On September 18, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, SEP 18, 2019, View Source [SID1234539629]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD), is acting as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement

On September 18, 2019 NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’), reported encouraging findings from the Company’s phase I study evaluating first-in-class radioenhancer NBTXR3 activated by stereotactic body radiation (SBRT) (Press release, Nanobiotix, SEP 18, 2019, View Source [SID1234539628]). These data were presented at the ASTRO 2019 Annual Meeting by investigator Dr. Enrique Chajon.

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Hafnium oxide nanoparticles activated by SBRT for the treatment of hepatocellular carcinoma and liver metastasis: a phase I/II trial

Enrique Chajon1, Marc Pracht1, Yann Rolland1, Thierry de Baere2, France Nguyen2, Jérôme Durand-Labrunie2, Jean-Pierre Bronowicki3, Véronique Vendrely4, Antonio Sa Cunha5, Anne-Sophie Baumann6, Valérie Croisé-Laurent3, Emanuel Rio7, Samuel Le Sourd1, Pierre Gustin2, Patricia Said8, Christophe Perret7, Didier Peiffert5, Eric Deutsch2

1Radiation Oncology, Centre Eugene – Marquis, Rennes, FR, 2Radiation oncology, Institut Gustave Roussy, Villejuif, FR, 3Hepatology and Gastroenterology, Hôpital de Brabois, Vandoeuvre Les Nancy, FR, 4Radiotherapy, Groupe Hospitalier Sud – Hôpital Haut-Lévêque, Pessac, FR, 5Centre Hépato-Biliaire Paul Brousse, Villejuif, FR, 6Radiotherapy, Institut de Cancérologie de Lorraine, Nancy, FR, 7Radiotherapy, Institut de cancérologie de l’Ouest, Nantes, FR, 8Nanobiotix, SA, Paris, Fr

The population for this study included (i) hepatocellular carcinoma (HCC) patients with a minimum life expectancy of three (3) months that were unsuitable for local surgery or local treatment and (ii) liver metastasis (mets) patients with a minimum life expectancy of six (6) months whose tumors are unresectable. The total number of HCC patients was 11, the total numbers of mets patients was 6.

The HCC patient population has high unmet medical needs as they have underlying liver dysfunction and concomitant malignancies that limit treatment options. Stereotactic body radiation therapy (SBRT) is a well-tolerated alternative therapy, however the dose is limited by hepatic function which is widely impaired in this group. Therefore, these patients need a way to increase the dose delivered to the tumor while sparing surrounding healthy tissues without additional strain on the liver. Moreover, given the short life expectancy of these patients, the need is particularly urgent.

Given that NBTXR3 is inert unless exposed to radiotherapy, is not metabolized by the liver, and can be administered regardless of liver and renal function, the first-in-class treatment offers an opportunity to increase

the efficacy of SBRT while maintaining tolerable dose levels for the patient. In this study, the safety profile of NBTXR3 activated by SBRT was similar to SBRT alone with no dose-limiting toxicity (DLT). Additionally, NBTXR3 also proved to remain within the injected tumor with no leakage to surrounding tissue.

To date, 62.5% of evaluable HCC patients have shown a complete response while the rest have shown partial response. These results show that NBTXR3 activated by SBRT may present as a valuable option in patients with HCC not amenable to curative local treatment or with unresectable liver metastases.

In liver mets, 50% of patients have shown partial response and 50% show stable disease.

Given that the safety profile was very good and there were no DLTs, the protocol was amended to include a fifth dose escalation level of 42%. Three (3) patients have already been recruited and recruitment is expected to be complete in Q4. Results for all patients are expected in Q1 2020.

These results are significant for the Company as they increase the scope of patients NBTXR3 may treat beyond Soft Tissue Sarcoma and Head and Neck cancer. The Company remains focused on its head and neck plan but will now accelerate integration of HCC into its go-to-market strategy.

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About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with very limited therapeutic options. Promising results have been observed in the phase I/II trial regarding the local control of the tumors. In the United States, based on the discussions with the Food and Drug Administration that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. In the United States, the Company received approval from the Food and Drug Administration to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with antiPD-1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Further, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

On September 18, 2019 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS), reported the appointment of Robert Petit, Ph.D., as its Chief Medical and Scientific Advisor. He is continuing to support the technology that he helped to develop at Advaxis (Press release, OS Therapies, SEP 18, 2019, View Source [SID1234539627]).

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Dr. Petit is a highly successful C-level executive and biopharma leader with a diverse background in research and development with over 25 years of experience in clinical development, and pre-clinical and translational research. In addition, he has helped to build, grow and secure investments for respected academic organizations, as well as private and publicly traded biopharma companies. An accomplished immuno-oncology scientist, innovator and drug developer, he has been integral to 7 NDA/BLA/EMA filings in the immuno-oncology space and was part of team at BMS who established the first checkpoint inhibitor therapy. Most recently, Dr. Petit served as Chief Scientific Officer of Advaxis, Inc., contributing to their successful NASDAQ IPO, raising significant capital, and evolving their platform technology to leverage both personal and shared neoantigens.

