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Inova Health System and Roswell Park Comprehensive Cancer Center Join KIYATEC Clinical Trial to Predict Patient Response to Cancer Drugs Prior to Treatment

On March 15, 2019 KIYATEC, Inc. reported that the company has opened Inova Health System (Inova) and Roswell Park Comprehensive Care Center as sites for its U.S. clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies in ovarian, glioblastoma (GBM) and rare cancer patients (Press release, KIYATEC, MAR 15, 2019, View Source [SID1234534402]).

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"The addition of Inova Health System and Roswell Park Comprehensive Cancer Center to our clinical study is an important milestone as we continue on the path to determine the best drug option for cancer patients before they begin their treatment journey," said Matthew Gevaert, CEO of KIYATEC. "Both hospitals are known for their excellence in clinical research and patient care, most notably in ovarian cancer. Not only will this be significant for our trial, it underscores their commitment to finding the best, personalized care for their patients."

The 3D-PREDICT clinical study analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors. The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on Clinicaltrials.gov.

"Roswell Park has the unique distinction of being the first clinical center in the world to focus exclusively on cancer, and we are continuously seeking new and improved methods to provide the best care for our patients," said Kunle Odunsi, MD, PhD, FRCOG, FACOG, deputy director, chair of gynecologic oncology and executive director of the Center for Immunotherapy, Roswell Park Comprehensive Cancer Center, and lead investigator. "The 3D-PREDICT trial presents an opportunity to utilize an emerging technology for identifying biomarkers of response in our ovarian cancer immunotherapy research."

Inova has already accrued patients into the trial and G. Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC) is the lead investigator. Inova Strategic Investments, the strategic investing division of the Inova Health System, is an investor in KIYATEC. The division invests in companies that align with Inova’s strategic priorities of delivering personalized health and healthcare services.

KIYATEC will be exhibiting at the Society for Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer, which is being held March 16-19, 2019 at the Hawaii Convention Center in Honolulu, Hawaii.

Oragenics, Inc. Announces Enrollment of 60th Patient in Clinical Trial

On March 15, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the enrollment of the 60th patient in its Phase 2 double blind, placebo controlled clinical trial of AG013 (NCT03234465) (Press release, Oragenics, MAR 15, 2019, View Source [SID1234534401]).

AG013 is an oral mouth rinse composed of a recombinant Lactococcus lactis bacteria strain that contains the coding sequence for human trefoil family factor 1 (hTFF1), which is continually secreted by the bacteria. The trefoil factor family (TFF) is a family of three different peptides secreted by epithelial cells of the gastrointestinal tract in response to injury (Hoffman, 2004). Their presence has been implicated in reducing chemotherapy- and radiation-induced injury, both in preclinical studies (Beck et al., 2004) and in clinical trials (Peterson et al., 2009).

"We are encouraged and pleased to have made this important intermediate progress. The number of patients interested in participating in the clinical trial highlights the need for new treatment options for prevention of severe oral mucositis in this patient population," said Alan Joslyn, CEO of Oragenics, Inc. "While we are confident in the measures we have taken to potentially expedite the pace of patient enrollment in future periods and we remain optimistic about such enrollment rates, given the pace of patient enrollment to date, we now anticipate that the top-line data readout of the AG013 study will likely occur in early 2020."

Adamis Pharmaceuticals Announces 2018 Financial Results and Provides Business Update

On March 15, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2018 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 15, 2019, View Source [SID1234534400]).

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "There were several significant developments for our company during 2018. I view the marketing and distribution agreement with Sandoz for our SYMJEPI products, approval of the SYMJEPI 0.15mg product and submission of a new drug application (NDA) for our higher dose naloxone injection product to be the most significant developments, laying the groundwork for what I hope will be a transformative year for the company. We are also encouraged by the performance of US Compounding in early 2019 and we look forward to expanding our production capacity."

Select Events Since Last Business Update:

First commercial product delivered to Sandoz;

NDA submitted to the FDA and accepted for review for the higher dose naloxone injection product candidate;

NDA submitted to the FDA and received a refusal to file letter for the tadalafil product candidate;

Drug Outsourcing Facility (U.S. Compounding) increased revenue by 15%; and

Sandoz announces launch of SYMJEPI 0.3mg product to the institutional market in the U.S.
Product Updates

SYMJEPI (epinephrine) Injection (0.3mg and 0.15mg)

As announced in the third quarter of 2018, the company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg (upon approval) in the U.S. The company also granted Sandoz a right of first negotiation for territories outside the U.S. On September 27, 2018, the FDA approved the SYMJEPI 0.15mg product. In January 2019, Sandoz announced the launch of SYMJEPI 0.3mg product for the institutional market in the U.S.

