On December 7, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that on November 23, 2018 the U.S. Food and Drug Administration ("FDA") released a letter to the U.S. Patent and Trademark Office ("USPTO") indicating that the USPTO is allowed to extend the patent duration of U.S. patent 6,409,990 for an additional 5 years or until May 12, 2025 (Press release, Navidea Biopharmaceuticals, DEC 7, 2018, View Source [SID1234531972]).

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This patent claims Lymphoseek (technetium (Tc 99m) tilmanocept) and has been exclusively licensed with varying geographical and medical indication coverages to Cardinal Health and Navidea. Allowance of this patent extension will permit Cardinal Health and Navidea to extend their exclusive rights to manufacture and commercialize Lymphoseek until the end of the extended patent term in 2025.

"I am pleased the FDA has taken positive action to extend the Lymphoseek patent until May 12, 2025," said Jed Latkin, CEO of Navidea. "We are excited that this extension allows us to continue advancing the science as Navidea prepares for the many other indications for which Tilmanocept can be used."

On December 7, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported reported the completion of its rights offering, which expired at 5:00 p.m. Eastern Time on December 6, 2018 (the "Expiration Date") (Press release, Pulse Biosciences, DEC 7, 2018, View Source [SID1234531940]).

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In accordance with the pricing structure of the rights offering described in the prospectus relating to the offering, Pulse Biosciences has determined that the final subscription price per share for the shares offered in the rights offering is $12.5658 per share, which is the volume weighted average price of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company had received basic subscriptions and over-subscriptions for a total of 4,023,779 shares, exceeding the 3,581,148 shares offered in the rights offering, subject to adjustment upon expiration of the guaranteed delivery period. Available shares will be distributed proportionately among rights holders who exercised their over-subscription right based on the number of shares each rights holder subscribed for under the basic subscription right, in accordance with the procedures described in the prospectus relating to the rights offering. The Company expects the Subscription Agent to distribute the shares and the sale proceeds on or about December 14, 2018.

"We are pleased with the results of the rights offering," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The rights offering offered our stockholders an opportunity to participate in this important financing that will enable us to continue progress towards our goal of commercializing our proprietary CellFX Nano-Pulse Stimulation platform, initially in aesthetic dermatology. We remain committed to building a viable company and to stockholder value, and look forward to updating you on our progress as we continue to generate important results in the future."

The Company will receive aggregate gross proceeds from the rights offering of $45 million. The results of the rights offering, including the allocation of shares to be issued in the rights offering, are preliminary and subject to change pending the expiration of the guaranteed delivery period under the offering and finalization of subscription procedures by the Subscription Agent.

A registration statement relating to the shares of common stock was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 6, 2018. A prospectus relating to the offering was filed with the SEC on November 19, 2018 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on December 6, 2018 have expired.

On December 7, 2018 Bio-Thera Solutions, a clinical-stage pharmaceutical company, reported that patient dosing has begun in a Phase I clinical study of BAT4306F in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma patients. BAT4306F is an ADCC-enhanced CD20 monoclonal antibody that has demonstrated enhanced potency in preclinical studies with potential to be a "best-in-class" therapeutic (Press release, BioThera Solutions, DEC 7, 2018, View Source [SID1234531957]).

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"Initiating our Phase I clinical trial for BAT4306F represents a major milestone for Bio-Thera Solutions as BAT4306F is our first clinical candidate developed for the treatment of hematologic malignancies," said Shengfeng Li, CEO, Bio-Thera Solutions. "While the BAT4306F development plan will be initially focused on CD20-positive B-cell non-Hodgkin’s lymphoma we believe BAT4306F also has great potential as a treatment for other hematologic malignancies."

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT4306F is designed to assess the safety and tolerability of BAT4306F as a single agent. The study will enroll subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. Key objectives in the study include determining maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and recommended doses for phase II clinical studies.

More information on the trial is available at View Source (CTR20181568).

About BAT4306F

BAT4306F is an investigational ADCC-enhanced CD20 monoclonal antibody that has the potential to be a "best-in-class" therapeutic. BAT4306F is currently being evaluated in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. CD20 is a naturally occurring receptor that is overexpressed in many types of hematologic malignancies. BAT4306F is being developed for use as a single agent and in combination with other agents for a variety of hematologic malignancies.

On December 7, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, showing that it inhibits tumor cell growth in hormone receptor-positive (HR-positive) breast cancer cell lines that are resistant to treatment with CDK4/6 inhibitors and that it has synergistic activity in combination with fulvestrant in these treatment-resistant cells (Press release, Syros Pharmaceuticals, DEC 7, 2018, View Source [SID1234531956]). These data are being presented by Syros’ collaborators from Dana-Farber Cancer Institute at the San Antonio Breast Cancer Symposium (SABCS).

