Relay Therapeutics Strengthens Leadership Team with Key Team Appointments in Research and Development

On November 19, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Ben B. Wolf, M.D., Ph.D., has joined as chief medical officer, Mrunal "Monica" Phadnis has joined as vice president of clinical operations and Iain Martin, Ph.D., has joined as vice president, drug metabolism and pharmacokinetics (Press release, Relay Therapeutics, NOV 19, 2019, View Source [SID1234551482]).

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"As we advance multiple programs into the clinic in the coming year and continue to deepen our early stage pipeline, Ben’s extensive experience in clinical development and translational medicine, Monica’s background in clinical operations, and Iain’s expertise in drug discovery will be critical in helping propel the company in the next phase of our growth," said Don Bergstrom, M.D., Ph.D., executive vice president and head of research and development of Relay Therapeutics. "We are pleased to welcome these respected leaders, who together bring a wealth of expertise to our growing team."

Dr. Ben B. Wolf is a precision oncologist who brings to Relay Therapeutics nearly 20 years of experience in the biopharmaceutical industry, with expertise advancing new oncology programs in the clinic and optimizing patient selection to enable rapid proof of concept and registration. He has authored more than 30 peer-reviewed publications and multiple patents related to drug discoveries. Most recently, Dr. Wolf served as chief medical officer at KSQ Therapeutics, a biotechnology company advancing a pipeline of CRISPR-based tumor- and immune-focused drug candidates for the treatment of cancer. Prior to KSQ, Dr. Wolf was senior vice president, clinical development at Blueprint Medicines, where he advanced three oncology programs for novel kinase inhibitors from investigational new drug (IND) applications to clinical proof-of-concept. Prior to Blueprint, Dr. Wolf held clinical and medical director roles at Merrimack Pharmaceuticals, ImmunoGen, Amgen and Genentech. Dr. Wolf holds an M.D. and Ph.D. in biochemistry from the University of Virginia and a B.S. from Union College. He completed medical training in internal medicine and medical oncology at the University of California at San Diego.

Monica Phadnis is an end-to-end delivery expert with more than 15 years in clinical oncology research. Prior to joining Relay Therapeutics, she was the executive director of clinical development in oncology and hematology at Syneos Health, where she worked primarily on early phase solid tumors. Before Syneos, she was the director and clinical operations lead at EMD Serono, where she led Precision Medicine clinical programs in Non-Small Cell Lung Cancer. Additionally, she held roles of growing responsibility at Quintiles Translational Corporation, Sanofi-Aventis, Memorial Sloan-Kettering Cancer Center and Selventa Inc. Ms. Phadnis received a B.S. in mathematics from the University of Mumbai in Mumbai, India and a pre-medical diploma with specialization in genetics from Harvard University.

Dr. Iain Martin brings to Relay Therapeutics more than 30 years of experience in pharmaceutical drug metabolism and pharmacokinetics (DMPK) across therapeutic areas, including oncology and neuroscience. Prior to joining Relay Therapeutics, he was executive director within the department of pharmacokinetics, pharmacodynamics and drug metabolism at Merck, where he led groups responsible for DMPK support of small molecule and peptide programs across the company. Prior to Merck, Dr. Martin held roles of increasing responsibility at The Upjohn Company, AstraZeneca, Organon and Schering Plough. He received his Ph.D. in drug metabolism and a B.S. in biochemistry from the University of Surrey (UK).

International Isotopes Inc. Announces Financial Results for The Third Quarter 2019

On November 19, 2019 International Isotopes Inc. (OTCQB: INIS) (the "Company") reported its financial results for the three and nine months ended September 30, 2019 (Press release, Institute of Isotopes Co, NOV 19, 2019, View Source [SID1234551499]).

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Revenue for the three months ended September 30, 2019 was $2,337,488 as compared to $2,680,760 for the same period in 2018, a decrease of approximately 13%. Revenue for the nine-month period ended September 30, 2019 was $ 7,001,179 as compared to $7,874,092 for the same period in 2018, a decrease of approximately 11%. This decrease in revenue for both periods was largely the result of revenue decreases in the Company’s cobalt products and radiological services segments.

