On September 27, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) (“Propanc Biopharma” or “the Company”), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that results from recent scientific experiments provide strong indicators of PRP’s therapeutic potential as a new clinical approach that might ultimately improve outcomes for cancer sufferers. The conclusion comes from observing the dramatic reduction of Epithelial to Mesenchymal Transition (EMT) markers as a consequence of PRP treatment, which not only reverses the EMT process, thereby stopping tumor progression and metastasis, but also represses the development of Cancer Stem Cells (CSCs).

The EMT is a process by which the characteristics of a cell become altered, where epithelial cells (from a normal functioning organ) adopt characteristics of mesenchymal cells (from lymphatic and circulatory systems, as well as bone or connective tissue), which enables them to migrate, invade surrounding tissues and survive longer. It is usually a normal biological process during embryogenesis and wound healing, but is also involved with tumor metastasis, chemo-resistance and spreading of CSCs, and is known to interact with other pathways central to cancer progression. Pathways which play an especially important role in aggressive tumors, like pancreatic cancer.

“Being able to simultaneously affect invasion, chemo-resistance and cancer stem cells makes the EMT an attractive target for developing new treatments, like PRP,” said Dr Julian Kenyon, Propanc Biopharma’s Chief Scientific Officer. “Especially in cases of pancreatic cancer, with its rapid growth and dense fibrous tissue, which is a product of mesenchymal fibroblast cells and the EMT. My colleagues and I are convinced that halting this process is an extremely promising approach, especially for pancreatic cancer sufferers.”

Part of the Orphan Drug Designation (ODD) application for treatment of pancreatic cancer recently granted by the US Food and Drug Administration (FDA) involved experiments investigating the expression of key genes involved in the EMT, or the generation of CSCs, using human pancreatic cancer stem cells treated with PRP. Results showed up-regulation of selective genes that are usually down-regulated during the EMT process. E-Cadherin, involved in cell to cell adhesion and an indicator of an ‘epithelial’ cell, was increased 4-fold in response to PRP treatment. Furthermore, Kruppel-like factor 17 (KLF17), a negative regulator of metastasis and EMT, increased 6-fold. The latter results particularly relevant because KLF17 directly suppresses EMT, angiogenesis (tumor blood vessel formation), invasion and metastasis.

“I look forward to targeting pancreatic cancer when we commence clinical development of PRP,” said Professor Kutz, Propanc Biopharma’s Chief Medical Officer. “The results from our genetic testing of various cancer markers provides strong evidence of a positive effect against aggressive tumor types, like pancreatic cancer. Indeed, based on the scientific evidence and the mechanism of action, as well as supportive human data from patients treated with a proenzyme suppository by Dr Kenyon at the Dove Clinic, we are convinced there is a significant effect on hormonal tumors, which includes ovarian and prostate cancers as additional target indications. In fact, a second ODD application to the FDA for ovarian cancer is currently under preparation.”

PRP is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

On September 27, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced details of the LOXO-292 abstract that will be presented as a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer being held from October 15-18, 2017, in Yokohama, Japan (Press release, Loxo Oncology, SEP 27, 2017, View Source [SID1234520670]). LOXO-292 is Loxo Oncology’s highly selective RET inhibitor.

The abstract describes the first two patients with RET-fusion lung cancer with and without brain metastases treated with LOXO-292. Both patients had disease progression while receiving prior multi-kinase inhibitors (MKIs). On LOXO-292, both patients achieved partial responses. The first patient was previously treated with RXDX-105, enrolled on the first dose cohort of the Phase 1 trial, received LOXO-292 20 mg daily, and demonstrated a RECIST confirmed partial response. The second patient was previously treated with alectinib (starting at 600 mg twice daily and increased to 900 mg twice daily) and experienced disease progression systemically and in the brain. Due to the rapidly progressive nature of the brain metastases, the patient was ineligible for the Phase 1 trial and received LOXO-292 in doses ranging from 20-100 mg twice daily under an intra-patient dose escalation single patient protocol. The patient demonstrated a RECIST unconfirmed partial response, including a response in the brain, with a confirmatory response assessment pending as of the abstract’s writing. Both patients remained on LOXO-292 as of the abstract’s writing; additional patient follow-up for these two cases will be discussed in the oral presentation. In this early, two patient data set, LOXO-292 has been well-tolerated, with no adverse events attributed to LOXO-292.

