Innovation Pharmaceuticals Receives FDA End-of-Phase 2 Meeting Minutes

On May 1, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported it has received Food and Drug Administration (FDA) End-of-Phase 2 (EoP2) meeting minutes, helping to guide the Company’s planned Phase 3 program for Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAY 1, 2019, View Source [SID1234535497]). Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).

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During the EoP2 meeting convened in December 2018, the Company and FDA agreed to an acceptable Brilacidin Phase 3 development pathway. The guidance from the FDA now also helps to frame ongoing discussions with the European Medicines Agency (EMA) as part of the Scientific Advice process. The purpose of both of these interactions is to ensure that proposed plans meet regulatory requirements for New Drug Application (NDA)/Marketing Authorization Application (MAA) filings and, ultimately, to obtain approval of Brilacidin for SOM in HNC in both the United States and Europe.

"Productive regulatory meetings for our Brilacidin SOM program with U.S. and European agencies are significant Company milestones," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Brilacidin oral rinse, to decrease the incidence of SOM, represents a potential future regimen for millions of head and neck cancer patients where no approved drug is available today. Furthermore, our hope is that Brilacidin will eventually emerge as a treatment for other indications where SOM also is a frequent side-effect of cancer therapies."

"It is time that the current standard of care for SOM takes a leap forward and a new market emerges," added Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "I am reminded of drugs for not only rare diseases that were overlooked by the market during development and then went on to become ‘company makers,’ but also a drug such as Tagamet. Eventually, it became the first blockbuster drug ever by treating the common problem of acid reflux, a disease that was casually written off for decades as not having an effective treatment beyond antacids. Treatment-related SOM in cancer patients is a real problem worldwide, affecting millions of patients, with physical and financial ramifications that genuinely must be addressed beyond today’s magic mouthwashes. And, we are currently the only company with an oral drug candidate being advanced into late-stage trials, positioned to fill this unmet need. I greatly look forward to initiating our planned Phase 3 program, adding further credibility and value to our Brilacidin Franchise."

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

Inovio Pharmaceuticals to Report First Quarter 2019 Financial Results on May 9, 2019

On May 1, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that first quarter 2019 financial results will be released after the market close on May 9, 2019 (Press release, Inovio, MAY 1, 2019, View Source [SID1234535496]). Following the release, the Company will host a conference call and live webcast at 4:30 p.m. ET, to provide a general business update and financial results for the first quarter 2019.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10131163.

VBI Vaccines Announces First Quarter 2019 Financial Results and Provides Corporate Update

On May 1, 2019 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the first quarter ending March 31, 2019, and highlighted progress of the company’s pipeline (Press release, VBI Vaccines, MAY 1, 2019, View Source [SID1234535495]).

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"2019 has the potential to be a transformative year for VBI, marked by clinical milestones across all four of our lead programs, and as such, the first quarter of 2019 was characterized by intense focus on the execution of our ongoing clinical programs," said Jeff Baxter, President and CEO, VBI Vaccines Inc. "In April 2019, all subjects in the Sci-B-Vac pivotal Phase 3 PROTECT study completed clinical visits, including follow-up visits for safety, which confirms the timeline to top-line data. This data read-out is the most significant clinical milestone in the history of VBI and we remain diligently focused and excited as we advance towards the data read-out, expected mid-year this year, 2019."

Recent Highlights and Upcoming Milestones
Sci-B-Vac: Trivalent Prophylactic Hepatitis B Vaccine
Sci-B-Vac is currently being evaluated in a global, pivotal Phase 3 clinical program, the results of which are intended to support future regulatory and marketing authorization submissions in the U.S., Europe, and Canada. The program consists of two concurrent Phase 3 studies – PROTECT and CONSTANT.

PROTECT: 2-arm safety and immunogenicity study in approximately 1,500 adults age 18 and older

Top-line data, expected mid-year 2019, will include both co-primary endpoints and key secondary endpoints.
Co-primary endpoints: After three doses of Sci-B-Vac vs. three doses of Engerix-B, (i) non-inferiority of seroprotection rates in adults age 18 and older, and (ii) superiority of seroprotection rates in adults over the age of 45.
Secondary endpoints: (i) non-inferiority of seroprotection rates after two doses of Sci-B-Vac vs. three doses of Engerix-B, and (ii) safety and tolerability.
In April 2019, VBI presented data in a poster presentation at The International Liver Congress (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which support the secondary endpoints in PROTECT. The poster illustrated data from three previously-conducted clinical studies – two randomized Phase 3 studies comparing Sci-B-Vac to Engerix-B conducted in Vietnam and Russia, and one single-arm Phase 4 study conducted in Israel – in subjects aged 18 to 45 years. Data from all three studies demonstrated a clean safety profile for Sci-B-Vac and seroprotection rates of more than 98% after two vaccinations in all subjects receiving Sci-B-Vac.
CONSTANT: 4-arm lot-to-lot consistency study in approximately 2,850 subjects

The primary endpoint is to demonstrate consistency of immune response, measured by geometric mean concentration (GMC), across three independent, consecutively manufactured lots of Sci-B-Vac.
Top-line CONSTANT data is expected around year-end 2019.
VBI-1901 – Glioblastoma (GBM) Immunotherapeutic
VBI-1901 is currently being evaluated in a two-part Phase 1/2a study in recurrent GBM patients.

