On October 28, 2019 Lineage Cell Therapeutics, Inc.(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that it will participate in Solebury Trout’s KOL Event for analysts and investors on November 15, 2019 at 11am ET in New York City at the offices of White & Case, LLP (Press release, Lineage Cell Therapeutics, OCT 28, 2019, View Source [SID1234549908]). Lineage will begin with a corporate overview from Brian M. Culley, Chief Executive Officer and Edward D. Wirth, III, MD, PhD, Chief Medical Officer, which will be followed by presentations from Lineage therapeutic area experts Allen C. Ho, MD, FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research and John Steeves, BSc, PhD, Emeritus Principal Investigator, ICORD and Professor, Department of Neuroscience at the University of British Columbia.

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Interested parties can access a live webcast of the Lineage presentations on the Events and Presentations section of Lineage’s website and an archived presentation will be available for 30 days.

On October 28, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease, reported plans to release its financial results for the third quarter ended September 30, 2019, on Tuesday, November 12, 2019 before the opening of the financial markets (Press release, Akebia, OCT 28, 2019, View Source [SID1234549925]).

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Akebia will host a conference call at 9:00 a.m. Eastern Time on Tuesday, November 12th, to discuss its third quarter financial results and recent business highlights. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 9996464. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through November 18, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 9996464. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

On October 28, 2019 Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NASDAQ: NEPT) (TSX: NEPT), reported that it will be holding a conference call on November 11, 2019 at 8:30 AM (EST) to discuss its second quarter results ended September 30, 2019 (Press release, Neptune Technologies et Bioressources inc, OCT 28, 2019, View Source [SID1234549941]).

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The Second quarter results press release will be issued on November 11, 2019 before the conference call.

Conference Call Details:

Date:

Monday, November 11, 2019

Time:

8:30 AM Eastern Standard Time

Call:

1 (888) 231-8191 (Canada and U.S.)

1 (647) 427-7450 (International)

Conference ID: 8390812

Webcast:

A live audio webcast and presentation of the results can be accessed at: View Source

A replay of the call will be available shortly after the call’s completion and until December 11, 2019. The replay can be accessed online in the Investors section of Neptune’s website under Investor Events and Presentations. It is also under this section that you will find the archive of the webcast, along with its accompanying presentation.

On October 28, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq:ZIOP), and The University of Texas MD Anderson Cancer Center reported a new research and development agreement relating to Ziopharm’s Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific T-cell receptors (TCRs) in T cells (referred to as TCR-T) (Press release, Ziopharm, OCT 28, 2019, View Source [SID1234552231]).

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"We are delighted to deepen our relationship with MD Anderson, which provides treatment to a large and diverse population of cancer patients with solid tumors," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "This new agreement is a launch point to expand our TCR library and execute two new clinical trials; a trial for utilizing TCRs from the library targeting hotspot mutations in KRAS, TP53 and EGFR, and a second trial for personalized TCRs targeting patient-specific neoantigens."

"Cell-based immunotherapies have emerged as a powerful new option for treating patients with hematological cancers, but we have not yet had the same success for patients with solid tumors," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Ventures at MD Anderson. "We are pleased to be working with Ziopharm to advance a new generation of cell therapies, and we are hopeful they can one day be effective in treating a broader group of our patients."

Under the terms of the new agreement, Ziopharm commits to fund an additional $20 million for this expanded work in the TCR-T program through 2023, as well as certain milestone payments for clinical development or regulatory approval in the U.S., European Union, Japan and the rest of the world. The funding for this new agreement was included within the budget forecast provided by Ziopharm in its second quarter 2019 financial results news release and webcast commentary.

MD Anderson will receive low, single-digit royalties on net sales in the U.S. and international markets, as well as warrants for Ziopharm common stock which vest upon achievement of clinical milestones. According to institutional guidelines, MD Anderson has implemented an Institutional Conflict of Interest Management and Monitoring Plan to manage this research.

This new agreement expands the relationship between Ziopharm and MD Anderson, established under a 2015 research agreement related to CD19-specific CAR-T. Earlier this month, the Food and Drug Administration cleared an IND application for a phase 1 clinical trial to evaluate CD19-specific CAR-T, manufactured and infused within two days of gene transfer using Ziopharm’s rapid personalized manufacture (RPM), as an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas. Ziopharm has approximately $20 million of pre-funded R&D at MD Anderson under the prior agreement, which may now be used under the new agreement, for both the CAR-T or TCR-T initiatives.

In addition to the new research and development agreement, Ziopharm has entered a lease agreement with MD Anderson through which the company accesses additional laboratory and office space within the institution’s campus. This new facility will serve as home for Ziopharm’s expanded Houston office, under the direction of Eleanor de Groot, Ph.D., EVP, GM Cell Therapy and Drew Deniger, Ph.D., head of Ziopharm’s TCR-T cell therapy program.

On October 28, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, reported that the follicular lymphoma (FL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, met the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=118) who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent (Press release, TG Therapeutics, OCT 28, 2019, View Source [SID1234549909]). The results met the Company’s prespecified ORR target of 40-50%. Importantly, umbralisib monotherapy appeared to be well tolerated with a safety profile consistent with previous reports.

The Company plans to present the data at a future medical conference as well as discuss the data with the U.S. Food and Drug Administration (FDA).

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to announce that the UNITY-NHL follicular lymphoma cohort evaluating umbralisib monotherapy met the primary endpoint of ORR. There are no fully approved drugs for patients with follicular lymphoma that have progressed following two or more prior lines of therapy and we are excited by the potential to offer a novel treatment for this underserved population. We look forward to sharing these results with the FDA and discussing submission opportunities for accelerated approval of umbralisib in follicular lymphoma." Mr. Weiss continued, "These are very exciting times for TG and with two additional major events targeted to occur over the next several months, including commencing our first NDA filing for umbralisib in patients with relapsed/refractory marginal zone lymphoma and results from our UNITY-CLL Phase 3 trial, we expect that excitement to continue. Taken together, we see 2020 shaping up as a pivotal year where we transition from a development-stage company into a fully-integrated development and commercial organization."

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

The multicenter, open-label, UNITY-NHL Phase 2b study – Follicular Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, 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).

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The positive ORR outcome announced today was based on 118 FL patients that received at least one dose of umbralisib and who previously had received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Monday, October 28, 2019 at 8:30 AM ET to discuss the UNITY-NHL FL news. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call.

A live audio webcast of this call will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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 usually not considered to be 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.