On March 28, 2019 Xcovery Holdings, Inc., an oncology-focused biopharmaceutical company, reported the appointment of Li Mao, M.D., as Chief Executive Officer (CEO) and Giovanni Selvaggi, M.D., as Chief Medical Officer (CMO) (Press release, Xcovery, MAR 28, 2019, View Source [SID1234534716]). With more than 50 years of clinical experience in oncology between them, Dr. Mao and Dr. Selvaggi will oversee the clinical development of ensartinib and vorolanib, Xcovery’s two leading drug candidates currently in a global Phase 3 trial for ALK positive non-small cell lung cancer (NSCLC) and in a Phase 1/2 trial in combination with immune-oncology (IO) agents for thoracic cancer, respectively.

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"Following a thorough and rigorous process, the Board has unanimously elected Li as the CEO of Xcovery," said Lieming Ding, M.D., Chairman of Xcovery’s Board of Directors. "He will bring deep expertise in oncology, unwavering commitment to patients, and strong track record of building high performing organizations to his new role. I am confident that under Li’s leadership, Xcovery will continue to expand its impact in oncology."

"I am humbled and privileged to be the CEO of Xcovery," said Dr. Mao. "This is an extraordinary company of talented people with incomparable passion and dedication to helping patients. I look forward to working with our talented team to build on what we’ve accomplished, to deliver on the promise of our innovative programs and to make a real difference for our patients."

Prior to joining Xcovery, Dr. Mao was Vice President and Head of the Johnson & Johnson China Lung Cancer Center. Before that, he acted as a Professor and Chair of Department of Oncology and Diagnostic Sciences, and Associate Dean for Research at University of Maryland, Baltimore. Dr. Mao has also served as Leader, Experimental Therapeutics Program in the Marlene and Stewart Greenebaum Cancer Center. Previously, he was a Professor in the Department of Thoracic and Head & Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, where he is currently an Adjunct Professor. Dr. Mao has played a critical role in a number of landmark multi-institution research programs, and has authored and co-authored more than 200 peer-reviewed articles cited more than 24,000 times.

"We are also pleased to welcome Giovanni to the Xcovery team as he brings broad oncology drug development expertise and strong leadership skills," Dr. Ding added. "His recent experience in spearheading the clinical development of ceritinib (Zykadia) at Novartis and leading the immunotherapy program at Bristol-Myers Squibb in thoracic malignancies will be invaluable to us as we work to not only bring ensartinib over the finish line, but also explore synergies in the ever-changing scenario of combination therapies for vorolanib."

"It is a very exciting time to be joining Xcovery as Chief Medical Officer," stated Dr. Selvaggi. "I am very encouraged by the clinical progress to date and look forward to building on this work in the ongoing and future clinical trials. Xcovery is uniquely positioned to make meaningful impact on oncology with ensartinib having the potential to be the best in class in first line therapy for ALK positive NSCLC patients, and vorolanib being tested in various combination trials with anti PD-1 agents. I look forward to working with my colleagues to advance our programs and to help cancer patients to live longer and better lives."

Dr. Selvaggi held positions of increasing responsibility at various global pharmaceutical companies prior to joining Xcovery. He joined the pharmaceutical industry in 2010 as a medical director at GlaxoSmithKline in the MAGE-A3 cancer vaccine lung program. He then played an instrumental role in the successful development and registration of ceritinib (Zykadia) at Novartis in ALK translocated NSCLC. Most recently, Dr. Selvaggi was a part of the immunotherapy team at Bristol-Myers Squibb as Program Lead in different thoracic malignancies with a focus on SCLC. Dr. Selvaggi received his medical degree at the University of Torino Medical School in 1992 and served as staff physician of Thoracic Oncology at the University Hospital in Torino, Italy, participating in several clinical trials in lung cancer and mesothelioma over a span of 16 years.

On March 28, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the European Medicines Agency (EMA) has granted a meeting with the Company’s European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program 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, MAR 28, 2019, View Source [SID1234534715]).

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The purpose of such meetings is for the EMA to provide guidance on the appropriate tests and studies in the development program for a medicine. Receiving formal scientific advice helps ensure health authority alignment regarding appropriate testing to support an eventual marketing-authorization application in Europe.

The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC.

"We are extremely pleased to have been granted this scientific meeting with the EMA, particularly in such rapid fashion," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "New and effective treatments that not only help mitigate, but actually prevent the occurrence of oral mucositis, have been long sought-after. Currently there is no approved drug to decrease the incidence of Severe Oral Mucositis in Head and Neck Cancer. We look forward to advancing Brilacidin toward potential regulatory approval, both in Europe and the United States, as we refine key aspects of our planned Phase 3 program in oral mucositis."

About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis

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

The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.

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 currently in clinical development.

