On January 14, 2020 LabCorp (NYSE: LH) reported it will adopt the Ion Torrent Genexus System* and Oncomine Precision Assay* for use in research and development of companion diagnostics as well as other future oncology and precision medicine applications (Press release, LabCorp, JAN 14, 2020, View Source [SID1234553167]). LabCorp will also evaluate the potential for future deployment of the system and test across its network of laboratories and partner facilities. The adoption is enabled through LabCorp’s participation in Thermo Fisher Scientific’s Next-Generation Sequencing Companion Dx Center of Excellence Program (COEP).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are very excited to collaborate with Thermo Fisher and leverage the capabilities of the Genexus system," said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. "This streamlined platform, with fast turnaround time and automated workflow, has the potential to bring the power of next-generation sequencing to a broader range of settings and to stimulate significant advances in the future for the diagnosis and treatment of a broad range of cancers."

LabCorp will explore a variety of applications for the Genexus System and the Oncomine Precision Assay, in addition to their immediate use for cancer research and development of new tests. Upon validation, the platform’s automation will be ideal for accelerating access to next-generation sequencing (NGS) testing for clinical trials through LabCorp’s specialty and drug development central laboratories. If cleared or approved for diagnostic use, the system could be made available to smaller LabCorp laboratories, in addition to hospitals and other LabCorp customers, to help expand the reach of efficient, expedient, and cost-effective NGS testing.

Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher, said, "Through our valued partnership with LabCorp, we have a pivotal opportunity to expand access to comprehensive genomic profiling. Our goal is to improve the future standard of care by enabling our customers to leverage genomic information in every setting possible."

The Genexus System is the first fully integrated NGS platform that delivers results in a single day. It features a specimen-to-report workflow that enables laboratories to scale their sequencing runs for processing small batches of samples economically. Developed for the Genexus System, the Oncomine Precision Assay is a pan-cancer panel that enables comprehensive genomic profiling from formalin-fixed, paraffin-embedded (FFPE) tissue and liquid biopsy samples. Currently, the Genexus System and Oncomine Precision Assay are being used for research purposes only.

"The Thermo Fisher Genexus System and Oncomine Precision Assay could one day be deployed throughout our central laboratories to accelerate the development of precision medicine applications, including companion diagnostics," said Steve Anderson, Ph.D., chief scientific officer of Covance. "This platform has the potential to help expand access to NGS testing and become pivotal to LabCorp maximizing our unique capabilities in both diagnostics and drug development to benefit customers and, most importantly, patients."

*For research use only. Not for use in diagnostic procedures.

On January 14, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary fourth quarter and full-year 2019 financial results (Press release, Integra LifeSciences, JAN 14, 2020, View Source [SID1234553166]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Preliminary Fourth Quarter and Full-Year 2019 Revenue Results

Fourth quarter 2019 reported revenue is expected to be at or near the low end of the previously communicated guidance range of $395 million to $400 million, representing organic revenue growth of slightly less than 5% and reported growth of approximately 3%.

As a result of its fourth quarter preliminary results, the company expects full-year 2019 reported revenue to be at or near the low end of the previously communicated guidance range of $1,517 million to $1,522 million, representing organic growth of slightly less than 5% and reported growth of approximately 3%.

The preliminary results set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

Preliminary 2020 Financial Guidance
The company expects full-year 2020 reported revenue to be in the range of $1,550 million to $1,570 million, representing organic revenue growth of approximately 5% and reported growth of approximately 3%. The company expects full-year 2020 earnings per share to increase double digits compared to the full-year 2019.

Share Repurchase Program

The company plans to implement a share repurchase program, previously approved by the Board of Directors, with an authorization of up to $225 million. The company may repurchase shares from time to time in the open market or otherwise at the company’s discretion, subject to applicable regulatory and other legal requirements. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions, regulatory requirements, other corporate considerations, and could be suspended or discontinued at any time as determined by Integra management.

"In 2019, we completed the integration of Codman and began making significant investments to increase manufacturing capacity for our regenerative tissue products. We also launched 10 new products in the first part of 2019. We are confident that these actions, and a full-year contribution from our new products, will result in accelerated revenue growth in 2020 and beyond," said Peter Arduini, president and chief executive officer, Integra LifeSciences. "In addition, our capital allocation strategy is supported by a strong balance sheet and strong cash flows, which will enable the company to reinvest in the business, pursue strategic acquisitions, and implement a share repurchase program to return value to shareholders."

The company is scheduled to present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 3:30pm PT (6:30pm ET). A live audio webcast of the presentation will be available on the Investor section of the company’s website at www.integralife.com
The company will report its fourth quarter and full-year 2019 financial results during a conference call in February 2020. A press release with the date, time and webcast information will be provided closer to the reporting date.

On January 14, 2020 Invicro LLC, a Konica Minolta Company and Paige, Inc., the leader in computational pathology, reported a strategic alliance to provide integrated pathology solutions to support Pharmaceutical and Biotechnology sponsors with their drug discovery and development initiatives (Press release, Immudex, JAN 14, 2020, View Source [SID1234553165]). Invicro is a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery and development . Paige is a pioneer in transforming the diagnosis and treatment of cancer through clinical-grade artificial intelligence (AI).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

As part of its pathology services, Invicro currently provides a wide-range of CAP-CLIA laboratory testing and analysis services including core histology, custom assay development, multiplex immunohistochemistry (m-IHC) and its novel technology, Quanticell. Quanticell is a highly sensitive nanoparticle-based IHC assay that is amplification-free and quantitative which can simultaneously detect low expressing drug targets, immune cells and therapeutics in tissue samples.

