On October 12, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported that the Company has been included in the SU2C CatalystTM program, a cutting-edge research initiative led by Stand Up To Cancer (SU2C) designed to bring innovative cancer treatments to patients quickly through novel collaborations between industry and academia (Press release, Mirati, OCT 12, 2017, View Source [SID1234520918]).

A clinical trial research grant has been awarded to the Van Andel Research Institute (Grand Rapids, Michigan) to evaluate the potential of epigenetic agents to improve patient responses to immunotherapy in non-small cell lung cancer (NSCLC). The $2.5 million research grant will support a Phase 1/1b study combining Mirati’s mocetinostat, an orally-bioavailable, spectrum-selective Class 1 & IV HDAC inhibitor, guadecitabine, a DNA methyltransferase (DNMT) inhibitor from Astex, and pembrolizumab, a PD-1 checkpoint inhibitor from Merck (known as MSD outside the U.S. and Canada). The grant is provided by Merck, a SU2C Catalyst Founding Supporter.

“We are honored to participate in this ground-breaking trial with pembrolizumab and guadecitabine. The combination of immunotherapy with epigenetic agents such as mocetinostat has great potential to positively impact outcomes for patients with NSCLC,” said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. “The SU2C Catalyst program is an exceptional example of a collaboration designed to benefit cancer patients in an unprecedented way.”

The team is led by Stephen Baylin, M.D., and Matthew Hellmann, M.D. Dr. Baylin is the co-director of the Cancer Biology Division and associate director for research programs for Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins as well as the co-leader of the VARI-SU2C Epigenetics Dream Team while Dr. Hellmann is an oncologist at Memorial Sloan Kettering Cancer Center in New York. Memorial Sloan Kettering will coordinate the trial with Dr. Hellmann as principal investigator.

“Despite the current and exciting advances with immune checkpoint therapy, many patients with NSCLC still do not receive benefit and this continues to be an extremely challenging disease. However, we remain optimistic that with continued research on the immune modulatory effects of epigenetic agents, the ability to test the hypothesis in trials like this, that these drugs combined with immune checkpoint therapy will contribute to improved ways to treat patients with NSCLC,” said Dr. Baylin.

The trial is now open and enrolled its first patient in August 2017. Additional information on the trial can be found at View Source For information on SU2C Catalyst and this project, visit SU2C.org.

Mirati is also conducting a Phase 2 study of mocetinostat in combination with durvalumab in NSCLC patients who have experienced progression of disease after treatment with checkpoint inhibitor therapy. Patients are stratified into two cohorts based upon their best response to prior checkpoint therapy. Stage 1 of the study is currently enrolling nine patients in each cohort; one cohort has already met the prespecified criteria for expansion into stage 2 with at least one confirmed partial response. Mirati will provide an update on this study by the end of the year.

About Mocetinostat (MGCD103)
Mocetinostat (MGCD103) is an orally-bioavailable, spectrum-selective Class I & IV HDAC inhibitor. Class I HDAC inhibition of histone acetylation is predicted to enhance the recognition of tumor cells by anti-tumor T cells and reverse immunosuppressive factors in the tumor microenvironment. Epigenetic immunomodulation may enhance immune response to tumors, and ultimately improve patient response to immunotherapies. Mocetinostat is being studied in a Phase 2 trial as a combination therapy with durvalumab, targeting the programmed death ligand 1 (PD-L1) pathway, which has been implicated in advanced lung cancers.
Mirati retains worldwide rights to mocetinostat except for certain Asian territories where the program is partnered with Taiho.

On October 12, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on developing gene and cell-based immunotherapies for cancer, reported that three abstracts highlighting data from the Company’s Ad-RTS-hIL-12 + veledimex program have been accepted for presentation at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO). The meeting will be held Nov (Press release, Ziopharm, OCT 12, 2017, View Source [SID1234520884]). 16 – 19 in San Francisco. Additional information will be available from the Society when all abstracts are released from embargo on Nov. 6.

Details for the SNO presentations with discussion are as follows:

E-Talk: 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, Nov. 18, 5:32 — 5:36 p.m. PST
Abstract Code: ATIM-26

Oral Presentation: 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, Nov. 19, 9:15 – 9:20 a.m. PST
Abstract Code: IMMU-34

Oral Presentation: 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, Nov. 19, 10 – 10:05 a.m. PST
Abstract Code: IMMU-33

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 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, and 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 October 12, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it has appointed Ingmar Bruns, M.D., Ph.D., as Vice President of Clinical Development (Press release, Pieris Pharmaceuticals, OCT 12, 2017, View Source [SID1234520882]). Dr. Bruns is an accomplished physician and brings to Pieris a wealth of oncology and hematology experience, a deep science background, and a strong clinical development acumen.

