On October 18, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported the appointment of Ironwood Pharmaceuticals, Inc.’s Chief Financial Officer Gina Consylman to its Board of Directors (Press release, Verastem, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372372 [SID1234530233]). Ms. Consylman, who will also serve as the Chair of the Board’s Audit Committee, replaces Louise Phanstiel who is leaving the Board to pursue other professional opportunities.

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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

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In addition, Hagop Youssoufian, MSc, MD is transitioning to serve as Verastem Oncology’s Head of Medical Strategy from his prior role as Head of Hematology and Oncology Development. Dr. Youssoufian will be taking over responsibilities from Diep Le, MD, PhD who is stepping down as Chief Medical Officer. Kirk Taylor, MD has also joined the Company as Senior Vice President, Medical Affairs Strategy and Operations.

"We are delighted to have Gina and Kirk join the Verastem Oncology team as we enter this new period of growth with our first commercial product launch," said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. "Gina brings a unique financial acumen to the Board of Directors with more than 25 years of experience in the fields of corporate finance, accounting and tax management for commercial-stage pharmaceutical companies, including organizations navigating through first commercial product launches. Kirk is an accomplished medical affairs executive and prior practicing clinician with vast experience leading global cross-functional teams and successfully bringing drug candidates and products to market. On behalf of the entire Board and management team, we sincerely welcome Gina and Kirk and look forward to their insights and contributions."

Mr. Forrester added, "Over the past several years, Hagop has played a pivotal role in the growth and success of Verastem Oncology and I have no doubt he will continue delivering successful results with distinction. The Board and I wish to express our gratitude to Louise and Diep for their outstanding contributions and service. They have each played important roles in building the Company into what we believe will be a successful commercial organization. We wish both Louise and Diep all the very best in their future endeavors."

"Verastem Oncology is entering an exciting new chapter and I am honored to join the Board of Directors to help the Company execute on its strategic and commercial corporate goals," said Ms. Consylman. "I believe the Company is well-positioned for the next stage of evolution with a robust commercialization plan to help address the significant unmet need for the patients and families suffering from hematological malignancies."

Ms. Consylman currently serves as Senior Vice President and Chief Financial Officer of Ironwood Pharmaceuticals, Inc., a commercial biotech company, where she oversees the finance, planning, accounting, tax, treasury and insurance functions. Prior to joining Ironwood, Gina was Vice President, Corporate Controller and Principal Accounting Officer of Analogic Corporation, a healthcare and security technology solutions company, where she led the company’s global accounting and treasury teams. Prior to Analogic, Gina held senior level accounting and corporate controller positions at Biogen Inc. and Varian Semiconductor Equipment Associates, Inc. (acquired by Applied Materials, Inc.). She began her career in public accounting at Ernst & Young LLP. Ms. Consylman holds a Bachelor of Science degree in accounting from Johnson & Wales University, a Master of Science degree in taxation from Bentley University, and is a Certified Public Accountant.

Dr. Taylor brings more than 21 years of pharmaceutical industry experience and 12 years in clinical practice to Verastem Oncology. He has led cross-functional teams as Chief Medical Officer and Senior Vice President, covering many parts of the world including the United States, Europe, Latin America, North America and Asia. Dr. Taylor has held executive leadership positions at Pfizer, Actelion, Biogen, Alzheon, Sanofi Genzyme, Prescient Medicine and Finch Therapeutics. Dr. Taylor specializes in late phase development and medical affairs. Dr. Taylor received his B.A. from Harvard University and his M.D. from SUNY Downstate. He completed his internship at Roosevelt Hospital Columbia University, his residency at the Albert Einstein College of Medicine, and a Post Doctorate at The University of California San Francisco, where he also served as a faculty member.

On October 18, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, targeting tumor DNA Damage Response (DDR) to fight resistant cancers, reported that the Company was invited to present an overview of AsiDNA for the treatment of solid tumors at the 2nd DNA Damage Response Therapeutics Summit (DDRTS) to be held January 29-31, 2019, in Boston, MA (Press release, Onxeo, OCT 18, 2018, View Source [SID1234529961]).

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This leading industry summit provides the opportunity to gain exclusive insights on the latest innovations in the field of tumor DNA Damage Response. The presence of prominent pharmaceutical groups and research institutions testifies to the attractiveness of this rapidly growing field.

Onxeo will present an overview of AsiDNA, the Company’s first-in-class compound targeting tumor DNA break repair pathways, during a session entitled, "New Developments in PARP Inhibitors & Novel DDR Pathway Targets."

