On March 5, 2020 City of Hope reported that $12 million federal grant enabled and collaborators to deploy a novel cloud-computing platform, making an immense amount of data from a historic 25-year study more accessible and user-friendly (Press release, City of Hope, MAR 5, 2020, View Source [SID1234555292]).

The ongoing California Teachers Study that first began in 1995 has already given researchers a bevy of data on how to better prevent and treat cancers, heart conditions and Alzheimer’s disease. In the past, this data was available only to a select few researchers. Opening the data to researchers worldwide and making it user-friendly will fast-track scientific discoveries that can improve the quality of life for people around the world, said James Lacey Jr., Ph.D., M.P.H., director of the Division of Health Analytics at City of Hope and one of the principal investigators of the study.

"We might be one of the first in the world to use secure cloud computing to build a data commons for an observational study," Lacey said, adding that observational studies are expensive, so synthesizing data from disparate sources and making the information widely available is one way to ensure that federal grant dollars "get more mileage."

"City of Hope continues to lead the health provider pack when it comes to collaborating with cutting-edge technology companies to deploy solutions that accelerate the translation of precision medicine into disease prevention and, potentially, therapies for patients," Lacey said. Precision medicine is a personalized approach to disease prevention and treatment that takes into account each person’s specific genes, environment and lifestyle choices.

The study, published on Feb. 12 in the journal Cancer Epidemiology, Biomarkers and Prevention, provides a roadmap for other population health experts who want to broaden the reach and potential impact of their own research. The novel open cloud-computing platform City of Hope, San Diego Supercomputer Center (SDSC) and UC San Diego created for the California Teachers Study has simplified the process for understanding the incidence and distribution of disease. As a result, scientists can more quickly detect patterns and trends that could be translated into better health for individuals and the public.

The California Teachers Study was created in 1995 and enrolled 133,479 current and former public-school teachers or administrators. They agreed to have their health and lifestyle tracked to help understand why teachers historically have higher rates of breast cancer. The study has since expanded to address other cancers including colon, pancreatic and bladder, as well as heart disease and even Parkinson’s and Alzheimer’s disease. More than 190 published studies have resulted from the data.

This is an example of how sharing is really caring, Lacey said. "Cancer, heart disease and Alzheimer’s disease are big problems that need the combined brainpower of the brightest minds around the world. Cloud computing directly helps cancer researchers store, share, analyze and use their data in new and more efficient ways. In short, our open website allows interested individuals to securely access, explore and generate discoveries with our California Teachers Study data."

The new platform shortens the time needed to launch a research project from weeks to days, Lacey said. Previously, every research project had to be custom built, but now with the data commons framework, users can get started quickly, apply workflow templates for their projects and start analyzing the data right away.

"It is gratifying to see the grant for the California Teachers Study infrastructure successfully deliver on its promise of building a secure, cloud-based data commons platform for the cancer epidemiology research community," said Sandeep Chandra, director of SDSC’s Sherlock Division and senior author of the study. "What is more exciting is the potential of how this data commons can serve as a model for other current, and future, observational studies through adoption of this framework; thereby, reducing time and investment to deploy data management and analysis capabilities."

Elena Martinez, Ph.D., professor in the Department of Family Medicine and Public Health at UC San Diego and one of the principal investigators of the study added, "The newly implemented California Teachers Study infrastructure exemplifies what is possible when leveraging the knowledge and experience of population scientists who work alongside data scientists to move research into the 21st century. I am proud to be a part of an innovation leader that will serve as a model for future observational studies."

The University of California, San Francisco, also contributed to the creation of the open platform. The study was supported by the National Cancer Institute of the National Institutes of Health (CA199277).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 5, 2020, XOMA (US) LLC (the "Company" or "XOMA"), a wholly-owned subsidiary of XOMA Corporation, reported that it has entered into a Collaboration and License Agreement (the "Agreement") with Cadila Healthcare Limited ("Zydus"), a company organized and existing under the laws of India, effective as of March 3, 2020 (Filing, 8-K, Xoma, MAR 5, 2020, View Source [SID1234555316]). Pursuant to the Agreement, the Company acquired the rights to receive potential royalty payments in the single to low double-digit percentages of the aggregate net sales in India, Brazil, Mexico and certain other emerging markets (the "Zydus Territory") associated with an IL-2-based immuno-oncology drug candidate that combines Zydus’s IL-2 candidate with XOMA’s anti-IL-2 monoclonal antibody (the "Drug Candidate"). Pursuant to the Agreement, Zydus will make certain development, regulatory and commercial milestone payments to the Company in the potential aggregate amount of up to $24 million upon the occurrence of certain events as set forth in the Agreement and share with the Company revenue received from third party sublicensees in the Zydus Territory. Zydus will be solely responsible for the development of the Drug Candidate through the first Phase 2 clinical study at its sole cost.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Subject to a right of first negotiation granted to Zydus to acquire rights to the Drug Candidate world-wide outside of the Zydus Territory (the "XOMA Territory"), which expires 180 days following the completion of the Drug Candidate’s first Phase 2 clinical study, the Company retains the rights to develop and commercialize the Drug Candidate in the XOMA Territory itself or through one or more third party sublicensees. The Company’s development and commercialization of the Drug Candidate in the XOMA Territory would be subject to the payment of low to mid teen-digit royalties to Zydus on the aggregate net sales of the Drug Candidate, or sharing with Zydus revenue received from third party sublicensees.

