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Data from OncoSec’s Visceral Lesion Applicator (VLA) to be Presented at the Society of Interventional Oncology Annual Meeting

On January 27, 2020 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported data from initial feasibility studies of its novel visceral lesion applicator (VLA) have been accepted to be presented at the Annual Meeting of the Society of Interventional Oncology in New Orleans from January 30 – February 3, 2020 (Press release, OncoSec Medical, JAN 27, 2020, View Source [SID1234553598]).

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The Company’s visceral lesion applicator (VLA) technology is designed to treat non-cutaneous, internal tumors through the direct delivery of OncoSec’s lead product candidate, TAVO (plasmid-based interleukin-12), or other immunologically relevant genes. Visceral lesions are typically difficult to treat, and include gastrointestinal tumors, pancreatic tumors, and hepatocellular carcinomas.

The study, titled, "Novel Controlled Delivery of Potent Anti-Cancer Immunotherapy Directly to Deep Visceral Lesions," will be featured in a poster displayed throughout the Society of Interventional Oncology’s annual meeting from January 30 – February 3, 2020 at the New Orleans Marriott.

About the Society of Interventional Oncology
The SIO Annual Scientific Meeting offers sessions on medical technology and how to implement new technology in oncologic practice. The conference provides a multi-disciplinary approach to cancer care. The annual meeting brings together international health care providers for international sharing of ideas. The conference leverages a combination of state-of-the-art lectures, panel discussions, invited papers, and selected abstracts of basic, translational, and clinical research to promote meaningful dialogue.

NCCN Oncology Research Program to Oversee Trials of the FGFR Inhibitor Futibatinib in Tumors with Aberrant FGFR Expression, in Collaboration with Taiho Oncology

On January 27, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported plans to evaluate futibatinib (TAS-120), a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR) (Press release, NCCN, JAN 27, 2020, View Source [SID1234553597]). The project will include pre-clinical, translational and clinical trials using futibatinib as monotherapy and in biologically relevant combination regimens for malignancies with FGFR 1-4 aberrations. This project will be the first NCCN research program to study an FGFR inhibitor. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team. The research funding is supported by a $2-million grant from Taiho Oncology.

"We’re excited to help facilitate new research into innovative ways for managing cancer," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We still have a lot to learn about FGFR signaling and how to optimally target this receptor as a component of cancer therapy. We look forward to the potential new discoveries that may come from these investigations."

"We are proud to support NCCN ORP research to better understand the optimal role of futibatinib in treating malignancies with FGFR 1-4 aberrations," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "Every day, we are learning more and more about futibatinib, and this research will expand our knowledge of how this investigational compound works, with the goal of being able to better target its use in those who may see the greatest benefit from it."

The first phase of this project will involve the creation of an RFP, which will be distributed in the next few months. The awarded projects will be announced following review of submitted proposals.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

ORIC Pharmaceuticals Announces First Patient Dosed in Phase 1b Clinical Trial of ORIC-101 in Combination with XTANDI® for the Treatment of Prostate Cancer in Collaboration with Astellas

On January 27, 2020 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported dosing of the first patient in a Phase 1b clinical trial being conducted under a collaboration with Astellas Pharma Inc., to evaluate the combination of ORIC-101, ORIC’s investigational glucocorticoid receptor (GR) antagonist, with XTANDI (enzalutamide) as a treatment for patients with metastatic prostate cancer that is progressing on enzalutamide (Press release, ORIC Pharmaceuticals, JAN 27, 2020, View Source [SID1234553596]).

Research conducted by ORIC’s co-founder Charles Sawyers, MD, published in Cell, has elucidated that increased expression of GR in prostate cancer is associated with resistance to enzalutamide therapy. Furthermore, preclinical data generated by ORIC demonstrated that inhibition of GR signaling by ORIC‑101 can re-sensitize treatment-resistant prostate cancer models to enzalutamide.

"Enrollment of the first patient in this Phase 1b clinical trial of ORIC-101 marks the second clinical trial for this program and another major milestone for ORIC," said Jacob M. Chacko, MD, Chief Executive Officer. "Just as the glucocorticoid receptor has been linked to treatment resistance for multiple classes of chemotherapeutics across a variety of solid tumors, there are also strong scientific rationale and preclinical evidence supporting its linkage to prostate cancer resistance. We are delighted to collaborate with Astellas on this important study assessing the potential of ORIC-101 to benefit patients with metastatic prostate cancer that has progressed on enzalutamide, for which there are limited treatment options today."

The Phase 1b trial is a multi-center, open label, dose finding study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ORIC-101 combined with enzalutamide when administered to patients with metastatic prostate cancer that has progressed on enzalutamide. Once the recommended Phase 2 dose of ORIC-101 in combination with enzalutamide has been identified, the study will enroll patients into expansion cohorts based upon GR expression using ORIC’s proprietary immunohistochemistry assay.

