On October 28, 2019 Nuvation Bio, Inc., a stealth biotechnology company developing proprietary therapies focused on oncology, reported the closing of $275 million in an oversubscribed Series A financing (Press release, Nuvation Bio, OCT 28, 2019, View Source [SID1234550204]). The round was led, structured and syndicated by Omega Funds and included participation from leading biotechnology investors including Aisling Capital, Altitude Life Science Ventures, The Baupost Group, Boxer Capital of the Tavistock Group, EDBI (global Asian-based Investor), ECOR1 Capital, Fidelity Management and Research Company, Pavilion Capital, Perceptive Advisors, Redmile Group, Surveyor Capital (a Citadel Company) and other institutional investors.

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The Series A financing will enable Nuvation Bio to expand its development activities and advance a number of its oncology programs.

Nuvation Bio was founded by industry veteran David Hung, M.D., who previously founded and served as President and Chief Executive Officer of Medivation, Inc., which was subsequently sold to Pfizer, Inc. for $14.3 billion in 2016.

"My vision for Nuvation Bio is to provide patients with dramatic medical advancements that address their unmet needs across a wide range of oncology applications," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "I am extremely proud of what we accomplished at Medivation, developing in just seven years what is now the world’s largest prostate cancer drug. However, I believe we could have done so much more had we had more time. With seven mechanistically distinct programs at Nuvation Bio, along with the strong support of Omega Funds and a formidable syndicate of investors, we are well-positioned to expand upon the mission we started at Medivation. My team and I are extremely excited to develop even more game-changing therapies for the foremost unmet needs in oncology."

The Nuvation executive team is comprised of former senior leaders at Medivation including Michele D. Bronson, Ph.D., Melanie Morrison, and Thomas Templeman, Ph.D., who will serve as Nuvation’s Chief Development Officer, Vice President of Clinical Operations and Data Management and Senior Vice President of Pharmaceutical Operations and Quality, respectively. They are joined by new senior leaders including Chief Scientific Officer, Gary Hattersley, Ph.D., Chief Medical Officer, Sergey Yurasov, M.D., Ph.D., and Senior Vice President of Human Resources, Stacy Markel.

"The whole Omega Funds’ team has been thrilled to partner with David on the launch and Series A syndication of Nuvation Bio and thanks to deal leads Richard Lim and Michelle Doig for their efforts executing this transaction," said Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. "The breadth and depth of Nuvation Bio’s innovative pipeline demands a large initial investment. By syndicating one of the largest-ever Series A biotech financings, David and his exceptional team are well-positioned to advance Nuvation Bio’s deep portfolio of therapies focused on dramatically improving the standard of care for those living with cancer," Stampacchia continued.

Joining Founder David Hung, M.D., on Nuvation Bio’s Board of Directors are Michelle Doig, Richard Lim and Otello Stampacchia of Omega Funds, as well as former Medivation directors Tony Vernon and Kim Blickenstaff.

On October 28, 2019 NeoTX Therapeutics, Ltd. reported the dosing of the first patient in its Phase 1b trial of naptumomab estafenatox (Nap) in combination with AstraZeneca’s checkpoint inhibitor IMFINZI (durvalumab) for the treatment of advanced or metastatic solid tumors (Press release, NeoTX, OCT 28, 2019, View Source [SID1234640359]). The company aims to establish the maximum tolerated dose in the dose-escalation Phase 1b study before advancing to a cohort expansion study.

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"The dosing of the first patient in our Phase 1b trial is a significant milestone for NeoTX, as it is our first clinical-stage molecule developed with our Selective T Cell Redirection (STR) platform," said Asher Nathan, Ph.D., chief executive officer of NeoTX. "Previous clinical studies have shown Nap to be well-tolerated, and preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumors, especially in combination with checkpoint inhibitors. We’re looking forward to bringing this therapy to patients suffering from advanced cancers that have thus far been unresponsive to therapy with checkpoint inhibitors alone."

The open-label, multicenter, dose-finding Phase 1b trial (NCT03983954) will enroll patients with previously treated advanced or metastatic tumors. Patients will be treated with a combination of Nap and durvalumab.

About the STR platform
The STR platform leverages the body’s natural antibacterial immune response to selectively expand and redirect T cells to rapidly infiltrate and kill tumor cells, offering unique advantages in the field of T cell redirection. STR compounds induce the activation and expansion of specific T cells outside of the tumor microenvironment and redirect the T cells to attack the tumor cells.

About naptumomab estafenatox (Nap)
Naptumomab estafenatox is the lead compound in NeoTX’s STR platform and is designed to target the 5T4 antigen that is present on many tumors.

Naptumomab estafenatox was licensed from Active Biotech in 2016. Active Biotech AB (publ) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Please visit www.activebiotech.com for more information.

About Durvalumab

Durvalumab (IMFINZI) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III non-small cell lung cancer (NSCLC) in more than 50 countries including the US, in the EU, and Japan based on the Phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in 10 countries, including the US.

As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.

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 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