On November 25, 2024 AbbVie (NYSE: ABBV) reported that it will participate in Citi’s 2024 Global Healthcare Conference on Tuesday, December 3, 2024 (Press release, AbbVie, NOV 25, 2024, View Source [SID1234648628]). Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., executive vice president, Research & Development and chief scientific officer, will present at 9:15 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On November 25, 2024 Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, reported that the company will participate in two upcoming investor conferences in December (Press release, Flare Therapeutics, NOV 25, 2024, View Source [SID1234648627]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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7th Annual Evercore ISI HealthCONx Conference: Douglas Manion, M.D., FRCP (C), Chief Executive Officer and Daphne Karydas, President and Chief Financial Officer will participate in a fireside chat on Wednesday, December 4, 2024 at 12:55 p.m. ET in Coral Gables, Florida.

Piper Sandler 36th Annual Healthcare Conference: Douglas Manion, M.D., FRCP (C), Chief Executive Officer, will present a company overview on Thursday, December 5, 2024 at 9:50 a.m. ET in New York, NY. Daphne Karydas, President and Chief Financial Officer will also be available for meetings with investors.

On November 25, 2024 Novartis reported that it will present data from more than 65 abstracts, including investigator-initiated trials at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium (SABCS) (Press release, Novartis, NOV 25, 2024, View Source [SID1234648625]).

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"By prioritizing research in areas of greatest medical need and focusing on earlier stages of disease, we aim to change the treatment paradigm for people who require additional treatment options," said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. "The new data being presented at ASH (Free ASH Whitepaper) and SABCS underscore our commitment to patients with cancer or blood disorders and follow new, expanded indications for Scemblix and Kisqali along with recent updates in national treatment guidelines."

In addition to late-breaking data, Novartis will host an art gallery-style exhibit at SABCS featuring personal letters and stories written by people impacted by breast cancer, sharing their raw, authentic perspectives on aspects of the breast cancer journey. These letters and stories aim to uplift patients, encourage reflection, and demonstrate strength and unity among the breast cancer community.

Key abstracts accepted by ASH (Free ASH Whitepaper) include:

Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details      
Scemblix Asciminib (ASC) Demonstrates Favorable Safety and Tolerability Compared with Each Investigator-Selected Tyrosine Kinase Inhibitor (IS TKI) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in the Pivotal Phase 3 ASC4FIRST Study

Abstract #475
Oral Presentation
Sunday, December 8
9:30 – 11:00 AM PT
Scemblix    Efficacy and Safety of Asciminib in Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Interim Results from the Phase 2 ASC2ESCALATE Trial in the Cohort of Patients (Pts) after 1 Prior Tyrosine Kinase Inhibitor (TKI)

Abstract #479
Oral Presentation
Sunday, December 8
9:30 – 11:00 AM PT
Scemblix Asciminib Shows High Efficacy and Favorable Tolerability at 80 Mg Once Daily and 40 Mg Twice Daily in Patients with Chronic Phase Chronic Myelogenous Leukemia Previously Treated with 2 or More Tyrosine Kinase Inhibitors: Primary Analysis from the ASC4OPT Study

Abstract #4526
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
Scemblix Treatment with Asciminib as a Second Line after One Prior Tyrosine Kinase Inhibitor (TKI) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CML-CP)– a Chart Review Study in the United States

Abstract #3812
Poster Presentation
Sunday, December 8
6:00 – 8:00 PM PT
Ianalumab (VAY736) A Phase 2 Study of Ianalumab in Patients with Primary Immune Thrombocytopenia Previously Treated with at Least Two Lines of Therapy: Interim Results from VAYHIT3

Abstract #710
Oral Presentation
Monday, December 9
10:30 AM – 12:00 PM PT
Rapcabtagene autoleucel (YTB323) Rapcabtagene Autoleucel (YTB323) in Patients (Pts) with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): Phase II Trial Clinical Update

Abstract #67
Oral Presentation
Saturday, December 7
9:30 – 11:00 AM PT
Fabhalta Oral Iptacopan Monotherapy Leads to Long-Term Improvements in Patient (Pt)-Reported Health-Related Quality of Life (HRQoL) and Investigator-Assessed Signs and Symptoms of Paroxysmal Nocturnal Hemoglobinuria (PNH): 48-Week (Wk) Results from the Phase III APPLY-PNH and APPOINT-PNH Trials

Abstract #4079
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
Fabhalta The Effect of Oral Iptacopan Monotherapy on Hematological Parameters in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Is Consistent Regardless of the Type of Prior Anti-C5 Treatment Received: A Post Hoc Analysis of 24-Week Data from the Randomized Phase III APPLY-PNH Trial

Abstract #4087
Poster Presentation
Monday, December 9
6:00 – 8:00 PM PT
Fabhalta Baseline Characteristics of Individuals with Paroxysmal Nocturnal Hemoglobinuria in an App-Based Home-Reported Outcomes Study to Evaluate Disease Burden

Abstract #2327
Poster Presentation
Saturday, December 7
5:30 – 7:30 PM PT
Pelabresib (CPI-0610) Updated Results from the Phase 3 Manifest-2 Study of Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor–Naïve Patients with Myelofibrosis Abstract #3178
Poster Presentation
Sunday, December 8
6:00 PM – 8:00 PM PT
Key abstracts accepted by SABCS include:

Medicine or Disease State      Abstract Title      Abstract Number/ Presentation Details      
Kisqali (ribociclib)* Distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2- early breast cancer (EBC)

