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BioLineRx Announces Pricing of $15.4 Million Underwritten Public Offering of its American Depositary Shares and Warrants

On February 5, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has priced an underwritten public offering of 28,000,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, and warrants to purchase 28,000,000 ADSs, at a public offering price of $0.55 per ADS and accompanying warrant (Press release, BioLineRx, FEB 5, 2019, View Source;p=RssLanding&cat=news&id=2386087 [SID1234533062]). The warrants will be exercisable immediately, will expire five years from the date of issuance and will have an exercise price of $0.75 per ADS. The gross proceeds of the offering to the Company are expected to be $15.4 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioLineRx, and excluding the exercise of any warrants. All of the securities in the offering are to be sold by BioLineRx. The closing of the offering is expected to occur on or about February 7, 2019, subject to customary closing conditions. BioLineRx anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.

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Oppenheimer & Co. Inc. acted as sole book-running manager for the offering. Maxim Group LLC acted as co-manager for the offering.

The securities described above will be issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement related to the offering was filed with the SEC on February 4, 2019 and is available on the SEC’s website located at www.sec.gov. The final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement may also be obtained, when available, from Oppenheimer & Co. Inc., 85 Broad St., 26th Floor, New York, New York 10004, Attention: Syndicate Prospectus Department, or by telephone: (212) 667-8055 or by email: [email protected].

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

BerGenBio ASA: Invitation to Fourth Quarter and Full Year 2018 Results Presentation and Webcast

On February 5, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the fourth quarter and full year 2018 on Tuesday, 12 February 2019 (Press release, BerGenBio, FEB 5, 2019, View Source [SID1234533060]). A presentation by BerGenBio’s senior management team will take place at 10:00 am CET at:

Hotel Continental
Stortingsgaten 24/26
0117 Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

Moleculin Announces the FDA has Granted Orphan Drug Designation for its Brain Tumor Drug

On February 5, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Status for its drug candidate WP1066 for the treatment of glioblastoma, the most aggressive form of brain tumor (Press release, Moleculin, FEB 5, 2019, View Source [SID1234533053]).

"We continue to be encouraged by the progress of the physician-led clinical trial of WP1066," commented Walter Klemp, Moleculin’s Chairman and CEO, "and, now having the FDA grant Orphan Drug status for WP1066 positions us well for potential marketing of this drug. We believe that WP1066 represents a new class of drugs which we call ‘Immune/Transduction Modulators’ because it has demonstrated the ability in preclinical testing in animals to both stimulate a natural immune response to tumors and directly attack tumor cells by inhibiting multiple key oncogenic transcription factors, including STAT3, HIF1-α and c-Myc."

Dr. Sandra Silberman, Chief Medical Officer for New Projects at Moleculin added: "The development of WP1066 is gaining momentum. In addition to the glioblastoma trial at MD Anderson, we have had interest from additional investigators, including Emory University and Mayo Clinic for conducting clinical trials for the treatment of pediatric brain tumors, as well as others interested in treating a range of highly resistant tumors including AML and pancreatic cancer. Because we’ve seen strong anti-tumor activity in a wide range of animal models, we believe this represents an important new approach to treating many types of cancer."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment

On February 5, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) with residual disease after neoadjuvant (before surgery) treatment (Press release, Hoffmann-La Roche, FEB 5, 2019, View Source [SID1234533047]). The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.[1,2] For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.[3]

"Kadcyla was granted Breakthrough Therapy Designation and is also the first Roche medicine to be reviewed under the FDA’s Real-Time Oncology Review pilot programme; both FDA initiatives aim to expedite reviews and bring medicines to patients sooner" said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring Kadcyla to people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy as early as possible."

This application is based on results of the phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual disease present following neoadjuvant treatment.[4] People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%.[4]

The most common Grade 3-4 side effects (>1%) with Kadcyla in the KATHERINE study were decreased platelet count; high blood pressure; radiation-induced skin injury; numbness, tingling or pain in the hands or feet; decreased neutrophil count; low blood potassium level; fatigue and decrease in red blood cells.[4]

About the KATHERINE study[5]
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomisation free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues.[6,7] It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.[8] Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.[9] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

ENB Therapeutics Announces Clinical Trial Collaboration with Merck to Evaluate ENB-003 in combination with KEYTRUDA® (pembrolizumab) for Advanced Solid Tumors

On February 4th, 2019 ENB Therapeutics, Inc., a clinical-stage, biopharmaceutical company developing innovative, endothelin-based oncologics, reported that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of ENB-003, a first-in class endothelin B receptor ("ETBR") inhibitor and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1/2 trial in patients with advanced solid tumors (Press release, ENB Therapeutics, FEB 4, 2019, View Source [SID1234626430]). The open-label, dose-escalation and expansion Phase 1/2 study will enroll patients with anti-PD-1 resistant malignant melanoma, platinum-resistant ovarian or pancreatic cancer with previous treatment failure. The dose escalation phase of the trial will evaluate the safety and tolerability of various doses of ENB-003 as a monotherapy and in combination with KEYTRUDA. The dose expansion will evaluate preliminary efficacy, safety and tolerability of the selected dose of ENB-003 combined with KEYTRUDA as well as changes in immunohistochemistry and pharmacodynamic biomarkers after administration of ENB-003.

"We are thrilled to collaborate with Merck, an established leader in the field of cancer immunotherapy," said Sumayah Jamal, M.D., Ph.D., President and CSO of ENB Therapeutics. "ENB-003 has both antitumor and immune-modulatory effects and augments the efficacy of anti-PD-1 inhibition in animal models. We are optimistic about exploring the combination of ENB-003 and KEYTRUDA ."

Under the terms of the agreement, ENB Therapeutics will sponsor the ENB-003 and KEYTRUDA clinical study.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.