With this strategic alliance, Invicro can now represent Paige’s digital diagnostic and biomarker solutions in the global pharma services market. "We are very excited to collaborate with Paige as the preferred partner to pharma and biotech for services based on their industry leading AI capabilities," said George Abe, Senior Vice President of Emerging Business and Corporate Development for Invicro. "With the rapid advancements in the development of immunotherapies, particularly in oncology, this alliance offers sponsors transformational biomarker solutions across all drug development stages, as well as the development and validation of companion diagnostics (CDx)."

Backed by the first FDA Breakthrough Device designation for AI in pathology and oncology and the first CE mark for Paige Prostate and Paige Insight, Paige offers seamless collaboration across teams and sites and deploys large-scale deep learning capabilities. The computational pathology solutions powered by Paige’s robust machine learning infrastructure aim to improve patient stratification, scale and augment workflows and improve reproducibility.

"Paige is very pleased to partner with Invicro to help further the imaging biomarker space," stated Leo Grady, CEO for Paige. "Together, Invicro and Paige will uniquely offer a comprehensive suite of digital pathology solutions and digital assays, enabling sponsors to precisely detect, quantify and characterize tumors in the tissue context."

With both companies having advanced technologies and deep-learning expertise, the complimentary nature of this relationship will help maximize productivity and efficiencies, reduce turnaround times, and most importantly, help bring more personalized treatments to patients.

On January 14, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported an update on its outlook for 2020, including financial guidance (Press release, Halozyme, JAN 14, 2020, View Source [SID1234553164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We have made tremendous progress repositioning the company to focus solely on driving the growth and profitability of our ENHANZE business," said Dr. Helen Torley, president and chief executive officer. "Looking ahead, we anticipate a number of value-creating financial and ENHANZE-related milestones will be achieved during 2020."

Anticipated 2020 ENHANZE Key Events

U.S. Food and Drug Administration (FDA) decision on the approval of the Biologics License Application submitted by ENHANZE collaboration partner Janssen Biotech, Inc. (Janssen) in July 2019 for Daratumumab SC.
European Medicines Agency (EMA) decision on the approval of the extension application submitted by Janssen-Cilag International NV (Janssen) in July 2019 for Daratumumab SC.
Completion in Q1 2020 of regulatory submissions to the FDA and EMA by Roche seeking approval for the fixed-dose combination of Perjeta and Herceptin utilizing ENHANZE in combination with intravenous chemotherapy.
At least 3 new Phase 3 and 1 Phase 2 clinical trial initiations by ENHANZE collaboration partners.
Initiation of at least five new Phase 1 clinical trials with partner products utilizing the ENHANZE drug delivery technology.
Update on Capital Return Program

On November 4, 2019 the Company announced its Board of Directors approved a plan to repurchase up to $350 million in stock over the next three years. Subsequently, on November 12, 2019 the Company announced the Board further approved the repurchase of an additional $200 million worth of shares in conjunction with an offering of convertible senior notes, due 2024, resulting in a total three-year share repurchase authorization of up to $550 million.

As of December 31, 2019, the Company had repurchased 8.5 million shares of Halozyme stock under this program. In addition, 2.1 million shares had been delivered to the Company as part of a $50 million Accelerated Share Repurchase (ASR), which is expected to be completed in the first quarter of 2020. Following completion of the ASR, the Company will have repurchased a total of $200 million worth of shares. As of December 31 2019, the Company had 136.7 million shares outstanding.

The Company plans to repurchase an additional number of shares, up to $150 million worth, during 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

2020 Financial Guidance

For 2020, Halozyme expects revenues of $230 million to $245 million, representing growth of 18% to 26% over the 2019 expected revenue of approximately $195 million.

The Company expects sustainable profitability beginning in the second quarter of 2020. Also, the Company continues to project annualized operating expenses, excluding cost of goods sold, of between $65 million and $75 million will be achieved by the fourth quarter of 2020.

On January 14, 2020 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported that it has entered a service agreement with Biose Industrie, a France based CDMO, for the scale-up production of its drug candidates, microbial consortia BMC121 & BMC127 for its Immuno-Oncology program (Press release, Biomica, JAN 14, 2020, View Source;bmc127-for-its-immuno-oncology-program-300985551.html [SID1234553161]). This agreement will accelerate the Company’s Immuno-Oncology program which is currently planned to enter the clinic in 2021 for proof of concept studies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. Biomica engaged with Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

As previously announced, BMC121 & BMC127 were recently evaluated in pre-clinical studies in a mouse cancer model under Biomica’s immuno-oncology program, aiming to improve the efficacy of immune checkpoint inhibitors therapy. The results of these trials validated the Company’s computational predictions by demonstrating preliminary positive effects when administered in combination with checkpoint inhibitor therapy (anti-PD1), compared to using checkpoint inhibitor therapy alone. This effect was manifested in improved anti-tumor immune response through multiple bacterial-induced mechanisms of action.

Dr. Elran Haber, Biomica CEO, stated: "We are very pleased to work with Biose Industrie, an expert in GMP manufacturing of bacteria-based therapeutics. In parallel with on-going additional preclinical activities, this is an important step in the advancement of our Immuno-Oncology program, as we prepare for initiation of first in man, proof of concept clinical trials that are currently anticipated to begin next year."

Dr. Adrien Nivoliez, Biose industrie CEO, stated: "Biose Industrie is proud to collaborate with Biomica in the development of this novel LBP within the exciting field of Immuno-Oncology. This is another example of Biose Industrie’s ability to support and partner for both Drug Product and Drug Substance within the world of Microbiome Therapeutics, assisting Biotech’s and pharmaceutical companies in their drive to treat patients."

About BMC121 & BMC127

Developed as Live Bacterial Products (LBPs), BMC121 & BMC127 are rationally-designed LBP consortia comprised of unique bacterial strains that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.