On March 2, 2020 The board of directors of Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) is reported the appointment of Paul Lévesque as the company’s President and CEO, effective April 6, 2020, replacing Luc Tanguay, who is retiring after a 23-year career (Press release, Theratechnologies, MAR 2, 2020, View Source [SID1234555050]). Mr. Tanguay will remain available to ensure a smooth transition.

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"Theratechnologies is at a turning point in its history. I am extremely proud to join this team and leverage my knowledge and expertise to ensure the company’s continued growth, as well as to harness its full potential," said Mr. Lévesque. "One of my main goals is to bring Trogarzo to people living with HIV. Trogarzo, whose approval has already been fast tracked, is a breakthrough drug designed to meet an unmet medical need."

Paul Lévesque boasts over 30 years of experience in the pharmaceutical field. After beginning his career in 1985 at UpJohn in Montreal, he joined Pfizer Canada in 1992, then Pfizer France in 2002, where he held various positions, eventually serving as president of Pfizer Canada from 2007 to 2012. Since then, he has held several marketing and executive positions at Pfizer headquarters in New York, as part of which he had international responsibilities, notably in Asia-Pacific and in the United States. Mr. Lévesque is and will remain the Global President of Pfizer Rare Disease until he takes up his position at Theratechnologies.

"We are thrilled that Paul Lévesque is joining the company. On behalf of the board and management, we look forward to working with him and benefiting from his considerable experience in the global commercialization of pharmaceutical products," said Dawn Svoronos, Chair of the Board of Directors.

Theratechnologies would like to take this opportunity to recognize the immense contribution of Luc Tanguay, who skillfully led the company’s critical restructuring initiatives through his leadership and innovative vision.

"On behalf of the board of directors, management and shareholders, the company thanks Luc for his close collaboration with board members and wishes him a well-deserved retirement," added Ms. Svoronos.

Mr. Tanguay, who has been involved in the biotechnology industry for over 20 years, has been a member of the Theratechnologies management team since 1996. As President and CEO since 2012, Mr. Tanguay has transformed the company into a fully integrated business operating in the United States, Canada and Europe, with a significant research and development portfolio.

"It was an honour to be able to make a significant contribution to the growth of Theratechnologies," said Mr. Tanguay. "I am proud to leave Theratechnologies by handing over a company with a solid infrastructure and financial health to my successor. I would like to thank the loyal and high-performing management team members who have contributed to the company’s success over the past few years. I have no doubt that they will be able to support Paul Lévesque and help him build on this momentum."

On March 2, 2020 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported that it has entered into definitive agreements with several institutional investors for the issuance and sale of 4,000,000 shares of its common stock and warrants to purchase up to 2,000,000 shares of its common stock, at a combined purchase price of $2.50 per share and associated warrant, for aggregate gross proceeds of $10.0 million, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aviragen Therapeutics, MAR 2, 2020, View Source [SID1234555049]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $2.50 per share and exercise period commencing immediately upon issuance and a term of five years.

The offering is expected to close on or about March 2, 2020, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from this offering to support the clinical and preclinical development of its product candidates, to conduct clinical trials, and for general corporate and working capital purposes.

The securities described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-228910), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on March 15, 2019. The offering of the securities is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

On March 2, 2020 CNS Pharmaceuticals Presented he Corporate Presentation (Presentation, CNS Pharmaceuticals, MAR 2, 2020, View Source [SID1234555048]).

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On March 2, 2020 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the first patient has been dosed in the second study arm in the ongoing Phase 2a clinical study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate (Press release, VBI Vaccines, MAR 2, 2020, View Source [SID1234555047]). The Phase 2a study is a two-arm, open-label study, enrolling 20 first-recurrent GBM patients to receive VBI-1901 in combination with either GM-CSF or AS01B, GlaxoSmithKline’s (GSK) proprietary adjuvant system, as immunomodulatory adjuvants.

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"We are excited to initiate enrollment in this study arm to evaluate VBI-1901 in combination with AS01B, GSK’s effective proprietary adjuvant system," said David E. Anderson, Ph.D., VBI’s Chief Scientific Officer. "AS01B has been shown to boost T-cell mediated immunity and, building on the encouraging early immunologic and tumor response data we’ve seen to-date from the VBI-1901 with GM-CSF study arm, we look forward to evaluating the benefit this combination could have for patients with GBM, a devastating disease with few treatment options."

"We are pleased that this study is now underway as this is the first time AS01B will be assessed in oncology for GBM patients in a clinical setting. We are looking forward to seeing initial results later this year and hope that this technology will be able to make a real difference for GBM patients. Applying our expertise in adjuvant technologies in new fields of vaccines research is a core part of our innovation strategy," said Emmanuel Hanon, Senior Vice President, Head of R&D at GSK Vaccines.