Abstract #P4-09-22
Poster Session
Thursday, December 12
5:30 – 7:30 PM CST

Kisqali      Impact of ribociclib dose reduction on efficacy in patients with hormone receptor– positive/human epidermal growth factor receptor 2–negative (HR+/HER2-) early breast cancer (EBC) in NATALEE

Abstract #P1-11-16
Poster Session
Wednesday, December 11
12:30 – 2:00 PM CST
Kisqali Risk of recurrence in real-world (RW) NATALEE- and monarchE-eligible populations of patients with HR+/HER2- early breast cancer (EBC) in an electronic health record (EHR)-derived database

Abstract #P2-12-02
Poster Session
Wednesday, December 11
5:30 – 7:00 PM CST

Kisqali Tolerability of First-Line (1L) Treatment (tx) With Ribociclib (RIB) for Metastatic Breast Cancer (MBC) Using 2 Large US Data Sources

Abstract #P3-10-14
Poster Session
Thursday, December 12
12:30 – 2:00 PM CST

Kisqali Impact of body mass index (BMI) on the safety and efficacy of ribociclib (RIB) in patients (pts) with HR+/HER2- advanced breast cancer (ABC): pooled analysis of the MONALEESA (ML)-2, -3, and -7 trials

Abstract #P2-09-20
Poster Session
Wednesday, December 11
5:30 – 7:00 PM CST

Kisqali First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of RIGHT Choice by intrinsic subtype & gene & signature expression

Abstract #PS2-06
Poster Presentation
Thursday, December 12
7:00 – 8:30 AM CST

Product Information    
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On November 25, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, reported that it will take part in an unplugged fireside discussion at the Piper Sandler 36th Annual Healthcare Conference being held in New York, NY, Dec 3-5, 2024 (Press release, Cue Biopharma, NOV 25, 2024, View Source [SID1234648624]).

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During the fireside discussion, Cue Biopharma will provide an overview highlighting recent clinical and preclinical program updates as well as strategic business and partnering model objectives.

Presentation Details
Date and Time: Wednesday, December 4, 2024, from 9 a.m. EST – 9:25 a.m. EST
Webcast Link: View Source;tp_key=a82c532edc
Presenter: Daniel Passeri, M.Sc., J.D., chief executive officer, Cue Biopharma

A live and archived webcast of the fireside discussion will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

On November 25, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) (Press release, Plus Therapeutics, NOV 25, 2024, View Source;_hsenc=p2ANqtz-_3e0WGfQoHRDQoflB8bgcdLP1VppeVihSjFAT8Q37cK6JGFkK9Te1jlmJ403sVhwpNZ8VRDvKJ-vbFbySCRjXI4iQIEQ&_hsmi=335602723&utm_content=335602723&utm_source=hs_email [SID1234648623]). The data were presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.

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"The combination of a high absorbed radiation dose, favorable safety profile, and consistent response data is very encouraging, particularly in a Phase 1 trial," said Dr. Andrew Brenner, M.D., Ph.D. "Furthermore, the observed median overall survival rate and long tail survivors receiving multiple doses via compassionate use are uncommon in LM patients, driving our commitment to move rapidly into dose expansion and multiple-dose trials."

The data were presented in a session titled, "Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection," by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.

KEY HIGHLIGHTS

ReSPECT-LM Single Administration Dose Escalation Trial

Overview:

Twenty patients with LM were treated and evaluable through Cohort 5, receiving a single intrathecal dose of Rhenium (186Re) Obisbemeda of up to 66.14 mCi of radiation
Primary cancer diagnosis for the 20 patients with LM included breast cancer (n = 9), non-small cell lung cancer (n = 5), and other primary cancers (n = 6)
Safety:

The safety profile through Cohort 5 was favorable, with 1 dose-limiting toxicity (thrombocytopenia) observed in Cohort 5
Pharmacodynamic and pharmacokinetic analyses indicated that after a single administration, Rhenium (186Re) Obisbemeda remained in the cerebrospinal fluid space for at least 7 days and achieved average absorbed doses of up to 253 Gy to the cranial subarachnoid space in Cohort 5
Response:

The best clinical benefit rate from a single dose of Rhenium (186Re) Obisbemeda, assessed from baseline to day 112, was measured through complete response, partial response, and stable disease across three key metrics:
Circulating tumor cells: 93% (14/15 patients) responded, including 1 complete response and 1 stable case
MRI imaging: 75% (12/16 patients), with 5 responses and 7 stable cases
Clinical Response: 86% (12/14 patients), with 2 responses and 10 stable cases
Median overall survival for Cohorts 1-4 was 9 months, with 6 out of the 16 patients alive at the time of analysis
Three of the 20 patients received up to 3 doses of Rhenium (186Re) Obisbemeda under compassionate use IND, all surviving over 400 days, with one exceeding 30 months
Next steps:

The first patient in Cohort 6 has been treated using a modified dose of 75 mCi
Cohort 6 is anticipated to conclude in Q1 2025
Planning is underway for a Phase 1b single dose expansion cohort trial using the Cohort 4 dose of 44 mCi, which is expected to fully enroll in 2025
ReSPECT-LM Multiple Administration Dose Interval Compression Trial

Obtained agreement from FDA to begin the ReSPECT-LM multi-administration trial for patients with LM (IND 153715); enrollment is expected to begin in early 2025 at seven U.S. trial sites
The trial will be a two-part study aimed at evaluating the safety, dosing intervals, and efficacy of administering multiple doses of Rhenium (186Re) Obisbemeda to patients with LM
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).