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LifeSpan BioSciences Releases Best-In-Class PathPlus™ Top Performing Immunohistochemistry Antibodies for Cancer Targets

On July 23, 2019 LifeSpan BioSciences, Inc. (LSBio), the industry leader in molecular pathology, reported the first release of its PathPlus series of antibodies (Press release, LifeSpan BioSciences, JUL 23, 2019, View Source [SID1234537676]). These 565 antibodies were selected from among thousands tested and identified to be the best performing reagents for immunohistochemical detection of 200 high-value cancer targets in formalin-fixed paraffin-embedded human tissues.

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Antibody validation has become an industry roadblock as thousands of antibodies have become available to customers who face difficult choices in determining which antibodies are the best performers for each application, including immunohistochemistry, flow cytometry, ELISA, Western blot, or immunofluorescence. Antibodies that perform well in one assay, such as IHC, may not be the most specific reagent for another assay, such as flow cytometry.

"Identifying the optimal reagents to use in their experiments is a pain point for researchers," said LSBio CEO Heather Holemon. "There is a tremendous need to identify the best performers in every application from among the hundreds of antibodies that are currently available to each target."

LSBio has initiated a program to systematically identify the best performing antibodies in each application. Its initial focus is to identify those antibodies that are the best performers in immunohistochemistry on formalin-fixed paraffin-embedded tissues. With a tissue archive of over two million samples, and more than 20 years’ experience performing IHC for pharma and biotech customers, LSBio is uniquely qualified to determine which reagents are the best-in class.

Immunohistochemistry, which is the technique used by pathologists to classify tumors, is a powerful method of antibody validation because it can be used to visualize the binding of an antibody to individual cell types within complex tissues and to subcellular structures within cells such as nuclei or cell membranes. Comparing the specific binding characteristics of multiple antibodies to the same target allows LSBio to identify those that have the highest degree of specificity and least nonspecific staining.

LSBio uses a stringent validation protocol that involves blinded IHC testing of up to 20 different antibodies to a target protein on a tissue microarray containing 21 different human tissue types. The results for each antibody are analyzed and compared in order to rank them by performance. Those antibodies that show the highest specificity and least nonspecific staining on formalin-fixed paraffin-embedded tissues are offered under the PathPlus brand.

"We have a unique opportunity to leverage our leadership position in antibody validation to set the standard for providing high-quality IHC antibodies to the research and pharmaceutical communities," said Glenna Burmer, M.D., Ph.D., Chief Scientific Officer of LifeSpan. "We plan to offer multiple series of PathPlus validated reagents as we evaluate antibodies to the most important targets in the human genome."

Genmab Announces the Closing of Over-Allotment Option in Initial Public Offering of American Depositary Shares (ADSs) in the United States and Registration of Capital Increase

On July 23, 2019 Genmab A/S (Nasdaq: GMAB) reported the closing of the exercise in full by the underwriters of their over-allotment option in connection with its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the increase of its share capital by 427,500 ordinary shares as a consequence of the issuance of 427,500 ordinary shares (the "New Shares") with a nominal value of DKK 1 per share in the form of 4,275,000 ADSs in connection with the exercise (Press release, Genmab, JUL 23, 2019, View Source [SID1234537675]). The subscription price of DKK 1,181.80 per New Share equals the public offering price of $17.75 per ADS at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one, and the gross total proceeds from the issuance of the New Shares amounts to US$75,881,250 (DKK 505.2 million).

Following the registration of the New Shares today with the Danish Business Authority, Genmab’s share capital amounts to DKK 64,967,643 divided into 64,967,643 ordinary shares with a nominal value of DKK 1 each. The New Shares account for 0.7% of Genmab’s total share capital.

The New Shares rank pari passu with Genmab’s existing shares and carry the same dividend and other rights. Each New Share carries one vote at Genmab’s general meetings. Genmab only has one class of shares. The ADSs do not carry the same rights as Genmab’s ordinary shares and are not entitled to receive a dividend or vote as ordinary shares, except to the extent provided for through the depositary as record holder of the ordinary shares underlying the ADSs as set forth in the deposit agreement governing the ADSs.

Genmab’s ordinary shares were previously listed on Nasdaq Copenhagen under the symbol "GEN" and are now listed under the symbol "GMAB." The ADSs are listed on the Nasdaq Global Select Market under this symbol. The New Shares have been issued today and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 24, 2019 with the permanent ISIN code DK0010272202.

The amendments to Genmab’s articles of association as a consequence of the registration of the New Shares have been registered today with the Danish Business Authority and have been published on Genmab’s website.

The registration statement on Form F-1 relating to the Offering was declared effective by the U.S. Securities and Exchange Commission on July 17, 2019.

BofA Merrill Lynch, Morgan Stanley and Jefferies acted as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets acted as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen acted as co-managers for the Offering. A copy of the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the final prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus was issued or offered.

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

IDERA PHARMACEUTICALS ANNOUNCES APPOINTMENTS OF ELIZABETH A. TARKA, MD, FACC AS CHIEF MEDICAL OFFICER AND JOHN J. KIRBY AS CHIEF FINANCIAL OFFICER

On July 23, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported the appointments of Elizabeth A. Tarka, MD, FACC as Chief Medical Officer and the promotion of John J. Kirby to Chief Financial Officer (Press release, Idera Pharmaceuticals, JUL 23, 2019, View Source [SID1234537674]). Dr. Tarka was most recently the Vice President of Clinical Development at Complexa, Incorporated. Mr. Kirby has led Idera’s finance department as Principal Financial Officer and Principal Accounting Officer since October 2018.