VBI’s ongoing two-part study is being conducted at The Neurological Institute of New York Columbia University Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, and the Ronald Reagan UCLA Medical Center.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

●Part A

●Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients, with any number of prior recurrences.
●This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
enrollment completed in December 2018

●Part B

●Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
●This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each arm, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01B adjuvant system as immunomodulatory adjuvants.
●Enrollment in each study arm is ongoing

VBI-1901 is administered intradermally when adjuvanted with GM-CSF and will be administered intramuscularly when adjuvanted with AS01B adjuvant system. Patients in the study will receive the vaccine immunotherapeutic every four weeks until clinical disease progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

On March 2, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported the publication of a large, retrospective study in which the Danish Breast Cancer Group (DBCG) used the Prosigna breast cancer prognostic gene signature assay to identify which women were more likely to benefit from aggressive chemotherapy based on their intrinsic breast cancer subtype (Press release, Veracyte, MAR 2, 2020, View Source [SID1234555046]). The findings appear online in npj Breast Cancer, a peer-reviewed open-source journal, and suggest that women with HER2-enriched subtypes may benefit from commonly used anthracycline-containing chemotherapy regimens, while those with luminal breast cancer subtypes – which accounted for 30 percent of the women in the study – could potentially be spared such treatment regimens, which have significant cardiotoxicity in some patients.

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The findings are from a retrospective analysis of the DBCG89D trial – a prospectively designed, randomized trial of 980 pre- and post-menopausal Danish women with early-stage breast cancer who were administered adjuvant chemotherapy regimens that contained anthracycline (epirubicin) or were CMF- (cyclophosphamide, methotrexate and fluorouracil) based. Among the 686 women with Prosigna results, overall survival was significantly different in anthracycline- versus non-anthracycline treated patients with HER2-enriched (Hazard Ratio of 0.72, 95% Confidence Interval 0.52; 0.99) tumors, but not in patients with luminal A (Hazard Ratio of 1.62, 95% Confidence Interval 0.97; 2.71) or luminal B (Hazard Ratio of 1.41, 95% Confidence Interval 0.80; 2.47) cancers. Of the 686 women with Prosigna results, the test identified 132 women with luminal A, 78 with luminal B, 259 with basal-like and 217 with HER2-enriched breast cancer subtypes.

"Our study was a carefully planned, formal re-analysis of an important Danish clinical trial that helped establish the use of anthracycline chemotherapies in breast cancer — an aggressive treatment that saves lives but can have serious side effects, including heart damage," said Torsten Nielsen, M.D., Ph.D., professor of pathology and laboratory medicine at BC Cancer, the University of British Columbia, a co-author of the study and a developer of the gene signature on which the Prosigna test is based.

"By applying Prosigna technology, which had not yet been invented when the tumor tissue from this trial was originally collected and stored, we found that patients with luminal subtypes did not benefit from putting anthracycline drugs into the chemotherapy regimen. These drugs only provided added benefit to those with non-luminal molecular subtypes. The study contributes to the accumulating body of evidence that the breast cancer molecular subtypes and risk scores identified with Prosigna technology can help identify which women can safely back off of aggressive chemotherapy."

The Prosigna test uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with clinical-pathological features, and can provide a hormone-receptor positive early breast cancer patient and her physician with a prognostic score indicating the probability of cancer recurrence during the next 10 years. Outside of the United States, it is also utilized to provide PAM50 molecular subtype information.

"These new data suggest that the Prosigna test may be able to offer new levels of individualized treatment for women with early-stage breast cancer, potentially enabling many to avoid more aggressive chemotherapy regimens," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These findings also suggest exciting future expansion opportunities for the Prosigna test’s positioning in global markets where intrinsic breast cancer subtypes are reported in the test results."

Veracyte acquired the Prosigna test from NanoString Technologies, Inc. in December 2019 as part of its acquisition of the exclusive global diagnostic rights to the nCounter FLEX Analysis System. The DBCG retrospective study was supported by funds from NanoString Technologies.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay

Physicians use Prosigna to help guide therapeutic decisions so that patients receive therapeutic interventions, such as chemotherapy, only if clinically warranted. The in vitro diagnostic test is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors; or
A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐positive (1‐3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.
The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Dx Analysis System and is available for use when ordered by a physician. The test is performed on formalin-fixed and paraffin-embedded tissue. The Prosigna test has been CE-marked, showing that it conforms with European Union regulations, and is available for use by healthcare professionals in the European Union and other countries that recognize the CE mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The test is covered by Medicare and leading private payers in the United States and is widely covered by government and private payers in the countries where it is available.