On November 20, 2017 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it will be presenting at the 10th Annual LD Micro Main Event on Tuesday, December 5th at 8:30 AM PT/11:30 AM ET (Press release, Cellectar Biosciences, NOV 20, 2017, View Source [SID1234522173]). Jim Caruso, president and CEO of Cellectar, will present the company and meet with investors.

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The company’s presentation will also be webcast at View Source, and will be posted on the company’s website following the conference. The LD Micro Main Event will be held at the Luxe Sunset Bel Air Hotel in Los Angeles.

On November 20, 2017 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or "the Company") reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the 29th Annual Piper Jaffray Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, NOV 20, 2017, View Source [SID1234522176]):

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Date: Wednesday, November 29, 2017
Time: 11:30 a.m. Eastern Standard Time
Location: Lotte New York Palace, New York
Webcast:

View Source;tp_key=fc44350be5

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors Section.

On November 20, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported the presentation of data from a Phase 1 study of indoximod, in combination with radiation, for children with progressive brain tumors (Press release, NewLink Genetics, NOV 20, 2017, View Source [SID1234522177]). These data were presented at the Society for NeuroOncology, 22nd Annual Meeting, in San Francisco, CA, on November 19, 2017, by Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University.

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The presentation entitled, "Radio-chemo-immunotherapy using the IDO-inhibitor indoximod for children with progressive brain tumors in the phase 1 setting" showed the combination of indoximod plus radiation was well-tolerated.

"We are very pleased with early study data combining salvage radiation therapy with indoximod. This combination seems to be well-tolerated in children with recurrent brain tumors, despite their previous treatment with high-dose radiation plans," said Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University. "We applaud NewLink Genetics for providing access to indoximod for the children enrolling in this first-in-children study."

A link to the presentation slides can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events & Presentations." A second presentation, complete with scan images, given by Dr. Johnson at the Texas Children’s Neuro-oncology Conference on November 10, 2017 can be found listed in the same location on NewLink’s website. Additional information for this study, NLG2105 for pediatric patients with refractory malignant brain tumors, may be found here.

On November 20, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported financial results for the quarter ended September 30, 2017 (Press release, Eleven Biotherapeutics, NOV 20, 2017, View Source [SID1234522156]).

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"I am very pleased with our progress this quarter. In addition to strengthening our balance sheet with a successful public offering in November, we also made strong progress during this quarter on our Phase 3 clinical trial examining Vicinium in patients with non-muscle invasive bladder cancer (NMIBC)," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "We are driving our Phase 3 enrollment forward and expect to achieve full enrollment in Q1 2018. The Company also remains on track to report top-line three-month data from our registration trial in mid-2018 with sufficient capital to carry us through this critical milestone. Also, we are excited that the combination trial of Vicinium and durvalumab, Astra Zeneca’s checkpoint inhibitor, has opened at the National Cancer Institute and we will be gathering immune biomarker data that we believe will provide insight into the complementary mechanism of action between checkpoint inhibitors and our TPT platform."

Third Quarter Results, Recent Business Highlights and Anticipated Upcoming Milestones:

Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade NMIBC in subjects who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. The company also has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) evaluating Vicinium in combination with AstraZeneca’s checkpoint inhibitor, durvalumab.

In September, the Company announced completion of the manufacturing of Vicinium necessary for the ongoing Phase 3 registration trial in patients with NMIBC, and the CRADA trial with the NCI.
Completion of enrollment for the Phase 3 registration clinical trial of Vicinium is expected in the first quarter of 2018.
Topline three-month data from the Phase 3 registration clinical trial of Vicinium is expected mid-2018 and topline twelve-month data is expected in the second quarter of 2019.
Initiation of a Phase 1 trial of Vicinium and durvalumab through the NCI CRADA will collect immune response biomarker data in patients with NMIBC and is expected to commence in the fourth quarter of 2017, with initial biomarker data expected in the third quarter of 2018.
Corporate:

In October, the Company announced the appointment of Richard F. Fitzgerald as Interim Chief Financial Officer, adding extensive capital raising and transaction execution experience to Eleven’s management team.
In November, the Company completed a public offering of 5,525,000 shares of its common stock, pre-funded warrants to purchase an aggregate of 4,475,000 shares of common stock, and common warrants to purchase up to an aggregate of 10,000,000 shares of common stock, raising approximately $8.0 million in gross proceeds and $7.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated expenses payable by the Company.
TPT Pipeline:

Eleven’s pipeline includes additional locally delivered product candidates, as well as a systemic TPT platform.

