On September 14, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that the Company will host a virtual Key Opinion Leader event on radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer on Thursday, September 23 at 11:00 a.m. ET (Press release, Galera Therapeutics, SEP 14, 2021, View Source [SID1234587659]).

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Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa, will provide a review of the current clinical treatment paradigm for patients with locally advanced head and neck cancer, including the use of intensity-modulated radiation therapy.

Dr. Anderson’s presentation will be followed by a video from a head and neck cancer survivor on his experience with SOM and a presentation from Galera’s President and CEO, Mel Sorensen, M.D., with an overview of the SOM market in patients with head and neck cancer.

The live audio webcast of the event will be accessible from the News & Events section of the Investors page of Galera’s website at investors.galeratx.com. Individuals can participate in an interactive Q&A session by submitting questions via the webcast platform.

An archived version of the webcast will be available for 30 days following the event.

On September 14, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported that it has entered into a collaboration agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), a cooperative group founded by the National Cancer Institute (NCI) (Press release, Exact Sciences, SEP 14, 2021, View Source [SID1234587658]). Working together, Exact Sciences and the NSABP plan to conduct a prospective, multicenter validation study with stage II and III colorectal cancer (CRC) patients, demonstrating the ability of Exact Sciences’ ctDNA test to detect MRD . The study, called CORRECT-MRD II, is expected to enroll approximately 750 patients at 35 study sites in the U.S. and Canada and is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed MRD liquid biopsy test.

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Exact Sciences and NSABP Announce Validation Study to Detect Minimal Residual Disease in Colorectal Cancer Patients
"Our longstanding relationship with the NSABP, through our work to develop and validate the Oncotype DX Breast Recurrence Score and Colon Recurrence Score tests, represents a remarkable collaboration between academic and industry partners. This relationship has fueled major advancements in understanding the role of molecular profiling in breast and colon cancer," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "NSABP’s expertise in colon research makes them ideal collaborators to conduct this important MRD study in colorectal cancer. We look forward to working together on this tremendous opportunity to help shape the future of precision medicine."

Exact Sciences is well-positioned to bring a highly sensitive MRD solution to patients in need. Its recent exclusive license of the Targeted Digital Sequencing (TARDIS) blood biopsy technology and acquisition of Ashion Analytics help prepare Exact Sciences to develop a differentiated patient-specific solution in MRD testing. With proven evidence-generation abilities and deep commercial relationships, Exact Sciences has the capability to bring its solution to patients and providers in the U.S. quickly and efficiently. In addition, the patient specific MRD test may have the potential to be synergistic with the predictive and prognostic insights provided by the Exact Sciences’ Oncotype portfolio to further inform treatment decisions to help improve patient outcomes. The company aims to explore the full potential of its MRD technology across all solid tumor types.

"The NSABP is committed to designing and conducting clinical trials that improve the treatment of colorectal cancer by evaluating promising new diagnostics and treatments," said Norman

Wolmark, MD, chairman of the NSABP Foundation and of the NCTN group NRG Oncology. "Highly sensitive MRD tests have the potential to fundamentally change the solid tumor treatment and monitoring paradigm. Exact Sciences’ unique approach to MRD and its commitment to improving patient outcomes make them ideal collaborators for advancing this promising new technology."

Exact Sciences and the NSABP are also working with patient advocacy organization Fight Colorectal Cancer (Fight CRC) to help inform MRD study designs and identify potential barriers to study participation, particularly in underserved populations. This joint effort will help ensure patient recruitment and patient-facing study materials are clear and sensitive to diverse cultures and socioeconomic backgrounds.

"Participating in a clinical study or trial is a personal journey and decision that includes many different factors and considerations for each patient," said Anjee Davis, president of Fight CRC. "Collaboration between patients, patient advocates, and clinical study professionals is vital. We’re proud to work with Exact Sciences and the NSABP on this important research, ensuring colorectal cancer patients from all backgrounds are represented and their voices are kept at the forefront."

About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a medical image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.

About Exact Sciences’ MRD Program
The Exact Sciences’ MRD solution is being designed to utilize a tumor-informed (bespoke) approach with whole genome sequencing. This approach identifies somatic genetic alterations in DNA extracted from the patient’s tumor tissue and detects a subset of these mutations in ctDNA present in the patient’s blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant or neoadjuvant therapy decisions and/or for monitoring of recurrence after completion of adjuvant or neoadjuvant therapy, in conjunction with other clinicopathological findings. The company estimates that more than 1.5 million patients1 in the United States alone could benefit from this type of MRD testing.

On September 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its oncology products and pipeline will be given at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, from September 16 to 21, 2021, including its in-house discovered lenvatinib mesylate (product name: LENVIMA, an orally available multi-kinase inhibitor, "lenvatinib") and eribulin mesylate (product name: HALAVEN, a halichondrin class microtubule dynamics inhibitor, "eribulin") (Press release, Eisai, SEP 14, 2021, View Source [SID1234587657]).