“We are excited to present LOXO-292 proof-of-concept clinical data to the clinical community,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “Just four months after initiating a Phase 1 trial, LOXO-292 is already achieving clinically meaningful levels of RET target coverage in patients, as evidenced by anti-tumor activity in pretreated patients. With our Phase 1 trial continuing to dose escalate, we look forward to providing a more comprehensive trial update in 2018.”

The schedule for the late-breaking oral presentation is as follows:

Presentation Date: October 18, 2017
Title: LOXO-292, a potent, highly selective RET inhibitor, in MKI-resistant RET fusion-positive lung cancer patients with and without brain metastases
Session Title: Emerging Genomic Targets
Presenter: Vamsidhar Velcheti, M.D.

The full text of the abstract can be found here.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as “oncogene addiction,” renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

On September 27, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that updated data on entrectinib – an investigational, CNS-active, potent and selective tyrosine kinase inhibitor being developed in tumors that harbor NTRK fusions or ROS1 fusions — will be presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan on October 18, 2017 (Press release, Ignyta, SEP 27, 2017, View Source [SID1234520669]). The oral presentation (abstract 8564) is entitled “Entrectinib in Patients with Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small Cell Lung Cancer (NSCLC).”

“We are excited to share updated ROS1 data from our ongoing clinical trials of entrectinib, including the registration-enabling STARTRK-2 trial, as we continue to move towards dual NDA submissions for entrectinib in 2018,” said Jonathan Lim, M.D., chairman and CEO of Ignyta. “In total, Ignyta has treated more than 70 ROS1 fusion-positive NSCLC patients with entrectinib across our Phase 1 and Phase 2 clinical trials, making it one of the largest clinical datasets evaluating efficacy in this patient population. In this difficult-to-treat cancer, we’ve seen how entrectinib can beneficially impact the lives of patients, and we hope these data will further demonstrate its compelling profile and potential role as a first-line targeted therapy in ROS1 NSCLC.”

A conference call and live webcast will be held on October 18, 2017 at 5:00 a.m. Pacific time (8:00 a.m. Eastern time) to discuss the data presented as well as the comprehensive entrectinib program. To participate in the conference call, please dial 800-946-0716 (U.S.) or 719-325-4934 (international) and provide Conference ID 7994148. To access the live webcast, go to View Source." target="_blank" title="View Source." rel="nofollow">View Source

A replay of the presentation will be available shortly after the conclusion of the live call in the Investors section of the company’s website at View Source, and will be archived and available at that site for 14 days.

On September 27, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported an overview of the comprehensive immune monitoring data from the Phase 2 Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) at the 2nd World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Norfolk, VA (Press release, OncoSec Medical, SEP 27, 2017, View Source [SID1234520665]). The trial assessed the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab in patients with unresectable metastatic melanoma and its ability to convert “cold” to “hot” tumors.

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In a plenary lecture entitled: “In situ priming with concurrent immune checkpoint inhibition: A phase 2 clinical trial of intratumoral plasmid IL-12 with electroporation in combination with pembrolizumab,” Alain Algazi, MD, Principal Investigator from UCSF, will discuss the clinical data presented at ASCO (Free ASCO Whitepaper)-SITC earlier this year, demonstrating that ImmunoPulse IL-12 in combination with pembrolizumab is well-tolerated and yields clinically meaningful synergy in immunologically “cold” tumors. Furthermore, translational data will be shown that suggest that therapeutic strategies depleting regulatory T-cells may enhance anti-tumor immunity potentially leading to additional improvements in objective response rates (ORR).

