Caris Life Sciences Receives FDA Approval for MI Cancer Seek™ as a Companion Diagnostic (CDx) Test

On November 6, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies (Press release, Caris Life Sciences, NOV 6, 2024, View Source [SID1234647857]). The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adults and pediatric patients, ages 1-22.

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"FDA approval of MI Cancer Seek – the first of its kind – further demonstrates Caris’ continued leadership in molecular science and our extreme focus on quality," said Caris Chairman, Founder and CEO David Dean Halbert, DSc (h.c.). "We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools."

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer.
MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.

"We are very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests," said Caris President David Spetzler, MS, PhD, MBA. "The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."

MI Cancer Seek Companion Diagnostic Indications

Indication

Biomarker

Therapy

Breast Cancer

PIK3CA (C420R; E542K; E545A, E545D [1635G>T only],
E545G, E545K, Q546E, Q546R; and H1047L, H1047R,
H1047Y)

PIQRAY (alpelisib)

Colorectal Cancer
(CRC)

KRAS wild-type (absence of mutations in exons 2, 3, and
4) and NRAS wild type (absence of mutations in exons 2,
3, and 4)

VECTIBIX (panitumumab)

BRAF V600E

BRAFTOVI (encorafenib) in combination with ERBITUX
(cetuximab)

Melanoma

BRAF V600E

BRAF Inhibitors approved by FDA*

BRAF V600E or V600K

MEKINIST (trametinib) or BRAF/MEK Inhibitor
Combinations approved by FDA*

Non-Small Cell Lung
Cancer (NSCLC)

EGFR exon 19 deletions and exon 21 L858R alterations

EGFR Tyrosine Kinase Inhibitors approved by FDA*

Solid Tumors

MSI-H

KEYTRUDA (pembrolizumab), JEMPERLI (dostarlimab-gxly)

Endometrial
Carcinoma

Not MSI-H

KEYTRUDA (pembrolizumab) in combination with
LENVIMA (lenvatinib)

*For the most current information about the device indications for the therapeutic products in this group, go to: View Source

PIQRAY is a registered trademark of Novartis AG. VECTIBIX is a registered trademark of Immunex Corporation. BRAFTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA is a registered trademark of Merck. LENVIMA (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Typically, DNA and RNA analysis by NGS requires two separate testing processes, which may require more tissue and time. However, by combining WES and WTS into one workflow, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. For complete product details, including companion diagnostic information and performance characteristics, please visit www.CarisLifeSciences.com/MICancerSeek.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The agency is also responsible for the safety of the United States’ food supply, cosmetics, and radiation-emitting electronic products and for regulating tobacco products.

Aadi Bioscience Announces Financial Results for the Third Quarter 2024 and Provides Corporate Update

On November 6, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI) reported financial results for the third quarter ended September 30, 2024, and provided recent corporate progress (Press release, Aadi Bioscience, NOV 6, 2024, View Source [SID1234647856]).

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"The third quarter saw strong sales growth for FYARRO, backed by continued account momentum, increased demand and a nearly 90 percent reorder rate – all reinforcing the clinical value of FYARRO for patients with advanced malignant PEComa," said Dave Lennon, President and CEO of Aadi Bioscience. "Our comprehensive review of strategic options to maximize value for shareholders is ongoing, and we will provide further updates when available."

Recent Operational Highlights

FYARRO net product sales were $7.2 million in the third quarter, an increase of 17 percent from Q2 2024 and 21 percent compared to the prior-year period. This increase is primarily driven by continued momentum from top accounts and strong demand.
Aadi completing wind-down of the PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. All patients who were still receiving benefit at the time the study was halted were transitioned to an expanded access protocol, and a report out of the PRECISION1 trial is expected to be provided in 2025.
The Phase 2 trials of nab-sirolimus for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs) enrolled 24 and 12 patients, respectively. Both studies enrolled sufficient patients to assess initial efficacy signals later this year.
Aadi remains actively engaged in a comprehensive strategic review to maximize shareholder value. Aadi has not provided a specific timeline to complete this process and will provide further updates when appropriate.
Third Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2024, were $62.6 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into at least 2H 2026 based on current plans.
Total revenue for the quarter ended September 30, 2024, was $7.2 million, resulting from sales of FYARRO.
Operating expenses for the third quarter September 30, 2024, were $20.6 million as compared to $23.8 million in the prior year quarter and included $2.6 million of restructuring expenses.
Net loss for the three months ended September 30, 2024, was $12.5 million as compared to $16.3 million for the three months ended September 30, 2023.

