On November 6, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO) reported that it will webcast its presentations at two investor conferences in November (Press release, Juno, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314671 [SID1234521607]). The presentations will feature a business overview and update by Steve Harr, Juno’s Chief Financial Officer and Head of Corporate Development.

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Juno will present at the 26th Annual Credit Suisse Healthcare Conference at 9:15 a.m. Mountain Time (MT) on Wednesday, November 8, 2017.

Juno will present at the Evercore ISI Biopharma Catalyst / Deep Dive Conference at 8:45 a.m. Eastern Time (ET) on Wednesday, November 29, 2017.

The webcasts will be accessible on the Investor Relations page of Juno’s website at www.JunoTherapeutics.com. A replay of each presentation will be available at the same location for 30 days following the corresponding conference.

On November 6, 2017 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported an exclusive license agreement with NanoCarrier Co., Ltd (Press release, VBL Therapeutics, NOV 6, 2017, View Source [SID1234521592]). (TSE Mothers: 4571) for the development, commercialization, and supply of ofranergene obadenovec ("VB-111") in Japan. VBL Therapeutics (VBLT) retains rights to VB-111 in the rest of the world.

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"Japan is potentially a large market opportunity for VBLT, and this agreement provides us with access into this important market as we continue to prepare for commercialization of VB-111 in recurrent glioblastoma (rGBM), and in other indications," said Dror Harats, M.D., chief executive officer of VBL Therapeutics. "We see this agreement with NanoCarrier as providing further validation of the potential of VB-111 and we look forward to working together to bring this important anticancer therapy to patients and health care professionals in Japan."

"We are continually looking for new opportunities in the treatment of cancer, and VB-111 is an innovative gene therapy which, if approved, could have significant market potential in Japan," said Ichiro Nakatomi, Ph.D., President and Chief Executive Officer of NanoCarrier. "VB-111 is a perfect fit for our portfolio of cancer drug candidates."

Under terms of the agreement, VBLT has granted NanoCarrier an exclusive license to develop and commercialize VB-111 in Japan for all indications, VBLT will supply NanoCarrier with VB-111, and NanoCarrier will be responsible for all regulatory and other clinical activities necessary for commercialization in Japan. In exchange, VBLT receives an up-front payment of $15 million, and is entitled to receive greater than $100 million in development and commercial milestone payments. VBLT will also receive tiered royalties on net sales in the high-teens. Other terms of the agreement are not being disclosed.

In addition to this agreement, VBL Therapeutics and NanoCarrier intend to explore future collaborations in oncology.

About VB-111 (ofranergene obadenovec)

VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead product currently being studied in a global Phase 3 pivotal trial for rGBM. VB-111 has demonstrated statistically significant overall survival and a progression-free survival in a Phase 2 trial in patients with rGBM, versus current standard of care. VBL-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum resistant ovarian cancer.

On November 6, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the release of four presentation abstracts highlighting data from the Company’s controlled human interleukin-12 (hIL-12) gene therapy candidate for brain cancer at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 16-19, 2017 in San Francisco (Press release, Ziopharm, NOV 6, 2017, View Source [SID1234521591]).

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With three oral and one poster presentations, the Company will update data on Ad-RTS-hIL-12 plus veledimex, a gene therapy designed to control the expression of hIL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent GBM (rGBM).

"In our Phase 1, multi-centric study of Ad-RTS-hIL-12 plus veledimex, we continue to show a marked improvement of survival in patients with recurrent glioblastoma over historical controls. We are excited about the long-lasting T-cell response that is being observed through brain biopsies as well as emerging radiologic and peripheral blood correlative studies," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM.

The Company previously presented data from a cohort of 15 patients receiving intra-tumoral Ad-RTS-hIL-12 with 20 mg of orally-administered veledimex following craniotomy with median overall survival (mOS) of 12.5 months at a mean follow up of 9.2 months, which compares favorably to historical controls. Emerging data revealed that an elevated ratio of circulating CD8+/FOXP3+ (effector/suppressor) T cells correlated with mOS which is consistent with IL-12-mediated activation of the immune system. The superior survival rate in the 20 mg cohort that had been observed will be updated in those patients that received low dose steroids.

"We look forward to sharing this important data with the scientific community at SNO," continued Dr. Lebel.

The Company plans to host a conference call and webcast soon after the presentations of data at SNO. Details of the call and webcast, including timing, will follow at a later date.

Details for the SNO presentations are as follows:

Poster Presentation Title: Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Pediatric Brain Tumors
Author: Stuart Goldman, MD
Session: Friday Traditional Posters
Date and Time: Friday, November 17, 2017, 7:30 p.m. PT
Abstract code: 5571

E-Talk Title: A Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Adult Recurrent Glioblastoma
Presenter: E. Antonio Chiocca, M.D., Ph.D.
Session Title: Adult Therapeutics
Date and Time: Saturday, November 18, 2017, 5:32 — 5:36 p.m. PT
Abstract Code: ATIM-26

Title: Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans
Presenter: John A. Barrett, Ph.D.
Session Title: Immunology — Preclinical and Clinical I
Date and Time: Sunday, November 19, 2017, 9:15-9:20 a.m. PT
Abstract Code: IMMU-34

Title: Controlled Local Expression of IL-12 as Gene Therapy Concomitant with Systemic Chemotherapy Improves Survival in Glioma
Presenter: John A. Barrett, Ph.D.
Session Title: Immunology — Preclinical and Clinical I
Date and Time: Sunday, November 19, 2017, 10:00-10:05 a.m. PT
Abstract Code: IMMU-33

All accepted abstracts will be accessible via SNO’s official journal.

