On August 14, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT:AST), a biotechnology company pioneering the field of regenerative medicine, reported that Cancer Research UK, supported by Asterias technical personnel, has successfully completed manufacture of the first cGMP (current Good Manufacturing Practice) clinical grade lot of AST-VAC2, which meets all specifications for release (Press release, BioTime, AUG 14, 2017, View Source [SID1234520223]). This lot will provide clinical trial material for patients enrolling in the first clinical study evaluating AST-VAC2 in non-small cell lung cancer.

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"The successful production of this first cGMP lot of AST-VAC2 is a major step towards initiating the upcoming study in non-small cell lung cancer," said Mike Mulroy, President and Chief Executive Officer. "With its potential as a ready-to-use, off-the-shelf cancer immunotherapy, AST-VAC2 represents an exciting opportunity for Asterias in the rapidly evolving cancer immunotherapy sector."

Investigational therapies intended for human clinical applications must be manufactured in accordance with cGMP standards designed to help assure the safety and potency of drug products. To achieve cGMP standards, a product must be manufactured and released according to rigorous systems designed to ensure appropriate control of manufacturing facilities, equipment, raw materials, processes and testing procedures. Under the company’s agreement with Cancer Research UK, Asterias has transferred its innovative laboratory scale AST-VAC2 manufacturing process to Cancer Research UK’s Biotherapeutics Development Unit, which has developed and optimized the process for cGMP manufacture and is responsible for producing cGMP AST-VAC2 for use in the upcoming clinical study in non-small cell lung cancer.

About AST-VAC2

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase permits enhanced stimulation of immune responses to the protein. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase which will target tumor cells. AST-VAC2 is based on a specific mode of action that is complementary and potentially synergistic to other immune therapies.

About Non-Small Cell Lung Cancer

Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the American Cancer Society. The three main types of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The American Cancer Society’s estimates for lung cancer in the United States for 2017 are: about 222,500 new cases of lung cancer, and about 155,870 deaths from lung cancer. Despite the large number of people afflicted by non-small cell lung cancer, patients remain vastly underserved due to a scarcity of effective treatments. According to statistics published by Cancer Research UK, the five year survival rate for lung cancer patients in England and Wales is less than 10%.

On August 14, 2017 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on the development of novel small molecule therapeutics for cancer and other hypoxia-related diseases, reported financial results for the three months ended June 30, 2017 and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 14, 2017, View Source [SID1234520221]).

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Highlights of the second quarter of 2017 and recent weeks include:

Advanced trans sodium crocetinate (TSC) for the treatment of newly diagnosed inoperable glioblastoma multiforme (GBM) in preparation for a planned Phase 3 trial with the engagement of a contract research organization and the completion of a major TSC production run
Appointed long-standing pharmaceutical executive Robert R. Ruffolo, Jr., Ph.D. to the Company’s board of directors
Received $8.3 million from the second closing of a private placement of Series A convertible preferred stock
Obtained stockholder approval for a potential offering of up to $20.0 million of Series B convertible preferred stock
David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, stated, "During the second quarter we made solid progress in advancing preparations for a planned Phase 3 trial of TSC in newly diagnosed inoperable GBM patients, and are on track to complete a protocol review in the third quarter of 2017. Assuming FDA sign-off on the final protocol design, we plan to begin enrolling patients into the study by the end of 2017."

"We have engaged a premier contract research organization to conduct the Phase 3 study and entered into agreements with top-tier partners to manage the MRI imaging, clinical data management, drug supply and other functions related to the trial," Mr. Kalergis added. "We completed a major production run of TSC and now have sufficient quantity of the drug to support the entire Phase 3 trial."

Second Quarter Financial Results

Research and development expenses for the second quarter of 2017 were $1.2 million, compared with $1.4 million for the second quarter of 2016. This decrease was attributable to lower expenses related to animal toxicology studies, partially offset by an increase in API and drug manufacturing costs.

