On May 25, 2023 Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, reported the title of an upcoming poster presentation on its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place in Chicago, June 2 – 6 (Press release, Convergent Therapeutics, MAY 25, 2023, View Source [SID1234632112]). The poster presentation entitled "Phase I dose-escalation results of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT) with alpha-radiolabeled antibody 225Ac-J591 and beta-radioligand 177Lu-PSMA I&T" will be presented by Dr. Scott Tagawa, Professor of Medicine and of Urology, member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and Attending Physician at NewYork-Presbyterian/Weill Cornell Medical Center.

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Details of the poster presentation are as follows:
Abstract Title: Phase I dose-escalation results of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT) with alpha-radiolabeled antibody 225Ac-J591 and beta-radioligand 177Lu-PSMA I&T
Presenter: Dr. Scott Tagawa*, Professor of Medicine and of Urology, member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and Attending Physician at NewYork-Presbyterian/Weill Cornell Medical Center
Date & Time: June 3, 1:15 pm CDT
Location: E450 | On Demand
Session Type: Poster Discussion Session
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Clinical Trial Registration Number: NCT04886986
Abstract number: 5018
Poster Bd number: 112

Dr. Tagawa is a paid consultant and equity stakeholder for Convergent Therapeutics and has been a paid consultant for POINT, Sanofi, Medivation, Astellas, Dendreon, Janssen, Genentech, Bayer, Endocyte, Eisai, Immunomedics, Karyopharm, Abbvie, Tolmar, Seattle Genetics, Amgen, Clovis, QED, Pfizer, AAA/Novartis, Clarity, Genomic Health, Blue Earth, Alkido Pharma, Telix Pharma, EMD Serono, Myovant, Merck, and Daiichi Sankyo.

On May 25, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will host a webcast to review the zanidatamab biliary tract cancers (BTC) data being featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2023 (Press release, Jazz Pharmaceuticals, MAY 25, 2023, View Source [SID1234632111]). Previously disclosed positive top-line findings from the pivotal Phase 2b trial of zanidatamab as a monotherapy demonstrated a confirmed objective response rate (cORR) of 41.3% and median duration of response of 12.9 months in patients with previously treated HER2-positive BTC. The ASCO (Free ASCO Whitepaper) presentation will provide additional safety and efficacy data.

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Shubham Pant, M.D., MBBS, a professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, will provide an overview of new data from the trial and Jazz senior management will discuss the development and commercialization of zanidatamab.

"There are currently no HER2-targeted therapies approved for patients with BTC; disease control with front-line therapy is modest and patients need treatment options after progression.i,ii Zanidatamab, a novel HER2-targeted bispecific antibody, is one of the most exciting and near-term programs in our pipeline, and the presentation at ASCO (Free ASCO Whitepaper) demonstrates its compelling anti-tumor effects in HER2-positive BTC. We are committed to advancing this program as rapidly as possible to potentially transform the lives of patients in critical need," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "With our impressive portfolio of oncology therapeutics approaching $1 billion in annual revenue, we remain focused on further enhancing our capabilities, advancing our pipeline and delivering treatments for difficult-to-treat cancers."

Webcast Details
The webcast will start on June 2, 2023, at 6:45 p.m. CT / 7:45 p.m. ET / 12:45 a.m. IST (June 3). Interested parties may register for the webcast in advance here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.

About Zanidatamab
Zanidatamab is an investigational bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks, along with collaborators Jazz and BeiGene, Ltd. (BeiGene), are developing zanidatamab in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

On May 25, 2023 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company finding safe, effective ways to use CAR T cells against solid cancers, reported positive safety and early efficacy results from a Phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers, which will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, on June 5, 2023 (Press release, AffyImmune Therapeutics, MAY 25, 2023, View Source [SID1234632109]).

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"We are very encouraged by the early data, as it marks a groundbreaking CAR T patient response in aggressive and difficult to treat anaplastic thyroid cancers," said Matt Britz, Chief Operating Officer at AffyImmune. "This is an important clinical milestone for AffyImmune as we continue to develop AIC100 in the clinic and explore additional solid tumor indications with high unmet need."

The current Phase 1 study is exploring three dose levels (DL) of AIC100 CAR T cells, which are developed using AffyImmune’s proprietary Tune & Track CAR T cell platform. To date, AIC100 CAR T cells demonstrated excellent safety and encouraging efficacy in anaplastic (ATC) and poorly differentiated (PDTC) thyroid cancers.

As of May 1, 2023, seven patients (4 ATC; 3 PDTC) were infused with AIC100: three patients (2 ATC, 1 PDTC) in DL1 and four patients (2 ATC, 2 PDTC) in DL2. Early results from the Phase 1 study include:

No DLTs were reported; two patients had transient grade 1 CRS.
For the four patients infused in DL2, two patients were evaluable for efficacy assessment at day 42. Both had tumor reductions. One ATC patient achieved partial response (PR) with 42 percent reduction in target tumor lesion and a second PDTC patient had stable disease (SD).
"The objective partial response in DL2 for a patient with metastatic ATC who failed multiple lines of therapy is unprecedented and very encouraging," said Samer Ali Srour, MB ChB, MS, assistant professor of Stem Cell Transplantation & Cellular Therapy at The University of Texas MD Anderson Cancer Center. "AIC100 demonstrated an excellent safety profile with no DLTs in patients with ATC and PDTC, and the antitumor activity is promising, especially these responses were observed at the low dose levels 1 and 2."

