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.

On November 15, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported its new data from the Company’s ongoing Phase 3 TAPPAS study of TRC105 and Votrient (pazopanib) in patients with angiosarcoma at the Connective Tissue Oncology Society (CTOS) annual meeting, taking place in Rome, Italy (Press release, Tracon Pharmaceuticals, NOV 15, 2018, View Source [SID1234531358]).

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In a poster presentation entitled, "Detection of Endoglin-Expressing Circulating Tumor Cells in Patients Enrolled in An Adaptive Enrichment Phase 3 Trial of TRC105 And Pazopanib versus Pazopanib alone in Patients with Advanced AngioSarcoma (TAPPAS)," circulating tumor cell data were presented from patients enrolled into the TAPPAS Phase 3 trial. Endoglin expressing nucleated CTCs were detected using ApoStream technology (ApoCell, a Precision Medicine company).

Paired patient plasma samples taken at baseline and six weeks following treatment with either TRC105 and Votrient or single agent Votrient were analyzed in a blinded manner, without knowledge of treatment assignment. Endoglin+ CTCs decreased overall after 6 weeks of study treatment (baseline mean = 66/ml; median = 1.38/ml; range 0 – 1172/ml versus 6 week mean = 1.30/ml; median = 1.38/ml; range 0 – 185/ml). Three key findings emerged in the blinded analysis:

18 of 51 patients (35%) had a greater than two-fold reduction in endoglin+ CTCs, including 13/51 patients (25%) with a greater than 10-fold reduction.
19 of 51 patients (37%) had a greater than two-fold increase in endoglin+ CTCs, including 13/51 patients (25%) with a greater than 10-fold increase.
14 of 51 patients (27%) had no significant change in endoglin+ CTCs, all but one of whom had fewer than four endoglin+ CTCs per mL detected at baseline.
"The CTC analysis done as part of the TAPPAS Phase 3 trial has been robust and we have seen differences in CTC count following treatment which will be unblinded and correlated with treatment arm in the final analysis. Change in CTC count on study may be useful as a prognostic biomarker, and baseline CTC count may be useful as a predictive biomarker," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "In the meantime, we look forward to the Phase 3 TAPPAS trial interim analysis expected in the first quarter of 2019."

The poster is available on TRACON’s website at www.traconpharma.com

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.