Gross profit for the three months ended September 30, 2019 increased approximately 10% compared with the same period in 2018. Gross profit for the nine-month period ended September 30, 2019 increased approximately 9% compared to the same period in 2018. The increase in gross profit for both periods was largely the result of increased gross profit in the radiochemical products segment. Operating expense increased approximately 9% for the three months ended September 30, 2019. Operating expenses increased approximately 6% for the nine-month period ended September 30, 2019, compared to the same period in 2018. The increase in operating expense for both periods was primarily due to an increase in general and administrative costs.

The Company reported a net income for the three months ended September 30, 2019, of $236,462 compared to a net loss of $333,222 for the same period in 2018. The net loss for the nine-month period ended September 30, 2019, was $972,689 as compared to $631,097 for the same period in 2018, an increase in loss of approximately 54%. The increase in net income for the three-month period was a result of the timing of recognition of estimated cost recovery of expenses related to the cleanup of a contamination event that occurred in the State of Washington during the second quarter 2019. The increase in net loss for the nine-month period was due to increased costs attributed to the cleanup and recovery from the same contamination event. Further discussion of this event and the impact to the Company financial statements is included in the radiological services segment discussion in this release.

Further detail on the performance of each of the Company’s business segments is provided in the following paragraphs.

Revenue from radiochemical products for the three months ended September 30, 2019 increased approximately 99% compared to the same period in 2018. Revenue from radiochemical products for the nine-month period ended September 30, 2019 increased approximately 31% compared to the same period in 2018. The major contributor to increased revenue within this segment for both periods was attributed to increased revenue from contract manufacturing operations.

Revenue from the sale of cobalt products for the three months ended September 30, 2019 decreased approximately 91% compared to the same period in 2018. Revenue from the sale of cobalt products for the nine-month period ended September 30, 2019 decreased approximately 61% compared to the same period in 2018. The Company has been working toward a resumption of cobalt sales by producing cobalt in the U.S. Department of Energy’s (DOE) Advanced Test Reactor (ATR) under a ten-year agreement with the DOE. Revenue from the sales of that material should begin in 2020. In the meantime, the Company had acquired cobalt from an alternate supplier in 2018, which allowed the resumption of some cobalt product manufacturing. Similar alternate supplies were not available in 2019 and that caused the decline in revenue for both period comparisons.

Revenue from radiological services for the three months ended September 30, 2019 increased approximately 91% compared to the same period in 2018, but the Company reported a decrease in revenue in this segment of approximately 29% for the nine-month period ended September 30, 2019 compared to the same period in 2018. Most of the radiological services revenue is generated by the performance of contract field service activities for the DOE and International Atomic Energy Agency (IAEA). The increase in revenue for the three-month comparison was due to the timing of these contracts where revenue may fluctuate quarter to quarter based on when the contracts are completed. The decrease in revenue for the nine-month period comparison is the result of the decrease in the amount of these contracts the Company has been able to secure in 2019.

In May 2019, the Company’s radiological services team was involved in a contamination event involving a breached cesium-137 source at an off-site location in the state of Washington. This work was being performed under a contract with the DOE. The Company is supporting an investigation, in conjunction with the DOE, to help determine the cause of this event. The Company supported the initial onsite contamination clean-up operations at that location as well as completing the removal of the cesium source for shipment to an off-site location and the disassembly and removal of all Company equipment used in the facility for source removal. All of the Company operations were successfully completed in the third quarter. Since that time the DOE has assumed full control of the ongoing cleanup operations and has assumed all of the past and future financial obligations associated with the contractor currently hired to carry out all of the facility recovery operations. Under the terms of the contract with the DOE the Company believes it should be indemnified from financial liability for this event under the Price Anderson Act. Such indemnification would allow the Company to recoup all its allowed costs associated with this contamination event. During the nine months ended September 30, 2019, the Company incurred $2,141,559 in expenses related to the contamination and its cleanup. These costs are recorded as "other expense" in the Company’s Condensed Consolidated Statements of Operations. During the nine months ended September 30, 2019, the Company received $964,958 in reimbursements from its insurance company for expenses related to the contamination and its cleanup, and the Company has determined that an additional $970,417 of its incurred expenses related to the contamination and its cleanup are probable for recovery pursuit to ASC 410-30. These actual and estimated reimbursements are recorded as "other income" in the Company’s Condensed Consolidated Statements of Operations.

