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Sarah Cannon to Present Latest Cancer Research Insights at ASCO®20 Virtual Meeting

On May 28, 2020 Sarah Cannon reported that it will present its latest cancer research insights at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually May 29 – 31, 2020 (Press release, Sarah Cannon Research Institute, MAY 28, 2020, View Source [SID1234558641]). This year, Sarah Cannon’s drug development and research expertise is featured through more than 110 abstracts and presentations, including data from more than 50 phase 1 studies.

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The ASCO (Free ASCO Whitepaper)20 Virtual Meeting will bring together the largest community of oncology leaders worldwide to discuss pivotal clinical research that is influencing the latest care and treatment standards for patients facing cancer. This year’s event is being led by Sarah Cannon’s President of Clinical Operations and Chief Medical Officer, Howard A. "Skip" Burris III, MD, FACP, FACSO, who is serving as the 2020 ASCO (Free ASCO Whitepaper) President.

"When I chose my presidential theme to Unite and Conquer: Accelerating Progress Together, I never imagined what new meaning it would take over the course of this year, especially in the time of a global pandemic," says Dr. Burris. "In spite of recent challenges, we know that by bringing together oncologists, pharmacists, nurses, staff, lab techs, scientists, practice administrators and academic researchers, we are more united than ever with our patients to accelerate progress in the fight against cancer."

Dr. Burris will deliver this year’s presidential speech on Saturday, May 30 at 8:30 AM CT.

Melissa Johnson, MD, Sarah Cannon’s Associate Director of Lung Cancer Research and Drug Development, serves as this year’s ASCO (Free ASCO Whitepaper) Scientific Committee Chair, leading the scientific program at the meeting. In this role, Dr. Johnson will lead two key programs: the clinical science symposium on "Cancer Care in the Time of COVID: Assessing Impact and Future Direction" on Saturday, May 30 from 3:30-4:30 PM CT, and will also chair the Plenary Session on Sunday, May 31 from 12-2:30 PM CT.

A number of Sarah Cannon research leaders will also participate in the following educational and oral presentations:

Johanna Bendell, MD, Chief Development Officer and Director of the GI Cancer Research Program, will present "Phase I Monotherapy Dose Escalation of RGX-202, a First-In-Class Oral Inhibitor of the SLC6a8/CKB Pathway, in Patients with Advanced Gastrointestinal Solid Tumors" in an oral presentation. (Abstract 3504)
Jesus Berdeja, MD, Director of Myeloma Research and Senior Investigator of Hematologic Malignancies, is the discussant on the plenary session focused on "Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone for Initial Therapy of Newly Diagnosed Multiple Myeloma" on Sunday, May 31 from 12-2:30 PM CT. Dr. Berdeja will also highlight data in an oral presentation on "Update of CARTITUDE-1: A Phase Ib/II Study of JNJ-4528, a B-Cell Maturation Antigen-Directed CAR-T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma." (Abstract 8505)
Ian Flinn, MD, Director of Lymphoma Research, is the discussant during the poster presentation on "Reassessing PI3K Inhibitors in Indolent Lymphomas."
Stephanie Graff, MD, Director of the Breast Cancer Program and Clinical Research for Sarah Cannon Cancer Institute at HCA Midwest Health, is the discussant on the poster presentation of "Mind the Gap: Identifying Disparities and Actionable Insights."
Anthony Greco, MD, Co-founder of Sarah Cannon, is the discussant during the clinical science symposium on "Redefining Cancer of Unknown Primary: Is Genomics the Answer?" on Saturday, May 30, from 2:30-3:30 PM CT.
Erika Hamilton, MD, Director of the Breast Cancer and Gynecologic Cancer Research Program, will review key advancements in breast cancer research during the "Highlights of the Day" session on Saturday, May 30 9:30-10 AM CT.
Dr. Johnson will present "CX-2029, a PROBODY Drug Conjugate Targeting CD71 (Transferrin Receptor): Results from a First-In-Human Study in Patients with Advanced Cancer" and "Primary Analysis of a Randomized, Double-Blind, Phase II Study of the Anti-TIGIT Antibody Tiragolumab Plus Atezolizumab Versus Placebo Plus Atezo as First-Line Treatment in Patients with PD-L1-Selected NSCLC (CITYSCAPE)" in two oral presentations. (Abstract 3502, Abstract 9503)
Aravind Ramakrishnan, MD, Medical Director of the Bone Marrow Transplant and Cellular Therapy Program for Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center, will present "Phase I Alexander Study of AUTO3, the First CD19/22 Dual Targeting CAR T-Cell Therapy, with Pembrolizumab in Patients with Relapsed/Refractory DLBCL" in an oral presentation. (Abstract 8001)
David Spigel, MD, Chief Scientific Officer and Director of the Lung Cancer Research Program, will be the discussant in a plenary session focused on "Osimertinib as Adjuvant Therapy in Patients with Stage IB–IIIA EGFR Mutation Positive NSCLC After Complete Tumor Resection: ADAURA" on Sunday, May 31, from 12-2:30 PM CT.
At the ASCO (Free ASCO Whitepaper)20 Virtual Meeting, posters with Sarah Cannon experts as first authors will be presented by:

