On September 24, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported the pricing of senior unsecured notes in an aggregate principal amount of $7.25 billion, in an underwritten, registered public offering, consisting of seven tranches (Press release, Gilead Sciences, SEP 24, 2020, View Source [SID1234565574]):

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$500 million of floating rate notes maturing in 2021 (the "2021 floating rate notes")
$500 million of floating rate notes maturing in 2023 (the "2023 floating rate notes" and together with the 2021 floating rate notes, "the floating rate notes")
$2 billion of 0.75% senior notes maturing in 2023 (the "2023 fixed rate notes")
$750 million of 1.20% senior notes maturing in 2027 (the "2027 fixed rate notes")
$1 billion of 1.65% senior notes maturing in 2030 (the "2030 fixed rate notes")
$1 billion of 2.60% senior notes maturing in 2040 (the "2040 fixed rate notes")
$1.5 billion of 2.80% senior notes maturing in 2050 (the "2050 fixed rate notes")
The offering is expected to close September 30, 2020, subject to customary closing conditions.

As previously announced, Gilead entered into an Agreement and Plan of Merger with Immunomedics, Inc. ("Immunomedics") on September 13, 2020, pursuant to which Gilead will acquire Immunomedics. Under the terms of the agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Immunomedics’ common stock at a price of $88.00 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as the tender offer. The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Immunomedics shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. The acquisition is anticipated to close in the fourth quarter of 2020.

Gilead intends to use (i) the net proceeds from the floating rate notes, the 2023 fixed rate notes, the 2030 fixed rate notes and the 2040 fixed rate notes to finance a portion of the cash consideration payable in connection with the acquisition and to pay related fees and expenses and (ii) the net proceeds from the offering of the 2027 fixed rate notes and 2050 fixed rate notes to repay $1,000 million in aggregate principal amount of its 4.50% Senior Notes due 2021 and $1,250 million in aggregate principal amount of its 4.40% Senior Notes due 2021. If the acquisition is terminated or otherwise not consummated on or before September 13, 2021, Gilead will be required to redeem the floating rate notes, the 2023 fixed rate notes, the 2030 fixed rate notes and the 2040 fixed rate notes at a redemption price equal to 101% of the principal amount of such notes, plus accrued and unpaid interest. The closing of the offering is not contingent on the closing of the tender offer or the acquisition.

Barclays Capital Inc. and Wells Fargo Securities are acting as lead joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead’s effective shelf registration statement on Form S-3 (File No. 333- 242321), copies of which may be obtained from:

An electronic copy of the prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the U.S. Securities and Exchange Commission’s website at View Source This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities, 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.

On September 24, 2020 The University of New Hampshire reported that it will receive $1.8 million from the National Institutes of Health (NIH) that will further molecular research to better understand drug interactions at the cellular level and help lead to the development of new targeted drugs to treat wide-spread metabolic, growth, neurological and visual disorders including diabetes and cancer (Press release, University of New Hampshire, SEP 24, 2020, View Source [SID1234565572]).

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"This is an exciting opportunity to support some of our preliminary research that showed promise in new protein drug targets involved in several diseases," said Harish Vashisth, associate professor of chemical engineering and recipient of the NIH’s Outstanding Investigator award. "The NIH MIRA award (Maximizing Investigators’ Research Award) is meant to provide flexibility to investigators and will allow us to explore new ideas and change direction based on our findings during the process."

Vashisth and his team will use computational techniques combined with experimental data to explore new and more suitable stages in the signaling cycle of a cell protein to target drug interventions. One of the studies will focus on better understanding the folding and binding mechanisms of novel peptides, a short string of amino acids that are building blocks of proteins and perform biological functions. Researchers will look at how they affect cell surface receptor proteins, part of the tyrosine kinase family, to signal responses within the cell. Small peptides can fold and bind to the receptor and mimic the normal physiological effects of natural peptides. The goal is to understand the folding and binding and ultimately find drugs to work around the fold.

"Imagine a cell as a flexible bag with the outer surface as the cell membrane containing proteins that act as gate keepers to communicate, or sense, specific conditions outside the cell that in turn trigger a cascade of signaling inside the cell," said Vashisth.

Their second research project will take an unconventional approach to target protein-protein interactions in proteins inside the cell, part of the G-protein coupled receptor family, that are important in touch, smell and sight and are implicated in many diseases. This work would create new small molecule drugs that would cross inside the membrane rather than bind to an outside receptor. These drugs would be synthetic and not naturally occurring.

The NIH MIRA provides support for the research in an investigator’s laboratory that falls within the mission of National Institute of General Medical Sciences (NIGMS). The goal of MIRA is to provide investigators with greater stability and flexibility, allowing them to pursue new research directions as opportunities arise, thereby enhancing scientific productivity and the chances for important breakthroughs. The program helps distribute funding more widely among the nation’s highly talented and promising investigators. MIRA grants are generally for 5 years, for both established investigators and early stage investigators.

The University of New Hampshire inspires innovation and transforms lives in our state, nation, and world. More than 16,000 students from all 50 states and 71 countries engage with an award-winning faculty in top-ranked programs in business, engineering, law, health and human services, liberal arts and the sciences across more than 200 programs of study. As one of the nation’s highest-performing research universities, UNH partners with NASA, NOAA, NSF and NIH, and receives more than $110 million in competitive external funding every year to further explore and define the frontiers of land, sea and space.

