Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research FoundationPrecision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combinationLed by Professor Lisa Horvath, the study is expected to recruit people at sites across Australia and New ZealandProstate cancer is the s ...

Core Insights - Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials, demonstrating promising efficacy and safety profiles in treating metastatic cancers [1][4][5] Phase 1 Clinical Trial in mCRPC - In the Phase 1 trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (mCRPC), the six-month radiographic progression-free survival (rPFS) rate was reported at 66% [1][4] - The trial involved 38 patients, with two arms receiving different doses of gedatolisib (120 mg and 180 mg) alongside darolutamide [2] - No patients discontinued treatment due to treatment-related adverse events (AEs), and less than 3% experienced Grade 3 stomatitis [4][5] Phase 2 Clinical Trial in HER2+ Metastatic Breast Cancer - In the Phase 2 trial for HER2+ metastatic breast cancer (mBC), the objective response rate (ORR) was 43% among 44 patients treated with gedatolisib plus trastuzumab-pkrb [1][6] - The median number of prior anti-HER2 therapies for enrolled patients was four or more, with 86% having received at least three prior treatments [6] - No patients discontinued treatment due to treatment-related AEs, and no Grade 3 hyperglycemia was reported [5][6] Future Directions - The company plans to amend the clinical trial protocol to explore additional dosing options for gedatolisib in the ongoing Phase 1/1b trial [4] - Up to six patients will be enrolled in each of three arms to determine the recommended Phase 2 dose (RP2D), with a total of approximately 30 subjects expected to be treated with the RP2D in the Phase 2 dose expansion study [4][5] - Celcuity is also conducting other clinical trials, including a Phase 3 trial evaluating gedatolisib in combination with fulvestrant for HR+/HER2- advanced breast cancer [7]

2025 年 06 月 11 日 行业周报 看好/维持 医药 医药 板块持续跑赢大盘，关注后续创新药催化（附 CD73 靶点研究）(2025.06.03-2025.06.08) 走势比较 (20%) (10%) 0% 10% 20% 30% 24/6/11 24/8/22 24/11/2 25/1/13 25/3/26 25/6/6 | 君实生物 | 买入 | | --- | --- | | 华领医药-B | 买入 | | 奥锐特 | 买入 | | 同和药业 | 买入 | | 阳光诺和 | 买入 | | 泓博医药 | 买入 | | 福元医药 | 买入 | | 三生制药 | 买入 | | 京新药业 | 买入 | | 共同药业 | 增持 | | 亿帆医药 | 买入 | | 诺诚健华 | 买入 | | 诺思格 | 买入 | | 奥翔药业 | 买入 | | 科伦药业 | 买入 | | 国邦医药 | 买入 | | 来凯医药-B | 买入 | | 百利天恒 | 买入 | | 益方生物 | 买入 | | 皓元医药 | 买入 | | 普洛药业 | 买入 | | 信达生物 | 买入 | | 加科思-B | 买入 | 子行业评级 ...

Oric Pharmaceuticals (ORIC) FY Conference June 10, 2025 10:00 AM ET Speaker0 Good morning, everyone. Thanks for joining us at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined today by the team from ORIC. And maybe you guys could start with a brief introduction and then give us an overview of the company and pipeline with a focus on near term value drivers. Speaker1 Sure. My name is Dominic Picciatelli. I'm the Chief Financial Officer, and I'm joined with Matt Hanyoadd, our Chief Busines ...