Details of the poster presentation:

Abstract Title: Safety and early efficacy results of phase 1 study of affinity tuned and trackable AIC100 CAR T cells in ICAM-1 positive relapsed and/or refractory advanced poorly differentiated and anaplastic thyroid cancers

Session Title: Head and Neck Cancer

Date and Time: Monday, June 5, 1:15 PM-4:15 PM CDT

Location: McCormick Place Convention Center, Exhibit Hall A, Poster Board 87

Presenter: Samer Ali Srour, MBChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

On May 25, 2023 Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that it will showcase new data across its robust oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting June 2-6, 2023 (Press release, Servier, MAY 25, 2023, View Source [SID1234632108]). These latest data, including a plenary session selection, underscore the breadth of Servier’s oncology pipeline and portfolio and the company’s commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.

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Among the data to be presented is a late breaking abstract featuring the results from the Phase 3 INDIGO study of vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma. These data represent the first study to show clinically meaningful and statistically significant improvements in low-grade glioma in 23 years and was accepted as one of only four presentations for a plenary session to take place on June 4, 2023 from 1:00 – 4:00 p.m. C.T.

"Servier is leading the scientific research with IDH inhibition across a variety of difficult to treat cancers, and this year at ASCO (Free ASCO Whitepaper), we are excited to showcase data that has the potential to shift the treatment paradigm for patients with IDH-mutant glioma," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "IDH mutations are recognized as drivers of disease biology in patients with a broad range of cancers, including glioma, and the distinguishing selection of the Phase 3 INDIGO trial for a plenary session is a testament to the groundbreaking research that is yielding long-awaited progress for glioma patients."

Additional research to be presented includes:

Long-term follow up data, including updated overall survival, from the Phase 3 AGILE study of TIBSOVO (ivosidenib) plus azacitidine in patients with previously untreated IDH1-mutant acute myeloid leukemia (AML) who are not eligible to receive intensive chemotherapy.
Long-term follow-up data for TIBSOVO monotherapy in patients with IDH1-mutant conventional chondrosarcoma, a rare bone malignancy for which there are no approved systemic therapies
Clinical and molecular characteristics for patients with relapsed/refractory IDH1-mutant AML with an exceptional response to TIBSOVO
Data from across Servier’s global colorectal cancer (CRC) research
"Through a persistent focus on smart science, we are coming into ASCO (Free ASCO Whitepaper) with incredible momentum and exciting data from across our diversified portfolio," said Philippe Gonnard, M.D., Executive Vice President, Global Product Strategy at Servier. "Building off the recent European Commission approval for TIBSOVO in certain patients with acute myeloid leukemia (AML) and cholangiocarcinoma, we look forward to showcasing updated overall survival for TIBSOVO in patients with AML, as well as sharing the positive results from our Phase 3 INDIGO study of vorasidenib in residual/recurrent grade 2 IDH-mutant diffuse glioma – marking the first major advancement in low-grade glioma in more than two decades and cementing our leadership in IDH inhibition."

Servier abstracts being presented at ASCO (Free ASCO Whitepaper) are listed below (all times in Central Time) and are available online on the ASCO (Free ASCO Whitepaper) website here.

Abstract LBA1: A Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation

Date & Time: Sunday, June 4, 1:00 – 4:00 p.m.
Lead Author: Ingo K. Mellinghoff
Abstract #7012: Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Monday, June 5, 12:30 p.m. – 2:00 p.m.
Lead Author: Stephane de Botton
Abstract #11532: Phase I study of the mutant IDH1 inhibitor ivosidenib: long-term safety and clinical activity in patients with conventional chondrosarcoma

Date & Time: Saturday, June 3, 2:15 – 5:15 p.m.
Lead Author: William D. Tap
Abstract #7036: Clinical and molecular characteristics of AML patients with an exceptional response to ivosidenib

Date & Time: Monday, June 5, 9:00 a.m. – 12:00 p.m.
Lead Author: Justin Watts
Abstract #3512: Overall survival results for trifluridine/tipiracil plus bevacizumab vs capecitabine plus bevacizumab: results from the phase 3 SOLSTICE study

Date & Time: Monday, June 5, 2:15 – 3:45 p.m.
Lead Author: Thierry Andre
Abstract #3594: Effect of trifluridine/tipiracil in combination with bevacizumab on ECOG-PS in refractory metastatic colorectal cancer: An analysis of the phase 3 SUNLIGHT trial

Date & Time: Monday, June 5, 9:00 a.m. – 12:00 p.m.
Lead Author: Julien Taieb
Abstract #3556: Trifluridine/tipiracil (FTD/TPI) in extensively pre-treated metastatic colorectal cancer (mCRC) patients – Evaluation of prognostic subgroups of the TALLISUR study

