Core Insights - Processa Pharmaceuticals, Inc. announced the acceptance of three abstracts for the 2025 ASCO Annual Meeting, showcasing its Next Generation Cancer (NGC) drug candidates, including PCS6422 and PCS11T [1][6] Abstract Summaries - The first abstract discusses the safety and efficacy of Eniluracil + Capecitabine (6422 + Cap) in a Phase 1b trial, highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine [3][4] - The second abstract outlines a Project Optimus-aligned approach for the preclinical study of PCS11T, a tumor-targeted pro-drug of SN-38, aimed at increasing drug concentration in tumors while minimizing systemic toxicity [4][5] - The third abstract presents an overview of an ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 combined with capecitabine in patients with advanced or metastatic breast cancer, focusing on optimal dosing regimens and personalized medicine [9]

REDWOOD CITY, Calif., May 30, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (Coherus Oncology, Nasdaq: CHRS), a commercial-stage innovative oncology company, formerly named Coherus BioSciences Inc., announced its name change today to better align with its exclusive focus on proprietary innovative immuno-oncology medicines. “The field of cancer immunotherapy has been reinvigorated by the promise and power of combination therapies. Coherus Oncology has the expertise and pipeline to become a significant play ...

Core Viewpoint - ORIC Pharmaceuticals' shares increased over 20% in pre-market trading following the announcement of promising preliminary efficacy and safety data for its prostate cancer treatment candidate, ORIC-944 [1] Group 1: Study Results - ORIC-944 is being evaluated in a phase Ib study in combination with J&J's Erleada and Bayer's Nubeqa for treating metastatic castration-resistant prostate cancer (mCRPC) [2] - The study reported that 59% of the 17 previously-treated mCRPC patients showed a 50% drop in PSA levels (PSA50 response), with a confirmed PSA50 rate of 47% [4] - Additionally, 24% of patients demonstrated a 90% drop in PSA levels (PSA90 response), all of which were confirmed [4] - PSA responses were consistent across all dosage levels and combinations with either Erleada or Nubeqa, indicating a well-tolerated safety profile with mild to moderate adverse events [6] Group 2: Future Plans - ORIC Pharmaceuticals aims to complete the phase Ib dose exploration by mid-2025 and plans to test two potential recommended phase II doses in the second half of 2025 [7] - The results from the dose optimization phase will inform the best ORIC-944 dose for the first global phase III study, expected to start in the first half of 2026 [8] Group 3: Financial Aspects - ORIC Pharmaceuticals announced a $125 million private placement to fund operations through the second half of 2027, covering expenses until the primary endpoint data readout from the phase III mCRPC study [9]

Core Insights - Intensity Therapeutics is presenting its Phase 3 INVINCIBLE-3 clinical trial of INT230-6 for metastatic soft tissue sarcomas at the ASCO 2025 Annual Meeting [1][2] - The trial aims to compare the efficacy and safety of INT230-6 with standard systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas [2][6] Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing immune-based intratumoral cancer therapies [1][9] - The lead investigational product, INT230-6, combines cisplatin and vinblastine with a penetration enhancer to improve drug distribution within tumors [5][9] - The company has completed two clinical studies with over 200 patients enrolled, demonstrating the potential of INT230-6 to elicit an adaptive immune response [9] Clinical Trial Details - The INVINCIBLE-3 trial is a multicenter, randomized, global Phase 3 study assessing INT230-6 as a monotherapy compared to standard care [2][6] - Participants will be randomized in a 2:1 ratio to receive either INT230-6 or standard chemotherapy agents [6] - The trial includes specific inclusion and exclusion criteria to ensure appropriate patient selection [7][8] Previous Study Results - In earlier studies, patients with refractory metastatic sarcoma showed a disease control rate of 93% and a median overall survival of 21.3 months with minimal adverse events [4] - The Phase 1/2 trial indicated immune engagement and regression of uninjected tumors post-treatment [4] Future Plans - The company has paused new enrollment for the Phase 3 study until additional funding is secured, while continuing to treat enrolled patients [4]

Group 1 - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [2] - Syndax is committed to advancing cancer care and is conducting several clinical trials across various treatment stages [2] Group 2 - Michael A. Metzger, CEO of Syndax, and the management team will participate in investor conferences, including the Jefferies Global Healthcare Conference on June 5, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025 [1][3] - A live webcast of the fireside chats will be available on the company's website, with replays accessible for a limited time [1]