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"While CDK4/6 inhibitors have emerged as an important class of treatments for HR-positive metastatic breast cancer, patients eventually develop resistance," said Rinath M. Jeselsohn, M.D., Instructor in Medicine at Dana-Farber and principal investigator of the research presentation. "These data shed light on potential mechanisms behind resistance to CDK4/6 inhibitors, pointing to CDK7 as one of the genes critical to the growth of treatment-resistant HR-positive breast cancer cells and selective CDK7 inhibition as a promising new approach for the treatment of HR-positive breast cancer. I look forward to the continuing to evaluate SY-1365 in the ongoing Phase 1 trial focused on breast and ovarian cancers."

Researchers from Dana-Farber characterized an HR-positive breast cancer cell line that is resistant to treatment with CDK4/6 inhibitors, and they demonstrated that these cells have alterations in the RB-pathway, including loss of the retinoblastoma (Rb) protein, higher levels of p107, CDK2 and cyclin E2, and lower levels of the estrogen receptor.

The aim of this study was to identify genes critical for the growth and survival of these cells by evaluating both resistant and sensitive cell lines. The researchers also tested SY-1365 in these resistant cell lines as a single agent and in combination with fulvestrant, an estrogen receptor degrader. The data, highlighted in a Spotlight poster discussion session, show that:

CDK7 and ESR1 are critical for in vitro cell growth in both CDK4/6 inhibitor-sensitive and CDK4/6 inhibitor-resistant cells.
SY-1365 significantly arrests cell cycle progression and reduces the expression of cancer-promoting genes in both CDK4/6 inhibitor-sensitive and -resistant cell lines.
SY-1365 in combination with fulvestrant demonstrates synergistic activity in CDK4/6 inhibitor resistant cells.
"We are encouraged by these new preclinical data, which speak both to the importance of CDK7 inhibition in HR-positive breast cancer and to the specific potential of this approach in patients who develop resistance to CDK 4/6 inhibitors.," said David Roth, M.D., Chief Medical Officer of Syros. "We are particularly pleased by the data for SY-1365 in combination with fulvestrant, which demonstrate synergistic activity in CDK4/6 inhibitor-resistant HR-positive breast cancer cells. These data support the ongoing clinical evaluation of SY-1365 in combination with fulvestrant in HR-positive breast cancer patients who progress after treatment with a CDK 4/6 inhibitor. We are actively enrolling patients in the Phase 1 trial and are committed to exploring the full potential of CDK7 inhibition with SY-1365 for people with difficult-to-treat cancers."

The ongoing Phase 1 trial of SY-1365 is a multi-center, open-label trial designed to evaluate the safety, tolerability and anti-tumor activity of SY-1365 in patients with advanced solid tumors. Following completion of the dose escalation portion of the trial, Syros opened expansion cohorts to further assess the potential of SY-1365 in multiple ovarian and breast cancer patient populations. The expansion cohorts are evaluating SY-1365: as a single agent in primary platinum-refractory ovarian cancer patients; as a single agent in ovarian cancer patients who have relapsed after three or more therapies; in combination with carboplatin in ovarian cancer patients who have relapsed after one or more prior therapies; and in combination with fulvestrant in patients with HR+ metastatic breast cancer who have progressed after treatment with a CDK4/6 inhibitor. An additional cohort is enrolling patients with any solid tumor accessible for biopsy to further evaluate the mechanism of action of SY-1365. Additional details about the trial can be found using the identified NCT03134638 at www.clinicaltrials.gov.

On December 7, 2018 Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it has been selected by Astellas Pharma US, Inc. to be in the limited distribution network for XOSPATA (gilteritinib) (Press release, McKesson, DEC 7, 2018, View Source [SID1234531958]).

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XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018, based on an interim analysis of data from the ongoing phase III ADMIRAL trial. In May 2018, the FDA accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the FDA.

Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow, and its incidence increases with age. The American Cancer Society estimates that in 2018, approximately 19,000 new patients will be diagnosed with AML in the U.S. XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of adult patients with relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

"Patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia have had limited treatment options," said Brandon Tom, PharmD, vice president, Commercial Services, Biologics by McKesson. "We are pleased to be able to offer this much needed new drug to this patient population, who accounts for approximately 30 percent of all AML patients."

Biologics by McKesson 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 oncology therapies, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer 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 by McKesson team works closely with payers to ensure patients can access the specialty medications they need.

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