General and administrative expenses for the second quarter of 2017 were $1.8 million, compared with $2.3 million for the second quarter of 2016. The decrease was primarily attributable to lower professional fees, partially offset by an increase in salary and salary-related expenses.

The Company recorded a loss from operations of $3.0 million for the second quarter of 2017, compared with a loss from operations of $3.8 million for the second quarter of 2016. The narrowed operating loss reflects lower research and development expenses, as well as lower general and administrative expenses.

We recognized a non-cash gain of $23.4 million in the second quarter of 2017 related to the change in fair value of warrant liabilities, which was attributable to a decrease in the fair market value of our common stock during the period. This non-cash gain resulted in net income for the second quarter, which is not indicative of ongoing operations.

Net cash used in operating activities for the first half of 2017 was $6.2 million, compared with $7.5 million during the first half of 2016.

In April 2017 we received the remaining $8.3 million related to our Series A financing and as of June 30, 2017, the Company had cash and cash equivalents of $7.4 million and a certificate of deposit of $10.0 million.

At our annual meeting of stockholders on June 15, 2017, stockholders approved a potential offering of up to $20.0 million of shares of our Series B convertible preferred stock, $0.001 par value per share ("Series B Preferred Stock"), at a price of $2.10 per share, with each share of Series B Preferred Stock being initially convertible into one share of our common stock, subject to adjustment. For each share of Series B Preferred Stock purchased in the offering, the investor will receive a five-year warrant to purchase one share of common stock with an exercise price of $2.31. There is no assurance we will successfully close such an offering at such terms due to the current trading price of our common stock or for any other reason.

Additional Information

This press release is neither an offer to sell, nor a solicitation of an offer to buy, any securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. The Series B Preferred Stock and related warrants described herein have not been and will not be registered under the Securities Act, or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act, and applicable state securities laws.

On August 14, 2017 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported the following developments (Press release, BioTime, AUG 14, 2017, View Source [SID1234520216]).

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Financial results for the quarter ended June 30, 2017,
Planned expansion of the senior management team by adding a Vice President of Sales and full time Chief Financial Officer,
Branding for its lung cancer diagnostic test, and
Progress toward CLIA lab licensing.
OncoCyte announced that it is planning to expand its senior management team. The Company is now in the final stages of hiring a Vice President of Sales. If hired, this individual will bring many years of sales and marketing leadership within the healthcare industry at leading diagnostic companies. In addition, OncoCyte has begun the process of hiring a full time Chief Financial Officer.

The Company has selected the name DetermaVu for its lung cancer test, a name that directly speaks to how the test will assist clinicians in determining the next steps for their patients by providing information that is not available by using only the current standard of care, a low-dose CT scan.

OncoCyte also announced that its clinical laboratory has passed the required review and inspection by the California Department of Public Health Laboratory Field Services for State Clinical Laboratory licensing and CLIA certification. OncoCyte expects to receive its California State Clinical Laboratory license and CLIA Certificate in the coming weeks.

"Our team has established a solid track record of achieving important milestones and, as a result of recent progress, we are continuing to plan for the commercial launch of our lung cancer diagnostic test in the fourth quarter of 2017," said William Annett, Chief Executive Officer. "Upon launch, DetermaVu will be the only commercially available non-invasive liquid biopsy confirmatory lung cancer diagnostic test in what we estimate could be a $4.7 billion annual market in the U.S. depending on market penetration and reimbursable pricing."

Other Recent Operating Highlights

Announced positive data from the Company’s lung cancer Analytical Validation Study, which established the performance characteristics of DetermaVu. The results were consistent with the data reported at the American Thoracic Society 2017 International Conference, which demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92. Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The reported score of 0.92 means that 92% of samples were correctly identified,

Commenced its CLIA Lab Validation Study in which OncoCyte will assay approximately 120 samples previously tested in the 299-patient study presented at the ATS meeting, with the goal of demonstrating that OncoCyte’s new clinical laboratory will provide the same results on clinical samples as those obtained in the R&D lab, and

