On January 23, 2019 CEL-SCI Corporation (NYSE American: CVM) reported the U.S. Patent and Trademark Office has issued two new U.S. patents for the Company’s LEAPS platform technology (Press release, Cel-Sci, JAN 23, 2019, View Source [SID1234532831]).

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U.S. patent office issues CEL-SCI two patents for its LEAPS vaccine platform technology

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Patent #10,179,174 B2 titled "Method for inducing an immune response and formulations thereof" is focused on influenza
Patent #10,179,164 B2 titled "Method for inducing an immune response for treatment of cancer and autoimmune diseases or conditions"
CEL-SCI’s LEAPS inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides. LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.

The LEAPS platform technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis (RA) under a $1.5 million grant from the U.S. National Institutes of Health (NIH). Upon completion of preclinical and Investigational New Drug (IND) enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration.

"These patents will help provide the protection we need as development of our LEAPS candidates progress from preclinical to clinical studies and they strengthen our ability to attract potential partners to license this technology," said Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology.

This platform technology has been shown in several animal models to preferentially direct the immune response to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway and has been shown to involve upregulation of T-regulatory (Treg) cells in some animal models. It has the potential to be utilized in diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer’s).

On January 23, 2019 Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with the commencement of a proposed initial public offering of its common stock. Gossamer Bio is offering 14,375,000 shares of its common stock at an initial public offering price of $16.00 per share. Gossamer Bio has applied to list its stock for trading on the Nasdaq Global Select Market under the symbol "GOSS (Press release, Gossamer Bio, JAN 23, 2019, View Source [SID1234532832])." Gossamer Bio expects to grant the underwriters a 30-day option to purchase up to an additional 2,156,250 shares of common stock in connection with the offering. All of the shares are being sold by Gossamer Bio.

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Gossamer Bio has included in the registration statement the proposed public offering price and the number of shares offered and specific language under Rule 473(b) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), such that the registration statement is expected to become automatically effective 20 calendar days after today’s filing, or February 12, 2019, pursuant to Section 8(a) of the Securities Act. Gossamer Bio expects to complete the pricing of the offering on such date. In the event that the federal government and the SEC resume normal operations prior to February 12, 2019, Gossamer Bio will re-evaluate the use of Section 8(a) in connection with the offering.

BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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 such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from: BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at [email protected], or by telephone at (800) 808-7525, ext. 6132; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

On January 22, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its full year and fourth quarter 2018 financial results on Tuesday, February 5, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, JAN 22, 2019, View Source [SID1234532818]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On January 22, 2019 TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, reported it has completed formulation of its first allogeneic GDT cell banks (Press release, TC Biopharm, JAN 22, 2019, View Source [SID1234532819]). The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Union’s Horizon 2020 (H2020) Research and Innovation program via a €4million grant, the largest such EU award to any UK company for development of a healthcare therapeutic product.

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The GDT cell banks are collected and stored from healthy donors, providing a source for TCB to manufacture next-generation ‘off-the-shelf’ GDT cell therapies for future clinical product development. Using allogeneic material from healthy donors offers several advantages over conventional autologous CAR-T therapies, which use the patient’s own cells to treat their tumor, as TCB’s proprietary allogeneic CAR-T cells are not prone to ‘on-target, off-tumor’ toxicities. Additionally, a larger population of cancer patients can be treated with a single reproducible product, ‘campaign-manufactured’ in bulk to keep costs lower, consequently increasing accessibility and reducing financial burden for healthcare systems.

Benefitting from H2020 support, TCB is rapidly progressing its clinical evaluation of allogeneic therapies. Having recently demonstrated safety and efficacy of large-dose autologous gamma-delta T cells in cancer patients, TCB is commencing treatment of cancer patients with an allogeneic variant. By building on its exclusive CAR-T platform, the company also plans to treat leukemia patients with an allogeneic CD19-directed GDT CAR-T product.

Angela Scott, Co-Founder and Chief Operating Officer, TCB, said: "I am delighted we have completed manufacture of our first allogeneic cell banks. By combining allogeneic GDT therapy with our unique CAR-T platform it will allow us to develop the next generation of safe, cost-effective immunotherapy for cancer, improving patient outcomes and quality of life."

Dr Michael Leek, Co-Founder and Chief Executive, TCB, commented: "Availability of clinical-grade allogeneic GDT cell banks is an important commercial milestone for TCB. This allows us to transition our therapeutic approach from expensive and complex personalized therapy using patient’s own cells, to a more cost-effective ‘pharmaceuticalized’ approach."

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program.

On January 22, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its fourth-quarter and full-year 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EST on Friday, Feb. 1 Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its fourth-quarter and full-year 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EST on Friday, Feb. 1. During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9872199. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9872199. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 9872199. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 9872199. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.