On January 29, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported the publication of the results from a clinical phase I first-in-human study of the CD40 agonistic antibody ADC-1013 (JNJ-64457107) (Press release, Alligator Bioscience, JAN 29, 2019, View Source [SID1234538671]). The top line data from this study was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2017.

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The results show that the agonistic anti-CD40 antibody ADC-1013 is safe and tolerated at clinically relevant dose levels. Furthermore, the pharmacodynamic effects and the preclinical data support the further clinical development of ADC-1013 against cancer and demonstrate the potential of ADC-1013 as a combination therapy with PD-1 targeted therapies.

Title: First-in-human study with intratumoral administration of a CD40 agonistic antibody, ADC-1013, in advanced solid malignancies.

Journal: International Journal of Cancer, View Source

Authors: Sandra M. M. Irenaeus, Dorte Nielsen, Peter Ellmark, Jeffrey Yachnin, Adnan Deronic, Anneli Nilsson, Per Norlén, Niina Veitonmäki, Camilla S. Wennersten and Gustav J. Ullenhag.

A second phase I study assessing the safety and tolerability of intravenously administered ADC-1013 is ongoing with Janssen Biotech Inc. as a sponsor and is not part of the current publication.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 am CET on January 29, 2019.

About ADC-1013
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Preclinical data have shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T-cell activation enables the immune system to attack the cancer. In addition, since some cancer cells express CD40 on the surface, ADC-1013 may act also through a secondary mechanism of action killing cancer cells directly.

In August 2015, Alligator licensed global development rights for ADC-1013 (JNJ-64457107) to Janssen Biotech, Inc. Currently, Janssen Biotech, Inc. performs a phase I dose-escalation clinical study (ClinicalTrials: NCT02829099) with intravenous administration of ADC-1013.

On January 29, 2019 Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, reported that the results of a five-site study using the QuantideX NGS RNA Lung Cancer Kit* have been published as an article in press by The Journal of Molecular Diagnostics (see View Source) (Press release, Asuragen, JAN 29, 2019, View Source [SID1234532947]). The peer-reviewed article, titled "Design, Optimization, and Multisite Evaluation of a Targeted Next-Generation Sequencing Assay System for Chimeric RNAs from Gene Fusions and Exon-Skipping Events in Non–Small Cell Lung Cancer," also describes the design and development of the assay system. This system includes controls, pre-analytical sample QC, targeted RNA-based enrichment, library clean-up and pooling, and companion bioinformatics software that analyzes the corresponding next-generation sequencing (NGS) data.

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Non-small cell lung cancer (NSCLC) accounts for more than 10% of all newly diagnosed cancers and is characterized by diverse molecular drivers ranging from point mutations and insertion-deletions to gene fusions and exon skipping events. NGS offers a multiplexed approach for detecting RNA chimera from many different fused genes and splice variants but it requires integrated reagents, controls, and interpretive software to standardize testing procedures and assure consistent results across laboratories. This study details the verification and external evaluations of the targeted RNA-seq panel across a total of >200 FFPE tumor biopsy materials representing common and rare RNA variants that are associated with NSCLC.

The QuantideX RNA Lung Cancer Kit is a cGMP manufactured, end-to-end, NGS-in-a-Box product solution that simultaneously interrogates over 100 known clinically-relevant gene fusions, 3’/5’ imbalance markers to detect rare or novel fusions, MET exon 14 skipping events, and mRNA expression levels from 23 genes in NSCLC samples. The kit is part of an integrated workflow that delivers sequencing-ready libraries in approximately half the time of comparable competitor methods and incorporates push-button analytics to standardize test results. The assay is optimized for use with low-quality and quantity samples such as FFPE and fine-needle aspirations and can generate libraries from approximately 10-20 ng RNA or total nucleic acid.

The targeted RNA-seq system was assessed for sensitivity, accuracy, alignment of results with alternative testing methods, and multi-laboratory concordance. Targeted fusions and exon skipping events were detected down to a 1% cell fraction in a wild-type background. Non-targeted fusions could be detected by 3’/5’ imbalance, with 100% of cases detected at 15% positivity and 50% at 5% positivity. Results of the Asuragen NGS assay were also compared to those generated by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), and/or the nCounter Vantage Lung Gene Fusion Panel (Nanostring Technologies) using residual clinical specimens; all results reported by the Asuragen assay were consistent with those generated by these alternative methods. Lastly, a five-site precision study was conducted to evaluate assay reproducibility. Every fusion and exon skipping event in the cohort of nearly 250 sample libraries was correctly detected across sites, consistent with the reference results.

