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.

On September 27, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, reported that it will be presenting an abstract at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment, being held on October 1-4, 2017 in Pittsburgh, PA at the Wyndham Grand (Press release, DelMar Pharmaceuticals, SEP 27, 2017, View Source [SID1234520661]).

DelMar researchers will present a poster entitled, “Distinct mechanism of action of DNA damaging agent dianhydrogalactitol (VAL-083) suggests combination therapy with PARP inhibitors” on Monday, October 2nd from 6:00PM – 8:30PM EDT. DelMar’s presentation will focus on the mechanism of action (MOA) of DNA damaging agent dianhydrogalactitol (VAL-083) and activity as a single-agent against treatment resistant tumors and opportunities for combination therapy with PARP inhibitors and other common ovarian cancer treatments.

On September 18th, 2017, DelMar announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) for an open label multi-center Phase 1/2 Study of VAL-083 in Patients with Recurrent Platinum Resistant Ovarian Cancer (VAL-083 REPROVe Trial). The VAL-083 REPROVe Trial is designed to evaluate the safety and efficacy of VAL-083 in patients with recurrent adenocarcinoma of the ovary, whose cancer has been previously treated with a minimum of two courses of platinum-based chemotherapy, and whose cancer has recurred within six months of the most recent platinum-based chemotherapy. Further details can be found on clinicaltrials.gov: View Source

Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. In 2016, approximately 22,300 women in the US were diagnosed with ovarian cancer and 14,300 died from their disease. The vast majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. According to published literature, the overall response rate (ORR) to second line therapy is in the 10-15% range and overall survival is approximately 12-months.

About VAL-083

VAL-083 (dianhydrogalactitol) is a “first-in-class”, DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI).

VAL-083 has been granted an orphan drug designation by the U.S. FDA Office of Orphan Products for the treatment of glioma, medulloblastoma and ovarian cancer, and in Europe for the treatment of malignant gliomas. VAL-083 is currently being studied in multiple clinical trials as a potential new treatment for glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

DelMar has demonstrated that VAL-083’s mechanism of action is distinct from multiple chemotherapies widely used in the treatment of cancer and that this unique mechanism may offer opportunities to overcome treatment resistance thereby offering new treatment options to cancer patients. Further details regarding these studies can be found at View Source

On September 27, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), an oncology-focused, clinical stage biotechnology company (the “company”), reported that a patient treated with the company’s lead PDC compound, CLR 131 in the fourth cohort of its Phase I dose escalation safety trial in relapse or refractory multiple myeloma achieved a partial response (PR) (Press release, Cellectar Biosciences, SEP 27, 2017, View Source [SID1234520659]).

The primary objective of the study is to determine the highest dose patients can tolerate. The trial’s Data Monitoring Committee (DMC) determined that the fourth cohort dose of 31.25 mCi/m2 was safe and tolerated. Additionally, the company is monitoring signals of efficacy, including surrogate markers M protein and free light chain (FLC). The International Myeloma Working Group (IMWG) defines a PR as a greater than or equal to 50 percent decrease in FLC levels (for patients in whom M protein is unmeasurable) or 50 percent decrease in M protein.

Cohort 4 had three evaluable patients enrolled, each with heavily pretreated relapsed or refractory multiple myeloma (greater than five prior lines) and high degree of tumor burden upon entry into the trial. Each patient in the cohort received a single 31.25 mCi/m2 dose of CLR 131 as a 30-minute infusion, and was evaluated over the course of 85 days for safety and efficacy. All three patients in the cohort experienced clinical benefit with two patients achieving stable disease and one patient achieving a PR. One patient experiencing stable disease attained a 44 percent reduction in M protein. The patient experiencing a partial response had an 82 percent reduction in FLC. This patient did not produce M protein, received seven prior lines of treatment including radiation, stem cell transplantation and multiple combination treatments including one with daratumumab that was not tolerated.

“The encouraging data from Cohort 4 including the partial response and the DMC’s determination that the 31.25 mCi/m2 of CLR 131 was safe is impressive in light of the highly advanced disease and heavily pretreated patients within the cohort,” said Jim Caruso, president and CEO of Cellectar Biosciences. “Given the preclinical and clinical data results we’ve seen to date, the company intends to advance the compound into a fifth cohort using a multi-dose regimen.”

On April 27, 2017, the company reported that preclinical experiments providing multiple doses (two or three doses) of CLR 131 resulted in a statistically significant benefit in survival and tumor burden reduction compared to a single dose regimen. Therefore the company has now elected to advance with a multi-dose regimen, which may provide patients with enhanced clinical benefits and treatment outcomes.

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated as a single-dose treatment in a Phase 1 clinical trial in patients with relapsed or refractory (R/R) multiple myeloma (MM) as well as in a Phase 2 clinical trial for R/R MM and select R/R lymphomas with either a one- or two-dose treatment. CLR 131 represents a novel approach to treating hematological diseases and based upon preclinical and interim Phase 1 study data may provide patients with therapeutic benefits including, overall survival, an improvement in progression-free survival, and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate the discovery and development of improved targeted novel therapeutic compounds. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.