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At this congress, differences in outcomes by histology and prior therapy in the pivotal Phase 3 Study 309/KEYNOTE-775 trial, which compared the combination therapy of lenvatinib plus pembrolizumab (product name: KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), with TPC (Treatment of Physician’s Choice) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen, will be presented as an oral presentation (Abstract No: 726MO). In addition, a subgroup analysis and safety update from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581), which compared the combination of lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC) will be presented as an e-poster presentation (Abstract No: 660P). Additionally, e-poster presentations will be given on the outcomes of early clinical studies on a liposomal formulation of eribulin plus nivolumab (Abstract No: 980P), a CREB-binding protein (CBP)/β-catenin interaction inhibitor E7386 (Abstract No: 473P) and a compound derived from total synthesis of halichondrin, E7130 (Abstract No: 545P）.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Lenvatinib Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
Lenvatinib+Pembrolizumab
mini oral

726MO
Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer
(Study 309/KEYNOTE-775)

September 19 (Sun) 5:55 p.m. Central European Summer Time
Lenvatinib+Pembrolizumab
ePoster

660P
Phase 3 CLEAR Trial in Advanced Renal Cell Carcinoma (aRCC):
Outcomes in Subgroups and Toxicity Update

(Study 307/KEYNOTE-581)
Lenvatinib+Pembrolizumab
ePoster

506TiP
Pembrolizumab Plus Lenvatinib Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer (mCRC):

Phase 3 LEAP-017 Study
Lenvatinib+Pembrolizumab
ePoster

796P
Association Between Biomarkers and Clinical Outcomes of Lenvatinib (L) + Pembrolizumab (P) in Advanced Endometrial Cancer (EC): Results

From KEYNOTE-146/Study 111
Lenvatinib
ePoster

1746P
Health-related quality-of-life (HRQoL) analyses from Study 211-a phase 2 study in patients (pts) with radioiodine-refractory differentiated thyroid cancer (RR-DTC) treated with 2 starting doses of lenvatinib (LEN)

Lenvatinib
+anti-PD-1 antibody
ePoster

8P
The characterization of tumors associated with the antitumor activity of lenvatinib plus anti-PD-1 antibody combination therapy in a mouse syngeneic model panel

Eribulin Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
Eriburin
ePoster

304P
Incidence and resolution of eribulin-induced peripheral neuropathy (IRENE) in patients with locally advanced or metastatic breast cancer

(IRENE/Study 504)
Eriburin liposomal formulation
+Nivolumab
ePoster

980P
Phase 1b study of a liposomal formulation of eribulin (E7389-LF) + nivolumab (Nivo) in patients (pts) with advanced solid tumors

(Study 120)

Other Development Products Abstract Topics
Product / Compound
Abstract Type
Abstract No. Presentation Topic
E7386
ePoster

473P
A phase 1 study of E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (CRC)

(Study 103)
E7130
ePoster

545P
First-in-human (FIH) study of E7130 in patients (pts) with advanced solid tumors: primary result of dose-escalation part

(Study 101)

Other Abstract Topics
Abstract Type
Abstract No. Presentation Topic
ePoster

954P
Comparison of medical costs and outcome between hepatectomy and radiofrequency ablation for hepatocellular carcinoma

(Real World Evidence in Japan)
ePoster

305P
Real World Health-related Quality of Life (HRQoL) among HER2-negative (HER2-) Advanced Breast Cancer (ABC) Patients in EU3 and US

ePoster

306P
Real World Study of Treatments Received and Treatment Satisfaction Among HER2- Advanced Breast Cancer (ABC) Patients in EU3 and US

1. About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA (lenvatinib). Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types across more than 20 clinical trials.

2. Eisai’s Focus on Cancer

Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging RNA Splicing Platform) as areas (Ricchi) where real patient needs are still unmet, and where Eisai can aim to become a frontrunner in oncology. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

On September 14, 2021 Median Technologies (ALMDT: PA) reported that it will announce its H1 2021 results as well as its Q3 2021 business performance indicators on October 21, 2021 after trading close instead of October 14, 2021 after trading close (Press release, MEDIAN Technologies, SEP 14, 2021, View Source [SID1234587638]).

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On September 14, 2021 Biognosys, an innovator and leader in next-generation proteomics technology and solutions for life sciences research, reported that they have entered a collaboration with Evotec, a life science company that discovers, develops, and provides highly effective therapeutics for patients, to advance the adoption of next-generation proteomics in drug discovery and clinical research (Press release, Biognosys, SEP 14, 2021, View Source [SID1234587637]).

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Evotec has been a long-term user of Biognosys’ software and kits within its research. The two companies are now working closely together to integrate Biognosys’ next-generation proteomics data analysis platform in drug discovery and clinical proteomics.

Under the extended partnership, Evotec will continue to utilize Spectronaut, Biognosys’ flagship data analysis software for data-independent acquisition (DIA) mass spectrometry (MS) based proteomics, in its research. The software employs advanced Search, Artificial Intelligence (AI), and Machine Learning (ML) algorithms to translate data into actionable insights for life science research. Spectronaut enables reproducible and precise quantification of thousands of proteins in a single experiment and provides multidimensional insights into protein expression, function, and structure across all major biological species and sample types.

Additionally, Evotec is implementing Biognosys’ unique workflow for mass spectrometry facility management. This workflow combines Biognosys’ proprietary QuiC software with its patented indexed Retention Time (iRT) technology and iRT Kit to generate near real-time readouts from mass spectrometry instrument raw files for quality control.

The collaboration uniquely combines Evotec’s partnered drug discovery and development business model and focus on data-driven precision medicine, and Biognosys’ expertise and know-how in applying next-generation proteomics to transforming drug discovery and development.

Kristina Beeler, PhD, CBO of Biognosys, comments: "We are excited to deploy the power of proteomics to address some of the key challenges of drug development and work closely with Evotec to de-risk therapeutic assets early on."

Christoph Schaab, PhD, SVP Head of Proteomics & Metabolomics at Evotec, comments: "Discovery proteomics is increasing its importance to derive functional insights in the early stages of the drug development pipeline. We are thrilled to integrate Biognosys’ proteomics data analysis expertise into Evotec’s pre-clinical and clinical development solutions for the benefit of our biopharma partners."