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Onco360® Selected to Dispense Nubeqa® (darolutamide)

On August 21, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, announced today that it was selected to be a specialty pharmacy network partner for Bayer’s new product Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Onco360, AUG 21, 2019, View Source [SID1234538913]).

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"Onco360 is honored to be selected as a specialty pharmacy provider for Nubeqa patients," said Paul Jardina, President and CEO, Onco360. "The recent approval of Nubeqa provides another treatment option for patients with non-metastatic castration-resistant prostate cancer (nmCRPC). As a provider of this key treatment, Onco360 will utilize its expertise in service delivery, clinical, healthcare professional and community engagement, insurance and billing, and ongoing customer service to support the highly specialized needs of CRPC patients and their physicians."

Prostate cancer is the second most commonly diagnosed malignancy and fifth leading cause of cancer in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer and about 358,000 died from the disease worldwide. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age. Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists (i.e. substances that stop the formation of testosterone or prevent its effect at the target location.) However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

CRPC is an advanced form of the disease, where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is rapidly evolving. However, until two years ago, there have been no FDA-approved treatment options for nmCRPC patients with prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level. About one-third of men with nmCRPC go on to develop metastases within two years. In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.

Manufactured by Bayer, Nubeqa was approved by the U.S. FDA on July 30, 2019 Phase III ARAMIS trial, evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.

PER® Global to Present a Medical Crossfire®: Leveraging the Lung Cancer Team in Stage 3 NSCLC With Immuno-Oncology Strategies

On August 21, 2019 PER Global, a worldwide leading resource for continuing medical education (CME), reported that it will host the live CME-accredited Medical Crossfire: Leveraging the Lung Cancer Team in Stage III NSCLC With Immuno-Oncology Strategies, adjunct to the IASLC 2019 World Conference on Lung Cancer (Press release, Physicians’ Education Resource, AUG 21, 2019, View Source [SID1234538912]). The program will take place on Sunday, 08 Sept. 2019 from 11:30 a.m. to 13:30 p.m. in Hall 6 at Fira de Barcelona – Gran Via venue in Spain.

The Medical Crossfire will be chaired by Naiyer A. Rizvi, M.D., professor of medicine; director, thoracic oncology; co-director, cancer immunotherapy program; and the Price Family Professor of Medicine, Columbia University Irving Medical Center.

"The contemporary treatment of NSCLC requires the coordination and cooperation of the full treatment team," said Phil Talamo, president of PER Global. "Through our Medical Crossfire format, we will bring together pathology, medical oncology, and radiation oncology to foster a detailed discussion of the current and future of care for patients with non-small cell lung cancer (NSCLC)."

The variety of treatment options for patients with NSCLC continue to evolve, further complexifying the treatment landscape for this multifaceted illness. This program will feature a multidisciplinary faculty, world-renowned experts in medical oncology, radiation oncology and surgery. Current standards of care in patients with unresectable stage 3 NSCLC will be addressed, including the current and future roles of biomarkers and management of immune-related adverse events. Throughout the program, expert Medical Crossfire discussion panels will illustrate how experts address challenges in the implementation of immunotherapy for patients with locally advanced NSCLC.

The faculty panel includes the following experts:

Keith M. Kerr, FRCPath, consultant pathologist, department of pathology, Aberdeen Royal Infirmary, and professor of pulmonary pathology, Aberdeen University Medical School.
Suresh Senanm, MRCP, FRCR, Ph.D., professor of clinical experimental radiotherapy, department of radiation oncology. Amsterdam University Medical Center.
Rolf A. Stahel, M.D., professor in the oncology clinic, University Hospital Zurich.
This live activity is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) for 2 European CME credits for physicians. Through an agreement between the Union Européenne des Médecins Spécialistes and the American Medical Association, physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 Credits. For more information and to register, click here.

ROZLYTREK™ (entrectinib), FDA Approved for Hard-to-Treat NTRK Fusion-Positive Tumors, Available at Biologics by McKesson

On August 21, 2019 Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by Genentech as a specialty pharmacy provider for ROZLYTREK (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumors (Press release, McKesson, AUG 21, 2019, View Source [SID1234538911]).

ROZLYTREK, approved by the FDA on August 15, 2019, is an oral therapy for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA also granted accelerated approval for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In February 2019, the FDA accepted, with Priority Review, a New Drug Application (NDA) for ROZLYTREK based on findings from an integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, which demonstrated a 57.4% overall response rate in patients with NTRK fusion-positive solid tumors.

"Combining comprehensive genomic profiling with targeted therapies provides patients with precision medicine to treat their specific cancer," said Ann Steagall, director of Clinical Policy, Biologics. "This represents a breakthrough in cancer treatment, and this is the first therapy of its kind offered by Biologics. We are excited to work with Genentech to help make this important new therapy available to patients."

The FDA has approved two oral oncology therapies based on tumor genetics rather than the organ of origin of the disease. VITRAKVI (larotrectinib) was approved in November of 2018 for the treatment of solid tumors that exhibited a NTRK gene fusion. Now the FDA approved ROZLYTREK for the treatment of cancers harboring not only a TRK mutation but also ROS1 and ALK mutations. This represents a paradigm shift in the oral cancer therapy landscape. By approving these therapies as "tissue agnostic," the FDA recognizes the key role mutations play in response to therapy. Historically, cell type and organ of origin have been the key drivers of therapy decision making.