"I am excited to join the OS Therapies team and contribute toward realizing the potential of the OS Therapies lead program in the treatment of osteosarcoma," said Dr. Petit. "I also look forward to furthering the mission of OS Therapies by assisting in building a pipeline of assets that will improve treatment options and outcomes for patients with osteosarcoma."

"From our first meeting with Advaxis to discuss out-licensing for the Osteosarcoma indication, we knew Robert was the driving force behind the development of the technology," said Paul Romness, Chief Executive Officer of OS Therapies. "Already, he has been a crucial contributor to our team in bringing knowledge and passion for the technology. As our Chief Medical and Scientific Advisor, he is set to bring even more confidence and institutional knowledge to our investors and clinical researchers alike."

On September 18, 2019 Biodesix, Inc. reported findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC) (Press release, Biodesix, SEP 18, 2019, View Source [SID1234539624]). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer.

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Biomarker Identification for Immunotherapy

Data from a clinical study that examined the impact of VeriStrat testing on patients receiving immune checkpoint inhibitors (ICIs) as part of their NSCLC treatment strategy, showed that the VeriStrat MS-based proteomic signature has potential as a biomarker for survival outcomes in NSCLC patients receiving immunotherapy. Among NSCLC patients treated with ICIs, VeriStrat-Good classification was associated with significantly increased PFS in comparison to VeriStrat-Poor classification (median PFS of 6.2 vs. 3.0 months, p=0.012), while the differences in OS trended towards significance (median OS, not reached vs. 16.5 months p=0.076). These results were presented by Northwestern University Feinberg School of Medicine Professor Young Kwang Chae, MD, MPH, MBA at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer.

"As an oncologist, my goal is to identify the treatment course that will give each of my patients the best possible outcome," Dr. Chae stated. "By using VeriStrat, I am able to get a more complete clinical picture of my patient’s state of health, which allows me to work with that individual to determine the path forward that is best for them."

Improved Clinical Management of Advanced NSCLC Patients Unsuited for Chemotherapy

A recent University College London (UCL) study published in the European Journal of Cancer found that the VeriStrat test improved prognosis accuracy for patients with advanced NSCLC who were considered to be unsuitable candidates for chemotherapy. NSCLC accounts for 80-85 percent of all lung cancers and many patients are not diagnosed until their cancer has advanced to a late stage. Siow Ming Lee, PhD, UCL Professor of Medical Oncology and Chief Investigator of the TOPICAL trial, reported a strong correlation between the results of the VeriStrat test and patient outcomes. This VeriStrat correlation held even when the patients were split into the good and poor ECOG performance status subgroups; VeriStrat Good versus VeriStrat Poor in ECOG 0-1; HR 0.25, p=0.006 and ECOG 2-3; HR 0.60, p=0.002.

"The relationship between the VeriStrat test and survival is a major finding within this patient population, who have generally poor health and are difficult to treat," Dr. Lee commented. "The VeriStrat test seems to distinguish patients who have a shorter or longer survival. This has never been reported before in this particular patient group."

The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC. Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples. Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice. VeriStrat testing has been validated in more than 85 studies with more than 6,600 patients and is covered by Medicare and many private health insurers.

"VeriStrat blood testing continues to help guide treatment decisions as evidenced through these studies and many others," said Scott Hutton, Biodesix COO. "The potential for VeriStrat continues to expand as studies demonstrate relevancy in lung cancer with the latest therapies in development."

Veristrat is part of the Biodesix Lung Reflex Strategy (BLR), which integrates the GeneStrat genomic test. The BLR strategy has been widely adopted across oncology clinics due primarily to its ability to provide a more comprehensive understanding of patients’ health. Through a series of case studies, physicians detail the value offered through GeneStrat and VeriStrat testing, highlighting their ability to optimize treatment strategies, and to inform conversations on prognoses and treatment options with patients.

On September 18, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that it will present at the Singular Research Midwestern Values Conference on September 19, 2019 via webcast (Press release, Genprex, SEP 18, 2019, View Source [SID1234539623]).

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Genprex’s Chairman and Chief Executive Officer, Rodney Varner, will lead the company’s webcast presentation.

Genprex will present at the Singular Research Midwestern Values Conference as follows:

Date: Thursday, September 19, 2019

Time: 4:00-4:30 p.m. CDT

Webcast Link: http://bit.ly/2kpgxlu

Registration for the webcast can be completed on the Singular Research website at www.SingularResearch.com.