On November 15, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the third quarter ended September 30, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, NOV 15, 2018, View Source [SID1234531429]).

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"Throughout the third quarter, we continued to make meaningful progress advancing and expanding our robust clinical development pipeline of RNAi nanoparticle drugs to bring innovative new treatments to cancer patients with high unmet medical need," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Most recently, we were delighted to report that interim data from our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia (AML) were accepted for poster presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) taking place in early December 2018. This is an exciting opportunity to showcase this very promising program as earlier studies showed 47% of evaluable patients demonstrated some degree of response to prexigebersen in combination with LDAC in this patient population. In addition, we were pleased to report the dosing of the first patient in Stage 2 of this Phase 2 clinical trial where, at the recommendation of the study’s principal investigators, we are implementing a change in the dosing regimen administering a higher dosing of prexigebersen prior to starting treatment with LDAC. We also initiated a cohort of the Phase 2 AML trial assessing prexigebersen in combination with decitabine. We look forward to having interim results from these cohorts next year.

"We are also making progress expanding our clinical programs beyond AML. Enrollment in our global Phase 2 clinical trial of prexigebersen for the treatment of chronic myeloid leukemia (CML) continues apace and we continue to advance work on an Investigational New Drug (IND) application for prexigebersen for the treatment of solid tumors. In addition, we plan to submit an IND application by year-end to begin studies of our second drug candidate, BP1002, which targets Bcl-2 for the treatment of lymphoma and CLL. Finally, we continue our work to advance our third investigation drug candidate, BP1003, in pancreatic cancer. Toward that end, we were especially pleased to welcome Jason Fleming, MD, FACCP, to our Scientific Advisory Board (SAB). Dr. Fleming is a renowned gastrointestinal cancer specialist whose insight and guidance will be of particular value to the development of this clinical program.

"The considerable progress made in 2018 provides the foundation from which we expect to build and advance our new pathway in DNA-powered medicines into 2019 and beyond," concluded Mr. Nielsen.

Recent Corporate Highlights

·Interim data from the ongoing Phase 2 clinical trial of prexigebersen for the treatment of AML accepted for poster presentation at ASH (Free ASH Whitepaper) 2018. In November 2018, Bio-Path announced that data from its ongoing Phase 2 clinical trial of prexigebersen will be presented at ASH (Free ASH Whitepaper) 2018 by Maro Ohanian, MD, Assistant Professor of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, before an audience of the world’s leading blood cancer specialists.

·Commenced Stage 2 of the Company’s Phase 2 trial of prexigebersen in AML. In August 2018, Bio-Path announced the dosing of the first patient in the open-label Phase 2 study evaluating the efficacy and safety of prexigebersen in conjunction with LDAC and a second cohort of prexigebersen and decitabine, both therapeutic regimens well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether these combinations with prexigebersen provides greater efficacy than what would be expected with LDAC or decitabine alone in this de novo patient population.

·Appointed Dr. Fleming to the Company’s Scientific Advisory Board. In August 2018, Bio-Path appointed Dr. Fleming, a world-leading gastrointestinal cancer expert, to its SAB. Dr. Fleming offers substantial insight as the Company seeks to advance its lead drug candidate, prexigebersen, and its third drug candidate, BP1003, towards the clinic for the treatment of pancreatic cancer.

·Raised $1.5 million in a registered direct offering. In September 2018, Bio-Path issued and sold 2,261,538 shares of its common stock (or common stock equivalent) for a price of $0.65 per share, for gross proceeds of approximately $1.5 million. Additionally, in a concurrent private placement, Bio-Path issued to such investors unregistered warrants to purchase up to 2,261,538 shares of common stock with an exercise price of $0.96 per share and an exercise period commencing six (6) months following the issuance date and a term of five and one-half (5.5) years from the date of issuance.

