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Covance Forms Immunology & Immunotoxicology Unit Focused on Biologic Drug Development

On March 9, 2018 LabCorp (NYSE: LH), a leading global life sciences company, reported that its Covance Drug Development (Covance) business has formed a global immunology and immunotoxicology (I&I) unit dedicated to the specific needs of biologic drug development (Press release, Covance, SEP 9, 2018, View Source [SID1234524652]). This team brings together Covance’s operational expertise in flow cytometry, immunoassays and cell-based assays with its scientific expertise in immunotoxicology study design, direction and operation to provide a more comprehensive offering for large-molecule drugs.

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"With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities"

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"With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities," said John Ratliff, CEO of Covance. "Biologics make up more than one-third of biopharma’s pipeline. Integrating our scientific and operational know-how into a seamless group allows us to deliver even richer scientific insights and faster cycle times for clients’ biologic programs, which helps our clients bring cutting-edge new drugs to patients faster."

Covance’s immunology and immunotoxicology experts, overseen by Shawn Heidel, D.V.M., Ph.D., vice president and global head, Safety Assessment, Metabolism and Lead Optimization, support and advise in the development of biologic projects from pre-clinical evaluation to new drug regulatory submission and clinical study sample analysis. The new I&I unit’s comprehensive offering also includes a seamless bridge to bioanalysis for use in regulatory submissions and to Covance Phase I clinical research units for first-in-human and first-in-patient studies. As studies progress, the I&I team can complete its unique set of solutions by drawing on additional expertise from Covance’s clinical development and commercialization, translational biomarker, immuno-oncology and central laboratory teams, as well as LabCorp’s specialist scientific and technical capabilities. The formation of Covance’s I&I unit illustrates LabCorp’s continued focus on biologics, which extends through LabCorp Diagnostics’ expanding suite of biologic therapeutic drug monitoring tests.

Covance’s initial investment in I&I capabilities focused on increasing global capacity by expanding dedicated laboratory space, state-of-the-art instrumentation and scientific and operations teams. In 2017 alone, Covance more than doubled its I&I laboratory footprint, including additional space in three locations and establishing a new innovation laboratory for method development and validation. Staff size has also doubled, driven by an increase in the number of scientists with advanced degrees. Covance’s recent investments in technology and innovation capabilities have enabled the business to further scale production, as well as support the development and implementation of new services within the rapidly growing biologics market.

"Our growing I&I team is capitalizing on the global experience of our established facilities in the U.S., Germany and the U.K. to deliver comprehensive support for large-molecule development, from innovative testing methods to insightful data analysis and interpretation," said Steve Street, Ph.D., senior vice president of Covance Early Development. "In addition to study design, development and direction, the global innovation team within our I&I unit will focus on new assay development and validation, keeping Covance at the forefront of biologic research and development."

VBL Therapeutics to Report Fiscal 2017 Results on March 15

On March 9, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Thursday, March 15 at 8:30am Eastern Time to report fiscal year ended December 31, 2017 financial results (Press release, VBL Therapeutics, MAR 9, 2018, View Source [SID1234524634]).

X4 Pharmaceuticals to Present at Cowen and Company Healthcare Conference

On March 9, 2018 -X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that Paula Ragan, PhD, President and Chief Executive Officer, will present at the Cowen and Company 38th Annual Health Care Conference in Boston on Wednesday, March 14, 2018, at 8:00 a.m. Eastern time (Press release, , SEP 9, 2018, View Source [SID1234524617]).

Protagonist Therapeutics to Participate in the 28th Annual Oppenheimer Healthcare Conference

On March 9, 2018 Protagonist Therapeutics, Inc. (NASDAQ: PTGX) reported that Dinesh V. Patel, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview on Wednesday, March 21 at the 28th Annual Oppenheimer Healthcare Conference (Press release, Protagonist, MAR 9, 2018, View Source;p=RssLanding&cat=news&id=2337304 [SID1234524615]). The conference will be held at The Westin New York Grand Central hotel in New York, NY.

Protagonist Therapeutics, Inc. (PRNewsFoto/Protagonist Therapeutics, Inc.)

The Protagonist Therapeutics presentation is scheduled for 3:20 pm Eastern Time.

A live audio webcast of the presentation may be accessed by visiting the Investors page of Protagonist Therapeutics corporate website at View Source A replay of the presentation will be available for 30 days following the presentation.