Summary of Oric Pharmaceuticals (ORIC) 2025 Conference Call Company Overview - **Company Name**: Oric Pharmaceuticals (ORIC) - **Focus**: Development of small molecule drugs targeting solid tumors, specifically in lung cancer, prostate cancer, and breast cancer [4][5] Key Programs - **ORIC-944**: A PRC2 inhibitor for prostate cancer, currently in combination studies with two androgen receptor inhibitors (apalutamide and darolutamide) [5][6] - **ORIC-114**: A brain-penetrant inhibitor targeting lung cancer populations, including EGFR exon 20, EGFR atypicals, and HER2 exon 20 [6] Clinical Data and Comparisons - **Prostate Cancer Data**: - ORIC-944 showed a confirmed PSA 50 response rate of 47% compared to Pfizer's mevremetostat at 34% [10][13] - Confirmed PSA 90 response rate for ORIC-944 was 24% versus Pfizer's 12% [11][13] - Safety profile of ORIC-944 demonstrated lower rates of gastrointestinal toxicity compared to Pfizer's drug [14][15] Safety and Efficacy - **Toxicity Comparison**: ORIC-944 exhibited significantly lower rates of GI toxicity and anemia compared to Pfizer's data, which reported high rates of diarrhea and dysgeusia [14][15] - **Dosing Strategy**: ORIC-944 has a longer half-life allowing for once-daily dosing, while Pfizer's drug requires twice-daily dosing [26][27] Future Development Plans - **Phase III Study**: Planned to start in the first half of 2026, focusing on both post-abiraterone and post-AR inhibitor populations [33][44] - **Data Updates**: Two additional data updates expected later in 2025, focusing on dose escalation and optimization [34][36] Market Position and Strategy - **Competitive Landscape**: ORIC aims to close the timeline gap with Pfizer, emphasizing that being a second entrant in a large market can still yield significant commercial opportunities [60][61] - **Partnerships**: Strong relationships with Janssen and Bayer for drug supply and insights into clinical development [51][52] Financial Position - **Cash Position**: As of March, ORIC reported a pro forma cash position of $349 million, providing a runway into the second half of 2027 [73] Additional Insights - **ctDNA as a Biomarker**: ORIC is exploring ctDNA as a potential better marker for long-term durability compared to PSA activity [40][41] - **Focus on Frontline Opportunities**: ORIC is prioritizing frontline strategies for ORIC-114, aiming for robust data in competitive populations [63][64] Conclusion - ORIC Pharmaceuticals is positioned to advance its clinical programs with promising early data, a strong financial position, and strategic partnerships, while navigating a competitive landscape in oncology.

Core Insights - The U.S. FDA has approved darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), marking the third indication for this drug [2][9] - The approval is based on the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT [2][10] - Darolutamide is already approved in over 85 markets globally for various indications related to prostate cancer, including mHSPC and non-metastatic castration-resistant prostate cancer (nmCRPC) [5][6] Company Overview - Darolutamide, marketed as Nubeqa®, achieved blockbuster status with annual sales of EUR 1.52 billion reported by Bayer for the full year of 2024 [6] - The drug is developed jointly by Orion and Bayer, indicating a strong collaboration in the oncology sector [6][11] - Orion Corporation has a robust clinical development program for darolutamide, exploring its efficacy across various stages of prostate cancer [13] Industry Context - Prostate cancer is the second most common cancer in men, with an estimated 1.5 million diagnoses and approximately 397,000 deaths worldwide in 2022 [4] - The incidence of prostate cancer is projected to rise to 2.9 million by 2040, highlighting the growing need for effective treatment options [4] - The ARANOTE trial involved 669 patients and assessed the efficacy and safety of darolutamide plus ADT, reinforcing the drug's established safety profile [7][8]

Shares of ORIC Pharmaceuticals (ORIC) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer. ORIC-944, in combination with AR inhibitors, J&J’s (JNJ) Erleada (apalutamide) and Bayer’s (BAYRY) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mC ...

ORIC Pharmaceuticals Inc. ORIC released preliminary efficacy and safety data on Wednesday from its ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).Preliminary activity analysis:59% of patients (10/17) achieved a PSA50 response and nearly all patients with a PSA50 response were confirmed one month later, for a confirmed PSA50 response rate of 47% (8/17), which does not include one addi ...