An accompanying commentary on the study, also pending publication in the journal, described the value of targeted RNA-based assays for limited nucleic acid inputs and for their focus on clinically actionable findings. "[The authors’] efforts at standardization and streamlining the workflow process were demonstrated by good concordance across a multisite implementation… the [QuantideX NGS RNA Lung Cancer Kit] demonstrated good accuracy, reproducibility, and analytic sensitivity for detecting fusions that were specifically targeted by design," noted the commentary’s author, Lauren Ritterhouse, MD, PhD, Co-Director, Molecular Diagnostics and Clinical Genomics Laboratories at the University of Chicago. "As such, they were able to produce a comprehensive approach to targeted RNA sequencing that addressed several quality control metrics that could ease the adoption of this assay into laboratories seeking an RNA-based assay for identifying fusions and splicing events in NSCLC."

*For Research Use Only. Not for use in diagnostic procedures.

On January 29, 2019 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the fourth quarter and fiscal year 2018 (Press release, Illumina, JAN 29, 2019, View Source [SID1234532948]).

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Fourth quarter 2018 results:

Revenue of $867 million, an 11% increase compared to $778 million in the fourth quarter of 2017
GAAP net income attributable to Illumina stockholders for the quarter of $210 million, or $1.41 per diluted share, compared to $68 million, or $0.46 per diluted share, for the fourth quarter of 2017; GAAP earnings per share for the fourth quarter of 2017 included our provisional estimate of the one-time transition tax as a result of U.S. Tax Reform
Non-GAAP net income attributable to Illumina stockholders for the quarter of $197 million, or $1.32 per diluted share, compared to $212 million, or $1.44 per diluted share, for the fourth quarter of 2017 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $300 million compared to $294 million in the fourth quarter of 2017
Free cash flow (cash flow from operations less capital expenditures) of $235 million for the quarter compared to $218 million in the fourth quarter of 2017
Gross margin in the fourth quarter of 2018 was 68.1% compared to 69.7% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 69.1% for the fourth quarter of 2018 compared to 70.9% in the prior year period.

Research and development (R&D) expenses for the fourth quarter of 2018 were $176 million compared to $137 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 20.3%, including 0.8% attributable to Helix. This compares to non-GAAP R&D expenses as a percentage of revenue of 17.4% in the prior year period, including 0.7% attributable to Helix.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $217 million compared to $175 million in the prior year period. Excluding restructuring charges and acquisition related expense, non-GAAP SG&A expenses as a percentage of revenue were 24.5%, including 1.6% attributable to Helix. This compares to 22.1% in the prior year period, including 1.2% attributable to Helix.

Depreciation and amortization expenses were $49 million and capital expenditures for free cash flow purposes were $65 million during the fourth quarter of 2018. At the close of the quarter, the company held $3.5 billion in cash, cash equivalents and short-term investments, compared to $2.1 billion as of December 31, 2017.

Fiscal year 2018 results:

Revenue of $3,333 million, a 21% increase compared to $2,752 million in fiscal 2017
GAAP net income attributable to Illumina stockholders of $826 million, or $5.56 per diluted share, compared to $726 million, or $4.92 per diluted share, in fiscal 2017; GAAP earnings per share for fiscal 2017 included the one-time transition tax referenced previously
Non-GAAP net income attributable to Illumina stockholders of $850 million, or $5.72 per diluted share, compared to $591 million, or $4.00 per diluted share, in fiscal 2017 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $1.1 billion compared to $875 million in fiscal 2017
Free cash flow (cash flow from operations less capital expenditures) of $846 million, compared to $565 million in fiscal 2017
Gross margin for fiscal 2018 was 69.0% compared to 66.4% in the prior year. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 70.1% for fiscal 2018 compared to 68.4% in the prior year period.

Research and development (R&D) expenses for fiscal 2018 were $623 million compared to $546 million in the prior year. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 18.7%, including 0.9% attributable to Helix. This compares to 19.6% in the prior year period, including 1.0% attributable to Helix and GRAIL.

Selling, general and administrative (SG&A) expenses for fiscal 2018 were $794 million compared to $674 million in the prior year period. Excluding restructuring charges, amortization of acquired intangible assets, and acquisition related expense, non-GAAP SG&A expenses as a percentage of revenue were 23.6%, including 1.3% attributable to Helix. This compares to 23.9% in the prior year period, including 1.7% attributable to Helix and GRAIL.

"With revenue growth of 21% in 2018, Illumina delivered its 20th consecutive year of growth, with increasing adoption of innovative sequencing applications across a wide range of customers and geographies," said Francis deSouza, President and CEO. "From the evolving regulatory environment for oncology diagnostics to progress in reimbursement for non-invasive prenatal and undiagnosed disease testing, genomics is accelerating on its path into clinical standard of care."