Revenue from nuclear medicine products for the three months ended September 30, 2019 increased approximately 7% compared to the same period in 2018. Revenue from nuclear medicine products for the nine-month period ended September 30, 2019 increased approximately 4% compared to the same period in 2018. The increase in revenue within this segment for both period comparisons is primarily due to price increases of these products.

Steve Laflin, President and CEO of the Company, said, "The Company continued to face a significant challenge during the third quarter dealing with the radiological services contamination event in the State of Washington. I believe our staff did an outstanding job responding to the event and completing all of the recovery efforts within the Company’s scope of work. The Company is continuing to support the ongoing investigation into the cause of this event and will work to ensure that appropriate measures are put in place to prevent a similar event from occurring in the future. The long term impact to the Company’s prospects for further field service work are not known at this time.

We believe the major highlight of our third quarter performance was the 99% increase in revenue in the radiochemical segment for the three-month period compared to the same period in 2018. Revenue in this segment also increased 31% over the nine-month period compared to the same period in 2018. The increase in revenue for both periods was attributed to payments we received for the start-up of our contract manufacturing operations to fulfill our agreement with Progenics Pharmaceuticals Inc. to provide contract manufacturing services for AZEDRA (Ultratrace Iobenguane I-131) and other iodine products. Construction of the new facility spaces are going well and we expect to start commercial production of this product during the first quarter of 2020.

Also on the horizon is our expected return to cobalt product sales beginning in the first quarter of 2020. Our cobalt production from the DOE’s reactor has been curtailed since 2012. Resuming cobalt sales will again place the Company in the position of being the sole U.S. supplier of high specific activity cobalt, an isotope important for multiple medical and industrial applications."

Lilly Confirms Date and Conference Call for 2020 Financial Guidance Announcement

On November 19, 2019 Eli Lilly and Company (NYSE: LLY) will reported its financial guidance for 2020 on Tuesday, December 17, 2019 (Press release, Eli Lilly, NOV 19, 2019, View Source [SID1234551467]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial guidance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

Palleon Pharmaceuticals to Present Preclinical Data on EAGLE-Her2 and Anti-Siglec-9 Antibody Programs at the 11th Annual Protein & Antibody Engineering Summit

On November 19, 2019 Palleon Pharmaceuticals, a leading biotech company developing drugs that target the Siglec-Sialoglycan axis to treat cancer, reported that it will present preclinical data from two of its development programs today at the 11th Annual Protein & Antibody Engineering Summit (PEGS Europe) in Lisbon, Portugal (Press release, Palleon Pharmaceuticals, NOV 19, 2019, View Source [SID1234551483]).

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The Siglec-Sialoglycan axis, a previously underappreciated mechanism of immunosuppression in cancer, has recently emerged as a major tumor immune escape pathway. Palleon has leveraged its proprietary EAGLE and CONVERGENCE platforms to develop a suite of technologies that target both Siglec receptors and their sialoglycan ligands.

Li Peng, Ph.D., Senior Vice President of Research and Early Product Development at Palleon, will present preclinical data on the company’s lead candidate EAGLE-Her2, showing that selectively removing the terminal sialic acids of sialoglycans within the tumor microenvironment effectively inhibits the Siglec-Sialoglycan immune checkpoint and reinvigorates both the innate and adaptive responses to cancer. In addition, Dr. Peng will present Palleon’s anti-Siglec-9 monoclonal antibody program, including preclinical studies that detail the development of antagonistic anti-Siglec antibodies that block the Siglec-Sialoglycan axis.