Summary of Oric Pharmaceuticals (ORIC) Update / Briefing May 28, 2025 Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Focus**: Development of ORIC-944, a potential best-in-class PRC2 inhibitor for metastatic castration-resistant prostate cancer (mCRPC) in combination with androgen receptor inhibitors (ARIs) like apalutamide and darolutamide [3][6][10] Key Points and Arguments Clinical Pipeline and Study Updates - ORIC is advancing two key programs with multiple data readouts expected in 2025 and early 2026, aiming for Phase 3 trials initiation in 2026 [6][10] - The ongoing Phase 1b study of ORIC-944 is focused on its combination with epalutamide and darolutamide in mCRPC patients [3][6] - Initial data indicates a favorable safety and activity profile for ORIC-944, with a focus on overcoming resistance in prostate cancer [8][10] Mechanism and Rationale - ORIC-944 is designed to address limitations of first-generation PRC2 inhibitors, showing improved potency and tolerability [7][13] - The combination of PRC2 inhibitors with ARIs is supported by biological rationale to delay or overcome resistance in prostate cancer [7][15] - Preclinical data shows ORIC-944 enhances AR signaling and luminal cell state markers, increasing sensitivity to AR inhibition [15][19] Efficacy and Safety Data - In the study, 17 patients with mCRPC showed a 59% PSA50 response rate and a 24% PSA90 response rate, with responses confirmed one month later [29][30] - The safety profile of ORIC-944 was generally well tolerated, with most adverse events being grade one or two, primarily mild gastrointestinal issues [31][32] - The combination therapy demonstrated a wide therapeutic window, with doses as low as 400 mg showing efficacy [30][31] Market Opportunity - The global market for AR inhibitors reached approximately $11 billion, with significant potential for PRC2 inhibitors to enhance treatment durability and outcomes [38][42] - ORIC-944 targets an addressable market opportunity of over $7 billion annually in the U.S. for mCRPC patients treated with AR inhibitors [42] Expansion Opportunities - ORIC-944 may have potential applications in other cancers, including breast and colorectal cancers, due to shared reliance on PRC2 mechanisms [44][48] - Future studies will explore ORIC-944 in earlier stages of prostate cancer and in combination with other therapies [48] Additional Important Content - The company completed a $125 million PIPE financing, extending its cash runway into the second half of 2027 [50] - The competitive landscape includes comparisons with Pfizer's mebrametostat, with ORIC-944 showing promising early efficacy and safety data [85][88] - The decision on which AR inhibitor to combine with for Phase 3 trials will be based on overall data and strategic considerations [79][80] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic direction, clinical advancements, and market potential for ORIC-944 in prostate cancer treatment.

Core Insights - ORIC Pharmaceuticals announced promising preliminary efficacy and safety data for ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][3] - The company reported a 59% PSA50 response rate and a 24% PSA90 response rate in the ongoing Phase 1b trial, indicating substantial clinical activity [1][6] - A concurrent financing of $125 million is expected to extend the company's cash runway into the second half of 2027, supporting further development of ORIC-944 [10] Efficacy Data - The Phase 1b trial showed a confirmed PSA50 response rate of 47% and a PSA90 response rate of 24%, with responses observed across all dose levels of ORIC-944 [1][6][7] - The majority of patients are still ongoing with treatment, with several approaching one year or more on therapy [1][7] Safety Profile - ORIC-944 demonstrated a favorable safety profile, with most adverse events classified as Grade 1 or 2, primarily mild to moderate gastrointestinal issues [2][8] - Diarrhea was the most common treatment-related adverse event, occurring in 53% of patients, with only one Grade 3 event reported [8] Trial Design and Next Steps - The ongoing Phase 1b trial is designed to explore different doses of ORIC-944 in combination with apalutamide and darolutamide, with the primary objective of determining the recommended Phase 2 dose [4][9] - Following the completion of the dose exploration phase, the company plans to evaluate candidate doses for optimization in the second half of 2025, leading to a global Phase 3 trial expected to start in the first half of 2026 [9] Corporate Update - The $125 million financing is anticipated to close on May 29, 2025, and will support the company's operations through the primary endpoint readout of the first Phase 3 trial [10]