Financial Results for Third Quarter Ended September 30, 2018

·The Company reported a net loss of $3.1 million, or $0.27 per share, for the three months ended September 30, 2018, compared to a net loss of $2.5 million, or $0.25 per share, for the three months ended September 30, 2017.

·Research and development expenses for the three months ended September 30, 2018 increased to $2.3 million, compared to $1.6 million for the three months ended September 30, 2017 primarily due to costs related to the release of drug material for our Phase 2 clinical trials for prexigebersen in AML and CML.

·General and administrative expenses for the three months ended September 30, 2018 decreased to $0.7 million, compared to $0.9 million for the three months ended September 30, 2017 primarily due to decreased legal and audit fees.

·As of September 30, 2018, the Company had cash of $2.3 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the nine months ended September 30, 2018 was $4.8 million compared to $5.7 million for the comparable period in 2017. Net cash provided by financing activities for the nine months ended September 30, 2018 was $1.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these third quarter 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 8564777. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On November 15, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported that Lori Kunkel, M.D. has been named acting chief medical officer, effective November 26, 2018 (Press release, Tocagen, NOV 15, 2018, View Source;p=RssLanding&cat=news&id=2377408 [SID1234531471]). Asha Das, M.D., senior vice president and chief medical officer will be leaving the company effective November 23, 2018 to allow her to focus on unforeseen and immediate personal matters. The company has initiated a search process to fill the position.

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"On behalf of the management team and Board of Directors, we are thankful for the significant contributions Asha has made over the past three years," said Marty J. Duvall, chief executive officer of Tocagen. "With Lori’s remarkable track record in the biotechnology industry coupled with her deep familiarity of our program and clinical data we look forward to working closely with her to advance our cancer-selective gene therapy platform, and our lead product candidate. This transition is not expected to impact our current business plans or development timelines."

Among other responsibilities, Dr. Kunkel previously served as acting chief medical officer of Loxo Oncology, Inc, chief medical officer of Pharmacyclics LLC, acquired by AbbVie Inc., and chief medical officer of Proteolix, Inc., acquired by Onyx Pharmaceuticals. Dr. Kunkel currently serves on the board of directors of Loxo Oncology, Inc., a publicly held biotechnology company, Curis, Inc., a publicly held biotechnology company, and Maverick Therapeutics, Inc., a privately held biotechnology company. A full biography is available here. In connection with Dr. Kunkel’s appointment as acting chief medical officer of Tocagen, Dr. Kunkel will be temporarily leaving the board of directors of Tocagen in order for the company to maintain compliance with the Nasdaq listing rules regarding independent directors.

"Being dedicated to the development of new treatment options for patients with brain cancer, I am extremely grateful to have worked closely with the Tocagen team on advancing Toca 511 & Toca FC and regret having to leave the company at this time," said Dr. Das. "I am excited about the potential of the Toca 5 trial and future development in newly diagnosed brain cancer to positively impact patients around the world."

On November 15, 2018 Atlanta, GA and New York) Lori Chmura, CEO of Dune Medical Devices, reported that maker of the successful MarginProbe device is scheduled to present at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 15th at 2:30 p.m. EST at the Westin Grand Central in New York, NY (Press release, Dune Medical Devices, NOV 15, 2018, View Source [SID1234531341]).

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The presentation will be available as a webcast at dunemedical.com/investors.

Dune Medical Devices is a commercial-stage company revolutionizing tissue characterization technology in breast cancer surgery, diagnosis and targeted treatment with its proprietary Radio-Frequency Spectroscopy Technology (RFST). Dune’s first commercial product, MarginProbe, in routine commercial use in 70 hospitals and in over 16,000 surgeries in the US and Israel, has been proven to identify positive margins during breast conservation surgery, enabling surgeons to immediately remove additional microscopic residual cancer, thereby reducing the need for repeat surgeries. The second generation of the RFST, in development, serves as a platform to enhance diagnostic accuracy by providing pathologists with tissue characterization data alongside biopsy samples to increase interpretation accuracy and eliminate unnecessary procedures and costs

