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]).

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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.

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]).

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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.

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]).

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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.

On August 21, 2019 Genomic Health reported that, based on results from the prospective TAILORx1 and PlanB2 studies, the 16thSt. Gallen International Breast Cancer Conference Expert Panel has recommended the Oncotype DX Breast Recurrence Score test to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative early-stage breast cancer with and without lymph node involvement (up to three positive nodes) (Press release, Genomic Health, AUG 21, 2019, View Source [SID1234538908]).

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In particular, the panelists recognized the value of the landmark TAILORx study results and noted that women with node-negative cancers and Recurrence Score results ≤25 do not need chemotherapy.3 This group represents up to about 80% of patients who may be safely spared chemotherapy. The Breast Recurrence Score test also identifies those patients (with results of 26 to 100) who may receive a life-saving benefit from chemotherapy.

In the new guidelines, genomic testing with robust validation through prospective, randomized trials is preferred over clinical-pathological features "for basing the critical yes/no chemotherapy decision." 4 Results from a recently published subset analysis of the prospective, randomized TAILORx study5 showed that only the Breast Recurrence Score test is predictive of chemotherapy benefit; clinical and pathological features are only prognostic and do not provide predictive information.

"We are pleased that this expert panel once again recognized the unique value of the Oncotype DX test to guide chemotherapy treatment. An extensive body of clinical evidence supports the ability of the Recurrence Score to identify both patients who can be spared chemotherapy and, importantly, those who will clearly benefit from it," said Steven Shak, M.D., chief scientific officer, Genomic Health. "All major guidelines in the U.S. and Europe recommend Oncotype DX to help select patients for chemotherapy treatment, providing physicians with the highest level of evidence to support using the test as standard of care."

The new St. Gallen International Consensus guidelines, "Estimating the benefits of therapy for early stage breast cancer," were recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

The Oncotype DX Breast Recurrence Score test is incorporated in all major international guidelines.

Recently, it was elevated to highest 1A level of evidence in the updated ESMO (Free ESMO Whitepaper) guidelines for early-stage breast cancer. Similar to the St. Gallen guidelines, the ESMO (Free ESMO Whitepaper) guidelines refer to TAILORx and PlanB results, which identify groups of patients – both in the node-negative and node-positive setting – for whom chemotherapy can be safely spared, thus underscoring the clinical utility that the Breast Recurrence Score test provides to guide chemotherapy treatment decisions.

Over the last several months, results of the TAILORx study have influenced positive treatment guideline updates distinguishing the Oncotype DX Breast Recurrence Score test from prognostic-only tests based on clinical evidence and the critical importance of predicting chemotherapy benefit. This includes the recent update to ASCO (Free ASCO Whitepaper) guidelines, which increased the proportion of women who can be effectively treated without chemotherapy based on the Recurrence Score results, highlighting the importance of testing all medically eligible early-stage breast cancer patients with the Breast Recurrence Score test. The National Comprehensive Cancer Network (NCCN) updated its guidelines in 2018 to categorize the Breast Recurrence Score test as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative, early-stage breast cancer. NCCN also classified the Breast Recurrence Score test as the only test that is predictive of chemotherapy benefit.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On August 20, 2019, Vical Incorporated (the "Company") reported that it entered into an amendment (the "Amendment") with Brickell Biotech, Inc., a Delaware corporation and clinical-stage medical dermatology company ("Brickell"), and Victory Subsidiary, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), to the Agreement and Plan of Merger and Reorganization dated as of June 2, 2019 by and among the Company, Brickell and Merger Sub (the "Merger Agreement") (Filing, 8-K, Vical, AUG 21, 2019, View Source [SID1234538907]). Pursuant to the Merger Agreement, as amended, and upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, as amended, Merger Sub will be merged with and into Brickell (the "Merger"), with Brickell surviving the Merger as a wholly owned subsidiary of the Company.

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Pursuant to the Amendment, the parties revised the minimum Brickell net working capital closing condition from -$11.5 million to -$14.3 million, revised the Brickell valuation from $60.0 million to $50.2 million, and revised the range of Brickell closing net working capital, outside of which there will be a dollar-for-dollar adjustment to the Brickell valuation, to -$14.8 million to -$13.8 million and fixed the assumed share price for purposes of applying the treasury stock method to calculate the number of Brickell and Vical outstanding shares at $0.79 and $1.35, respectively. The amended Brickell valuation results in an ownership split between Brickell and Vical stockholders of approximately 56% and 44%, respectively (on a fully diluted basis using the treasury stock method in instances other than with respect to the NovaQuest Warrants (as defined in the Merger Agreement) and certain equity issuances by Brickell following the signing of the Merger Agreement and prior to the completion of the Merger), or 51% and 49%, respectively (on a fully diluted basis using the treasury stock method), subject to further adjustment pursuant to the terms of the Merger Agreement, as amended by the Amendment. Other than as set forth in the Amendment, the terms of the Merger Agreement are unchanged.