On May 20, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Healthcare Conference. The presentation is scheduled for June 2, 2021 at 9:30am ET (Press release, ImmunoGen, MAY 20, 2021, View Source [SID1234580399]).

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A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On May 20, 2021 H3 Biomedicine Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of four posters providing updated investigational data on its H3B-6545 clinical program for breast cancer and its H3B-6527 clinical program for hepatocellular carcinoma at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4–8, 2021 (Press release, H3 Biomedicine, MAY 20, 2021, View Source [SID1234580398]).

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"We continue to be encouraged by the insights gained through our evaluation of genomically and clinically defined patient populations in these two oncology programs in areas of tremendous unmet medical need," said Antonio Gualberto, MD, PhD, Chief Medical Officer of H3. "We look forward to further highlighting our innovative, data-driven approach to precision oncology research and to showcasing the potential clinical benefit of our product candidates for patients with cancer at ASCO (Free ASCO Whitepaper) 2021."

The investigational clinical data abstracts published online today for the H3B-6545 and H3B-6527 studies reflect data as of March 31, 2021 and Jan 04, 2021, respectively. Updated results from both studies will be presented at ASCO (Free ASCO Whitepaper).

H3’s ASCO (Free ASCO Whitepaper) abstract titles are as follows:

H3B-6545

Abstract Number: 1018
Title: Phase I/II Study of H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer
Poster Discussion Session: Breast Cancer – Metastatic
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: e13025
Title: Phase 1b Study of H3B-6545 in Combination with Palbociclib in Women with Metastatic Estrogen Receptor–positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative Breast Cancer
Poster Session: Breast Cancer – Metastatic (Online Publication Only)
Presenter: Stephen R.D. Johnston

Abstract Number: e13022
Title: Relative Bioavailability of H3B-6545 Tablets vs Capsules and Drug-Drug Interaction between H3B-6545 and Pantoprazole
Poster Session: Breast Cancer – Metastatic (Online Publication Only)
Presenter: Alan Xiao

H3B-6527

Abstract Number: 4090
Title: Phase 1 Study of H3B-6527 in Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC)
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Presenter: Teresa Macarulla

About H3B-6545

Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies. H3B-6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα. H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

About H3B-6527

Receptor tyrosine kinases (RTKs) can be dysregulated in cancer cells and can frequently promote abnormally rapid tumor growth and development. Hepatocellular carcinoma (HCC) can be driven in this way by hyperactivation of the fibroblast growth factor 19 (FGF19)/fibroblast growth factor receptor 4 (FGFR4) pathway. H3B-6527 is a selective, orally bioavailable, and covalent inhibitor of FGFR4 that has demonstrated tumor regression in several preclinical models of HCC. H3B-6527 is being tested specifically in patients with FGFR4-dysregulated advanced HCC.

The abstracts discuss investigational uses of agents in development and are not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

On May 20, 2021 Flatiron Health reported eight abstracts have been accepted for presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8 (Press release, Flatiron Health, MAY 20, 2021, View Source [SID1234580397]).

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"Flatiron’s research continues to demonstrate the important applications of real-world data and the insights of real-world evidence," said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron. "The research abstracts being presented at ASCO (Free ASCO Whitepaper) 2021 include work illuminating racial disparities in treatment among breast cancer patients, advancing our understanding of the COVID-19 pandemic’s impact on cancer treatment, and matching patients to clinical trials through an AI-based point-of-care tool."

This year’s accepted abstracts again reflect Flatiron’s many collaborations and partnerships in pursuit of its mission to improve lives by learning from the experience of every cancer patient.

Highlights include:

an investigation of racial disparities in treatment patterns among breast cancer patients, aligned with the 2021 ASCO (Free ASCO Whitepaper) theme of "Equity: Every Patient. Every Day. Everywhere."
a machine-learning tool that can ultimately improve patients’ access to clinical trials by improving the efficiency of patient ascertainment and thereby removing a barrier for practices to take part in studies of rare populations
a deep learning algorithm that automates the extraction of dates of key clinical events from unstructured chart notes, reducing the need for human curation in real-world data (RWD) research
leveraging the Flatiron Health-Foundation Medicine Clinico-Genomic Database to understand implications of NGS-defined biomarkers in patients with breast cancer and gastroesophageal cancers
an illustration of the power of a nationwide RWD network in aggregating clinical information to study treatment patterns and outcomes in patients with Castleman disease, a rare lymphoproliferative disorder
a description of the evolving impact of the COVID-19 pandemic on cancer treatment.
Flatiron collaborated on the accepted research with: Beth Israel Deaconess Medical Center, Birmingham Hematology Oncology (Alabama Oncology), Cancer Partners of Nebraska, Dana-Farber Cancer Institute, Foundation Medicine, Fox Chase Cancer Center, Massachusetts General Hospital, Moffitt Cancer Center, Penn Medicine, University of Alabama at Birmingham and Yale University.

Full abstracts will be posted at rwe.flatiron.com post-ASCO embargo on May 29.

