Additional product patent in the US for HyNap-Dasa

On February 12, 2020 Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) reported that the United States Patent and Trademark Office (USPTO) has granted Xspray a new US patent for HyNap-Dasa (Press release, Xspray, FEB 12, 2020, View Source [SID1234649566]). The new patent, US 10,555,937, covers the pharmaceutical composition of the company’s primary product candidate, HyNap-Dasa. This is Xspray’s fourth product patent in the United States, which is the company’s main market. The patent is valid until January 11, 2033.
"This new patent on our most important market is yet another confirmation of our innovative development work. The formal clinical bioequivalence of the company’s primary product candidate HyNap-Dasa, which has been previously communicated, means that the patent further strengthens our position in negotiations with potential partners", says Per Andersson, CEO of Xspray.

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Xspray strives to obtain patents for both composition and technology and this new patent claims an amorphous solid dispersion (pharmaceutical composition) of dasatinib.

"Our strategic patent work will generate additional patents in the United States on our product candidates in the near future. The new HyNap-Dasa patent makes it significantly more difficult for other companies to launch a dasatinib product based on amorphous solid dispersion in the United States during the lifetime of the patent, i.e. up until January 2033", Per Andersson concludes.

Fortress Biotech Announces Pricing of Series A Preferred Stock Offering

On February 12, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported that it has priced an underwritten public offering of 625,000 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $20 per share, with expected gross proceeds to Fortress of $12.5 million (Press release, Fortress Biotech, FEB 12, 2020, View Source [SID1234554215]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 93,750 additional shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 14, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

The offering is being made by Fortress pursuant to an effective shelf registration statement on Form S-3 (File 333-226089) previously filed with the Securities Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the SEC’s website at www.sec.gov.

Illumina to Webcast Upcoming Investor Conference Presentations

On February 12, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conferences and invited investors to participate via webcast (Press release, Illumina, FEB 12, 2020, View Source [SID1234554233]).

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SVB Leerink Global Healthcare Conference in New York, NY
Wednesday, February 26, 2020 at 11:00 a.m. Eastern Time

Cowen Annual Health Care Conference in Boston, MA
Tuesday, March 3, 2020 at 11:20 a.m. Eastern Time

The live webcasts can be accessed in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentations will be posted on Illumina’s website after the event and will be available for at least 30 days following.

NETRF funds $3.5 million in research to advance neuroendocrine tumor treatment

On February 12, 2020 The Neuroendocrine Tumor Research Foundation (NETRF), Boston, MA, reported $3.5 million in neuroendocrine tumor (NET) research grants to fund 12 projects around the world in pursuit of more precise treatments for this uncommon cancer affecting an estimated 171,000 Americans (Press release, NETRF, FEB 12, 2020, View Source [SID1234554385]).

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After investing $26 million in research during the past 15 years, NETRF has helped to establish the NET knowledge base needed to expand the exploration of improved treatments, according to Elyse Gellerman, NETRF chief executive officer. "We can see real momentum in this new round of grants. We hope the discoveries from these projects will lead to improved treatment options for patients."

NETRF is supporting a new pioneering approach to NET immunotherapy with a Petersen Accelerator Award to Steven Libutti, MD, Rutgers Cancer Institute of New Jersey, to characterize a novel immune regulator called B7x to determine whether it has a role in shutting off the body’s immune response to fight against pancreatic NETs.

This round of funding features multiple new fronts for NETRF. To help grow the NET scientific workforce, the Foundation granted two inaugural Mentored Awards for early career researchers, one of which was funded by an educational grant from Ipsen. There were also new areas of NET inquiry. For the first time, NETRF is funding pheochromocytoma and paraganglioma research, including an evaluation of a novel radiotracer for imaging adrenal NETs.

NETRF also funded four research projects in lung NETs, an area that has not previously received the attention of other NET sites. These lung studies include:

Conducting single-cell genomic analyses to understand how lung NETs form, grow, and spread.
Mapping the cellular networks of typical and atypical lung NETs to find biomarkers that help predict a tumor’s aggressiveness.
Characterizing the molecular makeup of a newly identified, aggressive lung NET called "supra-carcinoid."
Determining the sociodemographic and geographic patterns of lung NETs in California.
"Advances in NET research have been hampered by the lack of effective laboratory disease models, and a limited understanding of the molecular and genetic profiles of NETs," said John Kanki, PhD, NETRF director of research. "Now that we are making strong headway along these lines, we can finally begin to drill deeper with greater specificity, to identify and explore new strategies for treating NETs."