Core Insights - Verastem Oncology's shares increased by 22.2% in a month due to FDA approval of a new treatment for KRAS mutant recurrent low-grade serous ovarian cancer [1] - The FDA granted accelerated approval for the combination regimen of avutometinib and defactinib, marketed as "Avmapki Fakzynja Co-Pack," making it the first FDA-approved treatment for this indication [2][7] - The stock has surged 64.8% year-to-date, significantly outperforming the industry, which declined by 5.8% [5] FDA Approval and Treatment Details - The approval was based on results from the phase II RAMP 201 study, which showed a 44% overall response rate and a median duration of response between 3.3 to 31.1 months for patients with KRAS mutations [6] - Full approval is contingent on results from the phase III RAMP 301 confirmatory study, which will assess the treatment's efficacy in a broader patient population [3] Future Developments - Verastem is also exploring the use of the combination therapy for metastatic pancreatic ductal adenocarcinoma (PDAC), with positive results reported from the phase I/II RAMP 205 study showing an 83% overall response rate in one cohort [9][10] - The company plans to initiate a registrational phase III study for front-line metastatic PDAC in 2026 and is evaluating the combination with a KRAS G12C inhibitor for non-small cell lung cancer [12] Market Position - The Avmapki/Fakzynja combo has received Breakthrough Therapy designation and Orphan Drug designation from the FDA, indicating its potential significance in treating recurrent LGSOC [7] - The company is currently ranked 3 (Hold) by Zacks, with other biotech stocks like Bayer, Lexicon Pharmaceuticals, and Amarin holding better ranks [13]

UroGen Pharma (URGN) FY Conference May 28, 2025 09:00 AM ET Speaker0 Morning, everyone. I'm Tara Bancroft. I'm one of the senior biotech analysts at TD Cowen. I wanna thank you very much for joining our sixth annual oncology innovation summit. And so to start off the day, in the first session, we have a q and a with UroGen, and it's my pleasure to introduce Liz Barrett, the president and CEO, and Mark Schoenberg, the CMO. So it's a privilege to have you both here. Thank you. Thank you for being here with us ...

Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT for treating solid tumors [3] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] Product Information - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 impregnated sources to provide highly potent and conformal alpha-irradiation of solid tumors [4] - The therapy aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [4] Upcoming Events - The CFO of Alpha Tau, Raphi Levy, will present at the Jefferies Global Healthcare Conference on June 5, 2025, from 1:25 to 1:55 PM ET in New York, NY [2] - Mr. Levy will also be available for one-on-one investor meetings during the conference [2]

Core Insights - Olema Pharmaceuticals has aligned with the FDA to select a 90 mg dose of palazestrant for the Phase 3 OPERA-01 trial in ER+/HER2- metastatic breast cancer [1][2] - The OPERA-01 trial results are expected to be presented at the ASCO Annual Meeting from May 30 to June 3, 2025, with top-line data anticipated in 2026 and a potential commercial launch in 2027 [2][4] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company focused on developing targeted therapies for breast cancer, particularly through its lead product candidate, palazestrant (OP-1250) [4][5] - Palazestrant is a novel small molecule that acts as both a complete estrogen receptor antagonist and a selective estrogen receptor degrader, currently being evaluated in multiple clinical trials [3][5] Clinical Trials - The OPERA-01 trial is a randomized, open-label Phase 3 study comparing palazestrant monotherapy to standard endocrine therapy for patients with advanced ER+/HER2- breast cancer [2][4] - Palazestrant has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after endocrine therapy and at least one line of treatment with a CDK4/6 inhibitor [3][4]

Company Overview - BeyondSpring Inc. is a clinical-stage global biopharmaceutical company focused on developing cancer therapies, particularly its lead asset Plinabulin, which is in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Study Announcement - BeyondSpring announced a poster presentation on the 303 Study, an investigator-initiated study supported by Merck, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago, IL [1] 303 Study Details - The 303 Study is an open-label, single-arm Phase 2 study evaluating the efficacy and safety of Plinabulin in combination with docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC who have progressed after anti-PD-(L)1 inhibitor therapy [4] - The study involves 47 enrolled patients and is conducted at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang as the principal investigator [4] - The primary endpoint is the investigator-based overall response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety [4] Presentation Details - The presentation will take place on May 31, 2025, from 1:30 PM to 4:30 PM CDT at McCormick Place Convention Center, focusing on initial efficacy and safety results related to immune re-sensitization [5]