Senhwa Biosciences announces first patient dosed in the Phase I/II study of Silmitasertib in children and young adults with relapsed refractory solid tumors.

On November 6, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that the enrollment of the first patient at Penn State Health Children’s Hospital in its Phase I/II clinical study evaluating the efficacy of Silmitasertib (CX-4945) in combination with chemotherapy for children and young adults with relapsed or refractory solid tumors (Press release, Senhwa Biosciences, NOV 6, 2024, View Source [SID1234647855]). This innovative trial seeks to establish a recommended dose of Silmitasertib in combination with chemotherapy and assess the safety, tolerability and efficacy in patients with cancer, with a focus on neuroblastoma, Ewing’s sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.

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"This clinical trial is a critical piece in understanding the mechanism of how the medicine works and develop more precise treatments for our patients," said Dr. Chandrika Behura, study chair and principal investigator, Four Diamonds researcher and associate professor of pediatrics at the College of Medicine. "It’s very important to develop the right combination that can be the most toxic to cancer cells, but the least harmful to the normal cells around them."

The study is projected to enroll up to 114 participants nationwide through the Beat Childhood Cancer Research Consortium member hospitals. By evaluating the activity of the study treatments based on individual responses and duration of disease control, the trial aims to develop novel therapeutic approaches.

"We are thrilled to be able to move this important research forward on a larger scale," said Dr. Giselle Sholler, division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine and chairperson of the Beat Childhood Cancer Research Consortium. "The insights gained from this trial will help not only local patients and their families but can lead to new therapies that can help children throughout the US and internationally."

With the College of Medicine serving as its home, the Beat Childhood Cancer Research Consortium is a worldwide network of more than 50 universities and children’s hospitals focused on saving lives and helping the Children’s Hospital make a lasting difference around the world. Funding for this clinical trial is provided by the Beat Childhood Cancer Foundation and the Little Warrior Foundation. Funding for Behura’s research which led to the clinical trial was provided by Four Diamonds.

"This is the culmination of the work of many people over the years," said Suzanne Graney, executive director of Four Diamonds. "Without the dedication of our physician-scientists and the generosity of our donors and community, this kind of essential work to improve treatments with an ultimate goal of curing cancer would not be possible."

The pediatric cancer care specialists at Beat Childhood Cancer Research Consortium hospitals and researchers at the College of Medicine are dedicated to turning groundbreaking discoveries into lifesaving treatments for childhood cancer.

"By expanding our research and increasing clinical trials, we are exploring immunotherapy, cellular therapy and precision medicine to deliver the most optimized care to each unique patient," said Dr. Dr. Yatin Vyas, pediatrician-in-chief and chair of the Department of Pediatrics at the Children’s Hospital.

"We are greatly honored to collaborate with the Penn State College of Medicine and Beat Childhood Cancer Research Consortium, which have been diligently fighting childhood cancers by infusing invaluable resources from over 50 universities and children’s hospitals across the United States for the clinical study," said Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc. "We appreciate for having the opportunity of providing Silmitasertib as a potential effective treatment and look forward to realizing its therapeutic value in this urgently needed field for childhood cancers though this study".

AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024

On November 6, 2024 AstraZeneca reported its ambition to redefine cancer care with new data across its industry-leading and diverse pipeline in haematology at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition 7 to 10 December 2024 (Press release, AstraZeneca, NOV 6, 2024, View Source [SID1234647854]).

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A total of 57 abstracts will feature 13 approved and potential new medicines from across AstraZeneca’s portfolio and pipeline in haematology, including from Alexion, its rare disease group, with data in key settings including chronic lymphocytic leukaemia (CLL), multiple myeloma (MM), paroxysmal nocturnal haemoglobinuria (PNH) and other haematologic diseases.

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "Our data at ASH (Free ASH Whitepaper) from the AMPLIFY Phase III trial will demonstrate the efficacy and safety of our leading second-generation BTK inhibitor, Calquence, as a fixed-duration therapy in first-line CLL. In addition, new results for our novel T-cell engager, AZD0486, will reinforce its promising clinical profile in lymphomas, and data for our novel CAR T cell therapy, AZD0120, will highlight the potential of this therapy to transform treatment in multiple myeloma."

Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: "Our ASH (Free ASH Whitepaper) presentations will highlight the transformative impact of our medicines, including new analyses from the ALPHA Phase III trial reaffirming the safety and efficacy of our first-in-class Factor D inhibitor Voydeya as add-on to Ultomiris or Soliris for the subset of patients with PNH experiencing clinically significant extravascular haemolysis. Further, new insights from our robust pipeline will enhance the understanding of several rare haematologic and cardiovascular conditions, underscoring our commitment to innovation in rare disease."