Updates since our last earnings release:

Signed a definitive agreement to acquire Pacific Biosciences to expand biological discovery and clinical insight by adding long-read sequencing technology
Launched TruSight Oncology 500 (TSO 500) pan-cancer assay broadening insights into Tumor Mutational Burden and Microsatellite Instability. TSO 500 is shipping now as a research-use-only product
Received Breakthrough Device Designation from the FDA for Illumina’s TruSight Assay, which is based on the content of TSO 500. Illumina is seeking FDA approval of the assay as a companion diagnostic
Announced a new genotyping array and scientific contribution to support the All of Us research program
Repurchased approximately $98 million of common stock in the fourth quarter under the previously announced share repurchase program
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2019, the company projects revenue growth in the range of 13% to 14%, GAAP earnings per diluted share attributable to Illumina stockholders of $6.07 to $6.17 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $6.50 to $6.60. This guidance excludes any impact from the pending acquisition of Pacific Biosciences, which we expect to close in mid-2019.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, January 29, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (800) 708-4539, or 1 (847) 619-6396 outside North America, both with passcode 47970793.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Additionally, non-GAAP net income attributable to Illumina stockholders and diluted earnings per share attributable to Illumina stockholders are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

On January 29, 2019 Genetic Immunity, a clinical stage biotechnology company, is reported that it is expanding its collaboration with JSC Pharmadis by granting licenses to twenty cancer indications of its trans-dermally delivered pDNA-based vaccine technology (Press release, Genetic Immunity, JAN 29, 2019, View Source [SID1234554012]).

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The new indications cover twenty different cancer types including vaccines for the treatment of: prostate cancer, glioblastoma, colon & rectal cancer, Non-Hodgkin lymphoma, endometrial cancer, stomach cancer, bladder cancer, cervical cancer, lung cancer, thyroid cancer, leukemia, breast cancer, kidney cancer, ovarian cancer, liver cancer, myeloma, lip-oral cavity cancer, oesophagus cancer, brain cancer and gallbladder cancer.

"We are gratified to have expanded our collaboration with Pharmadis with the license of a tremendous portfolio of potential cancer immunotherapies. Closely following our HIV vaccine deal, the management of Pharmadis felt it would be a tremendous opportunity for them to have access to a broad range of possible treatment breakthroughs. Once they understood the basis of our platform technology, it was an easy next step for us to expand our collaboration and work with a single pharma player in Russia," stated Viktor Rozsnyay, CEO of Genetic Immunity.

"I think this is a singular collaboration, as to my knowledge, no-one has ever licensed such a broad range of product candidates based on a single product platform. We are excited for this opportunity and bring to market a revolutionary array of cancer treatments that can affect the lives of millions of people," added Rozsnyay.

Under terms of the new agreement, Pharmadis received rights to market all twenty cancer vaccines in Russia and the Commonwealth of Independent States. Genetic Immunity and Pharmadis will jointly develop all vaccines and seek Russian marketing approval. Clinical trials will be conducted beginning with prostate cancer and glioblastoma. Upon approval Genetic Immunity will receive double-digit royalties on sales.

The DermaVir immunotherapy vaccine platform contains a novel plasmid DNA that encodes disease specific antigens. The first product to demonstrate this technology is Genetic Immunity’s HIV vaccine that Pharmadis licensed in 2018. For cancer vaccines based on the technology platform the disease specific pDNA will be used with appropriate antigens coded. The vaccine is topically administered using the DermaPrep medical device.

"Upon completing our HIV vaccine license with Genetic Immunity, we continued discussion to see how we may use other products in Russia. As we became familiar with the Company’s pDNA platform technology we felt it would make sense to propose an extension to our licensing agreement to cover as many cancer types as possible. Genetic Immunity’s management agreed with our proposal and we are happy to further our collaboration. The next two to three years will be of paramount importance as we hope to bring to market a number of revolutionary cancer vaccines to combat the disease," stated Nikolai Kovalev, Managing Director of Pharmadis.

The design of pDNA needed for prostate cancer and glioblastoma is already underway. Once completed, an investigator sponsored trial will be conducted in Moscow, Russia, at the European Medical Center. The first indication will cover glioblastoma, an aggressive brain cancer, with principal investigator Professor Alexey Krivoshapkin, a world-renowned neurosurgeon.

Plasmid DNA based vaccines have been proven safe, but poorly immunogenic in human subjects. Genetic Immunity has developed several technologies to improve the immunogenicity of DNA-encoded antigens, including:

Antigeneering of plasmid DNA to safely and authentically express most of the antigens of HIV or other pathogens, including cancer.
The formulation of plasmid DNA to a pathogen-like nanoparticle called NanoComp. These nanoparticles target professional antigen-presenting cells, such as Langerhans cells and dendritic cells.
A targeted transdermal delivery device called DermaPrep. It has been shown that topical DermaPrep administration results in antigen expression in the lymph nodes by dendritic cells.

On January 29, 2019 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), a biopharmaceutical company developing its xB3 TM proprietary platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, reported that it has filed its unaudited quarterly financial statements and management’s discussion and analysis for the period ended Nov. 30, 2018 (Press release, biOasis, JAN 29, 2019, View Source [SID1234532949]). All are available under the Company’s profile on SEDAR at www.sedar.com and on the Company’s website at www.bioasis.us/investors/.

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On behalf of the Board of Directors of Bioasis Technologies Inc.

Mark Day, Ph.D., Director and President & Chief Executive Officer