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Quest Diagnostics to Present New Insights from Genetic Testing at the 2019 Annual American College of Medical Genetics and Genomics Annual Clinical Genetics Meeting

On March 26, 2019 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will present results of eight studies at the 2019 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting, to be held April 2 – 6, 2019 in Seattle, Wash (Press release, Quest Diagnostics, MAR 26, 2019, View Source [SID1234534666]). (Quest Diagnostics booth 929). These studies by Quest Diagnostics researchers evaluate a broad range of laboratory technologies and best practices for aiding in the evaluation of risk for cancer and other diseases.

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Among the research is a study that uses a "virtual panel" to estimate genetic disease prevalence in ethnic populations; and a study of associations between certain colorectal cancer genes and risk for breast cancer.

"With so much attention on new therapeutics for cancer and other disorders, people sometimes forget the crucial role of diagnostic insights in guiding treatments to improve outcomes. Genetics and genomics have a greater impact on the treatment and management of cancer and other disorders than ever before," said Felicitas Lacbawan, MD, FCAP, FACMG, Vice President and Executive Medical Director, Advanced Diagnostics Quest Diagnostics. "Quest is delivering diagnostic innovations that provide these insights through its advanced diagnostic services so more people can benefit from new, innovative treatments personalized for them."

A study titled "Anticipated Positive Rates for Genetic Testing in the General Population: a ‘Virtual Panel’ Approach" (Poster 736) evaluates a method for estimating the rate of positivity for multi-gene testing panels in the general population and ethnic sub-populations. The study uses hereditary cancer genes as an example. The level of disease prevalence in a population influences test design and results interpretation. The Quest team developed a method to better predict disease prevalence for inherited cancer genes in ethnic groups, many of which have been traditionally under-represented in genetic testing research.

Another study, "Lynch Syndrome Families with Breast Cancer: Majority of Observed Mutations Are in MSH6 and PMS2," (Poster 220) examined the clinical and family histories of individuals positive for a Lynch syndrome mutation. Lynch syndrome, historically known as hereditary non-polyposis colorectal cancer (HNPCC), is an inherited cancer syndrome associated with a predisposition to colorectal and other cancers. The researchers analyzed the frequency of breast cancer in this population to determine the relationship between Lynch syndrome genes and breast cancer and observed an association with the MSH6 and PMS2 genes. These data, which are in line with previous findings, may help refine breast cancer risk assessment in families with Lynch syndrome, guiding clinical surveillance and management.

Quest is a leader in advanced diagnostics, including the areas of genetic and genomics. The company offers more than 1000 genetic tests, including whole exome sequencing, germline and somatic gene sequencing, noninvasive prenatal screening, pharmacogenomics as well as cytogenetics and biochemical genetic testing. The company’s 650 MDs and PhDs and genetic counselors aid physicians in test selection and interpretation and publish hundreds of studies each year. In Advanced Diagnostics – Genetics, Genomics and R&D alone, there are at least 75 PhDs, MDs and MD/PhDs with 60 board-certified scientific and medical directors.

Abstracts can be accessed on the ACMG website at: View Source;search_type=abstracts&event_id=13

Among the Quest Diagnostics scientific and clinical work being presented at the meeting are:

Double Heterozygotes and Carriers of Biallelic Pathogenic Variants Identified During Genetic Testing for Hereditary Cancer Risk at a Diagnostic Laboratory (Poster: 211)
Lynch Syndrome Families with Breast Cancer: Majority of Observed Mutations Are in MSH6 and PMS2 (Poster 220)
Preliminary Insight from CADASIL Testing: Using Aggregate Patient Data to Correlate Position of Variants in NOTCH3 to Severity of Disease (Poster: 228)
Standards for the Classification and Reporting of Constitutional Copy Number Variants: A ClinGen/ACMG Joint Consensus Recommendation (Poster: 682)
Looming False Negatives: Reconsidering the Clinical Significance of Synonymous Variants (Poster: 705)
Anticipated Positive Rates for Genetic Testing in the General Population: A "Virtual Panel" Approach (Poster 736)
Maternal Chimerism as a Cause of Confounded Gender Reporting and Gender Discordance During cfDNA Screening (Poster: 897)
Confirmatory methods used for germline NGS Testing Teach Us About the Strengths and Weaknesses of Molecular Technologies (Poster: 8781)

Aeterna Zentaris Reports Fourth Quarter and Full-Year 2018 Financial and Operating Results

On March 26, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) reported its financial and operating results for the fourth quarter and year ended December 31, 2018 (Press release, AEterna Zentaris, MAR 26, 2019, View Source [SID1234534653]).