Calquence combinations demonstrate significant benefits across CLL and MCL

An oral presentation on interim results from the pivotal AMPLIFY Phase III trial will demonstrate the potential of fixed-duration Calquence in combination with venetoclax, with or without obinutuzumab, in previously untreated adults with CLL compared to standard-of-care chemoimmunotherapy.1 These results will be featured during the ASH (Free ASH Whitepaper) Press Briefing on Sunday 8 December.

An updated analysis from the pivotal ECHO Phase III trial will further highlight the use of Calquence in combination with bendamustine and rituximab as a first-line treatment option by demonstrating high and durable undetectable minimal residual disease (MRD) rates in previously untreated patients with mantle cell lymphoma (MCL) as well as showing the benefit of Calquence across all patients including those with high-risk disease characteristics.2 Results from ECHO were first presented as a late-breaking oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Hybrid Congress in June.3

Results will also be shared from the ChangE Phase III trial, evaluating Calquence compared with chlorambucil plus rituximab in first-line CLL in patients in China.4

New data show promise of next generation T-cell engagers and chimeric antigen receptor T-cell (CAR T) therapy

Two oral presentations will share results for the novel CD19xCD3 bispecific T-cell engager AZD0486, reinforcing the potential of this novel medicine as a new treatment option for B-cell malignancies.5,6 Phase I results demonstrate high response rates, with a 96% overall response rate, 85% complete response rate and high rates of undetectable MRD in patients with relapsed/refractory follicular lymphoma (R/R FL) at doses of 2.4 mg and above.5 Additionally, interim Phase I results will show the early potential of AZD0486 in patients with heavily pretreated diffuse large B-cell lymphoma (DLBCL).6 Data will also reinforce the safety profile of AZD0486, with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events effectively mitigated by the double step-up dosing schedule.7

Early data for AZD0120 (GC012F), a novel BCMAxCD19 dual-targeting autologous CAR T developed using the Gracell FasTCAR rapid manufacturing process, will show potential as a first-line therapy for elderly patients with newly diagnosed transplant ineligible MM.8 Preliminary results from the ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ICANS and no ≥Grade 2 CRS events observed in this patient population.8

An oral presentation will share preclinical data demonstrating the anti-tumour activity of AZD5492, a next-generation CD8 selective, CD20-targeting T-cell engager, designed using AstraZeneca’s innovative Target Induced T-cell Activating Nanobody (TITAN) platform. AZD5492 is currently being evaluated in Phase I clinical trials in R/R Non-Hodgkin lymphoma (NHL) and CLL.9

Voydeya (danicopan) as add-on to Ultomiris (ravulizumab) or Soliris (eculizumab) demonstrates low rate of mild or moderate BTH events and improves quality of life measures in patients with PNH and clinically significant EVH

Data will be presented detailing events of breakthrough haemolysis (BTH), a key indicator of intravascular haemolysis and PNH disease control, reported in the ALPHA trial evaluating Voydeya as add-on to Ultomiris or Soliris in patients with PNH experiencing clinically significant extravascular haemolysis (EVH) and separately in the PEGASUS Phase III trial evaluating pegcetacoplan in patients with PNH previously treated with Soliris. Data will show that 5/84 patients (6.0%) in the ALPHA trial and 19/80 patients (23.8%) in the PEGASUS trial experienced one or more BTH events. Moreover, most BTH events (6/7 or 85.7%) in the ALPHA trial were either mild or moderate, and all events were resolved without transfusion, dose modification or treatment withdrawal.10

Separately, final long-term patient-reported outcomes from the ALPHA trial will demonstrate Voydeya as add-on to Ultomiris or Soliris resulted in sustained improvements in fatigue, quality of life and physical function for up to 72 weeks in the subset of patients with PNH who experience clinically significant EVH.11

Advancing understanding of life-threatening rare diseases

A US, retrospective chart review will provide real-world evidence showing haematologic and renal improvements in adults with atypical haemolytic uraemic syndrome (aHUS) who switched to Ultomiris after short-term use of Soliris, with early responses and continued improvements through one year of treatment with Ultomiris.12

Additionally, two presentations on amyloid light chain (AL) amyloidosis will highlight unmet medical needs in this progressive, debilitating disease, reinforcing the importance of bringing forward novel therapies to improve cardiovascular outcomes and organ function.13,14

Key presentations during the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition

Lead Author

Abstract Title

Presentation details (PST)

Calquence (acalabrutinib)

Brown, JR et al.

