On August 15, 2019 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will participate in two upcoming investor conferences in New York, NY (Press release, ViewRay, AUG 15, 2019, View Source [SID1234538795]).

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Event:

Baird 2019 Global Healthcare Conference

Format:

Fireside Chat & 1×1 Meetings

Date:

Wednesday, September 4, 2019

Time:

9:40 am ET

Location:

Intercontinental New York Barclay

Event:

Morgan Stanley 17th Annual Global Healthcare Conference

Format:

Fireside Chat & 1×1 Meetings

Date:

Wednesday, September 11, 2019

Time:

1:35 pm ET

Location:

Grand Hyatt New York

An audio webcast of the Company’s presentations will be available on the events and webinars section of ViewRay’s investor relations website at View Source A replay of each webcast will be available for 14 days after the date of the presentation.

On August 15, 2019 The U.S. Food and Drug Administration granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments (Press release, Bonnie J Addario Lung Cancer Foundation, AUG 15, 2019, View Source [SID1234538896]).

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"We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine," said FDA Acting Commissioner Ned Sharpless, M.D. "Using the FDA’s expedited review pathways, including breakthrough therapy designation and accelerated approval process, we’re supporting this innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. We remain committed to encouraging the advancement of more targeted innovations in oncology treatment and across disease types based on our growing understanding of the underlying biology of diseases."

This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are "tissue agnostic." It follows the policies that the FDA developed in a guidance document released in 2018. The previous tissue agnostic indications approved by the FDA were pembrolizumab for tumors with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in 2017 and larotrectinib for NTRK gene fusion tumors in 2018.

"Today’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK-fusion-positive tumors by relying on efficacy information obtained primarily in adults. The FDA continues to encourage the inclusion of adolescents in clinical trials. Traditionally, clinical development of new cancer drugs in pediatric populations is not started until development is well underway in adults, and often not until after approval of an adult indication," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Efficacy in adolescents was derived from adult data and safety was demonstrated in 30 pediatric patients."

The ability of Rozlytrek to shrink tumors was evaluated in four clinical trials studying 54 adults with NTRK fusion-positive tumors. The proportion of patients with substantial tumor shrinkage (overall response rate) was 57%, with 7.4% of patients having complete disappearance of the tumor. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for nine months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid and colon/rectum.

Rozlytrek was also approved today for the treatment of adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and has spread to other parts of the body (metastatic). Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.

Rozlytrek’s common side effects are fatigue, constipation, dysgeusia (distorted sense of taste), edema (swelling), dizziness, diarrhea, nausea, dysesthesia (distorted sense of touch), dyspnea (shortness of breath), myalgia (painful or aching muscles), cognitive impairment (confusion, problems with memory or attention, difficulty speaking, or hallucinations), weight gain, cough, vomiting, fever, arthralgia and vision disorders (blurred vision, sensitivity to light, double vision, worsening of vision, cataracts, or floaters). The most serious side effects of Rozlytrek are congestive heart failure (weakening or damage to the heart muscle), central nervous system effects (cognitive impairment, anxiety, depression including suicidal thinking, dizziness or loss of balance, and change in sleep pattern, including insomnia and excessive sleepiness), skeletal fractures, hepatotoxicity (damage to the liver), hyperuricemia (elevated uric acid), QT prolongation (abnormal heart rhythm) and vision disorders. Health care professionals should inform females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Rozlytrek. Women who are pregnant or breastfeeding should not take Rozlytrek because it may cause harm to a developing fetus or newborn baby.

Rozlytrek was granted accelerated approval. This approval commits the sponsor to provide additional data to the FDA. Rozlytrek also received Priority Review, Breakthrough Therapy and Orphan Drug designation. The approval of Rozlytrek was granted to Genentech, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On August 15, 2019 Hemispherx Biopharma, Inc. (NYSE American: HEB), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases, reported the filing of its report 10Q for the second quarter, which ended June 30, 2019, and provides a business update (Press release, AIM ImmunoTech, AUG 15, 2019, View Source [SID1234540960]).

