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Onxeo receives EPO Intent-to-Grant Notice for new patent protecting AsiDNA™ in combination with any PARP inhibitor

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.

CTI BioPharma Provides Program Update Following Regulatory Feedback from the U.S. FDA on Pacritinib Development

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]).

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.

Phio Pharmaceuticals to Present at Biotech Showcase™ 2019 in San Francisco

On December 18, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) (formerly RXi Pharmaceuticals Corporation), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that Dr. Gerrit Dispersyn, President and Chief Operating Officer, will present at Biotech Showcase 2019, to be held January 7 – 9, 2019 at the Hilton San Francisco Union Square (Press release, Phio Pharmaceuticals, DEC 18, 2018, View Source [SID1234532115]).

Dr. Gerrit Dispersyn will present an overview of the Company’s novel self-delivering RNAi (sd-rxRNA) technology and the multiple business development and commercial opportunities available with this proprietary platform on:

Date: Monday, January 7, 2019
Time: 9:00 a.m. PST
Room: Yosemite C (Ballroom Level)

He will also be available for investor and executive meetings throughout the conference. The presentation will be webcast and available on the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com.

About Biotech Showcase
Now in its eleventh year, Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

Delcath Announces 4th Independent Safety Review of Registration Trial Data for Metastatic Ocular Melanoma: Recommended Continuation with no Trial Modification

On December 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the independent Data Safety Monitoring Board (DSMB) of the Registration trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial) completed another pre-specified review of safety data for treated patients in the trial (Press release, Delcath Systems, DEC 18, 2018, View Source;p=RssLanding&cat=news&id=2381000 [SID1234532112]). This review was conducted on data collected from both the prior randomized protocol and the amended single-arm protocol for the FOCUS Trial. The DSMB again recommended continuation of the study without modification.

In July, the Company announced that it has amended the protocol for the FOCUS trial, which is now enrolling as a single-arm, multi-center open label study. Safety data collected have not been modified as a result of the amendment, and safety data from both the randomized and single-arm protocols will be pooled in any analyses submitted to the Food & Drug Administration as part of a New Drug Application.

The FOCUS trial, now entitled A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), is enrolling a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled under the prior randomized protocol continue to be treated and evaluated as part of the amended trial, and periodic DSMB reviews will continue to be conducted.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath, said, "We are pleased with the safety profile observed by our therapy in the trial thus far, and the trial remains on track to complete enrollment by June 2019."

AOP ORPHAN ANNOUNCES POSITIVE CHMP OPINION FOR ROPEGINTERFERON ALFA-2B/BESREMI®

On December 17, 2018 AOP Orphan Pharmaceuticals AG (AOP Orphan) reported that EMA´s CHMP adopted a positive opinion for approval of Ropeginterferon alfa-2b/BESREMi indicated as monotherapy in adults for the treatment of Polycythaemia vera without symptomatic splenomegaly (Press release, AOP Orphan Pharmaceuticals, DEC 17, 2018, View Source [SID1234533574]).

Ropeginterferon alfa-2b/BESREMi is a novel, long-acting interferon, which is administered once every two weeks, or monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons.

AOP Orphan has been running the BESREMi clinical development in PV since 2010. The latest phase III data, three years treatment, and phase II data, up to seven years treatment, were presented at ASH (Free ASH Whitepaper) 2018. In summary, BESREMi showed high hematologic and clinical response rates with good tolerability.

 In addition, BESREMi showed high molecular response rates, associated with the ability to reduce allelic burden of both mutant JAK2 and importantly also non-JAK2 mutations, which are believed to have a role in disease progression.

Andreas Steiner, Chief Executive Officer of AOP Orphan commented: "Although interferons are a treatment modality widely used throughout the myeloproliferative neoplasms including CML, BESREMi will be the first licensed interferon in any of these indications. Physicians experienced in the management of the disease and administration of BESREMi during the clinical studies expect many advantages for the patients with PV."

About Ropeginterferon alfa-2b/BESREMi
Ropeginterferon alfa-2b/BESREMi is a novel, long-acting, mono-pegylated proline interferon (ATC L03AB15) with improved pharmacokinetic properties offering improved tolerability and adherence to treatment. It is administered once every two weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide.

Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Orphan. In 2009, AOP Orphan has in-licensed from PharmaEssentia Corporation the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV, other MPNs and CML for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

About Polycythemia Vera
Polycythemia Vera (PV) is a cancer of the blood-building cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition may result in circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2 that make the malignant clone.