APC-6000 (naloxone)

As announced in December 2018, the company filed an NDA relating to its higher dose naloxone injection product for the treatment of opioid overdose. On March 14, 2019, the company received notice from the FDA that it had determined the NDA was sufficiently complete to permit a substantive review and provided a target agency action date of October 31, 2019. Please refer to the company’s March 14, 2019 press release for additional information.

APC-8000 (sublingual tadalafil)

In December 2018, the company announced that it had filed an NDA for a fast-disintegrating sublingual tadalafil (APC-8000) product candidate. On February 26, 2019, the company received a refusal to file letter from the FDA indicating it had determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that the company supplement and include in a resubmitted NDA additional data and information. The company continues to evaluate the FDA’s comments, and it may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter and the specific deliverables the agency would require for a resubmitted NDA to be deemed complete.

APC-1000 (beclomethasone)

In 2018, the company submitted an IND application and received clearance from the FDA to begin Phase 3 efficacy studies for APC-1000. In Q4 2018, it initiated the start-up phase of the phase 3 studies of APC-1000. The company anticipates that trial enrollment will commence in 2019; however, the timing of enrollment and completion of such studies could be affected by a number of factors as described in the company’s Form 10-K.

APC-4000 (fluticasone)

During 2018, the company completed development and manufacturing work on the patented dry powder inhaler (DPI) technology that the company acquired from 3M. Adamis is now focused on continuing and completing the drug development work, which includes loading fluticasone onto the tape and into the device, in order to demonstrate the device can achieve the targeted dosing. Once completed, the company may seek a development or commercial partner to help advance the product through a regulatory pathway.

Drug Outsourcing Facility

The company’s wholly-owned subsidiary, US Compounding (USC), has continually grown its revenues year over year since Adamis acquired the division. During 2018, USC continued to make improvements in its processes and efficiencies while maintaining its focus on quality. Although net revenue grew 15% over 2017, it did not meet the company’s previously stated growth target. Therefore, during the first quarter of 2019, Adamis has made changes to USC personnel and strategy with the objective of achieving profitability for the division during 2019.

2018 Financial Results

Revenues were approximately $15.1 million and $13.1 million for the years ended December 31, 2018 and 2017, respectively. The increase of approximately $2.0 million reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases, increase in unit sales production capacity in order to meet product demand, and marketing personnel efforts.

Selling, general and administrative expenses (SG&A) for the years ending December 31, 2018 and 2017 were approximately $26.0 million and $22.8 million, respectively. SG&A expenses consist primarily of depreciation and amortization, legal fees, accounting and audit fees, professional/consulting fees and employee compensation. Compensation expense for SG&A employees increased by approximately $2.0 million for 2018 compared to 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with equity compensation and other employee benefits. Approximately $0.5 million of the increase for 2018 was due to PDUFA fees, marketing, selling, insurance, consulting, outside services and travel expenses; approximately $0.3 million of the increase was due to increases in patent fees; and approximately $0.4 million of the increase was due to increases in occupancy costs, insurance, supplies, taxes, and other related expenses.

Research and development expenses (R&D) were approximately $18.8 million and $7.5 million for the years ended December 31, 2018 and 2017, respectively. The increase in R&D for 2018, compared to 2017 was primarily due to an increase of approximately $8.8 million in development costs of the company’s product candidates, including APC-1000, APC-4000, APC-6000 and APC-8000. Compensation for R&D employees, consulting, and other operating expenses increased by approximately $1.6 million for 2018 compared to 2017, primarily due to new hires and cash and equity compensation expenses. As noted in its November 2018 press release, the company experienced increased research and development expenses for the fourth quarter of 2018.

At December 31, 2018, the Company had cash and cash equivalents of $19.3 million.

Targeted Future Milestones

FDA approval for the higher dose naloxone product candidate – target agency action date of October 31, 2019;
Sandoz’s launch of the SYMJEPI 0.3mg and 0.15mg products for the U.S. retail market;
Commercial agreements for the naloxone product candidate and for the SYMJEPI 0.3mg and 0.15mg products outside of the U.S.; and
US Compounding reaching profitability in 2019 (targeted by mid-year).

Curis to Present at the 6th Annual OMI Summit on Hematologic Malignancies

On March 15, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that Dr. Robert E. Martell, Head of Research & Development, will present a pipeline update at Oncology Meeting Innovation’s (OMI’s) 6th Annual Summit on Hematologic Malignancies on Saturday, March 16th, 11:10 a.m. PDT at the Fairmont Château in Whistler, British Columbia, Canada (Press release, Curis, MAR 15, 2019, View Source [SID1234534396]).

