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The Gray Foundation Announces $25 Million in New Team Science Funding for BRCA-Related Cancer Research

On July 23, 2019 The Gray Foundation reported $25M in funding for seven multi-institutional research teams to study new approaches for the early detection, diagnosis, and therapy of BRCA-related cancers (Press release, The Gray Foundation, JUL 23, 2019, View Source [SID1234537678]).

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These grants were the culmination of a strategic model designed to best align funding with the most promising topics in the field. After hosting a symposium in September 2018 for the world’s leading BRCA experts to debate the highest yielding areas of study, the Gray Foundation solicited applications for BRCA-related research proposals. Over 50 applications were vetted via a thorough review process and the Gray Foundation is awarding grants totaling $25 million to seven exceptional research teams. These multi-institutional, multi-disciplinary teams, some of which include international researchers, will receive up to $5 million each.

The 7 selected teams will commence studies into a variety of topics related to cancer risk prediction, prevention and treatment. Grants were awarded to teams led by:

Joan S. Brugge, PhD – Ludwig Center at Harvard; Harvard Medical School
Lewis C. Cantley, PhD – Sandra and Edward Meyer Cancer Center; Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center
Leif W. Ellisen, MD, PhD – Massachusetts General Hospital Cancer Center; Harvard Medical School
Charis Eng, MD PhD – Genomic Medicine Institute; Cleveland Clinic
Katherine Nathanson, MD – Abramson Cancer Center; University of Pennsylvania
Patrick Sung, D. Phil. – University of Texas Health Science Center at San Antonio
Victor E. Velculescu, MD, PhD – Johns Hopkins University School of Medicine
Other institutions contributing research as part of these teams include: Massachusetts Institute of Technology, Wellcome Sanger Institute, Beth Israel Deaconess Medical Center, University of Cambridge, Dana Farber Cancer Institute, University of British Columbia, Brigham and Women’s Hospital, Stanford University, QIMR Berghofer, Memorial Sloan Kettering Cancer Center and Case Western Reserve University.

Chi Van Dang, M.D., Ph.D., world-renowned medical oncologist and Chief Science Advisor for the Gray Foundation, oversaw the selection process. Dr. Dang commented: "We were overwhelmed with the caliber of proposals and thank all the applicants for their dedication to BRCA research. The selected teams include some of the brightest minds in cancer research and we look forward to the results of their work."

The Gray Foundation’s Mindy and Jon Gray added: "The progress being made in early detection and prevention of BRCA-related cancers is extraordinarily promising. Our goal is to accelerate this work by supporting the leading researchers in the field."

The Gray Foundation is committed to supporting BRCA research. In 2012, the Grays made a transformative gift to establish the Basser Center for BRCA at Penn Medicine’s Abramson Cancer Center. Additionally, the Foundation has made grants to a wide array of medical institutions including the Dana-Farber Cancer Institute, Duke Cancer Institute, Johns Hopkins School of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, University of Southern California Norris Comprehensive Cancer Center and Yale School of Medicine.

Crescendo Biologics’ Second Oncology-targeted Humabody® Licensed by Takeda

On July 23, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Takeda Pharmaceutical Company Limited (Takeda), has exercised a second option under its existing, multi-target collaboration and license agreement (Press release, Crescendo Biologics, JUL 23, 2019, View Source [SID1234537677]). Takeda has taken an exclusive license to Humabodies directed to another of its oncology targets.

This is the second license option that Takeda has exercised under the agreement with Crescendo and relates to the continued progression of an immuno-oncology programme. The license marks the successful delivery and further pre-clinical evaluation by Takeda of Humabody leads meeting its stringent criteria.

Theodora Harold, CEO of Crescendo, commented:

"This exciting news further underlines Crescendo’s ability to deliver innovative Humabody therapeutics which consistently meet the exacting specifications set by Takeda for progression towards the clinic. We are delighted that our close collaboration with Takeda continues to be so productive and we look forward to more successes in the future."

Chris Arendt, Head, Oncology Drug Discovery Unit & Immunology Unit, Takeda, commented:

"We are pleased that our partnership with Crescendo has continued to be fruitful in leading to another successful in-licensing milestone. This exciting immuno-oncology candidate Humabody that our teams have advanced through close collaboration aligns well with our ongoing efforts to pursue diverse modalities with transformative treatment potential."

Takeda’s option is part of the existing multi-target collaboration and license agreement announced in October 2016 in which Takeda received the right to develop and commercialize Humabody-based therapeutics resulting from the collaboration. Under the agreement, Crescendo is eligible to receive clinical development, regulatory and sales-based milestone payments of up to $754 million plus royalties on Humabody-based product sales by Takeda.

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.

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.