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In Promise of True Liquid Biopsy for Cancer, Chip Company BioFluidica® Awarded $1.7 Million by National Cancer Institute/National Institutes of Health for Clinical Trial in Children with Acute Lymphoblastic Leukemia

On January 10, 2019 BioFluidica, a privately held cancer diagnostics company, reported that it has been awarded an SBIR Phase II National Institutes of Health grant of $1.7 million for a clinical trial in support of "Increased sensitivity of minimal residual disease monitoring using peripheral blood in pediatric patients with acute lymphoblastic leukemia (Press release, BIOFLUIDICA MICROTECHNOLOGIES, JAN 10, 2019, View Source [SID1234532625])."

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In Promise of True Liquid Biopsy for Cancer, Chip Company BioFluidica Awarded $1.7 Million by National Cancer Institute/National Institutes of Health for Clinical Trial in Children with Acute Lymphoblastic Leukemia
In Promise of True Liquid Biopsy for Cancer, Chip Company BioFluidica Awarded $1.7 Million by National Cancer Institute/National Institutes of Health for Clinical Trial in Children with Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood and accounts for approximately 30% of all cancers diagnosed before the age of 18 years. The primary cause of death for ALL patients is disease relapse. Therefore, monitoring for minimal residual disease (MRD) is considered the most powerful predictor of outcome in acute leukemias.

Rolf Muller, CEO of BioFluidica, states that with BioFluidica’s technology, "We are able to program microfluidic chips to isolate any kind of diagnostically relevant cell from blood samples, whether from solid tumors or blood cancer. In the case of ALL we are detecting complex panels of Circulating Leukemic Cells (CLCs) to monitor cancer recurrence. The expansion of BioFluidica’s technology into the blood-born cancers is added to the clinical validation we have already achieved from 9 other cancers including lung, breast, pancreatic, prostate, and colorectal cancer. The high through-put instrumentation for cell isolation will now be used in clinical trials."

Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-1287 in Phase 1 Study in Patients with Advanced Solid Tumors

On January 10, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JAN 10, 2019, View Source [SID1234532624]). The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the maximum tolerated dose and dose-limiting toxicities of TP-1287 administered in patients with advanced solid tumors.

"The initiation of this study is an important step forward in understanding the potential of TP-1287 in patients with solid tumors," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We believe that the oral administration of TP-1287 may be beneficial in disease settings where this form of administration is preferred or when used in combination with other targeted agents."

The primary objective of the Phase 1 study is to determine the maximum tolerated dose and dose-limiting toxicities of oral TP-1287 administration in patients with advanced solid tumors. The study is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).

About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor entering into a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.

Presentation of Ziopharm Oncology, Inc. dated January 10, 2019.

On January 10, 2019 Ziopharm Oncology, Inc. is presented the corporate presentation (Presentation, Ziopharm, JAN 10, 2019, View Source [SID1234532618]).

Physicians’ Education Resource® to Host Symposium on Optimal Care for Patients with Hepatocellular Carcinoma

On January 10, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will conduct a CME-accredited satellite symposium, Optimizing Care in the Era of an Expanding Armamentarium for Hepatocellular Carcinoma, adjunct to the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium (Press release, Physicians’ Education Resource, JAN 10, 2019, View Source [SID1234532617]). The event will take place Thursday, Jan. 17, from 7 to 9 p.m. PST in ballrooms A and B of the InterContinental San Francisco in California.

"We are so excited to present our satellite symposium at this year’s ASCO (Free ASCO Whitepaper) GI Symposium," said Phil Talamo, president of PER. "The program will feature HCC experts presenting new clinical evidence to help attendees make decisions on selecting the best therapies to optimize patient outcomes, as multiple new agents have shown to be effective in treating HCC."

This interactive, case-based symposium on hepatocellular carcinoma (HCC) will be chaired by Alan P. Venook, M.D., FASCO, Madden family distinguished professor of medical oncology and translational research at the University of California, San Francisco (UCSF), and Shorenstein associate director for program development at the UCSF Helen Diller Family Comprehensive Cancer Center. Venook will be joined by a panel of renowned HCC experts who will provide nuanced insights into the most pressing clinical issues related to the management of patients with HCC.