Poster Presentations

Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi)
First author: Felipe Batalini (Beth Israel Deaconess Medical Center)
Abstract: 10512

Clinical characteristics, treatment patterns, and overall survival of real-world patients with idiopathic multicentric Castleman disease
First author: Aaron B. Cohen (Flatiron Health)
Abstract: 7048

Concordance of HER2+ status by IHC/ISH and ERBB2 status by NGS in a real-world clinicogenomic database and analysis of outcomes in patients (pts) with metastatic breast cancer (mBC)
First author: Cheryl D. Cho-Phan (Flatiron Health)
Abstract: 1036

ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA)
First author: Samuel J. Klempner (Massachusetts General Hospital)
Abstract: 4045

Extracting non-small cell lung cancer (NSCLC) diagnosis and diagnosis dates from electronic health record (EHR) text using a deep learning algorithm
First author: Alexander S. Rich (Flatiron Health)
Abstract: 1556

Racial disparities in second-line (2L) treatment and overall survival among patients (pts) with hormone receptor positive HER2 negative (HR+HER2-) metastatic breast cancer (mBC) treated in routine practice
First author: Xiaoliang Wang (Flatiron Health)
Abstract: 6541

Impact of COVID-19 pandemic on time to treatment initiation for patients with advanced cancer
First author: Samuel U. Takvorian (Perelman School of Medicine at the University of Pennsylvania)
Abstract: 1528

An automated EHR-based tool to facilitate patient identification for biomarker-driven trials
First author: Shailendra Lakhanpal (Birmingham Hematology Oncology/Alabama Oncology)
Abstract: 1539

On May 20, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported a publication in Cancer Cell, a premier peer-reviewed scientific journal that publishes high impact results in cancer research and oncology (Press release, BostonGene, MAY 20, 2021, View Source [SID1234580396]). The manuscript, "Conserved pan-cancer microenvironment subtypes predict response to immunotherapy", describes a transcriptomic-based tumor classification platform that identifies distinct tumor microenvironment subtypes across a broad array of cancers, predicting prognosis and response to immune checkpoint blockade.

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"These findings reinforce the power of integrated analysis to discover unique and clinically applicable characteristics of the tumor microenvironment, a crucial factor in therapeutic response in multiple cancers"

"These findings reinforce the power of integrated analysis to discover unique and clinically applicable characteristics of the tumor microenvironment, a crucial factor in therapeutic response in multiple cancers," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "The results of our study provided the foundation for us to launch BostonGene Tumor Portrait TestsTM, which are designed to identify key drivers of each tumor, enabling doctors to personalize therapy for cancer patients. The study also represents a major milestone in the landmark research BostonGene is conducting and underscores the importance of innovative multi-platform analytics combined with cutting-edge software to improve patient outcomes."

For this research study, tumor transcriptome sequencing was analyzed to holistically describe and comprehensively characterize cancer cells and the surrounding tumor microenvironment. Transcriptomic data of over 10,000 cancer patients were analyzed, leading to the identification of four unique microenvironment subtypes that are conserved across 20 different cancers. These four subtypes are strongly associated with prognosis and response to immunotherapy in different cancers. Additionally, a personalized tumor map was created to visually depict key molecular and immune characteristics of each tumor. The microenvironment classification platform and tumor map provide a clinically useful and robust methodology for response prediction and incorporate precision medicine strategies across varied cancer types.

The BostonGene Tumor Portrait TestsTM reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene Tumor Portrait TestsTM generate a personalized roadmap for therapeutic decision-making for each cancer patient.

On May 20, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company developing proprietary, intratumoral products to kill tumors and increase immune system recognition of cancers, reported two poster presentations to be made at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4 to 8 (Press release, Intensity Therapeutics, MAY 20, 2021, View Source [SID1234580395]).

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Title: A Phase 1/2 Study of Intratumoral INT230-6 Alone (IT-01) or in Combination with Pembrolizumab [KEYNOTE-A10] in Adult Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors Refractory to Therapy
Authors: El-Khoueiry, A.B., et al.
Session: Developmental Therapeutics – Immunotherapy
Session type: Poster Session
Abstract: 2592

Title: Early Results of Intratumoral INT230-6 Alone or in Combination with Ipilimumab in Subjects with Advanced Sarcomas
Authors: Ingham, M., et al.
Session: Sarcoma
Session type: Poster Session
Abstract: 11557

"INT230-6 is a novel, proprietary, locally-delivered anti-cancer product candidate that has shown very promising clinical results as monotherapy in a basket study of patients with advanced and refractory disease," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "We are excited that ASCO (Free ASCO Whitepaper) has offered us the opportunity to share our encouraging results in two presentations. The data to be reported in our first poster will update our safety and efficacy results for patients receiving INT230-6 alone or in combination with pembrolizumab. The second presentation details preliminary results of INT230-6 with or without ipilimumab to treat sarcomas, a complex cancer type with high unmet medical need."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells.

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination INT230-6, with Bristol Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized, controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).