Date & Time: Monday, June 5, 9:00 a.m. – 12:00 p.m.
Lead Author: M. Karthaus
Abstract #3580 Phase II trial of trifluridine/tipiracil (TAS102) and nanoliposomal irinotecan (nal-IRI) in advanced colorectal cancer (CRC)

Date & Time: Monday, June 5, 9:00 a.m. – 12:00 p.m.
Lead Author: O.B. Alese
Additionally, at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting in Frankfurt, Germany, June 8-11, 2023 Servier will present four posters, including updated substudy results for ivosidenib in IDH1-mutant relapsed/refractory myelodysplastic syndrome (MDS). Servier abstracts being presented at EHA (Free EHA Whitepaper) are listed below (all times in Central European Summer Time) and are available online on the EHA (Free EHA Whitepaper) website here.

Abstract #P490: Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Friday, June 9, 6:00 – 7:00 p.m.
Session: Acute myeloid leukemia – Clinical
Lead Author: Stephane de Botton
Abstract #P441: Clinical and molecular characteristics of AML patients with an exceptional response to ivosidenib

Date & Time: Friday, June 9, 6:00 – 7:00 p.m.
Session: Gene therapy and immunotherapy – Biology & translational research
Lead Author: Justin Watts
Abstract #P724: Updated substudy results for ivosidenib in IDH1-mutant relapsed/refractory myelodysplastic syndrome

Date & Time: Friday, June 9, 6:00 – 7:00 p.m.
Session: Myelodysplastic syndromes – Clinical
Lead Author: Courtney DiNardo
Abstract #P386: Comparison of the pharmacokinetics of the liquid and lyophilized formulations of pegaspargase in the treatment of pediatric patients with acute lymphoblastic leukemia (ALL)

Date & Time: Friday, June 9, 6:00 – 7:00 p.m.
Session: Acute lymphoblastic leukemia – Clinical
Lead Author: A.I. Karachunskiy

On May 25, 2023 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that it will give a poster presentation demonstrating the accuracy of its PROphet biomarker model at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023, in Chicago, Illinois (Press release, OncoHost, MAY 25, 2023, View Source [SID1234632106]).

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Initial treatment selection for advanced non-small cell lung cancer (NSCLC) patients without driver mutations is primarily based on evaluating PD-L1 expression levels in the tumor tissue. However, PD-L1 assays are only moderately predictive. In addition, guidelines for the PD-L1 ≥50% subpopulation are not definitive, enabling the use of immune checkpoint inhibitors (ICIs) either as monotherapy, or combined with chemotherapy.

OncoHost’s proprietary platform, PROphet, is a plasma-based, proteomic pattern analysis tool whose initial offering in NSCLC uses a single blood sample to guide first-line immunotherapy decision-making. The PROphet algorithm is trained on OncoHost’s large-scale clinical trial, PROPHETIC. To date, the trial has over 1,700 patients recruited across 40 sites worldwide, making it one of the largest prospective cohorts in the precision oncology field.

"Our goal is to provide a decision-making tool for the first-line treatment of advanced NSCLC patients based on plasma-derived biomarkers obtained before treatment initiation," said Itamar Sela, Ph.D., VP R&D at OncoHost and lead author of the study. "Our PROphet model continues to display strong performance, with a high correlation between the predicted clinical benefit and the observed clinical benefit rate, outperforming the current PD-L1-based prediction model. We’re excited to present this accurate alternative to improve the lives of patients."

The researchers examined the clinical utility of combining the PROphet output with PD-L1 levels by comparing different treatment modalities and concluded that the model output complements tissue PD-L1 expression levels as a tool to assist therapeutic decisions. Essentially, plasma proteomic profiling can provide biomarkers that accurately predict the benefit of ICI-based treatment for advanced, unresectable cancer patients.

"Traditional precision medicine searches for biomarkers at the therapy-tumor axis. By adding the patient to the equation, we’re fighting cancer through a unique, deep profiling of the patient-tumor interface," said Dr. Ofer Sharon, CEO of OncoHost. "Our ongoing research demonstrates the clear clinical utility of our PROphet platform, offering targeted treatment options for patients and identifying previously unanticipated targets for future interventions and clinical trials. This is a crucial time for precision oncology."

The clinical study was conducted in collaboration with Heidelberg University’s BioMaterialBank, Roswell Park Comprehensive Cancer Center, Thomas Jefferson University, Chaim Sheba Medical Center Institute of Oncology, UC Davis Comprehensive Cancer Center, OSUCCC – James – The Ohio State University, Asklepios Lung Clinic, Hadassah Cancer Research Center and Rambam Health Care Campus.

Poster Presentation Details
Session: Lung Cancer—Non-Small Cell Metastatic
Abstract #: 9122
Poster Bd #: 110
Title: A decision-making tool for first-line treatment in advanced non–small-cell lung cancer based on plasma proteome biomarkers.
Presenter: Itamar Sela, Ph.D., VP R&D at OncoHost
Date/Time: Tuesday, June 4, 2023, 8:00 AM-11:00 AM