- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure – - 50% Response Rate at the Selected Dose Level of 30 mg Twice a Week (BIW) – - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached - NEW YORK, Nov. 05, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“S ...

Core Insights - Lyell Immunopharma, Inc. is advancing a pipeline of next-generation CAR T-cell therapies targeting solid tumors and hematologic malignancies [1][3] - The company announced the presentation of initial clinical data for IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma, at the upcoming ASH Annual Meeting [1][2] Company Overview - Lyell is a clinical-stage company focused on developing CAR T-cell therapies enhanced with technology to generate T cells that resist exhaustion and maintain durable stemness [3] - The company is headquartered in South San Francisco, California, with additional facilities in Seattle and Bothell, Washington [3] Clinical Development - IMPT-314 has received Fast Track Designation from the U.S. FDA for treating relapsed/refractory aggressive B-cell lymphoma [2] - The presentation of IMPT-314's results will occur on December 9, 2024, at the San Diego Convention Center during the ASH Annual Meeting [2]

- CRG-023 is a CD19-, CD20-, CD22-targeting tri-specific CAR T product candidate designed with the goal of providing more patients with a broad range of B-cell malignancies with durable responses by addressing several known causes of relapse, resulting in a potential best-in-class CAR T-cell therapy - - First of its kind, tri-cistronic CAR T to express three independent CARs from a single vector, with each CAR having a distinct co-stimulatory domain – - Data demonstrated sustained anti-tumor activity and a ...

Core Insights - Kura Oncology announced that two abstracts featuring clinical data from the KOMET-007 trial of ziftomenib have been accepted for presentation at the ASH Annual Meeting in December 2024 [1][2] Group 1: Clinical Trial Details - KOMET-007 is a multicenter Phase 1 trial evaluating ziftomenib in combination with standard treatments for patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML) [2] - The Phase 1a dose-escalation portion of the study has shown that all four cohorts have cleared the highest dose and advanced to the Phase 1b expansion study at 600 mg [2] Group 2: Safety and Efficacy - Clinical data suggests ziftomenib has a potential best-in-class safety and tolerability profile, demonstrating robust activity in combination with standard care [3] - In the relapsed/refractory AML setting, ziftomenib combined with venetoclax/azacitidine has shown encouraging activity, with no dose-limiting toxicities or QTc prolongation reported [3] - In newly diagnosed adverse risk AML patients, 100% of NPM1-m patients and 84% of KMT2A-r patients remained on study approximately one year after the study start [3] Group 3: Upcoming Presentations - The oral presentation on ziftomenib combined with 7+3 will take place on December 7, 2024, at the San Diego Convention Center [4] - The poster presentation on ziftomenib combined with ven/aza is scheduled for December 8, 2024, at the same venue [4] Group 4: Company Overview - Kura Oncology is focused on precision medicines for cancer treatment, with ziftomenib being a key candidate targeting the menin-KMT2A interaction [5] - The company has received Breakthrough Therapy Designation for ziftomenib in treating relapsed/refractory NPM1-m AML and is conducting multiple clinical trials to evaluate its efficacy [5]

– Results from Phase 3 ENERGIZE-T Study of Mitapivat in Transfusion-dependent Thalassemia will be Presented in Oral Session – – Tebapivat Phase 1 Data in Sickle Cell Disease and Phase 2b Trial-in-progress Update in Lower-risk Myelodysplastic Syndromes will be Presented and Published – – Live and Webcast Investor Event with Agios Leadership and Medical Experts will be Hosted Onsite on Monday, December 9 – CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader ...

INDIANAPOLIS, Nov. 5, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Jaypirca® (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place Dec. 7-10 in San Diego.In an oral presentation, Lilly will report results from the Phase 3 BRUIN CLL-321 study, which is evaluating pirtobrutinib versus idelalisib plus rituximab (IdelaR ...

Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing an innovative pipeline of cancer therapies [3] - The company's notable pipeline includes revumenib, a selective menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody targeting the colony stimulating factor 1 (CSF-1) receptor [3] Upcoming Event - The company will host an in-person investor event and live webcast on December 9, 2024, at 7:00 a.m. PT/10:00 a.m. ET during the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, California [1] - Members of the Syndax management team will be joined by key opinion leaders to discuss data updates from the revumenib and Niktimvo™ programs [1] Webcast Availability - A live webcast of the event will be accessible on the investor section of the company's website, with a replay available for a limited time [2]

– New monotherapy and combination data in acute leukemia further highlight revumenib's compelling clinical profile –  – 64% ORR (62/97) in expanded dataset of patients with R/R KMT2Ar acute leukemia in Ph 2 AUGMENT-101 pivotal cohort ––  88% ORR (23/26) in SAVE trial testing revumenib, venetoclax and decitabine/cedazuridine combination in R/R AML –WALTHAM, Mass., Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that multiple abstracts evaluating revumenib, an oral small mole ...

Core Insights - Syndax Pharmaceuticals announced that multiple abstracts evaluating Niktimvo™ (axatilimab-csfr) for chronic graft-versus-host disease (GVHD) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting [1][3] Group 1: Clinical Trial Results - The pivotal Phase 2 AGAVE-201 trial of Niktimvo showed a 75% overall response rate (ORR) among patients receiving the approved dose of 0.3 mg/kg every two weeks [4] - An estimated 60% of patients who responded maintained their response at 12 months [4] - More than half of responders in the 0.3 mg/kg cohort had an overall clinical response by day 56 of treatment [5] Group 2: Mechanism of Action and Safety - Preclinical data will be presented detailing the anti-inflammatory and anti-fibrotic mechanisms of axatilimab in chronic GVHD [8] - The exposure-efficacy analysis indicated that lower axatilimab exposure increased the odds of response, while higher exposure was associated with increased treatment-emergent adverse events [7] Group 3: Upcoming Presentations - An oral presentation titled "Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease" will take place on December 7, 2024 [6] - A poster presentation on "Exposure-Response Relationships for Axatilimab" is scheduled for the same day [8] Group 4: Company Collaboration and Future Directions - Syndax is collaborating with Incyte to advance the clinical development of Niktimvo for chronic GVHD and other inflammatory diseases [3] - The company is also exploring the use of axatilimab in combination with other therapies for chronic GVHD and idiopathic pulmonary fibrosis [13]

Wall Street expects a year-over-year increase in earnings on higher revenues when Ashland (ASH) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on November 6. O ...