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.

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