The slides of the presentation will be available on the Company’s website: www.curis.com on the same day at 9:00 am EDT.

Nanobiotix 2018 Annual Results

On March 15 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited1 consolidated results for the fiscal year ended December 31, 2018 (Press release, Nanobiotix, MAR 15, 2019, View Source [SID1234534395]):

• Major milestones achieved during the year:

o Positive Phase II/III results for NBTXR3 in patients with locally advanced Soft Tissue Sarcoma demonstrating clinical meaningful benefits versus standard of care

o Positive clinical update from Phase I Head and Neck and Phase I/II Liver cancers trials presented at major congresses o Completion of Phase I dose escalation in Head and Neck cancers

o Engaged major preclinical collaborations with highly respected U.S. cancer centers including the University of Texas MD Anderson Cancer Center, the Providence Cancer Institute and Weill Cornell Medicine

• Consolidated cash available of €36.2M at December 31, 2018 o Strengthened by the payment of a €16M first tranche pursuant to a €40M non-dilutive financing agreement established with the European Investment Bank in 2018

• Expenses in R&D proceeding as expected according to clinical development plan

Philippe Mauberna, Chief Financial Officer of Nanobiotix said: "2018 has been a major year for Nanobiotix, we made significant progress in the financial and clinical plan of the company. R&D expenses are linked to our development plan and the hiring of experts in key positions. We are delighted by the positive results in Soft Tissue Sarcoma Phase II/III and the encouraging update from Head and Neck and Liver cancers Phase I/II trials. Indeed, the support of the European Investment Bank strengthens our balance sheet, which allows us to move forward with our 2019 upcoming key milestones."

The unaudited1 consolidated financial statements for the fiscal year ended December 31, 2018 were approved by the executive board and reviewed by the supervisory board of the Company on March 15, 2019.

Financial Review (unaudited)12

Total Revenue in 2018 amounted to €3.5M vs. €3.7M in 2017, mainly due to:
o Revenues related to services provided mainly by the Company to its partner, PharmaEngine, pursuant to a commercial agreement, amounted to €116K in 2018 (vs. €252K in 2017); and
o Other revenues of €3,363K in 2018 (vs. €3,469K in 2017) mainly related to the Research Tax Credit (Crédit d’Impôt Recherche-CIR).

Total Operating expenses reached €33.5M in 2018 vs. €29.0M in 2017:

o R&D expenses (including share-based payments) in 2018 amounted to €20.9M (vs. €17.7M in 2017); the variance comes from an increase in operations (opening of the new production site, launch and extension of new studies) as well as the addition of highly-qualified staff;

o SG&A costs (including share-based payments) in 2018 were €12.7M (vs. €11.3M in 2017).

Total headcount on a consolidated basis reached 102 as of December 31, 2018 vs. 85 as of December 31, 2017, in line with the Company’s growth.

Net loss after tax amounts to €30.3M as of December 31, 2018 (vs. €26.1M loss as of December 31, 2017).
Cash available at December 31, 2018 amounted to €36.2M.————————————-Nanobiotix activities and achievements in 2018
Clinical
Positive Phase II/III results for NBTXR3 in patients with locally advanced Soft Tissue Sarcoma demonstrated clinical meaningful benefits versus standard of care Nanobiotix announced positive results from its Phase II/III clinical trial of NBTXR3 in patients with locally advanced soft tissue sarcoma. The trial achieved its primary endpoint with a pathological complete response rate. It also achieved its secondary endpoint in operability. NBTXR3 demonstrated clinical meaningful benefits for such patients versus standard of care. The data also showed that NBTXR3 was well tolerated. The randomized trial validated the first-in-class mode of action of NBTXR3.
These positive results were presented by Dr. Sylvie Bonvalot at the ESMO (Free ESMO Whitepaper) and ASTRO annual conferences.

Positive Update on Head and Neck cancers Phase I trial showing potential impact for survival Nanobiotix provided an update on the Head and Neck Phase I Trial with NBTXR3 data presented at ImmunoRad 2018. The Phase I Trial focus on elderly and frail patients ineligible for cisplatin or intolerant to cetuximab. The data show the potential impact on survival in this patient population.

Encouraging Data from Phase I/II Liver cancers trial Nanobiotix presented initial promising data from Phase I/II Liver trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors at the American Society of Clinical Gastrointestinal annual meeting (ASCO GI). These positive results show that NBTXR3 was well tolerated with no adverse event related to NBTXR3 and no dose-limiting toxicity.