Dune is entering a phase of commercial growth and expansion of its RFST platform to establish RFST data as a unique tissue biomarker that provides information complementary to molecular (e.g., genomic) biomarkers for optimal personalized treatment selection and adoption of new therapies

On November 15, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a U.S. Food and Drug Administration (FDA) required formal report on the safety studies conducted by Bavarian Nordic using a pig model that were undertaken before the first clinical trial in humans using cellulose-based capsules that contain live genetically altered cells which activate the anticancer prodrug ifosfamide (Press release, PharmaCyte Biotech, NOV 15, 2018, View Source [SID1234531357]). The voluminous information contained in the formal report is another complicated Investigational New Drug Application (IND) component requested by the FDA to be included in the IND before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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A formal study report, including all the data from the previously performed porcine animal studies, has been completed and independently reviewed and verified. The original data was published in part in the journal Pancreatology, but the confines of that scientific publication did not allow for the complete volume of data to be included in the journal article, necessitating several components of the studies to be woven together in a formal study report according to FDA guidelines. The original data was compiled and independently reviewed by Facet Life Sciences with the support of original members of the team that performed the porcine experiments, including Prof. Matthias Löhr who was the Principal Investigator for the first two pancreatic cancer trials with what has evolved into PharmaCyte’s current treatment for pancreatic cancer. The final study report has now been signed off on by two members of the original team, Prof. Udo Losert and Prof. Walter H. Günzburg, and will be submitted to the FDA as part of the IND dossier required for approval for the commencement of PharmaCyte’s planned clinical trial in LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "These large animal studies, which had to be retrieved from locations in several countries in Europe, demonstrate the safety of delivering capsules to the blood vessels (vasculature) leading to the pancreas in pigs and are supported by the initial clinical trial data generated to date, primarily from trials in Germany. The formal study report allows us to submit the complete set of data in the appropriate fashion to the FDA as part of our IND submission for our upcoming LAPC trial in the U.S."

On November 15, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data from its ongoing studies in breast cancer utilizing Cchek, Anixa’s artificial intelligence (AI) driven early cancer detection technology, at the AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy (Press release, Anixa Biosciences, NOV 15, 2018, View Source [SID1234531342]). The conference is designed to integrate multidisciplinary facets of basic cancer immunology and immunotherapy to broaden the understanding of ways to harness the immune system to treat cancer. The conference will be held November 27–30, 2018 in Miami Beach, Florida and will be attended by world-renowned oncologists and scientists who will offer new insights on systems biology, checkpoints, combination therapies, and molecular targets, all in the pursuit of finding new ways to manipulate the tumor immune microenvironment and creating better treatments. To receive a copy of the presentation, please email your request to AACR (Free AACR Whitepaper)[email protected] starting November 30, 2018 and include your name, title, and contact information.

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"We are pleased to make our presentation titled, Combining the immunophenotyping of MDSCs and lymphocytes with artificial intelligence (AI) to predict early stage breast cancer, at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy conference. This data is focused on using our Cchek technology to detect breast cancer in its early stages. The majority of screening technologies currently used for breast cancer detection, such as mammography, have the ability to detect later stage breast malignancies rather successfully but have shown difficulty with earlier stages," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "As we have previously announced, our initial commercial focus is on a prostate cancer test for which we will be meeting with the USFDA on December 17, 2018. We recently presented our latest prostate cancer data at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), and we look forward to now present our latest breast cancer data at this AACR (Free AACR Whitepaper) special conference," added Dr. Kumar.

American Association of Cancer Research (AACR) (Free AACR Whitepaper)
The American Association of Cancer Research (AACR) (Free AACR Whitepaper) (www.aacr.org) is a 501(c)(3) public charity headquartered in Philadelphia, PA. The mission of the AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters cancer research and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer causes, prevention, diagnosis and treatment throughout the world.