On June 1, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that Mark Gelder, M.D. will be joining Onconova as Chief Medical Officer (CMO), effective as of June 14, 2021 (Press release, Onconova, JUN 1, 2021, View Source [SID1234583327]).

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"Mark’s extensive experience leading clinical oncology programs at all stages of development makes him an ideal fit for Onconova. He will add great depth to our management team," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "His wide ranging medical and scientific expertise, which notably covers the development of kinase inhibitors as cancer therapeutics, will be invaluable as we work to advance ON 123300’s clinical development, facilitate the progression of rigosertib’s investigator-initiated trials, and evaluate potential candidates for in-licensing. I am thrilled that Mark will be joining Onconova and eager to begin working together."

Dr. Gelder is an accomplished industry leader with more than 35 years of experience in clinical development, medical affairs, and medical marketing. He was most recently the CMO of Elevar Therapeutics, where he led the company’s clinical development, medical affairs, regulatory affairs, and preclinical teams. Prior to his time at Elevar, Dr. Gelder served as the CMO of Pierian Biosciences (formerly DiaTech Oncology), Accelovance, Inc., and Heron Therapeutics, Inc. Dr. Gelder also has extensive experience at large pharmaceutical companies, as he previously worked in global medical affairs and led therapeutic oncology programs for Pfizer, Wyeth, and Bayer. Dr. Gelder has led successful early- and late-stage global clinical trials and has been involved in the approval and launch of several cancer therapeutics. Prior to his career in the biopharmaceutical industry, Dr. Gelder was an investigator in multiple clinical trials and authored numerous scientific papers in the areas of women’s health and oncology. He earned his M.D. from the University of Virginia School of Medicine and completed a fellowship in gynecologic oncology. He is a Fellow of the American College of Physicians and the American College of Obstetrics and Gynecology.

Dr. Gelder commented, "The opportunity to serve as Onconova’s CMO is truly exciting, and I look forward to leading the continued development of the Company’s pipeline at this important time. ON 123300 is rapidly progressing through its two Phase 1 trials and the potential to bring a best-in-class novel agent to women with HR+ HER2- metastatic breast cancer and additional oncologic indications is a unique opportunity based on its mechanism of action to overcome CKD 4/6 resistance mechanisms. I am also highly impressed with rigosertib’s investigator-initiated program and am eager to apply my expertise towards the Company’s in-licensing strategy to expand its pipeline. I believe that my skill set and those of my new colleagues are highly complementary, which will serve us well as we seek to deliver new therapeutics to cancer patients in need."

On June 1, 2021 BostonGene Corporation, a biomedical software company focused on defining optimal, precision medicine-based therapies for cancer patients, reported that two abstracts have been accepted for online publication for the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, BostonGene, JUN 1, 2021, View Source [SID1234583344]).

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"We are pleased to have multiple abstracts accepted for online publication," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings underscore the importance of the application of novel and cutting-edge analytical tools to understand the composition and activity of the tumor and the microenvironment, which will improve treatment outcomes for cancer patients."

The abstracts will be published online in the Journal of Clinical Oncology supplement for the ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings.

Details about the abstracts selected for publication can be found below:

Abstract Number: e15050
Title: The development of a computational machine learning tool to decipher malignant cell gene expression from complex tumor tissue

Complex tumor tissue is composed of malignant cells and diverse tumor microenvironment (TME) cellular populations. The percentage of malignant cells present in tumor tissue varies by cancer type, with percentages sometimes falling below 10%. TME cellular transcripts may comprise the majority of the total transcripts in a tumor, potentially resulting in biases during biomarker development and for clinical decision-making. A computational tool was created to "subtract" TME-specific gene expression from total gene expression in an array of solid tumors, producing in silico "purified” malignant cell gene expression.

Abstract Number: e15085
Title: Analytical and clinical validation of the BostonGene Tumor Portrait assay

Analysis of the genetic and transcriptomic profile of solid tumors using next-generation sequencing (NGS) assays is fundamental to propel precision medicine into clinical practice. NGS technology applied to tumor analysis allows for the characterization of somatic alterations, clonality, altered gene expression, and other parameters using a small amount of tissue. The BostonGene Tumor Portrait TestsTM, which integrate whole-exome sequencing (WES) and mRNA sequencing (RNA-seq), were developed to uncover cancer-promoting and -suppressing activity of the tumor and the tumor microenvironment (TME).

On June 1, 2021 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, June 4-8 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, June 9-17 (Press release, Servier, JUN 1, 2021, View Source [SID1234583359]). Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include multiple company-sponsored and investigator-initiated trials, which underscore the depth and breadth of Servier’s oncology portfolio that is making strides toward addressing unmet needs of those living with cancer.