On September 24, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the company launches a new concept for patient specific immunotherapy, called Neo-X-Prime (Press release, Alligator Bioscience, SEP 24, 2020, View Source [SID1234565569]). Alligator presents the concept at the scientific congress 11th World Bispecific Summit held September 22-24, 2020.

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The new concept, based on Alligator’s bispecific format RUBY, build on bispecific antibodies that physically connect tumor debris from the patient’s cancer cells with the relevant immune cells, resulting in strong and tumor selective immune activation. This is thought to increase both the accuracy of the immune attack, and the overall anti-tumor effect. The issue with today’s cancer vaccines is that it is not obvious what structure the immune system should be directed towards, and the vaccine must be produced specifically for each single patient. In Alligator’s concept, the bispecific antibody could solve all this.

"The new concept may be viewed as a patient specific therapeutic vaccination with the aim of curing cancer. The early data are extremely promising and show that Neo-X-Prime antibodies have the potential to induce anti-tumor effects superior to any current treatment option", said Per Norlén, CEO at Alligator Bioscience.
Today, September 24 at 5:20 pm CEST (1:20 pm EDT) Dr Peter Ellmark, VP Discovery at Alligator, will give a presentation with the title "Priming Neoantigen Specific T-Cells with a Novel Bispecific Antibody". For further information, see bispecific.com.

The information was submitted for publication, through the agency of the contact person set out above, at 4:45 p.m. CEST on September 24, 2020.

On September 24, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported upcoming presentations highlighting data from multiple clinical programs – including Sci-B-Vac, the company’s 3-antigen hepatitis B vaccine; VBI-2900, the company’s coronavirus vaccine program; and VBI-1901, the company’s cancer vaccine immunotherapeutic – at the World Vaccine Congress Washington 2020 and ID Week 2020 (Press release, VBI Vaccines, SEP 24, 2020, View Source [SID1234565567]).

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Presentation Details

World Vaccine Congress Washington 2020: September 28 – October 1, 2020

COVID-19 Panel Discussion: What existing treatments and vaccine development platforms show promise to control the rate of infection and spread?

Session: Emerging and Infectious

Participant: David E. Anderson, Ph.D., VBI’s Chief Scientific Officer

Date: Monday, September 28, 2020

Time: 3:50 – 5:20 PM ET

Presentation: Sci-B-Vac: Results on Ph3 Hep B vaccine

Session: Emerging and Infectious

Presenter: Francisco Diaz-Mitoma, M.D., VBI’s Chief Medical Officer

Date: Tuesday, September 29, 2020

Time: 4:35 – 5:05 PM ET

Presentation: Targeting CMV for the development of effective GBM immunotherapy

Session: Cancer & Immunotherapy

Presenter: David E. Anderson, Ph.D., VBI’s Chief Scientific Officer

Date: Wednesday, September 30, 2020

Time: 1:40 – 2:10 PM ET

World Vaccine Congress Event Website: View Source

ID Week 2020: October 21-25, 2020

Poster #: 8

Title: Higher hepatitis B antibody titers induced in all adults vaccinated with a tri-antigenic hepatitis B (HBV) vaccine, compared to a mono-antigenic HBV vaccine: results from two pivotal phase 3 double-blind, randomized studies (PROTECT and CONSTANT)

Poster Session: Adult Vaccines

Presenter: Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study

Date: Available October 21-25, 2020

Title: Rapid onset of seroprotection rates in young adults immunized with a tri-antigenic hepatitis B virus (HBV) vaccine compared to a mono-antigenic HBV vaccine

Poster Session: Hepatitis

Presenter: Timo Vesikari M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies

Date: Available October 21-25, 2020

ID Week 2020 Event Website: View Source

About Sci-B-Vac

Sci-B-Vac is a licensed, third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 750,000 patients. Sci-B-Vac is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, will comprise the basis for the regulatory submissions in the U.S., Europe, and Canada, expected to begin in the fourth quarter 2020.

To learn more about Sci-B-Vac, visit: View Source

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and is exceptionally lethal.

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illness of varying severities, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).1,2

On September 24, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the U.S. Food and Drug Administration (FDA) has cleared a new Investigational New Drug (IND) application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504, the Company’s off-the-shelf neoantigen ADXS-HOT candidate for prostate cancer (Press release, Advaxis, SEP 24, 2020, View Source [SID1234565566]). This new IND is in addition to the Advaxis sponsored IND, previously announced in January 2020. Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.

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"We are excited to announce the transition of our ADXS-504 HOT prostate program to an investigator sponsored study at this time," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "By partnering with a prestigious academic medical center, we would be gaining access to world-class expertise and a high volume of patients that together, may expedite both enrollment and eventual study results. This strategic decision also conserves resources which can be leveraged to support our encouraging and expanding HOT program in NSCLC. Our data generated to date with ADXS-503 in NSCLC leave us increasingly confident that our off-the-shelf neoantigen program can provide well-tolerated treatments with robust innate and adaptive immune responses and potential clinical activity. We look forward to the initiation of this Phase 1 study with ADXS-504 monotherapy in patients with prostate cancer before year end."