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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 14, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the first clinical centers of the investigator-sponsored Phase II study EMERGE are open for patient recruitment (Press release, 4SC, JAN 14, 2019, View Source [SID1234532636]). The study is conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The multi-center, single-arm, open-label study examines domatinostat (formerly 4SC-202) plus checkpoint inhibitor avelumab in up to 70 patients with advanced gastrointestinal cancer – precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Prof. Cunningham said: "Although checkpoint inhibitors are very successful in various solid tumor indications, MSS-GI cancer has proven to be largely therapy-resistant to these. The EMERGE study will seek to address this high medical need by using domatinostat to render the tumor tissue susceptible to avelumab. We need to study more drug candidates like domatinostat, which aim to broaden the efficacy of checkpoint inhibitors when used in combination."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies. We are very proud that Prof. Cunningham, a widely respected expert in the field, chose to perform the EMERGE study with domatinostat and we are looking forward to the outcome."

Related articles
20 September 2018, 4SC AG: Domatinostat plus chemotherapy – Overcoming drug resistance

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in melanoma

31 July 2018, First patient enrolled in 2nd dose cohort of Phase Ib/II study SENSITIZE of domatinostat (4SC-202) + pembrolizumab in melanoma

About domatinostat (4SC-202)

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).

As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel-cell carcinoma (MCC).

On January 14, 2019 ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, reported an update on its global placebo-controlled, double-blind phase 2 clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6 (Press release, ASLAN Pharmaceuticals, JAN 14, 2019, View Source [SID1234532652]). In the recently completed study, varlitinib did not meet the primary endpoint of significant reductions in tumour size after 12 weeks of treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Based on independent central review, patients treated with varlitinib plus mFOLFOX6 had an average tumour shrinkage of 22.0% after 12 weeks compared to 12.5% for patients treated with mFOLFOX6 alone. This difference did not reach statistical significance. Upon review of 17 progression free survival (PFS) events to date, there was a trend towards an improvement in PFS in patients treated with varlitinib.

Overall patient characteristics were well-balanced between the two arms with the exception of baseline ECOG status. The proportion of patients with the best performance status (ECOG of 0) was substantially higher in the control arm (46.2%) than in the varlitinib arm (19.2%).

Varlitinib in combination with mFOLFOX6 was very well-tolerated with 73.1% of patients taking varlitinib experiencing a grade 3 or higher adverse event compared to 88.5% of patients taking mFOLFOX6 alone.

Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals, said: "First-line gastric cancer is a very challenging indication to treat and the majority of patients present with advanced disease at initial diagnosis. To date, no targeted therapies have been approved to treat gastric cancer with low HER-family expression. Whilst we are disappointed by the study findings, we are encouraged by the positive safety data and remain confident that varlitinib’s potent pan-HER inhibition has the potential to yield benefits in biliary tract cancer where HER family expression is known to be high. We look forward to presenting the upcoming data in first-line biliary tract cancer at ASCO (Free ASCO Whitepaper) GI later this week and delivering topline data from our pivotal TreeTopp study in second-line biliary tract cancer which is expected in the second half of 2019."

ASLAN will continue to analyse data from this study, working with study investigators on the future publication of these results, and will focus on development in biliary tract cancer and other indications where varlitinib has shown activity.

Ends

Media and IR contacts

Emma Thompson

Robert Uhl

Spurwing Communications

Westwicke Partners

Tel: +65 6340 7287

Tel: +1 858 356 5932

Email: [email protected]

Email: [email protected]

About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.