Dr. Bendell will present on "First-In-Human Phase I Study of HPN424, a Tri-Specific Half-Life Extended PSMA-Targeting T-Cell Engager in Patients with Metastatic Castration-Resistant Prostate Cancer." (Abstract 5552)
Dr. Hamilton will present on "Clinical Activity of MCLA-128, Trastuzumab, and Vinorelbine in HER2 Amplified Metastatic Breast Cancer Patients who Had Progressed on Anti-HER2 ADCs." (Abstract 3093)
Dr. Johnson will present "Safety of BI 754111, an Anti-LAG-3 Monoclonal Antibody, in Combination with BI 754091, an Anti-PD-1 Mab, in Patients with Advanced Solid Tumors." (Abstract 3063)
Dr. Spigel will present in two posters on "Randomized Phase II Study of Pembrolizumab Alone Versus Pegilodecakin in Combination with Pembrolizumab as First-Line Therapy in Patients with Stage IV Non-Small Cell Lung Cancer with High PD-L1 Expression (CYPRESS 1)" and "RESILIENT Part I, an Open-Label, Safety Run-In of Liposomal Irinotecan in Adults with Small Cell Lung Cancer who Have Progressed with Platinum-Based First-Line Therapy: Subgroup Analyses By Platinum Sensitivity." (Abstract 9563, Abstract 9069)
Denise Yardley, MD, Senior Investigator of the Breast Cancer Research Program, will present on "Overall Survival in Patients with Advanced Breast Cancer with Visceral Metastases, Including Those with Liver Mets, Treated with Ribociclib Plus Endocrine Therapy in the MONALEESA -3 and -7 Trials." (Abstract 1054)
Manish Patel, MD, Director of Drug Development for Sarah Cannon Research Institute at Florida Cancer Specialists, will present on "A Phase I Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36γ, for Intratumoral Injection Alone and in Combination With Durvalumab." (Abstract 3092)
Carlos Bachier, MD, Director of Cellular Therapy Research, will present on "Outpatient Treatment with Lisocabtagene Maraleucel Across a Variety of Clinical Sites From Three Ongoing Clinical Studies in Relapsed/Refractory Large B-Cell Lymphoma." (Abstract 8037)
Debra Richardson, MD, Stephenson Cancer Center at the University of Oklahoma, will present on "Phase I Expansion Study of XMT-1536, a Novel NaPi2b-Targeting Antibody-Drug Conjugate: Preliminary Efficacy, Safety, and Biomarker Results in Patients with Previously Treated Metastatic Ovarian Cancer or Non-Small Cell Lung Cancer." (Abstract 3549)
Gerald Falchook, MD, MS, Director of Drug Development for Sarah Cannon Research Institute at HealthONE, will present on "Pen-866, a Miniature Drug Conjugate of a Heat Shock Protein 90 (HSP90) Ligand Linked To SN38 For Patients with Advanced Solid Malignancies: Phase I and Expansion Cohort Results." (Abstract 3515)
Elisa Fontana, MD, Clinical Research Fellow at Sarah Cannon Research Institute – UK, will present on "Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer With Or Without Oxaliplatin: Individual Patient Data Meta-Analysis of Three Randomized Controlled Trials with Subgroup Analyses of Age Cohorts." (Abstract 4074)
Andrew McKenzie, PhD, Senior Manager of Personalized Medicine, will present on "Clinical and Genomic Analysis of Non-Small Cell Lung Cancer Patients with MET Exon14 Skipping (METex14) Mutations and Responses To Anti-MET Therapy." (Abstract 9613)
The researchers represent Sarah Cannon’s global network of strategic sites:

Sarah Cannon Research Institute at Tennessee Oncology, Sarah Cannon Research Institute at Florida Cancer Specialists, Colorado Blood Cancer Institute, Sarah Cannon Blood Cancer Center at St. David’s South Austin Medical Center, Sarah Cannon Center for Blood Cancer at TriStar Centennial, Sarah Cannon Research Institute at HCA Midwest Health (Kansas City), Sarah Cannon Research Institute at HealthONE (Denver), Sarah Cannon Research Institute – United Kingdom, Sidney Kimmel Cancer Center at Jefferson Health, and The Stephenson Cancer Center at the University of Oklahoma.

Humanetics Corporation to Present Clinical Trial Results at the Annual Meeting of the American Society for Radiation Oncology

On May 28, 2020 Humanetics Corporation (Humanetics) reported that an abstract reporting the results of a clinical trial of BIO 300 in non-small cell lung cancer patients undergoing radiochemotherapy has been selected for oral presentation at the annual meeting of the American Society for Radiation Oncology taking place virtually from October 25-28, 2020 (Press release, Humanetics, MAY 28, 2020, View Source [SID1234558640]). More than 3,300 abstracts were submitted to the premier international radiation oncology annual meeting, and Humanetics’s abstract was one of only 280 selected for this highest level of oral presentation.

Dr. Charles B. Simone, II, MD, FACRO, Research Professor and Chief Medical Officer for the New York Proton Center, will be the presenting author of the multi-site phase 1b/2a study. The trial investigated the safety and efficacy of BIO 300, a novel drug candidate focused on mitigating toxicities to normal tissues commonly experienced by patients from radiotherapy.

Lung cancer is the most common cause of cancer-related deaths in the United States and affects nearly 230,000 individuals per year. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, comprising approximately 87% of all cases. A common treatment for NSCLC is radiotherapy, which is often accompanied by chemotherapy, particularly for stage II, III and limited-extent IV disease. However, radiation therapy can cause unwanted side effects to otherwise healthy tissue surrounding the tumor or in the path of the radiation beam. These effects include esophagitis, pulmonary pneumonitis and fibrosis, all of which limit patient quality of life, can contribute to lasting health problems, and, in severe cases, can be fatal.

"Drugs that can reduce or prevent the unwanted side effects of radiotherapy are a truly unmet need for patients," said Dr. Simone. "Radiotherapy is an important standard of care, and its use is forecast to grow. Drugs like BIO 300 have the potential to significantly improve the quality of life and outcomes for our patients." Dr. Simone served as one of the principal investigators for the BIO 300 clinical trial.

BIO 300 is an oral medication, taken once daily by patients prior to their radiation treatment. Its properties as a radioprotectant were discovered by researchers at the U.S. Department of Defense, where it was studied as a potential agent to be used by warfighters to prevent injury from radiation on the battlefield. Humanetics acquired the rights to the drug and has active development programs ongoing in both oncology and for biodefense.