“These data support our planned phase 2b registration-directed trial, PISCES, which is designed to demonstrate that the combination of ImmunoPulse IL-12 and pembrolizumab provides an opportunity to address the resistance to anti-PD-1 therapy in the melanoma patient population,” said Punit Dhillon, CEO and President at OncoSec. “Patients with metastatic melanoma who are progressing or have progressed on anti-PD-1 therapy have limited treatment options and we look forward to presenting further data from our recently completed trials at a future medical conference later this year.”

Earlier in the week, Adil Daud, MD, Chief Clinical Strategist at OncoSec and Professor of Medicine at the University of California, San Francisco, gave an oral presentation at the 2nd World Congress of Electroporation titled, “Local and Systemic Immunotherapy by Electroporation,” which provided an overview of the development of OncoSec’s Phase 2 clinical studies assessing ImmunoPulse IL-12 as a monotherapy in patients with metastatic melanoma.

Shawna Shirley, Ph.D., Senior Scientist at OncoSec, also gave an oral presentation at the 2nd World Congress of Electroporation entitled, “Intratumoral Electroporation of Plasmid IL-12 Using Modified Parameters and an Optimized DNA Plasmid Increases Immunogenicity in Untreated Lesions in Mice,” which provided an overview of the improved preclinical efficacy using an optimized IL-12 plasmid and the novel TRACETM-enabled DNA electroporation device.

About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)
PISCES is a planned, global, multicenter phase 2b, open-label trial of intratumoral pIL-12 (tavokinogene telseplasmid or “tavo”) plus electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of ImmunoPulse IL-12 in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR) in anti-PD-1 non-responder patients.

For more information please visit our website at www.oncosec.com.

On September 27, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive, blood-based liquid biopsy tests to assist in the early detection of cancer, reported that its CLIA laboratory has successfully completed a rigorous validation study of DetermaVu, OncoCyte’s diagnostic test for lung cancer (Press release, BioTime, SEP 27, 2017, View Source [SID1234520663]). In this study, OncoCyte assayed approximately 120 samples previously tested in its 299-patient study presented at the American Thoracic Society conference in May 2017, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in its R&D lab. The results met all performance criteria, demonstrating the accuracy and robustness of the assay as performed in the Company’s CLIA laboratory. The CLIA lab validation study included specific protocols to confirm the accuracy, reproducibility, and precision/repeatability of DetermaVu.

“The laboratory staff and procedures in place in the clinical laboratory have been confirmed to provide accurate, reliable, consistent and reproducible results,” said William Seltzer, PhD, FACMG, VP of Clinical Services and the Laboratory Director for OncoCyte. “The results were consistent with the positive data reported at the American Thoracic Society 2017 International Conference, and have enabled us to initiate our Clinical Validation Study, the final step prior to the commercial launch of DetermaVu.”

The Clinical Validation Study has now begun and is expected to be completed in the fourth quarter of 2017. In this study, approximately 300 new blinded blood samples, which have been prospectively collected will be assayed in the CLIA lab using DetermaVu. The performance of the test will be assessed against the clinical diagnosis of the patients from whom the samples were collected. If the Clinical Validation Study is successful and the results meet commercial requirements, OncoCyte will commence the commercial launch of DetermaVu.

“Successful completion of the CLIA Lab Validation Study is another important step toward launching DetermaVu,” said William Annett, President and Chief Executive Officer. “We plan to complete the ongoing Clinical Validation Study in the fourth quarter.”

OncoCyte believes that widespread utilization of DetermaVu could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., with a corresponding reduction in the surgical risk to patients undergoing biopsy procedures. Broad use of DetermaVu would result in a fundamental advancement in the diagnosis of suspicious lung nodules by allowing physicians to determine more accurately which patients need biopsies and which patients only need follow-up imaging. The Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from the DetermaVu test. Depending on market penetration and reimbursable pricing, this could translate into a market opportunity of up to $4.7 billion annually.