Completed a follow-on study of OncoCyte’s breast cancer diagnostic test, confirming the findings of the Company’s previous breast cancer study, which were presented at the San Antonio Breast Cancer Symposium in December 2016. The follow-on study, known as NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer), has been submitted for presentation at a major medical conference.
Near-Term Milestones

OncoCyte’s goals for the near term include the following:

Data from OncoCyte’s latest confirmatory lung cancer diagnostic research will be presented in a slide presentation at the American College of Chest Physician’s CHEST 2017 annual meeting. The meeting will be held in Toronto, Ontario, Canada, from October 28 to November 1,

An abstract concerning the lung cancer Analytical Validation Study results has been accepted for presentation at the International Association for the Study of Lung Cancer, which will take place in Chicago from September 14-16. The oral presentation will be given by Philip McQuary, Ph.D., Director, Product Development, at OncoCyte,

William Haack, Vice President of Market Access at OncoCyte, will address the Next Generation Dx Summit 2017 on successful reimbursement strategies for diagnostic tests. Mr. Haack’s presentation will focus on clinical utility studies as the key to successful reimbursement, and is being given on August 16. The Next Generation DX Summit will take place at the Grand Hyatt Washington in Washington, D.C.,

A DetermaVu Clinical Validation Study to assess the performance of DetermaVu against clinically confirmed cancer diagnoses will be conducted. All of the samples required for this study have now been collected,

Commercial launch of DetermaVu as a liquid biopsy lung cancer diagnostic test, if the results of the CLIA Lab Validation Study and the Clinical Validation Study results confirm that the test meets commercial standards for sensitivity and specificity,

Expansion of OncoCyte’s commercial capabilities in sales and marketing, revenue cycle management and reimbursement,

Seek agreements with international distributors for DetermaVu, payments for which OncoCyte anticipates will be on a cash basis, and

Begin the execution of a comprehensive, proactive approach to pursuing coverage and reimbursement from Medicare and U.S. private payers. OncoCyte expects that U.S. revenue will be limited until if and when reimbursement is received from Medicare and/or private payers.
Second Quarter 2017 Financial Results

For the quarter ended June 30, 2017, OncoCyte incurred a net loss of $3.8 million, or ($0.13) per share, compared to a net loss of $2.5 million, or ($0.10) per share, in the second quarter of 2016.

Operating expenses for the three months ended June 30, 2017, were $3.6 million, as reported, and were $3.1 million, on an as adjusted basis.

Research and development expenses for the quarter ended June 30, 2017, were $2.0 million compared to $1.2 million for the same period in 2016. The increase is primarily attributable to increases of $0.3 million in development and clinical trials expenses for DetermaVu, $0.1 million in amounts charged to OncoCyte for facilities and services provided by BioTime, $0.1 million in salaries and payroll related expenses due to increased headcount, $0.1 million in stock based compensation expenses, and $0.1 million in outside service expenses and consulting fees.

General and administrative expenses of $1.1 million were substantially the same as the amount incurred during the same period of 2016.

At June 30, 2017, OncoCyte had cash and cash equivalents of $8.6 million and available-for-sale securities valued at $1.1 million. In July 2017, the Company raised $5.74 million through the exercise of stock purchase warrants by certain investors.

Six Month 2017 Financial Results

The net loss for the six months ended June 30, 2017, was $8.5 million, or ($0.29) per share, compared to $5.5 million, or ($0.22) per share, in the first six months of 2016.

Operating expenses for the six months ended June 30, 2017, were $8.1 million, as reported, and were $6.1 million, on an as adjusted basis.

Research and development expenses for the six months ended June 30, 2017, increased to $3.8 million from $2.9 million for the same period in 2016. The increase in research and development expenses of $0.9 million for the six months ended June 30, 2017, compared to six months ended June 30, 2016, is primarily attributable to increases of $0.3 million in development and clinical trial expenses for DetermaVu, $0.3 million in salaries and payroll related expenses, $0.3 million in stock based compensation expenses and $0.2 million in amounts charged to us by BioTime, Inc. for facilities and services. Those increases were offset by a decrease of $0.5 million in outside services expenses and consulting fees.

