 will be given initially in a dose-escalation phase (Part A) to determine the recommended Phase 2 dose. FX-909 will be given initially orally once daily in 28-day cycles. Part B will be a monotherapy expansion phase to further evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of FX-909 in patients with locally advanced (unresectable) or metastatic urothelial carcinoma. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05929235).

About Advanced Urothelial Carcinoma (UC)
There are an estimated 725,549 people living with bladder cancer in the United States alone, making it the sixth most common cancer overall, and fourth most common among men (SEER – 2020). Each year, there are more than 83,000 new cases diagnosed among men and women, and about 25% of those cases are classified as muscle-invasive UC (DRG 2020). Treatment outcomes have remained poor with typical five-year survival rates of 8% in advanced metastatic disease (SEER – 2020). The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype which represents approximately 65% of all advanced UC cases (Robertson, Cell 2017). Recurrent genetic alterations in PPARG are characteristic of this molecular subtype.

On January 26, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that, on January 25, 2024, the Compensation Committee of IDEAYA’s Board of Directors granted non-qualified stock options to purchase an aggregate of 123,000 shares of the Company’s common stock to three newly hired employees (Press release, Ideaya Biosciences, JAN 26, 2024, View Source [SID1234639572]). The stock options were granted under the IDEAYA Biosciences, Inc. 2023 Employment Inducement Incentive Award Plan (2023 Inducement Plan) as an inducement material to such individuals’ entering into employment with IDEAYA in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2023 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of IDEAYA, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with IDEAYA, pursuant to Nasdaq Listing Rule 5635(c)(4).

The stock options have an exercise price of $42.50 per share, which is equal to the closing price of IDEAYA’s common stock on The Nasdaq Global Select Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter. Vesting of the stock options is subject to such employee’s continued service to IDEAYA on each vesting date.