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Management Commentary

"The company’s stockholder equity increased by $2,618,000 during the second quarter to $6,548,000 and we expect to continue on this positive trajectory. We look forward to the results from our ongoing clinical trials over the next 18 months, seeing them as strong value drivers for the stock. Thus far, we have had strong, steady and consistent clinical progress in immuno-oncology. I believe this is critical to creating long-term stockholder value, as success in any one of our ongoing or upcoming clinical trials has the potential to be a strong market catalyst," said Hemispherx CEO Thomas K. Equels. "Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial combining Ampligen and pembrolizumab. All our trials are paid for by third parties without Hemispherx conceding any rights for development. I believe that third parties’ fronting of trial costs shows that it’s not just Hemispherx that believes in Ampligen, but that major cancer research centers, governmental grantors and the pharmaceutical industry grantors also see the potential of Ampligen as a combination therapy."

Balance Sheet Highlights

As of June 30, 2019, Hemispherx had cash, cash equivalents and marketable securities of $2,864,000 compared with $1,825,000 as of December 31, 2019.

Second Quarter Financial Highlights

Research and development manufacturing-related expenses for the second quarter of 2019 were $1,096,000, compared with $1,341,000 million for the second quarter of 2018. The decrease was due primarily to a general reduction of Ampligen manufacturing costs.

General and administrative expenses for the second quarter of 2019 were $1,942,000, compared with $1,733,000 for the second quarter of 2018. The increase was mainly due to an increase in stock compensation expense and an increase in public relations expenses.

The net loss from continuing operations for the second quarter of 2019 was $2,029,000, or $1.07 per share, compared with $2,415,000, or $2.38 per share, for the second quarter of 2018.

Ongoing Ampligen Clinical Studies

Advanced Recurrent Ovarian Cancer – A Phase 1/2 clinical trial of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. Eleven patients in the Phase 1 portion have been enrolled; 10 have completed treatment and one is undergoing treatment and evaluation. An interim report from Dr. Edwards’ team was received and they are drafting a manuscript on the biological and clinical outcomes from the Phase 1 portion of the trial. Dr. Edwards’ team has issued an updated report supporting the clinical safety of using Ampligen on an intraperitoneal basis in combination therapy, thus allowing a large Phase 2 trial combining Ampligen and pembrolizumab to begin. Separately, Dr. Edwards has reported that the Phase 1/2 clinical trial generated positive survival data, to be addressed in the manuscript. See ClinicalTrials.gov.
Advanced Recurrent Ovarian Cancer – A follow-up study to the Phase 1/2 above is a 45-patient, Phase 2 clinical trial combining Ampligen, cisplatin and pembrolizumab in the treatment of advanced recurrent ovarian cancer. This trial is being conducted at the University of Pittsburgh Medical Center by Dr. R. Edwards. The first patient was treated on June 11, 2019 and treatment of patients is underway. See ClinicalTrials.gov.
Stage 4 Colorectal Cancer Metastatic to the Liver – A 12-patient, Phase 2a clinical trial combining Ampligen, Intron A and celecoxib in Stage 4 colorectal cancer. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. P. Boland. To date, seven subjects have been enrolled and completed treatment, and the trial is progressing well. Data from this trial is expected in 2020. See ClinicalTrials.gov.
Stage 4 Metastatic Triple-Negative Breast Cancer – A Phase 1, 6-patient, open-label clinical trial combining Ampligen, Intron A, celecoxib and pembrolizumab in the treatment of Stage 4 triple-negative breast cancer. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. M. Opyrchal. Patients have been enrolled and are in early treatment. See ClinicalTrials.gov.
Early-Stage Prostate Cancer – A 60-patient, Phase 2 randomized, three-arm clinical trial of aspirin and Ampligen with or without Intron A compared with no drug treatment in patients with early-stage prostate cancer before undergoing radical prostatectomy. This trial is being conducted at Roswell Park Comprehensive Cancer Center by Dr. G. Chatta. IRB and FDA approval have been received. Roswell expects first enrollment in the immediate future. See ClinicalTrials.gov.
Expanded Access Program

Advanced Pancreatic Cancer – An Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands for Stage 4 pancreatic cancer at Erasmus Medical Center has been ongoing for two years. The team at Erasmus is making progress under the supervision of Prof. Casper van Eijck, MD, a world-renowned specialist in this dread malignancy, and Diba Latifi, MD. The Dutch government has approved and extended the therapeutic program for an additional year. Early progress was reported in a published abstract from Erasmus. The abstract was part of a larger original report covering a variety of medical topics, which can be found at View Source The last two patients planned to be enrolled for a planned paper are nearing the end of treatment. The paper analyzing the data is expected in 2020.

