On December 18, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), reported a company developing novel cancer immunotherapies, reported the publication of new research in the journal Immunity that finds that IL-12 producing dendritic cells play an essential role in enabling tumor responses to anti-PD-1 immunotherapy (Press release, OncoSec Medical, DEC 18, 2018, View Source [SID1234532123]). The study was conducted by researchers from Massachusetts General Hospital, Harvard Medical School, Dana-Farber Cancer Institute, and OncoSec, among others. As noted in the study, OncoSec’s lead compound, TAVO (tavokinogene telseplasmid; plasmid plasmid IL-12), which delivers IL-12 directly into tumors, was found to play in important role in enhancing the expression of cytolytic genes within tumors that are associated with anti-tumor responses. The paper, titled "Successful Anti-PD-1 Cancer Immunotherapy Requires T Cell-Dendritic Cell Crosstalk Involving the Cytokines IFN-γ and IL-12" appears in the December 18, 2018 issue of Immunity.

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"The evidence continues to build that IL-12 plays an important role in eliciting anti-tumor responses with anti-PD-1 immunotherapies. We’ve seen this in our own pre-clinical data and in our clinical programs to date," said Christopher G. Twitty, Ph.D., Chief Scientific Officer of OncoSec. "This study elegantly demonstrated that a critical subset of IL-12-producing dendritic cells in concert with IFN-g+ T cells are necessary for an effective anti-PD-1 therapy. Additionally, it was reported that intratumoral delivery of IL-12 with our TAVO system dramatically enhanced the tumor’s immunogenicity as well as cytolytic signature, further supporting this important mechanism of action."

The study explored the transcriptional effects of TAVO monotherapy in melanoma patients and found that IL-12 activates a cytolytic gene signature in tumor-infiltrating lymphocyte (TIL). Furthermore, this TAVO-related anti-tumor immune signature was more pronounced in patients with better clinical responses compared to those patients with progressive disease. This publication continues to elucidate the power of IL-12 to activate CD8+ TIL in patient’s tumor.

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]).

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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.

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.

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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 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]).

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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 CTI BioPharma Corp. (NASDAQ:CTIC) reported that it has received input from the U.S. Food and Drug Administration (FDA) at a recent Type C meeting on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need (Press release, CTI BioPharma, DEC 18, 2018, View Source [SID1234532119]).

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The planned Phase 3 study is designed to evaluate the effects of pacritinib as compared to physician’s choice of treatment. The primary efficacy endpoint will be the proportion of patients achieving a greater than or equal to 35% spleen volume reduction (SVR) between baseline and Week 24. Secondary efficacy endpoints of the study include total symptom score reduction and overall survival.

Before commencing the Phase 3 study, CTI plans to meet with the FDA to discuss the final optimal dose analysis from the PAC203 Phase 2 study. To expedite the transition to Phase 3, CTI intends to amend the PAC203 protocol to include a Phase 3 component. The PAC203 Phase 3 component is designed to enroll approximately 200 patients with enrollment expected to commence in the third quarter of 2019. The anticipated cost of the Phase 3 study is approximately $25 million. Taking into account the impact of recently-announced cost saving efforts and the anticipated cost of the new Phase 3 trial, the current CTI financial analysis projects a cash runway that extends into 2020.