All Amounts are in U.S. Dollars

Highlights

Total revenue for fiscal 2018 was $26.9 million, compared to $0.9 million for fiscal 2017

Income from operations for fiscal 2018 was $9.8 million, compared to a loss from operations of $23.1 million for fiscal 2017

Net income for fiscal 2018 was $4.2 million, compared to a net loss of $16.8 million for fiscal 2017

Total revenue for Q4 2018 was $1.4 million, compared to $0.2 million for Q4 2017

After our year-end, in January 2019, European Medicines Agency (EMA) granted marketing authorization for macimorelin for diagnosis of adult growth hormone deficiency

As of December 31, 2018, we had $14.5 million of unrestricted cash and cash equivalents
Summary of Full-Year Results

For the year ended December 31, 2018, we reported a consolidated net income of $4.2 million, or $0.25 per common share, as compared with a consolidated net loss of $16.8 million, or $1.12 loss per common share, for the year ended December 31, 2017. The $21 million improvement in results arose primarily from a $23.9 million increase in gross profit (which resulted primarily from the $24 million royalty payment received from Strongbridge Biopharma) and a $9.1 million reduction in operating expenses. These improvements were offset in part by the $5.55 million in tax expense in 2018 (compared to a tax recovery in 2017 of $3.5 million) and $1.6 million decrease in net finance income.

Revenues

Our total revenue for the year ended December 31, 2018 was $26.9 million as compared with $0.9 million for the same period in 2017, representing an increase of $26.0 million. The 2018 revenue comprised $24.3 million in license revenue, $2.2 million in product sales, $0.2 million in royalty income and $0.2 million in sales commissions as compared with $0.4 million in license fee and $0.5 million in license fees in 2017. The increase in total revenue in 2018 relates to license fees, royalty income and product sales associated with executing the License and Assignment Agreement for Macrilen (macimorelin) in January 2018.

Cost of sales

Our total cost of goods sold for the year ended December 31, 2018 was $2.1 million as compared with nil for the same period in 2017, reflecting the costs of our sales of Macrilen (macimorelin) inventory pursuant to an interim supply agreement under the License and Assignment Agreement.

Operating Expenses

Our total operating expenses for the year ended December 31, 2018 was $14.9 million as compared with $24.0 million for the same period in 2017, representing a decline of $9.1 million. This was primarily due to a $7.8 million decline in research and development costs, while the $2.0 million decrease in selling expenses was offset by $0.1 million increase in general and administrative expenses.

In 2018, our focus was on our PIP study for Macrilen (macimorelin), for which we received $0.4 million from our licensee for its share of such costs.

Our general and administrative expenses were higher in 2018 than expected as we incurred significant legal costs in the course of reaching settlement agreements for $1.4 million.

Our selling expenses are in-line with expectations and lower in 2018 than in 2017 due to the Q1 2018 termination of our North American sales team and our co-promotion activities as we shifted our focus to licensing Macrilen (macimorelin).

Net Finance Income

Our net finance income for the year ended December 31, 2018 was $1.2 million, as compared to $2.8 million for the same period in 2017, representing a decrease of $1.6 million. The decline in net finance income is primarily due to the change in fair value of our warrant liability. Such change in fair value results from the periodic "mark-to-market" revaluation via the application of pricing models to our outstanding share purchase warrants.

Summary of Fourth Quarter Results

For the three-month period ended December 31, 2018, we reported a consolidated net loss of $5.1 million, or $0.31 loss per common share, as compared with a consolidated net loss of $0.5 million, or $0.03 loss per common share, for the three-month period ended December 31, 2017. The $4.6 million increase in net loss in 2018, as compared with 2017, results primarily from $2.8 million in tax expense movement, $1.4 million increase in cost of goods, $0.9 million increase in finance costs and $0.8 million increase in settlements, offset by $1.2 million increase in total revenues. In the fourth quarter of 2018, unlike in 2017, we earned $0.2 million in royalty income from our licensee and expensed $0.8 million in one-time settlement costs to settle a lawsuit against the Company from two of our former executives. In the fourth quarter of 2018 we also actively began the EMA and FDA pediatric study for Macrilen (macimorelin).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and fiscal 2018, as well as the Company’s audited consolidated financial statements as at December 31, 2018, 2017 and for the years ended December 31, 2018, 2017 and 2016 will be available at www.zentaris.com in the "Investors" section or at the Company’s profile at www.sedar.com and www.sec.gov.