For the six months ended June 30, 2017, general and administrative expenses increased to $3.2 million from $2.1 million for the same period in 2016. The increase is mainly attributable to $1.1 million in shareholder noncash expense for the issuance of additional warrants to certain investors who agreed to exercise certain stock purchase warrants substantially before the warrant expiration date.

On August 14, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the Company has enrolled the first patient in a Phase 3 trial of Qapzola, a potent tumor-activated drug being investigated for low and intermediate risk non-muscle invasive bladder cancer (Press release, Spectrum Pharmaceuticals, AUG 14, 2017, View Source [SID1234520209]). Under the SPA, this trial will evaluate the intravesical use of Qapzola in patients with non-muscle invasive bladder cancer (NMIBC), as a single instillation 60 ± 30 minutes, following transurethral resection of the bladder tumor (TURBT).

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"Qapzola is being developed for low-to-intermediate risk non-muscle invasive bladder cancer for which there are no approved drugs in the 21st century," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "This is a novel drug that becomes cytotoxic only when it encounters hypoxic tumor such as non-muscle invasive bladder cancer. Bladder tumors are rich in DT-diaphorase, an enzyme that converts Qapzola into an alkylating agent that leads to cell death. One of the key challenges in the treatment of bladder cancer is a significantly high recurrence rate which leads to exorbitant costs and high patient morbidity. It is estimated that the cost of treatment of this disease will surpass $5 billion by 2020. The design of the current trial incorporates learnings from previous studies, feedback from leading KOL’s as well as from the FDA. I believe, Spectrum’s pipeline has never been as exciting as it is today. In addition to aggressive development of Qapzola, we expect to file a registration application (BLA) with the FDA for Rolontis in 2018 and we are very excited with the early data we are seeing with Poziotinib, our novel irreversible tyrosine kinase inhibitor."

In accordance with the SPA, the Phase 3 trial is a randomized, double-blind, placebo-controlled, multi-center trial that will enroll patients with low and intermediate risk NMIBC as per the American Urology Association (AUA) Guidelines. The new study design with a reduced sample size from 1557 to about 425 patients will significantly shorten the duration of this trial. The protocol includes a single instillation of Qapzola 60 ± 30 minute post-TURBT, to avoid inactivation of Qapzola by blood that is present after surgery. The patients will be randomized 2:1 to receive either 8 mg instillation of Qapzola or placebo post-TURBT. Following one instillation of study drug and a safety follow-up at Day 35, subsequent follow up visits will be conducted until tumor recurrence or end of study, whichever occurs first. The primary endpoint for this trial is Time to Recurrence.

About Bladder Cancer

According to the National Cancer Institute, bladder cancer is the fifth most common malignancy in the US with 79,030 new cases of bladder cancer expected in 2017, and currently over 500,000 patients living with the disease. Due to high recurrence rates, intensive surveillance strategies, and expensive annual treatment costs, bladder cancer has the highest lifetime cost per patient of all cancers, and an overall cost estimated at around $3.4 billion. Non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer that is localized in the surface layers of the bladder and has not invaded or spread to the deeper muscle layer. Approximately 70% of all patients newly diagnosed with bladder cancer have NMIBC. Urologists treat the disease predominantly by transurethral resection of the bladder tumor(s) (TURBT); in the U.S., there are approximately 300,000 TURBT procedures every year to treat bladder cancer. Because of the high recurrence rates, both professional urology associations and NCCN Guidelines recommend instillation of a cytotoxic agent following TURBT for NMIBC, although in the U.S., there are no FDA-approved agents for this indication.

About Special Protocol Assessments

A Special Protocol Assessment is a written agreement between a Sponsor and the U.S. Food and Drug Administration on the design, execution and analysis for a clinical trial that may form the basis of a new drug application, or NDA. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical program.