On January 14, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that its Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, will be featured in a trial-in-progress poster at The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, taking place February 28-March 2, 2019, in San Francisco, CA (Press release, Compugen, JAN 14, 2019, View Source [SID1234532648]).

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The poster titled "A Phase 1 Study Evaluating COM701 in Patients With Advanced Solid Tumors," will be presented by Drew W. Rasco, M.D, Associate Director of Clinical Research at the South Texas Accelerated Research Therapeutics (START), San Antonio, TX and a Principal Investigator in the Phase 1 COM701 study.

The poster abstract is expected to be published on the conference website on February 25, 2019, and will reflect enrolment information as of the date of the abstract submission. The poster presentation will take place on Thursday, February 28, 2019, and will include updated enrolment information.

The poster will be available on Compugen’s website at www.cgen.com following the conference presentation.

On January 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, BeiGene, JAN 14, 2019, View Source [SID1234532635]).

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"We are very excited to receive the Breakthrough Therapy designation from the FDA," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects. We believe that the Breakthrough Therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with MCL who have received at least one prior therapy. More than 1,300 patients worldwide have been treated with zanubrutinib, and it’s being developed in a broad clinical program that currently includes seven Phase 3 or pivotal trials conducted globally or in China."

About Breakthrough Therapy Designation
The FDA’s Breakthrough Therapy designation program is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. According to the FDA’s guidelines, the features of the program include more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the following actions, as appropriate: holding meetings with the sponsor and the review team throughout the development of the drug, providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable; taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-disciplinary members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s regulatory health project manager; and involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review. The designation may be rescinded if the drug candidate does not continue to meet the criteria for Breakthrough Therapy designation.

About Mantle Cell Lymphoma
Lymphoma is a diverse group of malignancies that originates from B-, T- or NK- cells. Mantle cell lymphoma (MCL) is typically an aggressive form of non-Hodgkin lymphoma (NHL) that arises from B-cells originating in the "mantle zone." In the United States, about 70,800 new cases of NHL were expected in 2014, with MCL representing about six percent (about 4,200 cases) of all new cases of NHL in the United States. In 2013, the incidence of lymphoma was 4.2 per 100,000 and the mortality was 2.2 per 100,000 in mainland China, making it the eleventh most common cancer and the tenth leading cause of cancer death. MCL usually has a poor prognosis, with a median survival of three to four years, although occasionally patients may have an indolent course. Frequently, MCL is diagnosed at a later stage of disease.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, the currently only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted Fast Track designation for the treatment of patients with WM and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy by the U.S. Food and Drug Administration (FDA). The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

On January 14, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $77.50 per share (Press release, Alnylam, JAN 14, 2019, View Source [SID1234532650]). The gross proceeds to Alnylam from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $387,500,000. The offering is expected to close on or about January 17, 2019, subject to the satisfaction of customary closing conditions. In addition, Alnylam has granted the underwriter a 30-day option to purchase up to an additional 750,000 shares of its common stock solely to cover over-allotments. All of the shares in the offering are to be sold by Alnylam.

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Barclays Capital Inc. is acting as sole book-running manager for the offering.

Alnylam intends to use the net proceeds from this offering for general corporate purposes, including advancing the ongoing commercialization of ONPATTRO (patisiran) in the United States and Europe and, assuming favorable regulatory reviews, the potential expansion into additional countries, development efforts directed towards the potential expansion of the ONPATTRO label in the United States, continuing to advance its late stage clinical pipeline and preparing for the potential global launch of several additional products, continuing investment in its early stage pipeline, including its CNS and ocular programs, clinical trial costs and other research and development expenses, continued growth of its manufacturing, quality, commercial and medical affairs capabilities to support its commercialization efforts, potential acquisitions, investments or licenses in businesses, products or technologies that are complementary to Alnylam’s business, working capital, capital expenditures and general and administrative expenses.

The securities described above are being offered by Alnylam pursuant to an automatically effective shelf registration statement that Alnylam previously filed with the Securities and Exchange Commission (SEC).

A registration statement (including a base prospectus and a preliminary prospectus supplement) relating to these securities has been filed with the SEC and has become effective. Before you invest, you should read these and other documents Alnylam has filed with the SEC for more complete information about Alnylam and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov.

The offering will be made only by means of a prospectus supplement and related prospectus. Copies of the preliminary prospectus supplement and, when available, the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained by contacting Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717; [email protected] (phone 888-603-5847).

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

On January 13, 2019 Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Inc. ("CURE") reported that it has entered into a collaboration agreement with Y Biologics ("YB"), a private R&D company in Korea who is specialized in antibody therapeutics in cancer, autoimmune disease and metabolic disease (Press release, Biocure Technology, JAN 13, 2019, View Source [SID1234628759]). The purpose of this agreement is to research the effectiveness of combined treatment of Immune Checkpoint Inhibitor PD-1 (Programmed Cell Death Protein-1) developed by YB and anti-CD19 CAR T-Cell Therapy developed by BPK. BPK and YB believe that the above combined treatment could maximize anticancer effects and eventually develop a next generation anticancer treatment for solid tumors.

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BPK and YB agreed to collaborate in the following areas to verify combined therapy of YBL-006 and anti-CD19 CAR T-cell therapy;

Plan and implement pre-clinical trial(animal) for combined therapy
Conduct a study of action mechanism and bio marker of combined therapy
Development of anticancer treatment and exchange of information
And other essential items to fulfill the intended goal of the agreement
Dr. Sang Mok Lee, CEO & President of CURE explains "I am excited to see BPK collaborate with Y Biologics to take the first step to move forward to develop a next generation anticancer treatment for solid tumors. CURE will be able to commercialize a blood cancer immune therapy using CAR T Cell Therapy within 2 years and it is our ultimate goal to treat solid tumors with CAR T Cell Therapy. I believe that a successful outcome from this collaboration could bring CURE an opportunity to present epoch-marking anticancer therapy for solid tumors to life-threatening patients. This might be one of our most powerful pipeline products to give the significant returns to our loyal shareholders who have been supporting us for many years."

Y Biologics is a Korean private R&D Company specialized in antibody therapeutics in cancer, autoimmune disease and metabolic disease. It has three platform technologies to accelerate development of antibody therapeutics – Human antibody library, Receptor library and mammalian transient expression. Y Biologics has a plan to enter into a preclinical trial for YBL-006 imminently.

On January 11, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it has entered into an exclusive License Agreement with Knight Therapeutics Inc. (TSX: GUD) that grants Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada (Press release, Puma Biotechnology, JAN 11, 2019, https://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-knight-therapeutics-enter-exclusive-license-agreement-commercia [SID1234532621]).

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Puma Biotechnology filed a new drug submission for NERLYNX with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX in Canada.

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX at the earliest opportunity."

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.