Personalis to Announce Third Quarter 2019 Financial Results on November 13, 2019

On October 30, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its third quarter 2019 financial results after the market closes on Wednesday, November 13, 2019 (Press release, Personalis, OCT 30, 2019, View Source [SID1234550061]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 8749318. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

The Mary Kay Foundation Donates $100,000 to Baylor Scott & White to Support Triple Negative Breast Cancer Research

On October 30, 2019 The Mary Kay FoundationSM, a decades-long leader in the mission to eliminate cancers affecting women, reported that donated $100,000 to Baylor Scott & White Dallas Foundation to help fund research conducted by Dr. Joyce O’Shaughnessy, breast oncologist with TEXAS Oncology and the Celebrating Women Chair in breast cancer research at Baylor University Medical Center (Press release, The Mary Kay Foundation, OCT 30, 2019, View Source [SID1234550060]). Dr. O’Shaughnessy’s deep portfolio of research includes the study of triggers that may cause heightened sensitivity of triple negative breast cancer (TNBC) cells and the effectiveness of therapies based on this sensitivity.

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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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TNBC is a high-risk breast cancer with few effective options for patients. It usually affects younger women, African American women, and women with a BRCA1 genetic mutation. Compared with other breast cancer subtypes, TNBC is associated with a worse prognosis, including shorter time to recurrence in early-stage diseases (within 3 years) and a shorter time between recurrence and death in the metastatic setting (between 9-12 months).

"At The Mary Kay Foundation, our mission is to eradicate cancers that affect women around the world, and each year we invest millions in groundbreaking research and support for organizations like Baylor Scott & White," said Dr. Lucy Gildea, Chief Scientific Officer of Mary Kay Inc. "We’re honored to help fund Dr. O’Shaughnessy’s potentially lifesaving research, and we look forward to following along and learning how these results might impact the prognosis of metastatic TNBC patients in the future."

Dr. O’Shaughnessy has focused her research on the metastatic TNBC population due to the very high, unmet medical need. Dr. O’Shaughnessy has worked with Baylor Scott & White Research Institute, which oversees research efforts and provides staffing and other clinical support for the healthcare system, to also design and develop Investigator Initiated Studies examining TNBC.

"The goal of this work is to understand more about the pathways that might allow patients to achieve highly durable complete responses to their treatment and to determine the molecular characteristics of TNBCs that predict the benefit from different treatment strategies," said Dr. O’Shaughnessy. "This type of work could expand the options available to patients with metastatic diseases and bring greater hope to those in need."

"As the largest not-for-profit healthcare system in Texas, Baylor Scott & White relies upon generous donations from organizations like The Mary Kay FoundationSM to continue our innovative research on behalf of patients," said Rowland K. Robinson, president of Baylor Scott & White Dallas Foundation. "We’ve seen promising results from Dr. O’Shaughnessy’s trials so far. And, with The Mary Kay Foundation’s support, we’re hopeful her important work will continue to help us gain additional insight to better serve those with metastatic triple negative breast cancer."

Over the course of more than two decades, The Mary Kay FoundationSM has awarded more than $80 million to women’s shelters and domestic violence service providers, as well as cancer research programs and related causes throughout the United States.

Refuge Biotechnologies to Present During Multi-Targeted Therapeutic Platforms Program at The Annual Meeting of The Society for Immunotherapy of Cancer

On October 30, 2019 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, reported that Francesco M. Marincola, M.D., chief scientific officer of Refuge, will present during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting & Pre-Conference Programs (SITC 2019) (Press release, Refuge Biotechnologies, OCT 30, 2019, View Source [SID1234550059]).

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Dr. Marincola will deliver a scientific overview detailing Refuge’s platform technology during the Novel Multi-Targeted Therapeutic Platform program, held November 6 at the Gaylord National Hotel & Convention Center in Maryland. The overview will include recent data from Refuge’s proprietary receptor-dCas platform and its multi-functional therapeutic applications.

"The work being done at Refuge Biotechnologies builds upon the promise of CRISPR interference and CRISPR activation, and has demonstrated the ability to develop a novel therapy that induces gene modulation of multiple genes simultaneously without making permanent edits to the genome," said Dr. Marincola. "This capability has the potential to be combined with numerous therapeutic mechanisms in a single customizable treatment. We look forward to sharing progress as we advance towards the clinic."

Details of the presentation are as follows:

Title: Contextual reprogramming of T cells for multi-targeted therapeutics: checkpoint blockade, immune resilience, and stemness to overcome immune resistance and reduce toxicity, all in one cell product
Presenter: Francesco M. Marincola, M.D.
Date and Time: Wednesday, November 6, 2019 at 4:15 p.m. ET
Session 2: Novel Platforms and Innovation

Asuragen to Present at 2019 Association for Molecular Pathology (AMP) Annual Meeting

On October 30, 2019 Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, reported that it will host three corporate workshops and present multiple scientific posters highlighting their rapidly expanding product portfolio and industry collaborations at the upcoming 2019 Association for Molecular Pathology (AMP) Annual Meeting & Expo November 7-9 in Baltimore (Press release, Asuragen, OCT 30, 2019, View Source [SID1234550058]).

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Asuragen’s sessions at the Corporate Workshop Day on November 6 will highlight user experiences with the new AmplideX PCR/CE SMN1/2 Plus Kit** and multiple assays within the company’s QuantideX oncology product portfolio.

