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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]).

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.

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.

IMV Appoints Joanne Schindler, M.D., D.V.M. as Chief Medical Officer

On October 30, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported the appointment of Joanne Schindler, M.D., D.V.M. as its new Chief Medical Officer, effective November 4, 2019 (Press release, IMV, OCT 30, 2019, View Source [SID1234550056]). Dr. Schindler will succeed Gabriela Rosu, M.D., who is leaving the company to pursue other opportunities.

"We are very excited to welcome Dr. Joanne Schindler, who brings a wealth of experience in oncology-focused drug development and clinical trial execution to IMV," said Fred Ors, Chief Executive Officer of IMV. "Over the last few years, our clinical efforts have sought to leverage the potential of our DPX technology to deliver a novel class of immunotherapies for the treatment of patients with hard-to-treat cancers. We expect to benefit greatly from Joanne’s leadership as we near key proof-of-concept readouts from our lead program and as we continue to explore the breadth of our platform across other targets of interest."

Mr. Ors continued, "We also want to take this opportunity to thank Dr. Gabriela Rosu for her many contributions to IMV’s clinical program and wish her the best in her future pursuits."

Dr. Schindler brings over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development and Executive Medical Director at H3 Biomedicine, overseeing the company’s clinical development efforts. Previously, she worked as Vice President, Clinical Development at Constellation Pharmaceuticals, and earlier held various clinical development leadership roles at SynDevRx, ImmunoGen, Novartis, Fresenius Biotech and GlycoGenesys. Over the course of her career, Dr. Schindler has played an instrumental role in advancing novel programs into the clinic, as well as the development and execution of clinical strategy. She holds an M.D. from the University of Connecticut School of Medicine, a D.V.M. from Tufts University School of Veterinary Medicine and a B.A. in biology from Brandeis University.

"I am delighted to join IMV at this critical stage in the company’s growth," said Dr. Schindler. "Immunotherapy is at the forefront of novel treatments for cancer and I have been deeply impressed with IMV’s sophisticated science and data produced to date. Targeted T-cells born out of IMV’s DPX platform have exhibited the potential to elicit a more rapid, robust and sustained immune response over other therapies, particularly when paired with a highly prevalent tumor-associated target like survivin. I look forward to working with the team to advance its clinical portfolio, to unlock the promise of this technology and to bring these important benefits to cancer patients in need."

McKesson Reports Fiscal 2020 Second-Quarter Results

On October 30, 2019 McKesson Corporation (NYSE:MCK) reported results for the second quarter ended September 30, 2019 (Press release, McKesson, OCT 30, 2019, View Source [SID1234550055]).

Represents continuing operations attributable to McKesson

Represents a non-GAAP financial measure; refer to the reconciliations of non-GAAP financial measures included in accompanying schedules

"McKesson’s second-quarter results reflect continued momentum across the business as well as further progress against our cost savings initiatives," said Brian Tyler, chief executive officer. "As we look forward to the second half of our fiscal year, we remain confident in the strength of our broad set of solutions and capabilities, delivering execution against our strategic imperatives as we become a more focused and efficient organization."

Revenues increased 9% year-over-year, primarily driven by growth in the U.S. Pharmaceutical and Specialty Solutions segment, largely due to branded pharmaceutical price increases and higher volumes from a retail national account customer.

Loss per diluted share of $(3.99) included charges of approximately $1.4 billion, or $5.73 per diluted share, primarily related to an impairment in connection with McKesson’s planned exit of its investment in Change Healthcare. Adjusted Earnings per diluted share of $3.60 was flat year-over-year, as a lower share count and growth in the Medical-Surgical and McKesson Prescription Technology Solutions (MRxTS) businesses were offset primarily by the lapping of a prior year pre-tax benefit of $90 million, or $0.33 per diluted share, related to a reversal of a contractual liability associated with McKesson’s investment in Change Healthcare. Excluding the prior year benefit of $0.33 per diluted share from Adjusted Earnings, second-quarter results per diluted share increased 10%.