About Ad-RTS-hIL-12 plus Veledimex:

ZIOPHARM is advancing Ad-RTS-hIL-12 plus veledimex as a gene therapy for glioblastoma. Ad-RTS-hIL-12 is an adenoviral vector administered via a single injection into the tumor and engineered to express hIL-12, a powerful cytokine that has demonstrated the potential to stimulate a targeted, anti-tumor immune response. The expression of hIL-12 is controlled and modulated with the RheoSwitch Therapeutic System (RTS) by the small molecule veledimex, an activator ligand which has been shown to cross the blood brain barrier. ZIOPHARM anticipates initiation of a pivotal registration trial for Ad-RTS-hIL-12 plus veledimex for the treatment of rGBM by the end of 2017. The Company also has initiated a Phase 1 study to evaluate the stereotactic administration of Ad-RTS-hIL-12 plus veledimex in adult patients with rGBM, as well as a trial to evaluate the gene therapy as a treatment for pediatric brain tumors. In addition, ZIOPHARM plans to initiate enrollment of adult patients with rGBM who will receive a single dose of Ad-RTS-hIL-12 plus veledimex in combination with a checkpoint inhibitor targeting programmed cell death protein 1 (PD-1) by the end of the year.

On November 6, 2017 Portola Pharmaceuticals (Nasdaq:PTLA) reported the appointment of John H. (Jack) Lawrence, M.D., as senior vice president and chief medical officer (CMO), effective immediately (Press release, Portola Pharmaceuticals, NOV 6, 2017, View Source;p=RssLanding&cat=news&id=2314505 [SID1234521587]). Dr. Lawrence will report to William Lis, chief executive officer, and will be responsible for leading all product development, as well as clinical strategies. He will also serve on the company’s Executive Committee.

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"Jack’s reputation and achievements in global thrombosis product development and regulatory approvals will be valuable assets to Portola as we begin to launch betrixaban and prepare for the potential approval of andexanet in 2018," said Mr. Lis. "We’re pleased to add his executive leadership and expertise to our management team to help us continue to advance Portola as a leading thrombosis and hematologic biotechnology company."

Dr. Lawrence joins Portola from Bristol-Myers Squibb (BMS), where he held positions of increasing responsibility in the company’s cardiovascular division. He was vice president and cardiovascular therapeutic area head with responsibility for global clinical development and regulatory activities of the Factor Xa inhibitor, apixaban. He also provided strategic input into the discovery and early development efforts for BMS’ cardiovascular programs, including phase 2 trials in heart failure and stroke prevention.

"I have long admired Portola’s leadership team and am incredibly excited by the unique opportunity to bring two important new therapies – andexanet alfa, the first ever reversal agent for Factor Xa inhibitors, and Bevyxxa (betrixaban), the first and only drug approved for extended-duration prophylaxis of VTE – to patients in need," said Dr. Lawrence. "I’m confident that my experience will support the company’s goals of continuing to develop transformative medicines and getting them to the patients who need them most."

Dr. Lawrence received his medical degree from the University of Virginia and completed his cardiology fellowship training at The Johns Hopkins University School of Medicine, where he later served as an associate professor.

On November 6, 2017 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that it is advancing COM902, its lead anti-TIGIT antibody, into manufacturing in anticipation of filing an investigational new drug (IND) application in 2019 (Press release, Compugen, NOV 6, 2017, View Source [SID1234521581]). As part of these activities, Compugen has entered into a process development and manufacturing service agreement with Bayer HealthCare LLC (Bayer) to produce COM902 for future use in clinical trials. This program follows COM701, an anti-PVRIG antibody, for which the submission of an IND application is anticipated towards the end of the first quarter of 2018.

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"As a company with long-standing advanced biologics manufacturing experience and a commitment to advancing novel cancer therapies, we collaborate with a few select partners to develop and manufacture their own pipeline programs," said Sunil Gupta, Vice President of Biological Development at Bayer. "Compugen has been a valued partner for Bayer and we look forward to working with the Compugen team to produce and prepare COM902 for clinical testing."

"The development of COM902 will allow us to address various drug combination possibilities of COM701, which can potentially offer significant therapeutic value for cancer patients. We are delighted to enter this service agreement with Bayer for the manufacture of COM902, and to benefit from their expertise and the quality of their cGMP operations," said Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We are working towards filing an IND for COM902 in 2019, making it available for our clinical testing in combination with COM701 and enabling us to more fully explore the commercial value of COM701."