“We are pleased to welcome Ingmar to the Pieris team at this time of rapid growth and advancement of key therapeutic programs into the clinic,” commented Louis Matis, M.D., Senior Vice President and Chief Development Officer. “His strong biomedical background, academic and industry networks, and track record in both research and clinical development bring exceptional value to the Company. We look forward to his leadership in advancing our lead immuno-oncology therapeutic, PRS-343, a HER2-CD137 first-in-class bispecific, as well as our other programs in immuno-oncology, respiratory and other diseases.”

Prior to joining Pieris, from 2013 through October 2017, Dr. Bruns led clinical development of several high priority oncology assets at Bayer Pharmaceuticals. Before his tenure at Bayer, Dr. Bruns served as an attending hematologist and oncologist as well as a basic, translational and clinical researcher at the University Hospital of Dusseldorf in Germany and Albert Einstein College of Medicine in New York. Dr. Bruns has authored over 50 papers in the field of hematology and oncology. He received his M.D. and Ph.D. from the University of Lubeck in Germany.

“I’m excited to join the dynamic Pieris team and look forward to contributing to the advancement of Pieris’ preclinical and clinical-stage Anticalin-based therapeutics into and through the clinic,” added Dr. Bruns. “In particular, the Company’s lead immuno-oncology program, PRS-343, a HER2-CD137 first-in-class bispecific, represents a potentially transformative therapy for a number of metastatic cancer patients without viable treatment options today.”

In connection with the hiring of Dr. Bruns, the Company’s Board of Directors authorized the grant to Dr. Bruns of a non-qualified stock option to purchase up to 175,000 shares of the Company’s common stock, effective as of the first day of his employment. The option grant is an inducement material to Dr. Bruns’ entering into employment with the Company in accordance with NASDAQ listing Rule 5635(c)(4). The option will have an exercise price corresponding to today’s closing price of Pieris stock, the fair market value of the Company’s common stock on the date of grant, and will vest as to 25% of the shares on the first anniversary of Dr. Bruns’ employment and as to an additional 6.25% of the shares per quarter thereafter for the following 12 quarters, provided that he continues to provide service to the Company on the applicable vesting dates. The option has a ten-year term and is subject to the terms and conditions of a stock option agreement.

On October 12, 2017 OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it will present new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or “tavo”] with electroporation), its lead program focused on oncology, at the upcoming 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR). In addition, Chris Twitty, Ph.D., Executive Director of Clinical Science, gave an oral presentation at the 2nd Annual Biomarkers & Precision Medicine USA Congress earlier this week (Press release, OncoSec Medical, OCT 12, 2017, View Source;a-joint-meeting-with-the-society-for-melanoma-research [SID1234520880]).

“We are excited to share updated data from our phase 2 clinical monotherapy trial with ImmunoPulse IL-12 in patients with stage III/IV melanoma,” said Punit Dhillon, CEO and President at OncoSec. “These data, along with the emerging clinical data from the phase 2 combination study, further support the rationale for our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018.”

9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research

Dr. Alain Algazi, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, will give an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the company’s recently completed monotherapy phase 2 trial. The 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR) is to be held on October 18-22, 2017, in Brisbane, Australia.

Details of the presentation are as follows:

Abstract Title: Clinical Immune Monitoring and Biomarker Data of pIL-12 Monotherapy Compared to pIL-12 with Pembrolizumab in Metastatic Melanoma Supports the Rationale for Combination Therapy (Abstract # FC05-3)

Session Title: Biology and Biomarkers

Date and Time: October 19, 2017 at 3:30 PM – 3:40 PM

Location: Brisbane Convention & Exhibition Centre

Dr. Algazi will present new clinical and immune monitoring data from patients treated with ImmunoPulse IL-12, as a monotherapy (n=51 patients) versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab (n=22 patients) to better understand the mechanisms associated with each immunotherapy protocol. In the 51 patients treated with ImmunoPulse IL-12 as monotherapy, an average of 33.5% best overall response rate (BORR) at 180 days by a modified “skin” RECIST was demonstrated, in addition to a favorable safety profile (no life threatening or grade 4 AE). In the combination trial of 22 patients treated to date, a 48% BORR was observed at 24 weeks. Biomarker analyses suggest ImmunoPulse IL-12 drives a cellular response leading to an inflamed tumor with an increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting “cold” tumors to “hot”.

Further details on this presentation will be provided in upcoming Company communications. For more information about this conference, please visit: View Source

2nd Annual Biomarkers & Precision Medicine USA Congress

Chris Twitty, Ph.D., Executive Director of Clinical Science at OncoSec, gave an oral presentation entitled: “Interrogation of the tumor microenvironment and associated immunity in patients with melanoma” in addition to leading a panel discussion at the 2nd Annual Biomarkers & Precision Medicine USA Congress on October 10, 2017 at the Hilton San Diego Mission Valley Hotel in San Diego, CA. For more information, please visit: View Source