During the first half of the fiscal year, McKesson returned $1.6 billion of cash to shareholders via $1.4 billion of common stock repurchases and $148 million of dividend payments. For the first half of the fiscal year, McKesson used cash from operations of $159 million, and invested $184 million internally, resulting in negative free cash flow of $343 million.

U.S. Pharmaceutical and Specialty Solutions Segment

Revenues were $46.0 billion, up 10%, driven primarily by branded pharmaceutical price increases and increased specialty pharmaceutical volume from the company’s largest retail national account customer, partially offset by branded to generic conversions.
Operating profit was $639 million and operating margin was 1.39%. Adjusted operating profit was $641 million, up 1%, due to continued growth in the specialty businesses, partially offset by customer and product mix. Adjusted operating margin was 1.39%, down 14 basis points, primarily resulting from the higher volume of specialty pharmaceuticals.
European Pharmaceutical Solutions Segment

Revenues were $6.6 billion, down 1% on a reported basis and up 4% on an FX-adjusted basis, driven primarily by growth in the pharmaceutical distribution business.
Operating profit was $1 million and operating margin was 0.02%. Adjusted operating profit was $41 million, down 23%, and adjusted operating margin was 0.62%. On an FX-adjusted basis, adjusted operating profit was $43 million, down 19%, and adjusted operating margin was 0.62%, down 18 basis points, driven by the challenging retail pharmacy environment in the U.K.
Medical-Surgical Solutions Segment

Revenues were $2.1 billion, up 6%, driven primarily by growth in the Primary Care business, largely due to the increase in volume of pharmaceutical products.
Operating profit was $129 million and operating margin was 6.27%. Adjusted operating profit was $166 million, up 20%, and adjusted operating margin was 8.07%, up 99 basis points. The year-over-year growth primarily reflects growth in the Primary Care business and the lapping of bad debt expense in the prior year.
Other remaining businesses

Revenues were $3.0 billion, up 4% on a reported basis and up 5% on an FX-adjusted basis, driven by growth in the Canadian and MRxTS businesses.
Operating loss was $(1.3) billion driven by charges of approximately $1.4 billion, primarily related to an impairment in connection with McKesson’s planned exit of its investment in Change Healthcare. Adjusted operating profit was $221 million, down 26% on both a reported and FX-adjusted basis, primarily due to the lapping of the $90 million contractual liability reversal in the prior year and lower contribution from the company’s investment in Change Healthcare, partially offset by higher volumes in the MRxTS business.
Company Updates

On October 21, 2019, the company announced an agreement in principle to settle all claims against the company in the first track of the multi-district opioid litigation, related to two Ohio counties. As a result, McKesson recorded a pre-tax charge of $82 million within operating expenses for the second quarter of fiscal 2020.
McKesson recently published its FY19 Corporate Responsibility Report, describing how the company continues to work to use its economic, environmental, social and governance resources thoughtfully and responsibly. This global report puts emphasis on three topics: product quality and patient safety; eco-efficient transportation and operations; and better health for employees and communities.
McKesson opened a new distribution center in the Seattle area, an eco-friendly facility featuring the latest in supply chain technology and state-of-the-art automation.
Maria Martinez joined McKesson’s Board of Directors as a new independent director effective October 18, 2019.
Fiscal 2020 Outlook

McKesson reaffirmed fiscal 2020 Adjusted Earnings per diluted share guidance range of $14.00 – $14.60.
Conference Call Details

The company has scheduled a conference call for today, Wednesday, October 30th, at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’. A telephonic replay of this conference call will be available for 14 calendar days. For individuals wishing to listen to the replay, the dial-in number is 404-537-3406 and the pass code is 6206708. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conference:

38th Annual J.P. Morgan Healthcare Conference, January 13-16, 2020, in San Francisco, CA.
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community is available on the company’s Investor Relations website.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, transaction-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments as well as the related income tax effects for each of these items, as applicable. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2 and 3 of the financial statement tables included with this release.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

FX-Adjusted

McKesson also presents its financial results on an FX-adjusted basis. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. FX-adjusted information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental FX-adjusted information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Free Cash Flow

McKesson also provides free cash flow, a non-GAAP measure. Free cash flow is defined as net cash provided by (used in) operating activities less payments for property, plant and equipment and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.