Collaboration in preclinical research
Collaboration with the Providence Cancer Institute Nanobiotix partnered with the Providence Cancer Institute to run immunotherapeutic preclinical research in pancreatic 21 The Company’s statutory auditors have completed their audit work on the 2018 financial statements and expect to issue their audit report on March 20th, 2019. 3 cancer. This collaboration will provide essential preclinical data on the ability of NBTXR3 activated by radiotherapy to induce an antitumoral immune response.

The University of Texas MD Anderson Cancer Center and Nanobiotix have an agreement in pre-clinical research Nanobiotix and the University of Texas MD Anderson Cancer Center have an agreement to run immunotherapeutic preclinical research in lung cancer. The main objectives of this project, with one of the world’s leading oncology research centers, is to provide preclinical data using NBTXR3 activated by radiotherapy plus anti PD-1 Nivolumab (murine version of Opdivo).

Partnering with Weill Cornell Medicine on pre-clinical studies Nanobiotix and Weill Cornell Medicine partnered to perform pre-clinical studies to evaluate the impact of NBTXR3 on cGAS-STING pathway in mammary cancers. The main objective is to study the impact of NBTXR3 activated by radiotherapy on cGAS-STING, a key component of the anti-tumor immune response. Data generated from this collaboration could provide support for the assertion that NBTXR3 activated by radiotherapy can increase the antitumor immune response compared to radiotherapy alone.

Preclinical data showing NBTXR3 can activate cGAS-STING pathway Nanobiotix presented preclinical data showing NBTXR3 nanoparticles can activate the cGAS-STING pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper). These observations support the rationale for using NBTXR3 with radiation therapy in combination with immunotherapeutic agents and/or STING agonist to transform tumors into an insitu cancer vaccine.

Financial events

Launch of a €40M non-dilutive financing agreement with the European Investment Bank Nanobiotix announced in July 2018, the launching of a non-dilutive financing agreement with the European Investment Bank to boost its research, development and innovation activities. This agreement will allow the Company to borrow up to €40M through loans before July 26, 2020 subject to achieving a set of agreed performance criteria. In October 2018, Nanobiotix received the first tranche disbursement of €16M. The proceeds will be used to speed up development of lead product NBTXR3 in Head and Neck cancers and to support the European go-to-market strategy.

Selection to the Euronext Tech 40

This honor recognizes the best performing Tech SMEs listed on Euronext markets. An independent group of European experts annually selects 40 great companies on the basis of their business, financial and stock market performance.

Events 2019

Large-scale collaboration on NBTXR3 with the University of Texas MD Anderson Cancer Center In January 2019, Nanobiotix and the University of Texas MD Anderson Cancer Center announced a large-scale comprehensive clinical collaboration on NBTXR3. The collaboration will initially support nine new Phase I/II clinical trials with NBTXR3 for use in treating six cancer types – head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers – and will involve around 340 patients. Most of the trials are expected to be launched in 2019. Nanobiotix will finance at least approximately $11M, a portion of which has been paid as of the start of the collaboration, with additional amounts payable during development and upon specified regulatory milestone.

Announced plans to conduct registered public offering in the US In January 2019, Nanobiotix announced that it plans to conduct a registered public offering of its ordinary shares, including the form of American Depositary Shares (ADSs) in the United States. Nanobiotix submitted a confidential draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission.

Second tranche disbursement from the European Investment Bank In March 2019, Nanobiotix received the second tranche of disbursement of €14M from the European Investment Bank. This payment was granted because of the company’s achievement on two criteria: determination of the recommended dose at 22% of the tumor volume for head and neck cancers treatment following the end of Phase I clinical trial with NBTXR3 and positive evaluation of the clinical benefit/risk ratio of NBTXR3 in soft tissue sarcomas Phase II/III by the clinical expert mandated by the French medical device notified body, GMED. 4

2019 Perspectives

This year, Nanobiotix expects to receive its CE mark for NBTXR3 for the treatment of Soft Tissue Sarcoma, which would improve access to the product for cancer patients. In parallel, clinical development should advance with the publication of data in several cancer types.

Newsflow (anticipated)
-2019 – European market approval/CE mark for the treatment of Soft Tissue Sarcoma cancer
-1H2019–Preclinical data regarding immuno-oncology using NBTXR3 in combination with checkpoint inhibitors-1H2019–FDA feedback on NBTXR3 clinical plan in Head and Neck cancers
-2H2019 – Presentation of final Head & Neck Phase I dose escalation results
-2H2019–Potential early results in immuno-oncology with anti-PD-1 study-Multiple launches of clinical trials within MD Anderson collaboration-Additional news on other clinical trials and preclinical programs Additional news on plans to conduct registered public offering in the United States