On December 19, 2018 INmune Bio Inc., an immunotherapy company developing treatments to reprogram the innate immune system to fight disease, reported that it has been granted Clinical Trial Authorization (CTA) by the United Kingdom (UK) regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA), for a Phase I clinical trial of its lead therapeutic candidate INKmune (Press release, INmune Bio, DEC 19, 2018, View Source [SID1234532170]). The innate immune drug will be used to treat relapsed and refractory ovarian cancer in a UK based trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The CTA approval for the first clinical trial of INKmune is a major milestone for the company," said RJ Tesi, M.D, chief executive officer and co-founder of INmune Bio. "INKmune is our second cancer program to enter the clinic and will be tested in women with relapsed and refractory ovarian cancer, which accounts for more deaths than any other cancer of the female reproductive system."

Modern cancer therapy strives to harness the patient’s immune system to help control the cancer. Natural killer (NK) cells of the innate immune system must function normally to eliminate residual disease – the cancer left over after traditional cancer therapy that is the cause of cancer relapse. INKmune is a novel cancer therapy that may switch on the patient’s NK cells to attack residual disease that can be the cause of treatment failure.

"This approval represents external validation of our pre-clinical data set using Tumor Primed NK cells against a range of cancer cells which are insensitive to NK killing," says Dr. Mark Lowdell, chief scientific officer and co-founder of INmune Bio. "The way that INKmune activates the patient’s own immune system means that it could be used for many types of cancer; women with ovarian cancer are just the first of many patients we hope to treat with INKmune."

Today, ovarian cancer ranks fifth in cancer deaths among women. In 2018 alone, the American Cancer Society estimated 22,240 new cases in the US. Unfortunately, when ovarian cancer relapse occurs, the average survival is between 12 to 18 months, and fewer than 1 in 10 patients survive beyond five years following standard chemotherapy treatment.

On December 19, 2018 MannKind Corporation (Nasdaq: MNKD) (MannKind) reported the pricing of an underwritten public offering of 26,666,667 shares of its common stock and warrants to purchase up to an aggregate of 26,666,667 shares of its common stock (Press release, Mannkind, DEC 19, 2018, View Source [SID1234532189]). Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined purchase price of $1.50, for a gross deal size of $40.0 million, not including any future proceeds from the exercise of the warrants and before deducting the underwriting discounts and commissions and offering expenses. Each warrant will have an exercise price of $1.60 per share, will be exercisable immediately and will expire on the 12-month anniversary of the date of issuance. The shares of common stock and warrants can only be purchased together but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on December 26, 2018, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leerink Partners is acting as sole book-running manager for the offering. BTIG, LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering. H.C. Wainwright & Co., LLC acted as a financial advisor to MannKind in connection with the offering.

The securities described above are being offered by MannKind pursuant to a shelf registration statement on Form S-3 (No. 333-210792) previously filed by MannKind with the Securities and Exchange Commission (SEC) on April 18, 2016 and declared effective on April 27, 2016. The offering will be made only by means of a written prospectus and prospectus supplement that form part of the registration statement. A preliminary prospectus supplement related to the offering and accompanying prospectus has been filed with the SEC and is available on the SEC website located at View Source Copies of the final prospectus supplement and the accompanying prospectus related to the offering, when available, may be obtained from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, or by email at [email protected].

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

On December 18, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology targeting tumor DNA Damage Response (DDR) to fight resistant cancers, reported having been notified by the European Patent Office (EPO) of its intent to grant the Company a new patent (EP3325623) covering the combination of AsiDNA, Onxeo’s first-in-class agonist of the DNA Damage Response (DDR) , with any PARP inhibitor (PARPi), in all countries of the European Union (EU) (Press release, Onxeo, DEC 18, 2018, View Source [SID1234532120]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This new patent protects the intellectual property of Onxeo relating to combined preparations comprising conjugated nucleic acid molecules, including its lead product candidate AsiDNA and a PARP inhibitor, as well as the use of the combined preparations for the treatment of cancer. Under the patent, AsiDNA and the PARP inhibitor may be present in one combined dosage form, or as part of separate dosage forms for sequential administration of the respective drugs. This European patent has a term expiring in mid-2036.

Onxeo has conducted extensive preclinical studies of AsiDNA in combination with various PARPi. These studies show that the combination has a strong synergistic anti-tumor activity in solid tumors, regardless of the genetic mutation status of the tumor. This synergy appears to be a class effect with all PARPi. Combination with AsiDNA could therefore represent an opportunity to expand PARPi indications to HR proficient tumors, which account for approximately 70% of tumors.

"This patent covering the combination of AsiDNA with any PARP inhibitor further reinforces our extensive patent portfolio, which is a key component of the value of AsiDNA. Our strong intellectual property position is an integral part of the Company’s business model, which aims to progress disruptive compounds up to the most valuable clinical inflexion points and then to partner or license them," said Judith Greciet, Chief Executive Officer of Onxeo.

On December 18, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported that the Company’s Board of Directors has approved a first-quarter 2019 dividend of $0.15 per share (Press release, West Pharmaceutical Services, DEC 18, 2018, View Source [SID1234532121]). The dividend will be paid on February 6, 2019, to shareholders of record as of January 23, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company also announced that management will be presenting an overview of the business at the J.P. Morgan Healthcare Conference in San Francisco, California, at 4:30 p.m. PST on Wednesday, January 9, 2019.

A live audio webcast of the presentation, as well as the presentation materials, will be accessible from the Company’s website: investor.westpharma.com.

On December 18, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that Kim Popovits, chairman of the board, chief executive officer and president, will present at the 37th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco on Monday, January 7, 2019 at 11:30 a.m. Pacific Time (Press release, Genomic Health, DEC 18, 2018, View Source [SID1234532122]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary. An archived replay will be available for three months beginning 24 hours after the live presentation.