Unless earlier terminated, the Agreement will remain in effect until the expiration of all payment obligations by either party with respect to the Drug Candidate. The Agreement may be terminated (i) by mutual agreement, (ii) by either party for the other party’s uncured material breach, bankruptcy or competitive change of control, (iii) by Zydus prior to expiration of its right of first negotiation due to safety or technical infeasibility or (iv) by Zydus following expiration of its right of first negotiation for convenience upon 90 days prior notice if prior to the first commercial sale of the Drug Candidate in the Zydus Territory or upon 180 days prior notice if after such first commercial sale.

The description of the Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to such Agreement, together with the exhibits thereto, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2020.

On March 5, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma (FL) (Press release, TG Therapeutics, MAR 5, 2020, View Source [SID1234555214]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Umbralisib is being evaluated across several types of lymphoma in the UNITY-NHL Phase 2b registration directed clinical trial. The FL cohort of the UNITY-NHL trial is designed to evaluate the safety and efficacy of umbralisib in patients with FL who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. In October 2019, the Company announced that the FL cohort met the primary endpoint of overall response rate (ORR), and in January the Company initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and FL.

The FDA has previously granted orphan drug designation to umbralisib, for the treatment of patients with all three types of MZL: nodal, extranodal, and splenic MZL.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated, "The receipt of orphan drug designation for umbralisib to treat patients with FL is another important milestone in the development and anticipated commercialization of umbralisib in MZL and FL." Mr. Weiss continued, "We were pleased to announce last year that both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints and have commenced our first rolling submission for these indications. We are excited by the progress so far and look forward to completion of this submission targeted in the first half of this year."

ABOUT ORPHAN DRUG DESIGNATION

Orphan drug designation is granted by the U.S. FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity.

ABOUT FOLLICULAR LYMPHOMA

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. Follicular lymphoma is generally not curable and is a chronic disease. Patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients1, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases2.

ABOUT THE UNITY-NHL PHASE 2b STUDY—FOLLICULAR LYMPHOMA COHORT

The multicenter, open-label, UNITY-NHL Phase 2b study follicular lymphoma (FL) cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. The primary endpoint is overall response rate (ORR) as determined by Independent Review Committee (IRC) assessment. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients (n=118). The results met the Company’s prespecified response target of 40-50% ORR. In January of 2020, the Company announced the initiation of a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

On March 5, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that it will report fourth quarter and full year 2019 financial results and provide a corporate update on Thursday, March 12, 2020 (Press release, Harpoon Therapeutics, MAR 5, 2020, View Source [SID1234555231]). Harpoon’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The live call may be accessed by dialing 866-951-6894 for domestic callers and 409-216-0624 for international callers and entering the conference code: 5468929. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.harpoontx.com.

On March 5, 2020 Biocept, Inc. (NASDAQ: BIOC) ("Biocept" or the "Company"), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that on March 4, 2020 it entered into a securities purchase agreement with several institutional investors for the issuance and sale of 16,000,000 shares of its common stock at a price of $0.41 per share, for aggregate gross proceeds of approximately $6.6 million, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Biocept, MAR 5, 2020, View Source [SID1234555249]). The Company currently expects that the proceeds from this registered direct offering, along with the approximate $9.2 million in gross proceeds from the Company’s registered direct offering announced on March 2, 2020 and its current cash and cash equivalents, will be sufficient to fund its current operations through at least December 31, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Maxim Group LLC is acting as the sole placement agent for the offering.

The offering is expected to close on or about March 6, 2020, subject to the satisfaction of customary closing conditions.

The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224946) previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by Biocept with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.