Clinical trials planned for initiation in 2019/2020

Stage 4 Brain Metastatic Breast Cancer – A multi-site Stage 4 brain metastatic breast cancer study testing Ampligen as an immunological agent increasing efficacy is awaiting funding.
Stage 4 Refractory Metastatic Colorectal Carcinoma – Phase 2 study that will evaluate Ampligen in combination with pembrolizumab in Stage 4 refractory metastatic colorectal carcinoma at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Roswell Park is reviewing the budget and preparing it for institutional submission.
Stage 4 Urothelial (Bladder), Melanoma and Renal Cell Carcinoma – Phase 2 study of Stage 4 urothelial (bladder), melanoma and renal cell carcinoma, resistant to checkpoint blockade, that will evaluate Ampligen in combination with a checkpoint blockade therapy at Roswell Park Comprehensive Cancer Center. Protocol design currently being finalized. Hemispherx Biopharma signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center to study Ampligen in combination with checkpoint inhibitors in a Phase 2a study in urothelial carcinoma, renal cell carcinoma and melanoma. Hemispherx is awaiting the study protocol, which is under review at Roswell Park, and confirmation of third-party funding.
Non-Small Cell Lung Cancer – First-line therapy for non-small cell lung cancer with SOC chemotherapy that will evaluate Ampligen in combination with pembrolizumab at University of Nebraska Medical Center. Dr. V. Ernani, PI. Study design and budget being developed. However, we now anticipate an extended delay at Nebraska because we were unable to obtain funding yet for the large trial. However, we are working on a pilot trial program at Roswell Park to create sufficient data for a large, multi-site non-small cell lung cancer Phase 2 clinical study.
Advanced Pancreatic Cancer – Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University of Nebraska Medical Center. Dr. K. Klute, PI. Protocol and budget being developed. Based upon success in the initial animal studies, an additional round of more extensive and comprehensive pre-clinical animal pancreatic cancer studies are being conducted at University of Nebraska to reconfirm results, test additional PC tumor types, examine anti-PD-1 in addition to the prior anti-PD-L1 analysis, then fine tune the focus of the proposed future pancreatic cancer clinical trial and reduce the chances of error in clinical trial design. This information will also be used to formulate proposed future combination therapy clinical activity in the Kingdom of the Netherlands.
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer is awaiting FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival.

On August 15, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that Janssen Biotech, Inc. (Janssen) will present data from a Phase I clinical study of ADC-1013 (JNJ-7107) at the upcoming ASCO (Free ASCO Whitepaper) Annual meeting held in Chicago on May 31- June 4 (Press release, Alligator Bioscience, AUG 15, 2019, View Source [SID1234538665]). The study results show that side effects were generally mild and transient.

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The primary aim of the study was safety and to establish a recommended dose for Phase II. The study is still ongoing and has enrolled a total of 95 patients. The maximum tolerated dose has not yet been reached. Doses up to 1200 μg/kg i.v without premedication, and up to 2000 μg/kg with premedication have been shown to be safe and tolerable. Early evidence of clinical activity in this study included a partial response (PR) in a patient with renal cell cancer and 10 patients with prolonged stable disease (SD) ≥6 months.

"I am glad to see the promising safety and tolerability profile of ADC-1013 in patients with cancer. This together with the early signs of clinical activity, gives me great confidence in this CD40 drug candidate", said Per Norlén, CEO of Alligator Bioscience.