Proxinium is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage, EpCAM-expressing, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In Phase 1 and 2 clinical trials, Proxinium demonstrated anti-tumor activity in both injected as well as un-injected tumors. The Company plans to evaluate Proxinium in a Phase 1/2a clinical trial in combination with a checkpoint inhibitor and is actively seeking partners for a combination program.
VB6-845d is a systemically-administered TPT utilizing a proprietary, highly potent, de-immunized plant toxin, deBouganin, for the treatment of solid tumors. The Company plans to file an investigational new drug (IND) application for VB6-845d and initiate a Phase 1 trial, once funding or a partner is secured for this program.
The Company has deferred further development of Proxinium and VB6-84d in order to focus its efforts and resources on the advancement of its Phase 3 registration trial of Vicinium. The Company is also exploring partnering and collaboration strategies to move these additional product candidates forward.

Third Quarter 2017 Financial Results:

Cash Position: Cash and cash equivalents were $11.3 million as of September 30, 2017, compared to $25.3 million as of December 31, 2016. These amounts do not include the approximately $7.0 million of net proceeds from the Company’s November 2017 public offering.
Revenue: Eleven did not record any revenue for the three months ended September 30, 2017, compared to revenue of $28.7 million for the same period in 2016. This decrease was due to revenue recognized in 2016 from the Company’s License Agreement with Roche. The next licensing milestone payment expected from Roche, if any, will be triggered upon commencement of a Phase 2 clinical trial by Roche.
R&D Expenses: Research and development expenses were $3.6 million for the three months ended September 30, 2017, compared to $2.8 million for the same period in 2016. This increase was primarily due to higher costs incurred for the Company’s ongoing Phase 3 clinical trial for NMIBC that were partially offset by the absence of costs associated with the product candidate licensed to Roche in 2016 and lower compensation related costs.
G&A Expenses: General and administrative expenses were $1.6 million for the three months ended September 30, 2017, compared to $6.4 million for the same period in 2016. This decrease was driven primarily by a reduction in severance, retention and stock-based compensation and professional fees related to the Company’s 2016 review of strategic alternatives and the acquisition of Viventia Bio, Inc.
Net Loss: Net loss was $9.1 million, or $0.37 per basic and diluted share, for the three months ended September 30, 2017, compared to net income of $19.5 million, or $0.95 per basic share and $0.91 per diluted share, for the same period in 2016. The change was primarily the result of revenue recognized in 2016 from the Company’s License Agreement with Roche.
Financial Guidance: Based on current operating plans, the Company anticipates that cash at September 30, 2017, plus the net $7.0 million raised in November 2017, will fund research and development programs and operations into mid-2018.

On November 20, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, reported positive data updates supporting survival benefit and the underlying immune system mechanism for Ad-RTS-hIL-12 plus veledimex, 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) (Press release, Ziopharm, NOV 20, 2017, View Source [SID1234522161]). This gene therapy has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent glioblastoma (rGBM).

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New data presented shows median overall survival (mOS) of 12.5 months has been sustained for patients treated with Ad-RTS-hIL-12 plus 20mg of veledimex (n=15) at a longer mean follow-up time of 11.1 months as of October 18, 2017. This mOS of 12.5 months continues to compare favorably to the 5 to 8 months survival established in historical controls for patients with rGBM. Furthermore, the four patients with rGBM who received low-dose steroids maintained 100 percent survival at a mean follow-up time of 11.1 months. An anti-tumor effect was also evident with centralized review of magnetic resonance imaging (MRI) showing decreasing size of brain tumor lesions in several patients.