Asuragen will present four posters during the Scientific Poster Sessions, demonstrating its continuing innovation in translating molecular biology to impactful diagnostic products. Of note, a recent collaboration with ProteinSimple, a Bio-Techne brand, combines the quantification of nucleic acid and protein markers relevant to targeted therapies and immune checkpoint inhibitors into a single, multiplexed workflow for Simple Western systems. "Diseases like non-small cell lung cancer require a multi-omics approach to better manage patients and this trend is likely to expand to other conditions as our knowledge of disease drivers grows," said Robert Gavin, senior vice president, Analytical Systems Division at Bio-Techne. "Our collaboration with Asuragen represents a forward-looking approach for streamlining the analysis of clinically relevant targets across analyte types with a goal of transforming how these patients are diagnosed, treated, and managed."

Asuragen’s Corporate Workshops will occur in Room 338 of the Baltimore Convention Center at 10am, 12pm, and 2pm, on Wednesday, respectively.

Simple, Sensitive, and Scalable Patient Monitoring with the QuantideX qPCR BCR-ABL IS Kit
Presenter: Emily Adams, BS(ASCP)CM, clinical laboratory specialist and lead technologist at Johns Hopkins University, will review her analytical and clinical validation of the QuantideX qPCR BCR-ABL IS Kit and how the assay provides a highly-sensitive, rapid, and scalable solution for their molecular diagnostics laboratory.
From Two Days to Four Hours: How the AmplideX PCR/CE SMN1/2 Plus Kit** Provides SMN1 and SMN2 Copy Number Information and More…
Presenter: Vivianna van Deerlin, MD, PhD, professor of pathology and laboratory medicine at the University of Pennsylvania Perelman School of Medicine, will share her experience with the new AmplideX PCR/CE SMN1/2 Plus Kit**, which automates the reporting of copy number, gene duplication, and disease modifier information on the SMN1 and SMN2 genes in less than four hours from a single PCR reaction.
Next-Generation Sequencing Within Your Reach: Complete, NGS-in-a-Box Testing Solutions for DNA and RNA Variants in Cancer
Presenters: Nimesh Patel, MD, director of molecular pathology at Lifespan Academic Medical Center, and Stephen Hyter, PhD, senior scientist in pathology and laboratory medicine at the University of Kansas Medical Center, will review why their institutions adopted the QuantideX NGS DNA Hotspot 21* and RNA Lung Cancer* Kits, respectively, and how these panels have empowered them to collect clinically relevant biomarker information via comparatively simple and streamlined NGS testing workflows.
The following will be presented during Friday’s poster session from 2:30 – 3:30 p.m.

G022: A Multiplex PCR/CE CFTR Assay Resolves Zygosity of the 23 ACMG/ACOG-recommended CFTR variants and Sizes poly-T and TG Repeats in a Single Tube. (Pranesh Rao)
G044: A Rapid Diagnostic and Screening System for Spinal Muscular Atrophy that Reports Copy Number Changes, Single Nucleotide Variants and Small Indels (Huiping Zhu, PhD)
I024: A Deep Learning Method for High-Throughput FMR1 Triplet Repeat Screening (Lando Ringel)
The following will be presented during Saturday’s poster session from 9:45-10:45 a.m.

TT049: A Single-Platform Technology for Proteogenetic Biomarker Analysis in Oncology: Complementary Protein and RNA Quantification Relevant to Targeted and Immuno-therapies in Non-Small Cell Lung Cancer (Gary Latham, PhD)
"AMP affords us the unique opportunity to showcase our rapidly growing genetics and oncology product portfolios to a diverse audience spanning disease areas and practice types," said Matthew McManus, MD, PhD, president and CEO of Asuragen. "As demonstrated through our numerous workshops, scientific posters, and collaborations, our best-in-class products for challenging genomic targets continue to provide simple, robust and reliable solutions for a highly dynamic customer base."

The company will also have a presence at booth #2525 during the conference.

* For Research Use Only. Not for use in diagnostic procedures.
** Product in development. Specifications not finalized.

Alpine Immune Sciences Completes Enrollment of Phase I Study of ALPN-101 and Announces Third Quarter Conference Call

On October 30, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported that it has completed enrollment in all planned cohorts of the Phase I study of its lead program, ALPN-101, a first-in-class dual ICOS/CD28 antagonist (Press release, Alpine Immune Sciences, OCT 30, 2019, View Source [SID1234550057]). Alpine will discuss the preliminary findings during its third quarter 2019 company update conference call and webcast scheduled for November 13, 2019 at 4:30 p.m. ET.

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The randomized, placebo-controlled, blinded study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ALPN-101 in adult healthy volunteers. The results from this trial will help inform further development of ALPN-101 in serious autoimmune and inflammatory diseases.

The company will hold a conference call on November 13, 2019 to discuss third quarter results, recent development progress, and upcoming clinical development plans for both ALPN-101 and ALPN-202, Alpine’s lead oncology program. The company will also review new ALPN-101 data presented at the American College of Rheumatology annual meeting and ALPN-202 data presented at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting.

Conference Call and Webcast Details

To access the live call by phone, dial (877) 407-0789 (domestic) or (201) 689-8562 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, which has the potential to improve upon the efficacy of combined checkpoint inhibition without significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. We anticipate initiation of the first-in-human clinical study of ALPN-202 to begin by the first quarter of 2020.