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Three abstracts have been selected for oral presentation, spanning multiple hard-to-treat solid tumor types, including glioma, biliary tract cancer, and colorectal cancer. These presentations highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating superior outcomes over current standards of care based on precision approaches. Research from several investigator-initiated trials will also be shared. These studies investigate evolving the standard of care in advanced cancers through the use of combination approaches in metastatic colorectal cancer, myeloid malignancies, gastric and gastroesophageal adenocarcinoma, and biliary tract cancer.

In addition, there will be an encore poster presentation of the final results from ClarlDHy, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. Data from this study were included in the company’s supplemental New Drug Application for TIBSOVO, which was recently accepted and granted Priority Review by the U.S. Food and Drug Administration. Currently, there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease.

"Our presence at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) showcase the very focused approach we are taking to place an emphasis on difficult-to-treat cancers with significant unmet need," said David K. Lee, CEO, Servier Pharmaceuticals. "We believe that our leadership in hematology and growing position in solid tumors ensures we are well poised to deliver more life-changing medicines to a greater number of individuals impacted by cancer worldwide."

Servier has experienced tremendous growth in the past several years. Much of this expansion is in the oncology space where the company is now allocating 50 percent of its research and development investment. With 19 oncology assets at varying stages of clinical development, and 20 research projects1, Servier is addressing areas of significant unmet need and difficult-to-treat cancers that target different types of lymphoma and leukemia, as well as solid tumors including gastrointestinal and lung cancers.

"Our significant presence at these key congresses is reflective of the successful expansion of our research and development for a variety of tumor types to benefit patients," said Claude Bertrand, Executive Vice President of Research and Development, Servier Group. "We are excited to present data across our hematology and solid tumor portfolio including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs."

Key highlights of data at ASCO (Free ASCO Whitepaper), sponsored by Servier, are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source

Abstract #2008: Impact of mutant IDH (mIDH) inhibition on DNA hydroxymethylation, tumor cell function, and tumor immune microenvironment (TIME) in resected mIDH1 lower-grade glioma (LGG)

Date & Time: Monday, June 7, 2021 at 8:00 a.m. EDT
Oral Session: Oral Abstract Session, Central Nervous System Tumors
Presenting Author: I. Mellinghoff
Abstract #4069: Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) vs placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: G.K. Abou-Alfa
Abstract #3526: Patient-reported quality of life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: interim results of the TALLISUR study

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
Presenting Author: M. Karthaus
Investigator-initiated trials to be presented at ASCO (Free ASCO Whitepaper) include:

Abstract #4006: Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): Multicenter comparative randomized phase 2b study (NIFTY)

Date & Time: Saturday, June 5, 2021 at 1:45 p.m. EDT
Short Oral Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: C. Yoo
Abstract #7012: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated myeloid malignancies

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C.D. DiNardo
Servier will be hosting five continuing medical educational programs at ASCO (Free ASCO Whitepaper) focusing on hematology and solid tumors including:

Hematology

"The AML ‘Hot Seat’: Challenging the Experts on How They Treat and Individualize Care with Novel Therapies," sponsored with Physicians’ Education Resource, June 4, 2021
"Clinical Consults on Modern AML Therapy: Where Precision Care Meets Potent Therapeutics," sponsored with PeerView Oncology, June 4, 2021
"Exploring a Continually Expanding AML Therapeutic Armamentarium: Expert Guidance to Optimize Outcomes," sponsored with National Comprehensive Cancer Network, June 4, 2021
Solid Tumors

"How Evolving Genomics and Molecular Testing are Moving the Treatment of Cholangiocarcinoma Forward," sponsored with Physicians’ Education Resource, June 6, 2021
"Taking Action in Advanced Biliary Cancers: Expert Insights on Integrating Newly-Available and Innovative Therapeutics to Deliver Precision-Based Care," sponsored with PeerView Oncology, June 4, 2021
In addition, an encore presentation from ASCO (Free ASCO Whitepaper) for an investigator-initiated trial will be presented at EHA (Free EHA Whitepaper):

Abstract #S136: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1 mutated myeloid malignancies

Date & Time: Friday, June 11, 2021 at 9:00 CEST (3:00 a.m. EDT)
Oral Session: Developments in AML therapy
Presenting Author: C. Lachowiez

On June 1, 2021 Cardiff Oncology, Inc. (the "Company") Presented its corporate slide presentation (Presentation, Cardiff Oncology, JUN 1, 2021, View Source [SID1234583312]).

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On June 1, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that invites investors and the general public to listen to webcasts at the following investor conferences (Press release, Myovant Sciences, JUN 1, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-present-upcoming-investor-conferences-3 [SID1234583328]):

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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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Goldman Sachs 42nd Annual Global Healthcare Virtual Conference on June 8, 2021 at 4:40 p.m. Eastern Time. Company management will participate in a fireside chat.

JMP Securities Life Sciences Conference on June 17, 2021 at 10:00 a.m. Eastern Time. Company management will participate in a fireside chat.
The presentations will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.com.