Fixed-Duration Acalabrutinib plus Venetoclax with or without Obinutuzumab versus Chemoimmunotherapy for First-Line Treatment of Chronic Lymphocytic Leukemia: Interim Analysis of the Multicenter, Open-label, Randomized, Phase 3 AMPLIFY Trial

Abstract #1009

Oral Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Frontline Targeted Therapy Combinations

9 December 2024

4:30 PM

Qiu, L et al.

Acalabrutinib Versus Chlorambucil Plus Rituximab in Patients with Previously

Untreated Chronic Lymphocytic Leukemia: A Randomized, Multicenter, Open Label, Phase 3 Study

Abstract #3251

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II

8 December 2024

6:00 – 8:00 PM

Dreyling, M et al.

High-risk Subgroups and MRD: An Updated Analysis of the Phase 3 ECHO Trial of Acalabrutinib with Bendamustine/Rituximab in Previously Untreated Mantle Cell Lymphoma

Abstract #1626

Poster Session 623. Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I

7 December 2024

5:30 – 7:30 PM

Simon, F et al.

Efficacy and Safety of Acalabrutinib Treatment in Very Old (≥80y) and/or Frail

Patients with Chronic Lymphocytic Leukemia (CLL) – Primary Endpoint Analysis of the Phase II CLL-Frail Trial

Abstract #4618

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

9 December 2024

6:00 – 8:00 PM

Swaminathan, M et al.

Early Obinutuzumab Significantly Increases Bone Marrow Undetectable MRD (10-4 sensitivity) (uMRD4) Rate when Combined with Acalabrutinib and Venetoclax in a Randomized Phase II Trial for Treatment Naïve CLL

Abstract #1855

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I

7 December 2024

5:30 – 7:30 PM

Jerkeman, M et al.

Acalabrutinib and Rituximab in Elderly Patients with Newly Diagnosed Mantle Cell Lymphoma Including a Matched Population-Based External Comparator- the Nordic Lymphoma Group NLG-MCL8 (ALTAMIRA) Phase II Trial

Abstract #747

Oral Session 623: Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Updates on Drug Treatments for Mantle Cell Lymphoma, and CAR-T and Transplants for Indolent Lymphomas

9 December 2024

11:00 AM

Christofyllakis, K et al.

Toxicity of R-mini-CHOP with or without Acalabrutinib in Older Adults with Untreated DLBCL – An Interim Analysis of Serious Adverse Events in the ARCHED / GLA 2022-1 Randomized, Open-Label, Phase 3 Trial

Abstract #4498

Poster Session 627: Aggressive Lymphomas: Pharmacologic Therapies: Poster III

9 December 2024

6:00 – 8:00 PM

AZD0486

Gaballa, S et al.

Evaluation of AZD0486, a Novel CD19xCD3 T-Cell Engager, in Relapsed/Refractory Diffuse Large B-cell Lymphoma in an Ongoing First-in-Human Phase 1 Study: High Complete Responses Seen in CAR-T–naive and CAR-T–exposed Patients

Abstract #868

Oral Session 627: Aggressive Lymphomas: Pharmacologic Therapies: Novel Monotherapies or Novel Disease Indications

9 December 2024

3:30 PM

Hou, J et al.

Escalating Doses of AZD0486, a Novel CD19xCD3 T-cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma

Abstract #341

Oral Session 623: Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Novel Treatment Strategies and New Data on Old Standards for Follicular Lymphoma

7 December 2024

5:00 PM

Zhu, X et al.

Exposure-Response analysis and Quantitative Systems Pharmacology modelling for an optimal dose selection of AZD0486 in follicular lymphoma patients

Abstract #2794

Poster Session 605: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

8 December 2024

6:00 – 8:00 PM

AZD0120

Du, J et al.

A phase I study of dual targeting BCMA and CD19 FasTCAR-T cells (GC012F)

as first-line therapy for transplant-ineligible newly diagnosed multiple myeloma

Abstract #2072

Poster Session 704: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I

7 December 2024

5:30 – 7:30 PM

AZD5492

Lawrence, R et al.