Annual and Special Meeting of Shareholders

The Company has scheduled its annual shareholders meeting for 10:00 am (Eastern time) on May 8, 2019 at 1155 René-Lévesque Blvd. West, 41st Floor, Montreal, Quebec. At that meeting, in addition to the presentation of the Company’s annual financial statements, the election of directors and the appointment of the Company’s auditors, shareholders will also consider resolutions to move the Company’s registered address from Quebec to Ontario, and to renew and amend the Company’s existing shareholders rights plan. These matters are described in detail in the Company’s 2019 Management Proxy Circular. This proxy circular and a copy of the proposed amended and restated shareholders rights plan will be available at www.sedar.com and www.sec.gov.

At the Company’s 2019 annual and special meeting, the Company will be proposing that the size of its board of directors be reduced from seven to five, with Mr. Mike Cardiff having resigned from the board of directors for personal reasons in March 2019 and Mr. Juergen Ernst having indicated to the Company his desire not to be nominated for re-election. The Company thanks both of them for their service to the Company.

Moleculin Announces Proposed Underwritten Public Offering

On March 26, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it intends to offer and sell units consisting of shares of common stock and warrants in an underwritten public offering (Press release, Moleculin, MAR 26, 2019, View Source [SID1234534647]). All units in the offering will be sold by Moleculin. The proposed offering is subject to market and other conditions. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Abcuro Announces Pre-Clinical Data on New Immuno-Oncology Target

On March 26, 2019 Abcuro, Inc., a biopharmaceutical company developing first-in-class immunomodulatory therapeutics, reported the publication of proof-of-concept data describing KLRG1 as a promising new target for cancer immunotherapy (Press release, Abcuro, MAR 26, 2019, View Source [SID1234534646]). The article, published in Oncotarget ( link ), reports the anticancer activity of KLRG1 antibody blockade in syngeneic mouse models of breast cancer, colon cancer and melanoma. The study also highlights the expression of KLRG1 in human tumor infiltrating lymphocytes (TILs) and its role in adaptive resistance to immunotherapies.

KLRG1 was identified as a critical immune inhibitory receptor by datamining expression profile databases with the aim of finding immune checkpoint receptors that align with the state of T cell differentiation. This analysis showed that KLRG1 is, genome wide, the immune inhibitory receptor that best aligns with degree of T cell differentiation. Compared to other clinical targets that are active in early and intermediate stages of T cell differentiation (such as CTLA-4 and PD-1), KLRG1 functions as the ultimate break on the most differentiated and cytotoxic T cells. Furthermore, KLRG1 expression on a differentiated subset of T cells and the high cytotoxic potential of these cells strongly suggests a beneficial therapeutic combination with existing treatments.

The results presented in the publication show in vivo proof-of-concept for the anti-cancer action resulting from KLRG1 blockade in mouse syngeneic models and highlight KLRG1 as an important driver of adaptive resistance to immunotherapy in humans. Abcuro has discovered KLRG1 blocking antibodies and is developing first-in-class new immunotherapy agents for treatment of cancer.

Charles River Laboratories Highlights Commitment to Oncology Research at 2019 AACR Annual Meeting

On March 26, 2019 Charles River Laboratories International, Inc. (NYSE: CRL) reported that its team of oncology experts will attend the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, with 19 scientific posters and two oral presentations to highlight its enhanced oncology portfolio (Press release, Charles River Laboratories, MAR 26, 2019, View Source [SID1234534645]). The meeting is taking place from March 29-April 3, 2019, at the Georgia World Congress Center in Atlanta, Georgia.

Charles River’s team of industry-leading oncology experts have been named as co-inventors on more than 60 patents secured by clients for compounds with an oncology indication, including one launched product, and have produced numerous development candidates in this therapeutic area. Additionally, the Company worked on over 85 percent of all oncology therapies approved by the FDA in 2018. At the AACR (Free AACR Whitepaper) Annual Meeting, researchers will present recent work utilizing emerging tools and approaches for cancer research.

Combination Therapies for Breast Cancer

PARP inhibitors have shown promise when used in combination with immunotherapy in women with breast and ovarian cancers who carry the BRCA mutations. In an oral presentation at the AACR (Free AACR Whitepaper) Annual Meeting, Julia Schueler, DVM, PhD, Research Director at Charles River, will discuss the crosstalk identified between PARP inhibitors and immune checkpoint inhibitors in cell and research models expressing the BRCA mutation. The crosstalk suggests this drug combination might be effective in women suffering from BRCA1-driven malignancies.