Françoise Bono, Chief Scientific Officer of Onxeo, said: "AsiDNA has shown unique properties in translational research, notably its ability to prevent resistance to PARP inhibitors and to potentiate their activity in cancer cells, regardless of genetic mutation status. Its strong synergy with DNA-damaging agents, such as chemotherapies and PARP inhibitors, could also open new therapeutic options in difficult-to-treat cancers. We are pleased to have been selected to present at this benchmark event among the world’s most recognized stakeholders in DNA Damage Response. This is the ideal forum to update the industry, scientific and clinical experts on the recent clinical development progress achieved with AsiDNA, a highly-differentiated molecule acting upstream of multiple DNA damage response pathways."

Session: New Developments in PARP Inhibitors & Novel DDR Pathway Targets
Date: Wednesday, January 30, 2019
Time: 2:00 pm
Location: Revere Hotel Boston Common, 200 Stuart St., Boston, MA 02116
Onxeo’s presentation: AsiDNA, A First-in-Class Decoy Oligonucleotide Targeting DNA Repair to Kill Tumor Cells

AsiDNA is an innovative global DNA damage response inhibitor preventing recruitment of enzymes involved in DSB and SSB repair at the damage site
AsiDNA is synergistic with PARP inhibitors, prevents and reverses PARPi-acquired resistance
Recent outcomes from the phase 1 clinical study of AsiDNA
For further information, please visit the DNA Damage Response Therapeutics Summit website.

On October 18, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), reported that it will announce third quarter 2018 earnings on Thursday November 1, 2018 (Press release, Shire, OCT 18, 2018, View Source [SID1234530027]).

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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

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Results press release will be issued at:

12:00 GMT / 08:00 EDT

Investor conference call time:

14:00 GMT / 10:00 EDT

Live conference call for investors:
Flemming Ornskov, MD, M.P.H., Chief Executive Officer and Thomas Dittrich, Chief Financial Officer will host the investor and analyst conference call at 10:00 am EDT / 14:00 GMT.

The details of the conference call are as follows:

UK dial in:

0800 358 9473 or +44 333 300 0804

US dial in:

1 855 857 0686 or 1 631 913 1422

International Access Numbers:

Click here

Password/Conf ID:

28705371 #

Live Webcast:

Click here

Replay:
A replay of the presentation will be made available, subject to approval by the UK Takeover Panel, for two weeks by phone and for three months by webcast. Replay information made available will be contained on the Investor Relations section of Shire’s website at View Source

For further information please contact:
Investor Relations

Christoph Brackmann [email protected] +41 41 288 4129
Sun Kim [email protected] +1 617 588 8175
Scott Burrows [email protected] +41 41 288 4195
Media
Katie Joyce [email protected] +1 781 482 2779

On October 18, 2018 Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported Medicare coverage for the DecisionDx-Melanoma test that predicts risk of metastatic disease and helps to guide use of sentinel lymph node biopsy (SLNB) in patients with cutaneous melanoma (Press release, Castle Biosciences, OCT 18, 2018, View Source [SID1234529962]).

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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

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"Improved access to the DecisionDx-Melanoma test for the 59 million Medicare recipients can drive better-informed management decisions for melanoma patients and help to safely avoid costly surgical procedures," said Derek Maetzold, President and CEO of Castle Biosciences. "Using the DecisionDx-Melanoma test to identify low-risk tumor biology and inform the discussion of SLNB options provides an important advance in the management of early stage melanoma patients."

Palmetto GBA, a Medicare Administrative Contractor (MAC), the administrator of the Medicare MolDX program that assesses molecular diagnostic technologies, issued a final local coverage determination (LCD) for the DecisionDx-Melanoma test effective December 3, 2018. Medicare beneficiaries will now have improved access to the test to help guide use of SLNB in the context of patient-specific management plans. The LCD provides for coverage of the DecisionDx-Melanoma test for SLNB eligible patients with T1 and T2 cutaneous melanoma tumors (2.0 mm in thickness or less, as defined in AJCC Staging Manual v8, 2017) and clinically negative sentinel node basins who are being considered for SLNB to determine eligibility for adjuvant therapy.

Approximately 12,000 patients had the DecisionDx-Melanoma test ordered in the last 12 months to better inform patient management decisions and help guide their melanoma care. This is an important milestone for the test, which is supported by more than 15 peer-reviewed publications including analytic and clinical validation, performance studies, and clinical utility in prospective and retrospective studies.

The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.

The DecisionDx-Melanoma test is a 31-gene expression profile (GEP) that determines a cutaneous melanoma patient’s risk for metastatic disease. The test classifies patients as having a tumor with low (Class 1) or high (Class 2) risk for developing metastasis within 5 years of diagnosis. Patients with a Class 1 tumor profile also have a low likelihood of being SLN positive. Thus, the individualized risk profile result of this test can be used to guide use of SLNB in the context of patient-specific management plans.

