On December 17, 2018 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2018 financial results on Wednesday, Jan. 23, 2019, before the market opens (Press release, Abbott, DEC 17, 2018, View Source [SID1234532099]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On December 17, 2018 RhoVac AB ("RhoVac") reported that the first prostate cancer patient included in the clinical phase I / II study with RhoVac’s drug candidate RV001 has completed it’s 12-month follow-up and thus the entire clinical phase I / II- study (Press release, RhoVac, DEC 17, 2018, https://www.rhovac.com/rhovac-announces-that-the-first-patient-completed-the-follow-up-phase-of-the-clinical-phase-i-ii-study/ [SID1234532083]).

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Prior to the clinical phase I / II study, conducted between 2017 and 2018, 22 patients with diagnosed prostate cancer and prostatectomized. Blood samples were taken before, during and after the study to analyse the product mediated immune response to treatments. The results, reported earlier this year, showed a significant immune response in 86% of the patients. Patients have also participated in a 3-, 6-, 9- and 12-month follow-up phase of the study, to assess the duration of the immune response.

RhoVac announces that the first patient has completed his 12-month follow-up and thus also completed his participation in RhoVac’s phase I / II clinical study. The samples for immunological analysis have been sent to the University of Tübingen. The interim report on the duration of the immunological responses, from all participating patients’ 3- and 6-month follow-up will be published in January 2019.

The last patient is expected to complete his 12-month follow-up in March 2019. The final report on the duration of the immunological responses is expected in the second quarter of 2019.

The company’s drug candidate RV001 activates T cells of the immune system to identify and eliminate cancer cells expressing the protein RhoC. As RhoC is generally overexpressed in metastatic cancer cells, RV001 can potentially be used in the treatment of several different cancer indications. It is the company’s ambition that the product being developed shall be used as a preventive treatment against metastases, thus preventing, or limiting the spread and recurrence of cancer

On December 17, 2018 Kineta Immuno-Oncology, LLC (KIO), a subsidiary of Kineta, Inc., reported that it has entered into a strategic research collaboration with Pfizer Inc. (NYSE: PFE) to develop RIG-I agonist immunotherapies for the treatment of cancer (Press release, Kineta, DEC 17, 2018, View Source [SID1234532100]). The research collaboration and license agreement grants to Pfizer the exclusive rights to KIO’s RIG-I screening platform and related compounds and technologies. The companies will collaborate to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic cell death (ICD) in tumors, providing both direct tumor cell killing and enhanced anti-tumor immune responses.

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In preclinical models, Kineta’s RIG-I agonists have demonstrated complete tumor regression and an increase in tumor-specific T cells when given as a monotherapy. Additionally, the compounds have demonstrated synergistic effects when used in combination with other immunotherapies like checkpoint inhibitors. Kineta’s proprietary approach is part of an internally developed discovery program focused on innate immune drug targets in cancer. The lead program is focused on the RIG-I pathway, which is differentiated from other innate immune-targeted immunotherapies as its compounds are small molecule drugs with the potential for oral and systemic administration.

"This alliance will enable Kineta and Pfizer to leverage each company’s expertise to accelerate the development of our RIG-I immuno-oncology program," said Kineta CEO, Shawn Iadonato. "Pfizer is an excellent partner for Kineta’s technology, with a strong commitment to oncology and outstanding development capabilities. We are very enthusiastic about this new cancer immunotherapy collaboration, which represents the second major partnering transaction for Kineta this year."

Dr. Robert Abraham, Senior Vice President and Group Head of Pfizer’s Oncology Research & Development Group said: "Therapies that trigger activation of the innate immune response in tumors have significant potential to expand the number of patients who will benefit from cancer immunotherapy, especially if they can be administered systemically. Kineta has taken a promising, differentiated approach to the discovery of RIG-I agonists, and we are looking forward to collaborating with Kineta and jointly developing these RIG-I-targeted agents into medicines with potentially unique immune-stimulating properties."

Under the terms of the agreement, KIO will receive a $15 million upfront payment and will be eligible to receive up to $505 million in potential research, development and sales milestone payments. Additionally, KIO is eligible to receive tiered royalties on net sales. Pfizer will fund RIG-I target-related research conducted by Kineta for an initial period of three years, after which Pfizer will be responsible for further development and commercialization of product candidates.

Torreya acted as exclusive financial advisor to Kineta on this transaction.

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.