NET tumors require the expansion of new blood vessels in order to grow and spread and two new grants explore new therapies that target developing tumor blood vessels. Researchers at Vanderbilt University will explore the potential efficacy of a combination therapy testing a drug known to affect the formation of new blood vessels (cabozantinib) together with an experimental drug called CB-839. At Columbia University Medical School, scientists will conduct preclinical laboratory experiments to test whether turning off two complementary blood vessel-forming processes together can improve therapeutic efficacy in pancreatic NETs.

NETRF also approved grants to study a potential cause of small intestinal multifocal tumors and to evaluate the role of the gut microbiome in carcinoid syndrome.

Seventy-five percent of the grants were awarded to research institutions that are new to NETRF including five grants funding international research at Erasmus MC, University Medical Center Rotterdam, Netherlands; Hebrew University of Jerusalem, Israel; International Agency for Research on Cancer (IARC-WHO), Lyon, France; Istituto Auxologico Italiano – Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy; and Weizmann Institute of Science, Rehovot, Israel.

Seven of the 12 grants fund innovative NET research at American academic institutions, including Columbia University Medical Center, New York, NY; Dana-Farber Cancer Institute, Boston, MA; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; University of California, San Francisco, CA; Tufts Medical Center, Boston, MA; University of Michigan, Ann Arbor, MI; and Vanderbilt University Medical Center, Nashville, TN.

The NETRF grant process is a competitive and structured peer-reviewed process. The Foundation is currently accepting applications for its next grant cycle. Applications must be received by March 9, 2020. View Source

Gellerman thanked the many individuals and foundations whose gifts to the 501(c)(3) nonprofit organization support NETRF’s research and educational activities. A generous gift from the Margie and Robert E. Petersen Foundation will fund several of the new projects. Additional support has been provided by the Goldhirsh-Yellin Foundation of Los Angeles and Advanced Accelerator Applications.

Anixa Biosciences and Moffitt Cancer Center Announce Completion of Viral Vector Reformulation for CAR-T Program

On February 12, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that the research team lead by Dr. Jose Conejo-Garcia, Chair of the Department of Immunology at Moffitt Cancer Center, Anixa’s development partner, has completed and validated the reformulation of the viral vector necessary for its CAR-T program (Press release, Anixa Biosciences, FEB 12, 2020, View Source [SID1234554216]).

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Last year, Anixa announced, that in order to improve the potential efficacy of its CAR-T therapy, it would reformulate the viral vector used to infect and engineer each individual patient’s T-cells. The purpose was to increase the expression level of the Follicle Stimulating Hormone (FSH) on the engineered, autologous T-cells. With the successful viral vector reformulation, verification and validation, the new viral formulation is now being manufactured under Good Manufacturing Practice (GMP) conditions. This manufacturing process is expected to take approximately three months and Anixa and Moffitt remain on track to file the Investigational New Drug (IND) application in 2020.

CAR-T therapy requires the extraction and isolation of an individual’s T-cells, followed by engineering these cells to enable them to more effectively kill cancer. These cells are then expanded and reinfused into the patient. Engineering these cells is performed by using a virus that itself has been engineered. The engineered virus initially infects the T-cells. Successive to infection, the virus induces the cellular machinery of the patient’s T-cell to create on its surface, the "homing missiles" which in the case of Anixa’s therapy are FSH molecules. It is expected that a T-cell with more FSH on the surface will be more effective at targeting ovarian cancer.

Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased to have completed this first milestone in our development program and remain confident in our previously stated development timeline."

"Our laboratory completed the reformulation of the viral vector, and we have demonstrated its ability to increase the concentration of FSH on the surface of transformed human T-cells. We expect the increased expression of FSH to provide better efficacy of our drug for ovarian cancer patients. We are looking forward to taking this therapy into the clinic as soon as possible," stated Dr. Conejo-Garcia.