Rebranding: ITG Isotope Technologies Garching GmbH will become ITM Medical Isotopes GmbH

On May 28, 2020 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, reported the change of name of its subsidiary ITG Isotope Technologies Garching GmbH (Press release, ITM Isotopen Technologien Munchen, MAY 28, 2020, View Source [SID1234558639]). With effect from May 28, 2020, the company responsible specifically for the production of medical isotopes within the ITM Group will operate under the name ITM Medical Isotopes GmbH. The background to the decision is to present a uniform external image of the ITM group of companies, which, alongside ITM Medical Isotopes GmbH, includes among others the highly specialized companies ITM Oncologics GmbH and ITM Solucin GmbH.

The change of name will have no other impact on business partners, customers and staff. The legal form of the company and the ownership structure will remain unchanged. The fields of activity of radioisotope production, the product portfolio and all contracts concluded up to the rebranding will remain unchanged under the new company name. The head office address, the commercial register number and all known contact partners will remain unchanged.

ITG Isotope Technologies Garching GmbH, or ITM Medical Isotopes GmbH, is a 100% subsidiary of ITM Isotopen Technologien München AG. Over the course of the company’s 16-year history, from a start-up housed on the Technical University of Munich (TUM) site, ITM has established itself as a worldwide biotechnology and radiopharmaceutical group of companies in Targeted Radionuclide Therapy with a global distribution network. ITM develops, produces and distributes radiopharmaceuticals and medical radioisotopes for the diagnosis and therapy of cancer. The current product portfolio and focus of research includes targeted candidates for the treatment of neuroendocrine tumors, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors such as lung, ovarian or breast cancer.

RefleXion Announces Clinical Collaboration to Evaluate Biology-guided Radiotherapy With Merck’s KEYTRUDA® for Certain Late-Stage Cancers

On May 28, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) for treating all stages of cancer, reported a clinical collaboration with Merck (known as MSD outside the U.S. and Canada) to evaluate the safety and efficacy of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with BgRT in multiple late-stage cancers, including non-small cell lung cancer (NSCLC), in two randomized controlled clinical trials (Press release, RefleXion Medical, MAY 28, 2020, View Source [SID1234558638]).

"It is exciting to see these companies from different fields collaborating to investigate immuno-radiotherapy approaches for patients with metastatic cancer," said Jason Luke, MD, director of the Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center and associate professor of medicine at the University of Pittsburgh School of Medicine. "Several published clinical and translational studies laid the foundation for combining immunotherapy and radiotherapy, but despite their promise, available conventional radiotherapy techniques are limited in their general ability to reach more than 1-2 tumors.

"We hypothesize that BgRT may improve treatment efficacy and expand the immunologic impact of therapy by overcoming this limitation and treating more tumors," continued Dr. Luke. "This expanded treatment potential allows the field to pose new questions such as: What outcomes can combination therapy achieve when BgRT treats 5, 10 or even more sites of disease?"

This clinical collaboration reflects interest by researchers, clinicians and industry in exploring external beam radiotherapy to potentially expand the application of immunotherapy and improve outcomes for patients with advanced-stage cancer. Worldwide, over 1,000 clinical trials registered with the National Institutes of Health seek to determine the effect of combining immunotherapy and radiotherapy. Currently, very few of these trials reflect collaboration between radiotherapy and pharmaceutical companies.1

The aim of the clinical collaboration between RefleXion and Merck is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment modality in development, is safe and amplifies KEYTRUDA’s therapeutic effect. The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy delivery to one or two sites of disease, and instead allow it to reach multiple sites during the same treatment session, even those sites that move due to breathing or digestion.

"We believe BgRT will one day treat all visible tumor sites, which could lead to better patient outcomes, particularly when used with immunotherapy," said Todd Powell, CEO and president of RefleXion. "The collaboration with Merck will allow us to explore this combined effect in randomized controlled clinical trials that, if successful, may lead to significant changes in the way physicians approach cancer care for patients with late-stage disease."