A poster (#171) with the title "A Phase 1 Study to Assess Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of JNJ-64457107, a CD40 Agonistic Monoclonal Antibody, in Patients (pts) with Advanced Solid Tumors" will be showcased at ASCO (Free ASCO Whitepaper) on June 1, 2019 from 8 – 11 a.m. in the session Developmental Immunotherapy and Tumor Immunobiology.

The licensing agreement with Janssen encompasses milestone payments up to a potential total value of USD 695 million. Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.

For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 11:00 p.m. CEST (5:00 p.m. ET) on May 15, 2019.

About ADC-1013 (JNJ-7107)
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Results from a previous clinical Phase I first-in-human study performed by Alligator (International Journal of Cancer, View Source) showed that ADC-1013 was generally well tolerated. Preclinical data have previously shown that the ADC-1013 antibody effectively activates T cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer.

On August 15, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first half of 2019 and releases its financial calendar for 2020 (Press release, Bavarian Nordic, AUG 15, 2019, View Source [SID1234538781]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We have made important progress in our strategic objectives during the first half of this year with the initiation of a Phase 3 study for the freeze-dried formulation of MVA-BN and the expansion of our proof of concept Phase 2 study for BN-Brachyury. Our financial results are fully in line with our guidance and expectations and we are looking forward to the rest of the year with a rich news flow ahead of us. We expect to report additional clinical oncology data for CV301; finalize our registration plans for RSV; obtain our first ever US approval together with a priority review voucher for MVA-BN and lastly complete the construction of our fill and finish plant that will unlock higher future revenues and return the company to profitability. It is a very exciting time to be at Bavarian Nordic".

OPERATIONAL HIGHLIGHTS

Delivering our strategy
Our strategy is four-fold, and aims to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities:

MAINTAIN global leadership of our smallpox vaccine business
EXPAND and rapidly ADVANCE the pipeline of infectious disease programs
ESTABLISH a broad and deep cancer immunotherapy portfolio
EXPAND the commercial footprint and capabilities
Smallpox

The BLA review for liquid-frozen MVA-BN is continuing, with an anticipated approval and award of a Priority Review Voucher in September 2019.
In June, we initiated the pivotal and fully funded Phase 3 trial of the freeze-dried formulation of MVA-BN as planned. This randomized and double-blind study will enroll 1,110 healthy subjects into 3 groups and investigate the safety and immunogenicity of 3 different lots of freeze-dried MVA-BN. The study is expected to be completed by the end of 2020 and will support the subsequent approval of the freeze-dried formulation.
In June, the U.S. Government passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA) of 2019. This bill improves the funding for critical federal biodefense programs and agencies, including Biomedical Advanced Research and Development Authority (BARDA) and the Strategic National Stockpile (SNS) at 1.2 billion annually for the next five years, while the Project BioShield Special Reserve Fund (SRF) will be funded at US$ 710 million annually over the next 10 years. This strong financial support creates a more sustainable market place for companies like ours developing biological countermeasures.
The production of the bulk vaccine for the current BARDA order for freeze-dried MVA-BN has been initiated and is running smoothly, however the majority of the batches will only be invoiced in the second half of 2019 adding up to a total of USD 50 million included in our guided 2019 revenues. By year-end we will then have produced bulk vaccine worth USD 333 million since our first order in 2015.
In January, we were awarded USD 44 million by the U.S. Government for qualification of our new fill and finish facility, as well as for transfer and validation of the production process for freeze-dried MVA-BN. These activities will be finalized in 2020 before starting production of the current order to convert the bulk vaccine to approx. 13 million freeze-dried doses.
Infectious diseases

We remain at the forefront of RSV vaccine development with our differentiated vaccine candidate, which has successfully concluded Phase 2 development in elderly subjects. We continue to prepare for initiating a Phase 3 trial in 2020 and plan to announce the final plans once the Phase 3 design has been confirmed with the US regulatory authorities.
In February, our partner Janssen initiated a Phase 1/2a of the therapeutic HPV vaccine regimen. This is the first of three commercial programs under our partnership to enter clinical trials. The second program for a therapeutic HIV vaccine, is also expected to enter a Phase1/2a clinical trial later this year. Collectively, these programs, along with our Ebola collaboration, represent USD 1 billion in potential future milestone payments, in addition to royalties on future sales.
Our partnership with the U.S. Department of Defense on the development of a prophylactic vaccine against the equine encephalitis virus – a rare, but potentially deadly illness – further evolved, as we received funding to support a Phase 1 clinical trial, which we expect to initiate later this year. Successful trial results could lead to additional funding of clinical development towards licensure.
Cancer immunotherapy