Additionally, data linking the intra-tumor production of hIL-12 to patients’ overall survival was presented by Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM during an oral poster session, "A Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Adult Recurrent Glioblastoma." Highlights of this presentation include:

Immunohistochemistry analyses from three of three patient biopsies after completion of veledimex demonstrated that IL-12 activates and sustains an immune response within rGBM;
All three biopsies of rGBM lesions demonstrated evidence of an anti-tumor response with extensive infiltration of CD8+ T cells within the rGBM;
Biopsies all showed sustained (greater than 4 months) production of interferon-gamma, a cytokine crucial to arming an immune response in the tumor microenvironment;
Ratio of circulating killer CD8+ T cells to suppressor FOXP3+ T cells correlates with survival;
Interferon-gamma was undetectable in the blood at the time of biopsies providing further evidence of an on-target response;
Expression levels of both PD-1 and PD-L1 were upregulated in all the biopsies, which suggests added potential efficacy for combining Ad-RTS-hIL-12 plus veledimex with an immune checkpoint inhibitor;
Ad-RTS-hIL-12 plus veledimex continues to be safe and well tolerated, as adverse events (AE) were predictable and reversible, neurologic AEs were relatively mild and transient, and there were no drug-related deaths.
"These new mechanistic data, especially taken together with the promising extension of patients’ median overall survival, provide additional validation that controlling IL-12 can engage the body’s own immune system safely to generate a T-cell response against rGBM. We are excited to see increasing evidence of a targeted, local immune response making brain tumors hot and illustrating how this immunotherapy contributes to patients’ survival," said Dr. Antonio Chiocca, M.D., Ph.D., lead author of this presentation and the 2017 President of the Society for Neuro-Oncology, Professor of Neurosurgery at Harvard Medical School, Surgical Director of the Center for Neuro-oncology at Dana-Farber Cancer Institute, and Chairman of Neurosurgery and Co-Director of the Institute for the Neurosciences at Brigham and Women’s Hospital.

Additional SNO presentations included:

"A Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Pediatric Brain Tumors," was presented in a poster by Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Ann & Robert H. Lurie Children’s Hospital in Chicago. The Company previously announced that the first patient was dosed in this open-label study designed to assess the safety and tolerability of a single intratumoral injection of Ad-RTS-hIL-12 plus veledimex in children.
"Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans," was presented during an oral session by John A. Barrett, Ph.D., Vice President of R&D/Translational Medicine at ZIOPHARM.
Dr. Barrett delivered a second oral presentation, "Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans."
A copy of all four SNO presentations is available in the Presentations and Publications section of the Company’s website, www.ziopharm.com.

"The established safety profile and tolerability of intra-tumor administration of Ad-RTS-hIL-12 plus oral veledimex, the durability of the overall survival results, and now the powerful evidence of sustained immune activation all support our goal of delivering a new treatment option to patients with recurrent glioblastoma," said Dr. Lebel. "We continue to work with regulators and thought leaders to initiate a pivotal study of Ad-RTS-hIL-12 plus veledimex in this setting before year end. In addition, the immunohistochemistry analyses revealing extensive and persistent immune cell infiltration within brain tumors and upregulation of immune checkpoint biomarkers support our initiation of a study of Ad-RTS-hIL-12 plus veledimex combined with an anti-PD-1 drug this year."

Conference Call and Webcast

In connection with this announcement, ZIOPHARM will host a conference call and webcast slide presentation featuring Drs. Chiocca and Goldman today, Nov. 20, at 10:15 a.m. ET. The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The conference ID number is 8089664. To access the accompanying slides and live webcast, or the subsequent archived recording, visit the "Investors & Media" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

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. The Company completed enrollment in a multi-center, Phase 1 dose escalation trial designed to evaluate Ad-RTS-hIL-12 in patients with recurrent or progressive Grade III or IV glioma. The trial evaluated three veledimex dosing cohorts (20mg, n = 15; 30mg, n = 4; and 40mg, n = 6). Patients undergoing resection were injected intratumorally with Ad 2 x 1011 viral particles and received daily oral activator veledimex for 15 doses. The majority of patients in the 20mg cohort had 2 or more recurrences prior to entry in the study, indicating very advanced disease. 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 has also 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 2017.