RefleXion recently announced the close of a $100M equity financing round, the sale of their first commercial system and FDA clearance for the X1 machine for conventional radiotherapy applications. The X1 is the only platform that includes high quality computed tomography (CT) imaging to reduce motion artifacts during patient setup and x-ray treatment delivery, resulting in accurate targeting of the radiation dose to a patient’s tumor.

About Combining Immunotherapy and External Beam Radiotherapy

External Beam Radiotherapy (EBRT) by itself treats a discrete target to provide local tumor control; however, clinical evidence suggests that EBRT potentially converts the locally radiated tumor into an in situ vaccine that contributes to systemic control of the cancer.2 The exploration of EBRT with immunotherapy began in earnest after a rapid succession of advances led to a corresponding acceleration of clinical trials and FDA approvals of different drugs for various cancer indications. Ongoing clinical trials for this combined approach are aimed at confirming safety and demonstrating clinical efficacy, determining the appropriate dosing and sequencing of each treatment, and developing biomarkers to identify the patients most likely to benefit.3

Daiichi Sankyo and Syneos Health® Form Strategic Coalition for Development of Daiichi Sankyo’s ADC Oncology Pipeline

On May 28, 2020 Daiichi Sankyo, Inc. (hereafter, Daiichi Sankyo) reported that it has entered into a strategic agreement with Syneos Health (Nasdaq:SYNH) (Press release, Daiichi Sankyo, MAY 28, 2020, https://www.businesswire.com/news/home/20200528005466/en/Daiichi-Sankyo-Syneos-Health%C2%AE-Form-Strategic-Coalition [SID1234558637]). The companies are coming together to form a coalition to accomplish their shared goal of bringing promising cancer therapies to patients as safely, effectively and efficiently as possible .

Under the agreement, Syneos Health will provide both strategic and operational solutions for three lead Daiichi Sankyo DXd antibody drug conjugates (ADC): DS-1062, U3-1402 and DS-8201 (known as ENHERTU). The coalition expands a strong, pre-existing relationship between the two companies, further leveraging Syneos Health’s insights-driven Syneos One product development model to de-risk and accelerate development.

The coalition will enable early strategic engagement of Syneos Health teams to inform critical drug development decision making from the start. Cross-functional teams from both companies will share therapeutic expertise and product development insights to shape optimal study designs and create a consistent quality clinical delivery process across a portfolio of studies. Adding to the world-class scientific and technological expertise at Daiichi Sankyo, Syneos Health brings strong clinical site-level relationships and field experts located across the globe who can engage more closely and effectively with investigator teams.

"We quickly recognized that our three flagship ADCs have transformative potential that our in-house structure and current CRO engagements could not deliver as fast as we feel obligated to for patients," said Marielle Cohard Radice, Global Head of Development Operations, Daiichi Sankyo. "The ‘one-team and patient-first’ philosophy we have built with Syneos Health will enable evaluation of our development candidates in more therapeutic settings, more swiftly and more effectively."

The combined end-to-end knowledge from the Daiichi Sankyo and Syneos Health teams will provide a robust understanding of how patients are cared for, which workflows exist, and how cutting-edge clinical investigation can best be embedded in the clinic setting. Shared insights will also enable optimized site selection and engagement to best address patient needs. By leveraging this coalition approach, Daiichi Sankyo expects deeper synergies, particularly at the clinical site level, across projects with common indications and patient populations.

"High unmet patient need and rapid scientific discovery in the oncology space are driving the need for a faster and more predictable approach to clinical development," said Paul Colvin, President, Syneos Health Clinical Solutions. "We’re pleased to collaborate with an innovative company like Daiichi Sankyo, using our unique outsourced product development model to improve clinical trial performance for their advanced oncology portfolio."