Pre-Clinical Evaluation of AZD5492, a Novel CD8-Guided T Cell Engager, for B-Non-Hodgkin Lymphoma Indications

Abstract #959

Oral Session 605: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Novel Therapeutic Approaches in Lymphoma

9 December 2024

5:30 PM

Voydeya (danicopan)

Schrezenmeier, H

Breakthrough Hemolysis Events in Patients with Paroxysmal Nocturnal Hemoglobinuria: Data from Danicopan and Pegcetacoplan Trials

Abstract #2694

Poster Session 508: Bone Marrow Failure: Acquired: Poster II

8 December 2024

6:00 PM

Piatek, C

Danicopan as Add-On Therapy to Ravulizumab or Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Long-Term Patient-Reported Outcomes from the Phase 3 ALPHA Trial

Abstract #2692

Poster Session 508: Bone Marrow Failure: Acquired: Poster II

8 December 2024

6:00 PM

Ultomiris (ravulizumab) and Soliris (eculizumab)

Griffiths, E

Real-World Drug Adherence, Persistence, and Healthcare Resource Utilization in Patients with Paroxysmal Nocturnal Hemoglobinuria in the USA: The ADVANTAGE Study

Abstract #5074

Poster Session 905: Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies

9 December 2024

6:00 PM

Chaturvedi, S

Real-World Effectiveness of Ravulizumab Among Adults with Atypical Hemolytic Uremic Syndrome (aHUS) who Switched to Ravulizumab Within 3 Months of Eculizumab Treatment: A Physician Panel-Based Chart Review Study (aHUS IMPACT)

Abstract #2613

Poster Session 330: Vascular Biology, Thrombosis, and Thrombotic Microangiopathies: Basic and Translational

8 December 2024

6:00 PM

Iori, AP

REACTION – Real Life Use of Ravulizumab in Italian PatiEnts with PAroxysmal NoCturnal Hemoglobinuria a MulTicenter ObservatIONal Retrospective and Prospective Cohort Study, Final Results

Abstract #2464

Poster Session 101: Red Cells and Erythropoiesis, Excluding Iron

8 December 2024

6:00 PM

PNH

Wagner-Ballon, O

High Proportion of PNH Type II Neutrophils, l.e Relative Percentage 3%, Is Associated with Thrombosis in Patients Displaying a PNH Clone >1%: Evidence from Analysis of the 5-Year French Nation-Wide Multicenter Observational Study

Abstract #4080

Poster Session 508: Bone Marrow Failure: Acquired: Poster III

9 December 2024

6:00 PM

HSCT-TMA

Dandoy, C

Survival Outcomes in Adult and Pediatric Patients Who Experienced Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant: A Systematic Review and Meta-Analysis

Abstract #7286

Online Publication

Amyloidosis

Laires, P

Comparison Of Alternative Mayo Staging Classification Systems Used in Light-Chain Amyloidosis

Abstract #6887

Online Publication

Thompson, J

Evaluation of Functional Cardiac Measures and Response to Treatment Initiation in Patients with Systemic Light-Chain (AL) Amyloidosis: Results from a Single Site Retrospective Study

Abstract #4677

Poster Session 652: MGUS, Amyloidosis, and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological

9 December 2024

6:00 PM

ONCOTELIC CLINICAL PRESENTATIONS AT SITC 2024

On November 6, 2024 Oncotelic Therapeutics, Inc (OTCQB:OTLC) reported its presentation at SITC (Free SITC Whitepaper) 2024. Dr. Cynthia Lee, VP of R&D will be presenting Sapu Bio pipeline of TGFB2 therapeutics (Press release, Oncotelic, NOV 6, 2024, View Source [SID1234647853]). For additional information please go to: View Source

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Dr. Lee has been leading our R&D programs for the past several years including the buildout of our GMP facility in San Diego. The presentations are:

Abstract Number 198: TGFB2 mRNA levels prognostically interact with Interferon-alpha receptor activation of IRF9 and IFI27, and makers for tumor-associated macrophages impacting overall survival in PDAC. Authors Sanjive Qazi, Cynthia Lee, Vuong Trieu

Abstract Number 218: Evaluating the prognostic impact of Transforming growth factor beta 2 mRNA levels, in conjunction with Interferon-gamma receptor activation of IRF5 and expression of CD276/B7-H3 in low-grade gliomas. Authors Sanjive Qazi, Anthony Maida, Vuong Trieu

Abstract Number 1444: Meta-analysis comparing the incidence of serious adverse events, overall survival, and progression-free survival in PDAC patients harboring unresectable tumors treated with mFOLFIRINOX or FOLFIRINOX. Authors Vuong Trieu, Sanjive Qazi, Seymour Fein, Anthony Maida, Tenshang Joh