This live activity is accredited by the Accreditation Council for Continuing Medical Education for 2.0 AMA PRA Category 1 Credits for physicians. For more information and to register, click here.

Advaxis Reports Fiscal Year 2018 Financial Results and Provides a Business Update

On January 10, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported its financial results for the fiscal year ended October 31, 2018 and provides a business update (Press release, Advaxis, JAN 10, 2019, View Source [SID1234532616]).

Fiscal Year 2018 and Recent Key Accomplishments

Received U.S. Food and Drug Administration allowance of the Investigational New Drug application for the Company’s first ADXS-HOT off-the-shelf neoantigen drug candidate, ADXS-503, for the treatment of all types of non-small cell lung cancer;
Dosed the first patients in the ADXS-NEO Phase 1 dose-escalation study in patients with several solid tumor types;
Raised gross proceeds totaling approximately $40 million from an underwritten public offering of common stock and an underwritten public offering of common stock and warrants;
Appointed a permanent chief executive officer, Kenneth A. Berlin, a new chief medical officer, Andres Gutierrez, M.D., and a new chief financial officer, Molly Henderson;
Licensed ADXS-HER2 to OS Therapies for evaluation in the treatment of pediatric osteosarcoma;
Significantly reduced annual net cash usage through a prioritization of programs and assets; and
Presented and published data from several preclinical and clinical trials with the Company’s drug candidates.
Management Commentary

"Fiscal 2018 was an eventful year for Advaxis as we worked to reorganize the company, prioritize our pipeline and define a strategic direction that supports our mission to improve the lives of people suffering from cancer and their loved ones," said Kenneth A. Berlin, president and chief executive officer of Advaxis. "Our diverse pipeline of drug candidates and constructs at various stages of development is based on our proprietary Lm platform, which has a significant safety database from first-generation constructs already tested in humans."

Mr. Berlin added, "We are dosing patients under our ADXS-NEO program and anticipate the first patient to be enrolled in our ADXS-503 study within the next several weeks. These are significant accomplishments for the Company and we’re excited to start to see early correlative and safety data from these neoantigen programs during the first half of 2019."

Mr. Berlin continued, "During the second half of fiscal year 2018 we took steps to significantly reduce our cash burn and align our spending in keeping with a company our size. We are committed to advancing our various clinical programs as rapidly and cost effectively as possible throughout fiscal year 2019. We also continue to evaluate opportunities for partnerships and collaborations across all of our programs, and anticipate several catalysts for the Company in 2019. We remain committed to demonstrating that the drug candidates emanating from our Lm platform have the potential to positively impact people with cancer," Mr. Berlin concluded.

Balance Sheet Highlights

As of October 31, 2018, Advaxis had cash and cash equivalents of $44.1 million. The Company used $62.1 million in cash to fund operations during fiscal 2018, mainly attributed to funding research and development and general and administrative activities. Throughout fiscal 2018, the Company completed an in-depth review of all programs and cash expenditures, and reduced its net annual cash usage to approximately $50 million.

Fiscal Year 2018 Financial Information

Research and development expenses for fiscal 2018 were $57.0 million, compared with $70.5 million for fiscal 2017. The $13.5 million decrease was primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies.

General and administrative expenses for fiscal 2018 were $19.5 million, compared with $40.0 million for fiscal 2017. The $20.5 million decrease was primarily attributable to an $18.0 million decrease in stock-based compensation expense.

The net loss for the fiscal year ended October 31, 2018 was $66.5 million or $1.29 per share based on 51.5 million weighted average shares outstanding. This compares with a net loss for fiscal 2017 of $93.4 million or $2.31 per share based on 40.5 million weighted average shares outstanding.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review financial results, provide a business update and answer questions at 11:00 a.m. Eastern time on Tuesday, January 15, 2019.

To access the conference call please dial (844) 348-6133 for domestic callers or (631) 485-4564 for international callers. A live and archived audio webcast of the call will be available on the Company’s website at www.ir.advaxis.com/news-events.

A recording will be available beginning two hours after the call ends by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and providing conference ID 4862946.