In June, we reported the first results from the ongoing Phase 2 trial of BN-Brachyury for the treatment of chordoma. A partial response was observed in one of the first 10 patients recruited and treated with the vaccine in combination with radiation, thereby reaching the threshold for advancing the study into stage 2, where enrollment will be expanded to a total of 29 patients. We have seen strong support from the chordoma community for this study and expect to see a rapid enrollment of patients. For the study to be considered successful, a minimum of four out of the 29 patients with objective responses are required.
Our other immune-oncology candidate, CV301, is currently subject of three Phase 2 trials in multiple cancers, where the vaccine is combined with different immune checkpoint inhibitors. The first results from one of these trials, where CV301 is combined with atezolizumab in bladder cancer, is expected to become available later in 2019.
Both vaccine candidates will also be employed in new trials later this year to investigate new routes of administration as part of our strategy to further enhance our immuno-oncology platform.
Commercial

Construction of our fill and finish facility is progressing according to plan, and we expect the building to be completed by end of 2019, which is the peak investment year with approximately DKK 270 million in total investments. Subsequently, qualification and validation activities will begin and continue into late 2020 before initiating production of MVA-BN.
OTHER DEVELOPMENTS

The Danish tax authority decided in July to withdraw the proposed adjustment of the allocation of the PROSTVAC development costs between Bavarian Nordic A/S and its U.S. subsidiary, Bavarian Nordic, Inc. for the income years 2012-2016. The transfer pricing tax audit for 2012-2016 has thereby been completed without any changes to taxable income.
FINANCIALS AND OUTLOOK

Financial results for the first half in line with expectations

Revenue generated for the six months ending June 30, 2019 was DKK 228 million/USD 35 million (DKK 98 million/USD 15 million in the first six months of 2018).
The income before interest and tax (EBIT) was a loss of DKK 201 million/USD 31 million (loss of DKK 280 million/USD 43 million in the six months of 2018).
As of June 30, 2019, the Group’s cash preparedness was DKK 1,882 million/USD 287 million (DKK 2,314 million/USD 353 million as of December 31, 2018), including unutilized credit lines of DKK 244 million/USD 37 million (DKK 244 million/USD 37 million as of December 31, 2018).
Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.56 per 1.00 USD, which was the exchange rate as of June 30, 2019.

Outlook for 2019 maintained

The majority of our 2019 revenues are related to the production and release of bulk smallpox vaccine for the U.S. Government, which will occur in the second half of 2019. Hence, we maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million and a cash preparedness at year-end of approximately DKK 1,600 million/USD 246 million.

While the Company anticipates the award of a Priority Review Voucher upon the expected approval of MVA-BN smallpox vaccine by the FDA in 2019, income from the sale of this voucher has not been included in the guidance.

The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.

Financial calendar 2019 and 2020

The 2020 dates for announcement of the Company’s financial reports and the annual general meeting have now been determined, and planned future reporting dates are as follows:

November 7, 2019 Third quarterly report (Q3) for the nine-month period ended September 30, 2019
March 13, 2020 2019 Annual Report
April 21, 2020 Annual General Meeting *
May 14, 2020 First quarterly report (Q1) for the three-month period ended March 31, 2020
August 26, 2020 Half-year report (Q2) for the six-month period ended 30 June 2020
November 11, 2020 Third quarterly report (Q3) for the nine-month period ended 30 September 2020
* Pursuant to Article 12 of the Articles of Association, shareholders who wish to submit a request for proposals for consideration at the annual general meeting must lodge this with the Company no later than Wednesday, March 11, 2020.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EST) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 5278296.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Graham Morrell
Paddock Circle Advisors (US)
[email protected]
Tel: +1 781 686 9600

Company Announcement no. 14 / 2019