Oncolytics Biotech® Inc. Announces 2017 Year-End Results

On March 9, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, reported its financial results and operational highlights for the year ended December 31, 2017 (Press release, Oncolytics Biotech, MAR 9, 2018, View Source [SID1234524614]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

"We view 2017 as a pivotal year for Oncolytics and one that positions us for a productive year ahead," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our IND 213 study in metastatic breast cancer, or mBC, generated compelling results and marked the first time that an oncolytic virus has demonstrated a statistically significant median overall survival advantage in a randomized clinical study. We received supportive regulatory feedback on our proposed registrational study design for pelareorep in HR-positive, HER2-negative breast cancer, the major genetic subgroup of mBC, from both the United States Food and Drug Administration and the European Medicines Agency. Looking forward, we are excited to initiate a phase 3 mBC registrational study later this year and also expand our development with highly focused phase 2 studies designed to further establish pelareorep as an immunotherapy and deliver near term clinical data. We plan to initiate three cost-effective, partner-sponsored phase 2 studies. These would include a basket study to generate efficacy data on pelareorep in combination with high profile checkpoint inhibitors in patients having specific genetic mutations across cancer types, and part two a trial using pelareorep in combination with pembrolizumab (KEYTRUDA) in patients with relapsed metastatic adenocarcinoma of the pancreas. We are also planning to initiate a window of opportunity study using pelareorep and the standard of care in a neoadjuvant setting for treatment naïve mBC patients, potentially broadening pelareorep’s treatment applicability to include first line treatment."

Selected Highlights

Since January 1, 2017, selected highlights announced by the Company include:

Clinical Updates
•
Presented findings from IND 213, an open-label, randomized, phase 2 study of intravenously-administered pelareorep given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer (mBC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2017. Results showed a statistically significant improvement in median overall survival (OS) from 10.4 months in the control arm to 17.4 months in the test arm.
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Presented additional clinical data from IND 213 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress that demonstrated a doubling of overall survival benefit for patients with HR double-positive, HER2-negative mBC when treated with pelareorep/paclitaxel combination treatment versus paclitaxel alone.
•
Announced a favorable End-of-Phase 2 meeting with the FDA for pelareorep in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) mBC patients. The agency’s guidance proposed a single, 400 patient registration study to support a future Biologics License Application submission in the U.S.
o
Subsequently, increased to 450 patients to ensure the completion of the study with the planned evaluable population
•
Received a Final Advice Letter from the EMA suggesting that a single phase 3 study may be acceptable to form the basis of a Marketing Authorization Application (MAA) in Europe.

•
Announced the launch of MUK eleven, a phase 1b trial studying pelareorep in combination with Celgene’s Imnovid (pomalidomide) and Revlimid (lenalidomide), as a rescue treatment in relapsing myeloma patients. Oncolytics treated the first patient in this trial in September 2017.
•
Presented the largest ever safety database for an oncolytic virus at the ESMO (Free ESMO Whitepaper) 2017 Congress that demonstrated pelareorep is safe and well tolerated when administered in combination with paclitaxel plus/minus carboplatin.
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Announced that the FDA granted Fast Track designation for pelareorep for the treatment of mBC, based on the data from IND 213. However, our request for breakthrough therapy designation (BTD) in mBC was not approved at this time based on certain data requirements. The FDA provided guidance that the Company may re-apply for BTD once additional supportive information is available.

Corporate Updates
•
Entered into a USD $86.6 million regional licensing agreement with Adlai Nortye for pelareorep covering China, Hong Kong, Macau, Singapore, South Korea and Taiwan. Under the terms of the agreement, Oncolytics is eligible to receive upfront, licensing fee and milestone payments of USD $21.2 million to support our phase 3 registration study and is eligible to receive up to an additional USD $65.4 million upon achievement of clinical, regulatory and commercialization milestones.
•
Received shareholder approval for the consolidation of the Company’s common shares, which enables Oncolytics to meet requirements for listing on the NASDAQ Capital Market.
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Closed an underwritten public share offering of 16,445,000 units at a purchase price of $0.70 for gross proceeds of approximately $11.5 million ($10.6 million net).
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Established a Scientific Advisory Board focused on pelareorep’s registration study in mBC.
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Appointed Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO.
•
Appointed Andrew de Guttadauro as President of its US subsidiary, Oncolytics Biotech (U.S.) Inc. and Head of Global Business Development.

Anticipated Milestones
•
Initiate a phase 3 registration study of pelareorep in combination with paclitaxel, for the treatment HR+/HER2- mBC patients in Q3 2018.
•
Initiate a phase 2 partner-sponsored window of opportunity study of pelareorep in combination with standard of care therapy in the neoadjuvant setting in mBC in H2 2018.
•
Initiate a phase 2 partner-sponsored basket study to generate important biomarker and efficacy data of pelareorep in combination with checkpoint inhibitors in H2 2018.
•
Initiate part two of a phase 2 North-West University/Merck sponsored trial of pelareorep in combination with pembrolizumab (KEYTRUDA) in patients with relapsed metastatic adenocarcinoma of the pancreas.
•
Re-list on the NASDAQ in 2Q 2018.

2017 Year-End Financial Results
•
At December 31, 2017, the Company reported $11.8 million in cash, cash equivalents and short-term investments.