The use of the DecisionDx-Melanoma test to inform SLNB decision-making was validated in two multicenter, prospective cohorts totaling 1,421 patients which showed that a Class 1A test result can identify a population with a >95% likelihood of a negative SLNB (>95% negative predictive value [NPV]). For the Medicare-eligible population (65 years old and over), patients with a T1 or T2 tumor and a DecisionDx-Melanoma Class 1A result have an NPV of 98.4%. Data from retrospective studies has shown that patients with a Class 1A result have a 99.6% melanoma-specific survival rate at 5 years. Thus, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive. These patients have a very low likelihood for metastatic disease, and thus can safely avoid this surgical procedure, potentially reducing the SLNB rate by up to 52% in the Medicare population.

Sentinel Lymph Node Biopsy Background

SLNB is a surgical procedure generally recommended to assess prognosis of cutaneous melanoma patients. The procedure provides prognostic information and can determine eligibility for adjuvant therapies, but can be associated with complications, adding a significant economic burden to the healthcare system. Elderly patients account for a substantial proportion of patients with melanoma, and 60% of melanoma-related deaths occur in patients 65 years of age or older. However, while older age is associated with a poor prognosis, fewer elderly patients are found to be SLN positive, which indicates that the prognostic value of SLNB is limited in this population.

Current guidelines recommend that clinicians discuss and/or offer the SLNB procedure with patients who have a greater than 5% likelihood of SLN positivity, and do not recommend the procedure if a patient has a less than 5% likelihood of a positive SLN. For patients who are SLNB eligible, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive, and thus can safely avoid the procedure.

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On October 18, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported the pricing of an agency offering (the "Offering") of 17,144,314 units (the "Units") for gross proceeds of approximately US$12,000,000 million at a price of US$0.70 per Unit (the "Offering Price") (Press release, IntelGenx, OCT 18, 2018, View Source [SID1234530113]). Each Unit will consist of one share of common stock of the Company (an "Offered Share") and one half of one warrant (a "Warrant") each whole Warrant to purchase one share of common stock of the Company at an exercise price of US$1.00 per share (a "Warrant Share"). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.

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The Offering is made on a best efforts basis in the United States and the Canadian provinces of British Columbia, Alberta, Manitoba, Ontario and Québec. H.C. Wainwright & Co. ("Wainwright") is acting as the exclusive agent for the Units offered in the United States. Echelon Wealth Partners Inc. ("Echelon") is acting as the exclusive placement agent for the Units offered in Canada.

The closing of the Offering is expected to occur on or about October 22, 2018.

The Company has granted Echelon an over-allotment option exercisable, in whole or in part, at the sole discretion of Echelon, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the closing of the Offering, to purchase shares of common stock of the Company and/or Warrants in an amount representing up to an additional 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The Company intends to use the net proceeds of the Offering for its 2a Montelukast study, Tadalafil 505(b)(2) submission to U.S. Food and Drug Administration, and working capital.

The Company has applied to the TSX Venture Exchange ("TSXV") for approval of the listing of the Offered Shares and the Warrant Shares. The approval is subject to fulfillment by the Company of customary conditions of TSXV. There is no established trading market for the Warrants and IntelGenx does not expect a market to develop. IntelGenx does not intend to list the Warrants on any national securities exchange or any other nationally recognized trading system

The Company intends to file a final prospectus supplement (the "U.S. Supplement") to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement (the "Canadian Supplement") to the Canadian MJDS short-form base shelf prospectus dated October 15, 2018 (the "MJDS Prospectus") with respect to the Offering today.

Before investing, you should read the Canadian Supplement, the U.S. Supplement, the MJDS Prospectus and the Registration Statement as well as other documents the Company has filed or will file later today with the United States Securities and Exchange Commission (the "SEC") and the Canadian securities regulators for more complete information about the Company and this offering. Copies of the Canadian Supplement and the MJDS Prospectus are available under the Corporation’s profile at www.sedar.com and copies of the U.S. Supplement and the Registration Statement can be obtained from the SEC’s website at www.sec.gov.

Copies of the U.S. Supplement, when filed, and the Registration Statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected], and copies of the Canadian Supplement and the MJDS Prospectus may also be obtained from Echelon Wealth Partners Inc., 1 Adelaide Street East, Suite 2100, Toronto, ON M5C 2V9, by calling (416) 479-7370 or emailing [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, Units, Warrants or shares of common stock of the Company in any state or province in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state, province, or other jurisdiction.