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.

On November 15, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, today reported preclinical data for its novel oral Chk1 inhibitor, SRA737, in a poster presented at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium held in Dublin, Ireland (Press release, Sierra Oncology, NOV 15, 2018, View Source [SID1234531379]).

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"Oncogene-driven high-grade serous ovarian cancers (HGSOC) with CCNE1 (gene encoding cyclin E) and MYCN pathway activation exhibit defective cell cycle checkpoint control and replicative stress. The DNA damage response effector kinase, Chk1, modulates the cellular response to replicative stress and has been shown to be upregulated in these subtypes of HGSOC," said Dr. Clare Scott, Professor at The Walter and Eliza Hall Institute of Medical Research, Parkville, Australia. "Our pre-clinical results show that the Chk1 inhibitor SRA737 has impressive efficacy in our most aggressive models of ovarian cancer."

As detailed in the poster, the efficacy of single agent SRA737 was explored in two cyclin E overexpressing HGSOC patient-derived xenografts (PDX), and also compared to olaparib, a PARP inhibitor recently approved for HGSOC. Both PDX models had pronounced amplification of CCNE1; one also harbored a MYCN amplification. Both PDX models were insensitive to standard platinum-based therapy and did not harbor BRCA1/2 or related gene mutations. Treatment with SRA737 resulted in significant and differentiated anti-cancer activity, including dose dependent tumor regression. As anticipated, the PARP inhibitor olaparib was inactive.

"Sierra’s ongoing SRA737-01 monotherapy and SRA737-02 low dose gemcitabine combination studies were recently prioritized for CCNE1-enriched HGSOC, a promising potential indication for Chk1 inhibition," stated Dr. Barbara Klencke, Chief Development Officer, Sierra Oncology. "We look forward to reporting clinical data from these studies in the first half of 2019."

The poster will be presented on Thursday, November 15th from 10:00 am – 5:30 pm (GMT).

Title: SRA737, a novel Chk1 inhibitor, shows efficacy in CCNE1-amplified and MYCN-overexpressing high-grade serous ovarian cancer patient-derived xenograft models

Authors: G.Y. Ho, H. Barker, C. Vanderberg, O. Kondrashova, E. Kyran, E. Lieschke, O. McNally, A. Hamilton, V. Heong, R. Hansen, S. Milutinovic, B. Strouse, M. Hedrick, C. Hassig, D. Bowtell, W. Matthew, C. Scott

About SRA737

SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). In cancer cells, intrinsic replication stress is induced by factors such as oncogenes (e.g., CCNE1 or MYC), genetic mutations in DNA repair machinery (e.g., BRCA1 or FANCA), genetic mutations leading to a dysregulated cell cycle (e.g., TP53 or RAD50) or other genomic alterations. This replication stress results in persistent DNA damage and genomic instability leading to an increased dependency on Chk1 for survival. Targeted inhibition of Chk1 by SRA737 may therefore be synthetically lethal to cancer cells with elevated intrinsic replication stress and have utility as a monotherapy in a range of tumor indications. The combination of SRA737 with other modalities, such as other agents that target the DDR network and certain chemotherapeutics, may also provide synergistic anti-tumor activity via a variety of potential biological mechanisms. Importantly, the oral bioavailability of SRA737 may afford greater dosing flexibility for both monotherapy and combination therapy settings than is possible with intravenously administered agents.

SRA737 is currently being investigated in two Phase 1/2 clinical trials primarily focused on patients with ovarian cancer: SRA737-01, a monotherapy study, and SRA737-02, a drug combination study evaluating SRA737 potentiated by low dose gemcitabine. Sierra has also prepared for a potential clinical study of SRA737 in combination with a PARP inhibitor

On November 15, 2018 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that Randall E. Woods, president and chief executive officer, will present a corporate overview at the Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 2:00 p.m. ET in New York, NY (Press release, Sophiris Bio, NOV 15, 2018, View Source [SID1234531402]).

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The discussion will be webcast live and can be accessed through the Investor Relations page at www.sophirisbio.com. A replay of the presentation will be available on the Company’s website for 90 days.