Monday, April 1, 3:35-3:50 p.m.: Modulation of the tumor infiltrating lymphocyte population by PARP inhibitor Talazoparib in combination with anti-PD1 treatment significantly enhances overall survival in a murine BRCA1-/- breast cancer model
Collaboration in Pediatric Oncology

Cancer remains the leading cause of death from disease among children, making a continued focus on research in this field extremely important. Charles River has partnered with Meds4Kids Pharma (M4K), an organization using open science to revolutionize how affordable new treatments are discovered and developed.

Since 2017, Charles River has donated drug discovery services to M4K, including medicinal and synthetic chemistry. Working collaboratively with M4K and their open science partners, the team has made progress towards the identification of potent, selective, brain-penetrant ALK2 inhibitors.

At the AACR (Free AACR Whitepaper) Annual Meeting, Sue Cramp, PhD, Team Leader, Chemistry at Charles River, will give an oral presentation on work conducted with M4K, the Ontario Institute for Cancer Research, and the Structural Genomics Consortium. She will discuss their combined efforts to generate an orally-available, brain-penetrant therapeutic to treat Diffuse Intrinsic Pontine Glioma (DIPG), a rare, aggressive, and uniformly fatal childhood brain cancer.

Tuesday, April 2, 3:00-5:00 p.m.: Open science medicinal chemistry: Towards a treatment for DIPG
Additionally, Charles River is a part of the Innovative Therapies for Children with Cancer Paediatric Preclinical Proof-of-Concept Platform (ITCC-P4), a public-private partnership with 21 members focused on establishing 400 new patient-derived xenografts (PDX) of high-risk pediatric tumors. By establishing and characterizing these PDXs, the consortium, funded under IMI2 Grant Agreement No. 116064, aims to build a sustainable, comprehensive platform for more translational drug testing.

Tuulia Huhtala, PhD, Head of Biomarkers and Molecular Imaging at Charles River, will present a poster based on the work done in characterizing these PDXs, which demonstrates the essential role of imaging in both clinical diagnosis and monitoring therapy response. The presentation will review volumetric, metabolic, and functional changes in an orthotopic PDX brain tumor model using MRI, MRS, and PET imaging.

Monday, April 1, 1:00-5:00 p.m.: Translational imaging findings in a pediatric patient-derived orthotopic xenograft brain tumor model
Charles River Launches New Drug Discovery Platforms

At the AACR (Free AACR Whitepaper) Annual Meeting Charles River is also launching a new model for oncology research. The HuPBMC-NCG Humanized Model is a humanized, PBMC-engrafted NCG mouse. This study-ready model eliminates the time, energy, and resources spent validating and humanizing a model, enabling researchers to quickly initiate short-term in vivo studies.

Humanized mice, which harbor human immune cells, can be utilized to test the safety and efficacy of compounds that manipulate the immune system to fight cancer. The HuPBMC-NCG Humanized Model will be commercially available in April 2019.

In addition, Distributed Bio scientists will join the Charles River team to highlight their recently announced partnership. A combination of Distributed Bio’s antibody discovery platform and Charles River’s extensive drug development expertise creates an elite end-to-end solution for therapeutic antibody discovery and development. With access to the Distributed Bio’s SuperHuman, AbGenesis, and Tumbler technologies, clients can discover, analyze, and engineer therapeutic antibodies with unprecedented speed.

A full schedule of Charles River’s activities during AACR (Free AACR Whitepaper) 2019 is available online. Reprints of each poster will be available in Booth 2914 during the conference, and Charles River experts will be available for meetings to discuss how an integrated approach can support drug discovery and development programs from hit identification to IND (Investigational New Drug) filing.

Throughout the conference, Charles River will be providing live updates on the Eureka Blog, including reviews of scientific sessions and input on the research being presented.

Approved Quotes

"Cancer remains a leading cause of death by disease across the globe. Our researchers are committed to finding novel treatments by harnessing innovative tools and methodologies." – Birgit Girshick, Corporate Executive Vice President, Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River
"The AACR (Free AACR Whitepaper) Annual Meeting affords us a unique opportunity to share our research in oncology and learn from our peers. I am hopeful that our presentation on the use of combination therapies in breast cancer treatment will inspire continued research in this promising area." – Julia Schueler, DVM, PhD, Research Director at Charles River
"For pediatric cancer patients, time is essential. I am proud that Charles River is part of collaborative groups, like M4K and ITCC-P4, that unite the best minds in the industry to focus on finding the most promising targets." – Ian Waddell, PhD, Executive Director, Biology at Charles River