On October 18, 2018 Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") reported the successful results of the Pre-Clinical Trial of safety and toxicity of CAR-T cells based treatment for Acute Lymphocytic Leukemia (Press release, Biocure Technology, OCT 18, 2018, View Source [SID1234628760]).

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This is the first breakthrough milestone achieved in Korea and serves as a pre-requisite by Korea FDA (KFDA) for proceeding to an IND (Investigation of a New Drug) application.

The trial results demonstrated a complete remission of the cancerous cells within 7 and 28 days from the injection of reengineered CAR-T cells into a mouse. The study further showed encouraging results as no toxicity symptoms have risen from the high-volume injection. Company believes these to be strong indicators for the next phase clinical trials.

CAR-T cells are a novel form of potential treatment for cancer by "enlisting" and strengthening the power of a patient’s own immune system to attack cancerous tumors. T-Cells are the fundamental protection agent of the human immune system and plays a critical role in orchestrating the immune response and killing cells infected by pathogens.

CAR-T cells immunotherapy essentially "trains" or "engineers" T-Cells to recognize specific cancer related proteins or antigens (CD19 in this case) and thus attach themselves to that cancer cell and destroy it specifically without harming healthy cells. The T-Cells are taken from the patient’s own blood, being reengineered (or "trained") and reintroduced back into the body with their new abilities to fight specific cancerous cells. The "training" entails a production of new receptors on the T-Cell surface that now will enhance the T-Cell with the ability to recognize/attach itself to the cancerous cell’s surface proteins/antigens. These new T-Cell receptors are called "Chimeric Antigen Receptors" or CARs in short which coined the industry name of this novel treatment to "CAR-T".

The trial, first of its kind in the history of Korea, is a result of a wide Korean scientific collaboration. BioCure has performed the trial via its wholly owned subsidiary BiocurePharm in collaboration with Pharos Vaccine with the assistance of Osong Medical Innovation Foundations as the trial CRO (Contract Research Organization) and Croen Corp. who led the toxicity tests under GLP (Good Laboratory Practice) standards.

Biocure has successfully completed the safety test of a Biodistribution analysis study and toxicity study for single dose intravenous injection as per the Korea FDA guidelines. This milestone allows BioCure to advance into the actual production of anti-CD19 CAR-T Cell for a clinical trial.

The Company has already contracted CdmoGen Co. Ltd. and Master Cell Bank to produce a Lentiviral Vector under GMP standards necessary for advancing to the next stage of CAR-T Cell based clinical trials.

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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"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 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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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 Exelixis, Inc. (NASDAQ: EXEL) reported that its third quarter 2018 financial results will be released on Thursday, November 1, 2018 after the markets close (Press release, Exelixis, OCT 18, 2018, View Source [SID1234529963]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 1043999 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 3, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 1043999. A webcast replay will also be archived on www.exelixis.com for one year.

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.