On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

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The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.

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.

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 17, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported a new Executive Leadership Team structure designed to streamline its organizational structure and support its long-term growth strategy (Press release, AbbVie, DEC 17, 2018, View Source [SID1234532084]). Effective immediately, the new Team will consist of the following individuals, all of whom report to AbbVie Chairman and Chief Executive Officer Richard A. Gonzalez:

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Michael E. Severino, M.D., AbbVie’s Executive Vice President, Research & Development and Chief Scientific Officer, has been named Vice Chairman and President. In his role, Dr. Severino will be responsible for research and development, human resources, operations, and the corporate strategy office.

Laura J. Schumacher has been named Vice Chairman, External Affairs and Chief Legal Officer. Ms. Schumacher currently serves as Executive Vice President, External Affairs, General Counsel and Corporate Secretary. In her new role, Ms. Schumacher will be responsible for legal, ethics and compliance, corporate governance, corporate aviation and all externally facing functions including health economics outcomes research, government affairs, corporate responsibility, brand and communications.
Carlos Alban, who currently serves as Executive Vice President, Commercial Operations, has been named Vice Chairman, Chief Commercial Officer. Mr. Alban will be responsible for global commercial operations of the Company, including the addition of Pharmacyclics commercial functions.
William J. Chase will continue in his role as Executive Vice President, Finance and Administration, responsible for all financial and administrative functions of the Company.
"AbbVie has grown significantly since our founding six years ago, and now is the right time to evolve our senior executive leadership structure to match our talent and our operating model as well as support our long-term growth strategy," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are fortunate to have a deep pool of senior leadership talent, and this streamlined structure will enhance our ability to execute against our long term strategies, provide additional scope for our senior leaders and facilitate our ability to meet our commitment to continuing to deliver value to all of our stakeholders, including patients, employees, shareholders and the communities we serve."

On December 17, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, DEC 17, 2018, View Source [SID1234532085]). Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).

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Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.

Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment. Conducted in accordance with the FDA guidance, the goal of the upcoming studies will be to satisfy requirements for a New Drug Application and, ultimately, obtain marketing approval of Brilacidin for SOM. Management further intends to solicit international regulatory bodies for the purpose of expanded registration globally.

"Our interactions with the FDA have been highly collaborative and constructive, providing us with clear guidance to help inform our Phase 3 development plans," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We are in alignment as to necessary key pivotal trial design features and Phase 3 clinical outcomes needed to support a NDA filing. We look forward to continue working closely with FDA on our Brilacidin oral rinse program as we prepare to enter the pivotal stage of clinical evaluation."

"This is an extremely exciting moment for Innovation Pharmaceuticals and its shareholders," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "In Brilacidin oral rinse, we now have a Phase 3-ready drug candidate targeting an area of large unmet need—comprising a worldwide annual market opportunity estimated to approach $1 billion—for which currently there are no FDA-approved treatments. Brilacidin is further advantageously differentiated from the two other OM drug candidates in Phase 3 testing which require being taken intravenously, whereas Brilacidin is easily administered as an oral rinse and conveniently packaged in sachet form, similar in design to a sugar packet. With a sachet, patients simply would mix the contents of the Brilacidin sachet with water for a quick-and-easy treatment at home or on-the-go."

Mr. Ehrlich continued, "This result further validates the breadth of the Brilacidin franchise. Our novel defensin-mimetic drug candidate is anchored with mid-and-late-stage trials in three clinical indications—oral mucositis, inflammatory bowel disease, and serious skin infections—and planned extensions into dermatological diseases, such as atopic dermatitis and acne. Effectively, we have a multi-indication drug platform in Brilacidin, now planning for Phase 3 testing for the first indication, thus moving us a significant step closer to bringing Brilacidin to market."

About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.

The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and -was well-tolerated.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs in clinical development.

View Source

About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.