On September 24, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy (Press release, Leap Therapeutics, SEP 24, 2020, View Source [SID1234565576]). DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.

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The Fast Track program is intended to facilitate the development and expedite the review of drug candidates and vaccines that treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. DKN-01 has also received Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer from the FDA.

"We are pleased with the FDA’s decision to grant Fast Track designation for the development of DKN-01 to treat patients with gastric and gastroesophageal junction cancer whose tumors express high levels of DKK1," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The designation highlights the existing unmet medical need for new and effective treatments for this patient population. We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01."

DKN-01 is currently being evaluated in clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. In September 2020, the first patient was dosed in the Company’s combination study of DKN-01 plus tislelizumab, BeiGene, Ltd.’s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells.

About gastric / gastroesophageal junction cancer

Gastric adenocarcinoma (gastric cancer) remains one of the most common and deadly cancers worldwide, especially among older malesi. Based on GLOBOCAN 2018 data, stomach cancer is the 5th most common neoplasm and the 3rd most deadly cancer, with an estimated 783,000 deaths globally in 2018i. Ninety-five percent of cancers of the stomach are adenocarcinomasi. Gastric cancer incidence and mortality are highly variable by region and highly dependent on diet and Helicobacter pylori infectioni. The gastroesophageal junction (GEJ) is the area where the esophagus and stomach join together. Given its anatomic location, GEJ adenocarcinomas have often been grouped together with either esophageal or gastric cancers in clinical trials.

On September 24, 2020 AbCellera and IGM Biosciences, Inc. (Nasdaq: IGMS), reported that they have entered into a multi-year, multi-target strategic research collaboration and license agreement to facilitate the discovery and development of novel IgM antibodies (Press release, IGM Biosciences, SEP 24, 2020, View Source [SID1234565575]). AbCellera will generate panels of antibodies for multiple therapeutic targets identified by IGM using its full-stack, AI-powered antibody discovery technology, and IGM will have the rights to develop and commercialize the novel antibodies resulting from this collaboration. Financial terms of the collaboration were not disclosed.

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"We believe that AbCellera’s technology will assist us in rapidly identifying the best antibodies against a large number of agonist targets, as well as other historically difficult targets, for both oncology and immunology applications," said Fred Schwarzer, CEO of IGM Biosciences. "Engineered IgM and IgA antibodies may be able to overcome some of the limitations of the current IgG-based therapeutics, and this partnership demonstrates the depth of our commitment to ensuring that the potential of our IgM and IgA technology platform is fully realized in areas of high unmet medical need."

"We believe partnerships like these, which connect breakthrough science with the teams and technologies needed to move forward quickly, are essential in expediting new therapeutic approaches against complex diseases," said Carl Hansen, Ph.D., President and CEO of AbCellera. "We look forward to working closely with IGM’s innovative team with the goal of accelerating their discovery efforts against high-value disease targets."

AbCellera sources, searches, decodes and analyzes natural immune responses to identify antibodies for next-generation therapeutics. A modern operating system for antibody discovery, the platform integrates patented and proprietary technologies to advance the development of existing and new biological modalities, from monoclonal, multi-specific, and single-domain antibodies, to bioconjugates, gene-encoded biologics, and cell therapies. IGM’s proprietary platform expands upon the inherent characteristics of IgM and IgA antibodies and is designed to enable the rapid development of engineered therapeutic antibodies. IGM’s technology allows it to create IgM and IgA antibodies with higher affinity and avidity than naturally occurring IgM and IgA antibodies, and is designed to overcome the historical difficulties in recombinantly expressing and manufacturing IgM and IgA antibodies.

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.