"Despite the introduction of novel antiandrogen therapies for the treatment of prostate cancer, such as enzalutamide, the majority of responsive patients will ultimately become treatment resistant, resulting in poor prognoses for men diagnosed with this devastating condition," said Pratik S. Multani, MD, Chief Medical Officer. "We are excited to evaluate the therapeutic potential of ORIC-101 to overcome what we believe may be a key mechanism of resistance to antiandrogen therapy."

Under the terms of the clinical trial collaboration and supply agreement with Astellas, ORIC is sponsoring and conducting the Phase 1b study of ORIC-101 in combination with enzalutamide. Astellas, which commercializes XTANDI in the United States with Pfizer Inc, is providing enzalutamide for the study. ORIC maintains global development and commercial rights to ORIC-101 and rights to develop the program in combination with other agents.

Further details about the clinical study are available at ClinicalTrials.gov (NCT04033328).

About Metastatic Prostate Cancer

In the United States, prostate cancer is the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society estimates there are approximately 175,000 new cases of prostate cancer and over 30,000 deaths from the disease in the U.S. annually.

In men with prostate cancer, the disease is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body, such as the bones, lymph nodes, bladder and rectum. Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels. Men are considered castration-resistant if their disease progresses despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen. Over 50,000 men are estimated to develop metastatic prostate cancer in the U.S. annually.

Intraoperative Molecular Imaging of Non-Small Cell Lung Cancer Improves Outcomes for 26 Percent of Patients in Multi-Institutional Phase 2 Clinical Trial

On January 27, 2020 On Target Laboratories, Inc., a privately-held biotechnology company developing the use of fluorescent markers to target and illuminate cancer during surgery, reported the results of a multi-institutional Phase 2 clinical trial in which outcomes were improved for 26 percent of patients undergoing pulmonary resection for non-small cell lung cancer (NSCLC) (Press release, Applied BioMath, JAN 27, 2020, View Source [SID1234553595]).

The results were presented today at the 56th Annual Meeting of the Society of Thoracic Surgeons (STS), held in New Orleans, LA., and were featured in a plenary session as a J. Maxwell Chamberlain Memorial Paper for General Thoracic Surgery, considered to be among the top-rated abstracts at STS.

"Our goal is to provide surgeons with new technology to help them provide a more complete resection to more patients. This gives patients the best chance of improved outcomes after surgery," said Christopher Barys, president and CEO of On Target Laboratories.

Lung cancer is the leading cause of cancer-related deaths in the United States. Pulmonary resection, either a wedge resection, segmentectomy, or lobectomy, is recommended for most patients who have operable stage I-II non-small cell lung cancer. Intraoperative molecular imaging (IMI)—also referred to as fluorescence-guided surgery—may increase the likelihood of a more complete surgical resection, which could translate into increased survival for patients and reduced re-operations or adjuvant treatment for hospitals.

Conducted over 18 months, the study included 92 patients eligible for analysis. There were no drug-related serious adverse events and 24 patients (26 percent) were impacted during pulmonary resection, with eight percent of patients having a change in their stage due to the use of IMI.

The study showed that IMI improved localization of small and peripheral lesions, which can be difficult for surgeons to identify visually or through manual palpitation, and enabled localization of otherwise unlocalizable lesions in 11 patients (12%). Further ten additional cancers were found in seven patients (8%). During the Specimen Check Phase, when the surgeon confirms the nodule is in the specimen and analyzes the margins, surgeons felt all margins were adequate, yet back-table inspection using IMI revealed inadequate margins in eight patients (9%).

"OTL38 is the first technique that is specific to imaging adenocarcinomas of the lung, which is one of the most common types of invasive lung cancer," said Inderpal (Netu) S. Sarkaria, MD, Department of Cardiothoracic Surgery at the University of Pittsburgh Medical Center in Pennsylvania. "Near-infrared imaging with OTL38 may be a powerful tool to help surgeons significantly improve the quality of lung cancer surgery by more clearly identifying tumors and allowing the surgeon to better see and completely remove them—one of the most vital components in the overall care of patients with this disease."

OTL38 is under development in two Phase 3 clinical trials for lung and ovarian cancer indications. Both trials are being conducted under a Special Protocol Agreement with the FDA. OTL38 has also received a Fast Track designation for both the lung and ovarian cancer indications and an orphan designation for ovarian cancer from the FDA.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. On Target Laboratories’ fluorescent markers are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. These markers illuminate the cancerous lesions, lighting the way for the resection of malignant tissue and enabling surgeons to see and remove more diseased tissue.

On Target’s first novel compound, OTL38, targets folate receptors commonly found on many cancers, including lung and ovarian cancers. A small single dose of the compound is administered via IV infusion one to 24 hours before surgery, allowing the surgeon to identify malignant tissue during the procedure using the near-infrared camera.

Amgen Announces Webcast Of 2019 Fourth Quarter And Full Year Financial Results

On January 27, 2020 Amgen (NASDAQ:AMGN) reported that it will report its fourth quarter and full year 2019 financial results on Thursday, Jan. 30, 2020, after the close of the U.S. financial markets (Press release, Amgen, JAN 27, 2020, View Source [SID1234553594]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.