"We are extremely pleased to bring Liz onto our team during this critical period for Idera as we advance tilsotolimod through its registrational trial in patients suffering from refractory metastatic melanoma and continue development work to bring the therapy to patients beyond melanoma," stated Vincent Milano, Idera’s Chief Executive Officer. "Throughout her career, Liz has demonstrated a strong track record of clinical development across therapeutic categories, which will benefit our company greatly as we work to deliver against our tilsotolimod objectives and as we also continue to aggressively explore growth opportunities in the rare disease space."

Dr. Tarka’s experience in the pharmaceutical and biotechnology industry includes leadership roles across all phases of late stage clinical development and reflects the ability to effectively partner with stakeholders to enable the successful execution of clinical trials. Prior to joining Complexa, she served as Clinical Program Leader for Xarelto (rivaroxaban) at Janssen Pharmaceuticals, where she was responsible for the design, implementation and medical oversight for large multinational trials. She also held various positions of increasing responsibility at GlaxoSmithKline in the Metabolic Pathways and Cardiovascular Therapeutic Area. She has been on the faculty and had numerous major teaching and clinical responsibilities at the University of Pennsylvania and affiliated hospitals. She is trained in Cardiology and Internal Medicine and has published in a number of peer-reviewed journals. Dr. Tarka earned a BA in Biochemistry and an MD from the University of Pennsylvania where she also completed her residency and fellowship training.

"I am excited to join the Idera team and continue to advance tilsotolimod through the ILLUMINATE-301 trial to understand the potential benefits of this novel approach in treating patients with anti-PD-1 refractory melanoma," stated Dr. Tarka. "I’m eager to work with this team to also realize the broader applications of tilsotolimod and identify additional rare disease assets to help drive the future growth of our company."

Mr. Kirby has been the Company’s Vice President of Finance since July 2018. Before joining Idera in 2015, Mr. Kirby served as Assistant Controller at Endo Pharmaceuticals. Prior to joining Endo, Mr. Kirby served as Vice President, Chief Accounting Officer and Corporate Controller at ViroPharma Incorporated. Mr. Kirby began his career at KPMG, LLP and served as a Regional Audit Director at AstraZeneca Pharmaceuticals prior to joining ViroPharma. Mr. Kirby received his Bachelor of Science from Villanova University and is a licensed certified public accountant.

"John has done a tremendous job leading our finance operations and team, and I am looking forward to continuing to work together with him as our Chief Financial Officer," continued Milano.

Supernus to Host Second Quarter 2019 Earnings Conference Call

On July 23, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the second quarter of 2019 after 5:00 p.m. ET on Tuesday, August 6, 2019 (Press release, Supernus, JUL 23, 2019, View Source;19.htm [SID1234537673]).

Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the second quarter 2019 business and financial results on Wednesday, August 7, 2019 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:
(877) 288-1043
International dial-in:
(970) 315-0267
Conference ID:
1527779
Conference Call Name:
Supernus Pharmaceuticals Second Quarter 2019 Earnings Conference Call

Following the live call, a replay will be available on the Company’s website under the ‘Investors Relations’ section. The webcast will be available on the Company’s website for 60 days following the live call.

Oncolytics Biotech® Announces Preliminary AWARE-1 Trial Data Demonstrating Viral Replication and Promotion of Inflammation Following Systemic Administration of Pelareorep When Combined with Tecentriq®

On July 23, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported completion of the three patient run-in for the AWARE-1 study in early-stage breast cancer combining pelareorep and Tecentriq (atezolizumab) (Press release, Oncolytics Biotech, JUL 23, 2019, View Source [SID1234537672]). All three patients demonstrated immunohistochemically positive viral replication in the tumor mass – two of the three patients showed greater than 50% of the tumor cells infected – following intravenous administration, generating inflammation and T cell recruitment at the tumor site. Increases in PD-L1 expression on tumor cells were noted in all patients, and early data suggest a correlation between T cell clonality and viral replication with highly infected tumors. Importantly, no additional side effects were observed with the combination of pelareorep and atezolizumab beyond those observed for each agent individually.

"Data from the Tecentriq safety run-in support our hypothesis that pelareorep can enhance tumor inflammation not only in HR+/HER2- patients but also in triple-negative breast cancer patients, and we are pleased with the favorable recommendation from the Steering Committee to advance into the next phase of the AWARE-1 study," said Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "Importantly, our previously identified biomarker of higher peripheral T cell clonality appears to correlate with patients having the most productive viral infection. As the study continues, we expect data will provide further evidence of the role of pelareorep enhancing the inflammatory process and synergizing with checkpoint blockade."

"These observations are supportive of our previous findings of improved survival in metastatic breast cancer patients which will allow us to further refine our phase three registration study," said Dr. Matt Coffey, President, and CEO of Oncolytics Biotech. "While we have previously demonstrated tumor targeting following systemic delivery in the metastatic setting, these data provide the first evidence that pelareorep can be effectively delivered intravenously and target primary breast cancer. The implications for the treatment of breast cancer in multiple settings and with immune and targeted therapies are vast. We hope to announce interim data at a scientific conference before the end of the year."

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early stage breast cancer that will enroll 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines the standard of care by breast cancer subtype with pelareorep and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.