Palleon Scientific Advisor, Joy Burchell, Ph.D. and Professor of Glyco-Oncology at Kings College London will also present at PEGS Europe. Dr. Burchell will discuss the role of a glycosylated form of tumor-associated mucin MUC1, which engages with Siglec-9 on monocytes and macrophages to create an immunosuppressive tumor microenvironment.

"Targeting the Siglec-Sialoglycan axis of immunosuppression is a truly novel approach to treating cancer that could potentially benefit patients who are resistant to first-generation immuno-oncology therapies," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "Our preclinical data demonstrates striking single agent efficacy across a range of animal models and human in vitro systems."

Agendia to Present New Data at SABCS 2019 Demonstrating How Comprehensive Genomic Profiling Benefits Early-Stage Breast Cancer Patients

On November 19, 2019 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that five abstracts featuring data and updates from its ongoing clinical research evaluating the MammaPrint and BluePrint genomic tests have been accepted for presentation at the 2019 San Antonio Breast Cancer Symposium (SABCS) taking place December 10-14, 2019, in San Antonio, Texas (Press release, Agendia, NOV 19, 2019, View Source [SID1234551500]).

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Data selected for presentation offer new insights into the unique clinical characteristics, tumor biology, risk of recurrence risk and treatment responses among specific populations of women with early-stage breast cancer. These include data from a study evaluating the clinical risk of recurrence among premenopausal women ≤50 years of age with breast cancer.

Two additional presentations will feature the first datasets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating the predisposing clinical and molecular features associated with breast cancer tumor biology in African American women, and an initial clinical review of the molecular profiles and clinical-pathological features of early-stage breast cancer in Chinese patients.

"These data offer important insights into unique patient characteristics and associated clinical risk that will better equip clinicians to provide personalized treatment plans for their patients with breast cancer," says William Audeh, MD, MS, chief medical officer at Agendia. "Agendia remains committed to advancing the scientific and medical community’s understanding of the biologic drivers of breast cancer among specific populations of women, especially those who have historically been under represented in clinical studies, and we are excited to share new data that may benefit these patients and their health care professionals. Given the comprehensive gene set interrogated by MammaPrint + BluePrint, we are uniquely positioned to deliver valuable clinical insights that may improve patient outcomes."

Following are details of the five Agendia abstracts that have been accepted for poster presentations at 2019 SABCS:

Title: Racial disparities in breast cancer: Identifying predisposing clinical and molecular features associated with African American patients (Presentation P2-10-08)
Authors: Nunes R., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Different MammaPrint and BluePrint molecular profiles and clinical-pathological features of early stage breast cancer in Chinese patients in the United States and Hong Kong (Presentation P2-10-15)
Authors: Kwong A., et al.
Session: Epidemiology, Risk, and Prevention: Ethnic/Racial Aspects
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Treatment recommendations in ER+ patients ≤ 50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study (Presentation P2-14-11)
Authors: Tsai M., et al.
Session: Treatment: Adjuvant Therapy – Adjuvant Chemotherapy
Date/Time: Thursday, December 12 at 7:00 – 9:00 am
Location: Poster Session 2, Hall 1

Title: Cyclin E overexpression is associated with high risk 70 gene signature, and may indicate intrinsic resistance to CDK4/6 inhibitors (Presentation P4-10-24)
Authors: Mittempergher L., et al
Session: Prognostic and Predictive Factors: Biomarkers Predicting Treatment Sensitivity and Resistance
Date/Time: Friday, December 13 at 7:00 – 9:00 a.m.
Location: Poster Session 4, Hall 1

Title: The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer (Presentation OT3-17-02)
Presenter: Crozier, J., et al.
Session: On-going Trial Response Predictions
Date/Time: Friday, December 13 at 5:00 – 7:00 p.m.
Location: Poster Session OT3, Hall 1

The full SABCS 2019 abstract book can be found at View Source Visit www.agendia.com for additional information about Agendia.