View Source
About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs to decrease the incidence of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (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 on a worldwide basis, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, 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.

On March 28, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), reported it will present and meet with investors at Spring Investor Summit on April 1, 2019 at 1:00 PM ET as part of Track 1 at The Essex House in New York City (Press release, Oragenics, MAR 28, 2019, View Source [SID1234534714]).

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Interested investors may request a one-on-one meeting at Spring Investor Summit by registering for the meeting at www.microcapconf.com, or contacting conference administrators at [email protected].

On March 28, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reportd that it will host a conference call and webcast discussion regarding the positive topline results from its pivotal clinical trial of enfortumab vedotin in locally advanced or metastatic urothelial cancer, which were announced in a press release earlier today (Press release, Seattle Genetics, MAR 28, 2019, http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-host-conference-call-positive-topline-results [SID1234534713]). Access to the event can be obtained as follows:

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LIVE access on Thursday, March 28, 2019

6:00 a.m. Pacific Time (PT) / 9:00 a.m. Eastern Time (ET)

Telephone 866-288-0540 (domestic) or +1 786-460-7199 (international); conference ID 3807860
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available until 5:00 p.m. PT on Monday, April 1, 2019 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 3807860
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section

On March 28, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2018 (Press release, Can-Fite BioPharma, MAR 28, 2019, View Source [SID1234534712]).

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Clinical Development and Corporate Highlights During 2018 Include:

In a deal worth up to $74.5 million, Can-Fite signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited for the commercialization of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis, and Namodenoson in the treatment of advanced liver cancer and NAFLD/NASH, in China.
In another multi-million dollar deal, Can-Fite signed a distribution deal with Gebro Holding GmBH in Spain, Switzerland, and Austria, to distribute Piclidenoson in the treatment of rheumatoid arthritis and psoriasis upon receipt of regulatory approval.
Can-Fite raised $5 million through a registered direct offering.
Can-Fite recently reported top line result from its Phase II trial of Namodenoson in the treatment of advanced liver cancer. While the study did not achieve its primary end point of median overall survival in the whole population of 78 patients, it did achieve superiority in median overall survival in the largest study subpopulation of 56 patients and in secondary end points for the whole population. These data support progression into a Phase III study.
Phase III clinical studies of Piclidenoson in the treatment of psoriasis and rheumatoid arthritis continue to enroll patients.
Top-line Data from Phase II NASH Study with Namodenoson expected in H2 2019
"2018 marked significant achievements for Can-Fite including our largest distribution deal to date valued at up to $74.5 million. We continued to build our intellectual property assets, presented new data at scientific conferences and saw our findings published in peer reviewed journals. We are particularly pleased to move much closer to commercialization with both Piclidenoson, now in two Phase III studies, and Namodenoson, now completing a Phase II study," stated Can-Fite CEO Pnina Fishman. "We just announced top line results from our Phase II Namodenoson study in advanced liver cancer which produced encouraging results to move into a Phase III, even though the primary end point was not met. We believe our drugs’ strong safety profile, combined with efficacy in a specific sub-population within each target disease indication will improve patient health and longevity."

Financial Results

Revenues for the year ended December 31, 2018 were $3.8 million, an increase of $3.0 million, or 384%, compared to $0.8 million for the year ended December 31, 2017. The increase in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical and from the recognition of a portion of the $2.2 million advance payment received in January 2018 under the Distribution and Supply Agreement with Gebro.

Research and development expenses for the year ended December 31, 2018 were $6.0 million, an increase of $0.9 million, or 19%, compared to $5.1 million for the year ended December 31, 2017. Research and developments expenses for the year ended 2018 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2019 and beyond.

General and administrative expenses were $3.1 million for the year ended December 31, 2018 an increase of $0.3 million, or 10%, compared to $2.8 million for the year ended December 31, 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect that general and administrative expenses will remain at the same level through 2019.

Financial expenses, net for the year ended December 31, 2018 aggregated $1.1 million compared to immaterial financial income, net for the same period in 2017. The increase in financial expense, net was mainly due to a loss from long-term investment revaluation and from recognition of interest expenses related to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.

Net loss for the year ended December 31, 2018 was $6.6 million compared with a net loss of $6.4 million for the year ended December 31, 2017. The increase in net loss for the year ended December 31, 2018 was primarily attributable to increase in revenues in 2018 which were offset by an increase in research and development expenses and increase in finance expenses, net.

As of December 31, 2018, Can-Fite had cash and cash equivalents of $3.6 million as compared to $3.5 million at December 31, 2017. The increase in cash during the year ended December 31, 2018 is due to increase in net cash provided by financing activity which was offset by a decrease in net cash used in operating activity. In January 2019, Can-Fite raised $2.35 million in a registered direct offering.