PART A: Dose-escalation phase designed to evaluate the safety, tolerability, and to define the optimal therapeutic dose level of VBI-1901

Expanded data from Part A of the study was recently selected for poster presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in early June, and will feature expanded immunologic data along with tumor and clinical responses, based on MRIs and survival data, from all three dose cohorts in Part A of the study.
The poster, number 237, will be presented during the Central Nervous System Tumors session on Sunday, June 2, 2019 from 8:00 AM ET to 11:00 AM ET.
PART B: Subsequent extension phase with a narrower enrollment criteria, designed to more clearly assess immunologic responses and the correlation with tumor and clinical responses, based on MRIs and survival data

As announced in April 2019, based on safety and immunogenicity data, the highest dose tested in Part A of the study, 10mcg, has been selected as the optimal dose level to test in Part B of the study.
Enrollment in Part B will be restricted only to those with a first tumor recurrence.
Initiation of enrollment of the 10 patients in Part B of the study is expected mid-year 2019.
VBI-2601 – Hepatitis B Immunotherapeutic
In December 2018, VBI announced a license and collaboration agreement with Brii Biosciences for the development of a functional cure for chronic hepatitis B using VBI-2601, the company’s novel immunotherapeutic candidate formulated to target and enhance B- and T-cell immunity.
In January 2019, VBI initiated pre-clinical studies required to enable initiation of a Phase 2 human proof-of-concept study, which is expected to initiate around year-end 2019.
VBI-1501 – Prophylactic Cytomegalovirus (CMV) Vaccine
In December 2018, VBI announced plans for a Phase 2 dose-ranging study following positive discussions with Health Canada, and the company anticipates similar discussions with the FDA in 2019.
The Phase 2 study is expected to assess the safety and immunogenicity of higher dosages of VBI-1501, up to 20mcg, with study initiation anticipated around the end of 2019.
A toxicology study to support the new dose levels is underway, the results of which are required prior to the start of the Phase 2 study.
First Quarter 2019 Financial Results
Cash Position: VBI ended the first quarter of 2019 with $43.3 million in cash and cash equivalents compared to $59.3 million as of December 31, 2018.
Net Cash Used in Operating Activities: Net cash used in operations for the three months ended March 31, 2019 was $14.0 million compared to $8.6 million for the same period in 2018.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.9 million for the three months ended March 31, 2019 compared to $1.0 million for the same period in 2018. The increase in spend is due to the modernization and capacity increase of the company’s manufacturing facility in Rehovot, Israel. The construction and temporary closure of the facility began in Q2 2018 and is now substantially complete. We anticipate being able to recommence operations in the facility by the end of 2019.
Revenue: Revenue in the first quarter of 2019 was $0.4 million, compared to $0.2 million for the same period in 2018. The increase was primarily due to R&D service revenues earned pursuant to the therapeutic hepatitis B license and collaboration agreement with Brii Biosciences, offset by a slight decrease in named-patient sales of Sci-B-Vac in Europe.
Research and Development (R&D): R&D expenses were $9.2 million for the first quarter of 2019, compared to $7.0 million for the same period in 2018. The increase was primarily due to the advancement of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients.
General and Administrative (G&A): G&A expenses were $4.0 million for the first quarter of 2019, compared to $3.4 million for the same period in 2018. The increase was primarily due to increased human resource expenses, the allocation of certain cost of revenues related to the temporary Rehovot facility closure, and pre-commercialization costs for Sci-B-Vac.
Net Loss: Net loss and net loss per share for the first quarter of 2019 were $14.6 million and $0.15, respectively, compared to a net loss of $12.3 million and a net loss per share of $0.19 for the first quarter of 2018.

TETRAPHASE PHARMACEUTICALS TO HOST FIRST QUARTER 2019 FINANCIAL RESULTS CONFERENCE CALL

On May 1, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, reported that company management will host a conference call at 4:30 p.m. ET on Wednesday, May 8, 2019 to discuss the Company’s first quarter 2019 financial results and provide a general corporate update (Press release, Tetraphase, MAY 1, 2019, View Source [SID1234535494]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 2794213. A live audio webcast of the conference call will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Wednesday, May 8, 2019, through 7:30 p.m. ET on Wednesday, May 15, 2019 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 2794213. A replay of the webcast will be available by visiting Tetraphase’s website.

Iovance Biotherapeutics to Host First Quarter 2019 Financial Results Conference Call and Webcast on Tuesday, May 7, 2019

On May 1, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its first quarter 2019 financial results on Tuesday, May 7, 2019 (Press release, Iovance Biotherapeutics, MAY 1, 2019, View Source;p=irol-newsArticle&ID=2396513 [SID1234535493]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EDT.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7393657. A live webcast can be accessed under "News & Events: Investor Calendar" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source An archived webcast will be available in the Investors section of www.iovance.com for thirty days following the call.