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of therapies, an experienced nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

Genprex to Present at the RHK Capital 4th Annual Disruptive Growth Conference

On August 21, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its Chairman and Chief Executive Officer, Rodney Varner, is scheduled to present at the 4th Annual Disruptive Growth Conference hosted by ReedSmith in New York City on September 4, 2019 (Press release, Genprex, AUG 21, 2019, View Source [SID1234538910]).

Genprex will present at the 4th Annual Disruptive Growth Conference as follows:

Date: Wednesday, September 4, 2019

Time: 5:00-5:15 p.m. EDT

Venue: ReedSmith Offices, 599 Lexington Avenue, 22nd Floor, New York City

Room: Presentation Room A/B

The 2019 Disruptive Growth Conference will offer the exclusive opportunity to discover growth companies with disruptive technologies and business models covering the following sectors: communications, consumer, energy/alternative energy, healthcare, industrial, life sciences, natural resources and technology.

Oncorus Announces $79.5 Million Series B Financing Co-Led by Cowen Healthcare Investments and Perceptive Advisors

On August 21, 2019 Oncorus, Inc., an oncolytic virus company focused on driving innovation to transform outcomes for cancer patients, reported the completion of an oversubscribed $79.5 million Series B financing (Press release, Oncorus, AUG 21, 2019, View Source [SID1234538909]).

Cowen Healthcare Investments and Perceptive Advisors co-led the financing, with participation from Oncorus’ syndicate of Series A investors including MPM Capital, UBS Oncology Impact Fund, Deerfield Management, Arkin Bioventures, Celgene and Astellas Venture Management. Additional new investors include Surveyor Capital (a Citadel company), Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp. and Shinhan Investment-Private Equity.

"Oncolytic virus therapies have the potential to transform outcomes for cancer patients," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We intend to use the proceeds from this oversubscribed financing to support our advancement of novel, proprietary intratumoral and intravenous approaches with the goal of addressing severe unmet medical needs in oncology. We’re thrilled to welcome Cowen Healthcare Investments, Perceptive Advisors and our other new investors and are grateful for the continued support of our existing investors."

Oncorus plans to use the Series B proceeds to advance its lead candidate, ONCR-177, into the clinic in early 2020. ONCR-177 is an intratumorally administered oncolytic virus clinical candidate for multiple solid tumor indications. ONCR-177 is built on the company’s next-generation oncolytic herpes simplex virus (oHSV) platform, which enables the development of oncolytic viruses with unparalleled payload capacity for potent activation of multiple arms of the immune system. Oncorus’ oHSV platform also uniquely enables full replication competency and selective attenuation in normal tissues to cause not only direct tumor destruction, but also exposure of all neoantigens within a tumor to the immune system in a highly immune activating environment. Oncorus also intends to progress its innovative synthetic oncolytic virus platform, which employs a novel delivery methodology to enable repeat, intravenous (systemic) administration of oncolytic viruses for the treatment of cancers, particularly in indications such as lung cancer where repeat, intratumoral administration is not feasible.

"The oncolytic virus space continues to gain momentum, as signaled by continued investment from both financial and strategic parties. Oncorus is poised to become a leader in this emerging modality," said Kevin Raidy, Managing Partner, Cowen Healthcare Investments. "There are significant distinctions among the various oncolytic virus platforms; we believe Oncorus is a standout in this class. We look forward to seeing Oncorus’ proprietary innovations translate in the clinical setting with the promise of dramatically improving clinical outcomes for cancer patients."

"We’ve been impressed by the progress the Oncorus team has made to enhance potency while ensuring safety – a balance that has challenged the oncolytic virus space historically," said Ellen Hukkelhoven, Ph.D., Managing Director, Perceptive Advisors. "Ted and the Oncorus team are truly committed to helping patients more effectively fight and defeat cancer. We look forward to working with the company as it transitions to the clinical stage and continues to advance its pipeline."

Robert L. Kirkman, M.D. and Spencer Nam, M.B.A. will join Oncorus’ Board of Directors as part of this round of financing. Dr. Kirkman currently serves as Executive Chairman of Trillium Therapeutics, Inc. and was most recently President and Chief Executive Officer of Oncothyreon, Inc. Mr. Nam is a Managing Partner of KSV Global and previously worked as a senior research fellow at the Christensen Institute for Disruptive Innovation.

"We’re pleased to welcome both Robert and Spencer to Oncorus’ Board of Directors at this pivotal time for the company," said Mitchell H. Finer, Ph.D., co-founder, founding CEO and Executive Chairman of Oncorus, and Executive Partner at MPM Capital. "This financing allows Oncorus to rapidly advance its lead program, ONCR-177, into the clinic, while also progressing its portfolio of innovative product candidates for repeat intravenous (systemic) administration."

About ONCR-177

ONCR-177, an intratumorally administered oncolytic virus therapy for the treatment of multiple solid tumor indications, is built on Oncorus’ proprietary, next-generation oncolytic herpes simplex virus (HSV) platform. ONCR-177 is armed with five transgenes, IL-12, CCL4, FLT3L, and CTLA-4 and PD-1 antagonists – representing the largest payload in the oncolytic virus therapy class – for the stimulation of multiple arms of the immune system. ONCR-177 is also a fully replication-competent virus in that it retains the ability to express γ34.5, which allows the virus to replicate in the presence of host antiviral immune responses, a feature unique among oncolytic HSV therapies. The ability to develop a heavily armed virus with native replication competency is enabled by propriety safety strategies that involve micro-RNA (miR) attenuation and inactivation of neuronal retrograde transport to enable selective and unattenuated viral replication in tumor cells, while preventing replication in healthy tissues. Oncorus presented preclinical data supporting the clinical advancement of ONCR-177 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting earlier this year.