Intrexon Forms Two New Collaborations with Harvest Intrexon Enterprise Fund

On April 13, 2016 Intrexon Corporation (NYSE: XON), a leader in synthetic biology, reported it has entered into Exclusive Channel Collaborations (ECC) with two startups backed by the Harvest Intrexon Enterprise Fund, sponsored by Harvest Capital Strategies, LLC (Press release, Intrexon, APR 19, 2016, View Source [SID:1234511218]). Through the proprietary technologies of Intrexon, these companies will pursue new approaches for unmet needs in human health:

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Relieve Genetics, Inc. will focus on a breakthrough, non-opioid gene therapy approach for neuropathic pain; and
Exotech Bio, Inc. will utilize a novel exosome-based platform for delivering therapeutic RNA to treat select cancer indications.

"We are excited to enter into these new collaborations within Intrexon’s Health Sector to advance medicine on multiple fronts," said Samuel Broder, M.D., Senior Vice President, Head of Intrexon’s Health Sector. "Neuropathic pain is a tremendous unmet need in healthcare today. The collaboration with Relieve Genetics offers a significant opportunity to materially impact the lives of many patients who are in desperate need of relief from pain refractory to other therapies including opiates."

Neuropathic pain is a common, chronic complication caused by a number of different medical conditions. Current standard of care focuses mainly on easing discomfort as treatments are limited by incomplete efficacy and dose-limiting side-effects. Relieve Genetics, Inc. will instead center its therapeutic efforts on the underlying pathophysiology of neuropathic pain through gene therapy. With a designed viral vector delivery system, the collaboration will target delivery of an immunomodulatory protein alone or in combination with multiple therapeutic effectors under the control of the RheoSwitch Therapeutic System, providing localized, persistent, and regulatable drug delivery for pain management.

Dr. Broder continued, "Intrexon’s work in engineering complex miRNAs holds particular promise for an exosome-based platform to address certain cancers, for which conventional approaches have failed. In addition to the significant progress underway with our partner ZIOPHARM Oncology in the utilization of gene and adoptive cellular therapies against numerous cancer types, we look forward to introducing a new and important modality with Exotech Bio to treat cancer patients who have limited options under current treatment approaches."

Exosomes are micro-vesicles that naturally contain RNA, proteins and small molecule metabolites and are transmitted between the body’s cells to facilitate intercellular communication, immune modulation and developmental cell differentiation. A growing body of research supports the re-engineering of exosomes to transport drugs, including various RNA classes, as cell-specific cargoes that can mediate therapeutic responses to a variety of cancer cell types for which conventional treatments have been unsuccessful at effectively addressing.

Intrexon’s unique expertise in the design of subcellular localization motifs, unique protein-protein interaction motifs, multimeric miRNAs, and other RNA-based modalities can be applied in a coordinated fashion for the purpose of increasing anti-cancer therapy efficacy while reducing side effects. The collaboration with Exotech Bio, Inc. is focused on developing engineered cell lines for production of tumor-targeted allogeneic exosomes carrying bioactive RNAs to act directly on intracellular cancer pathways to suppress or eliminate specific tumor cells.

Under the terms of the ECC agreements for both collaborations, Intrexon will receive a technology access fee in the form of equity equating to 25% of each startup, reimbursement for all research and development costs, as well as potential milestones and backend economics in the form of royalties.

Celprogen’s Novel CEP1430 & CEP1507 Compounds for Targeting Advanced Stage Pancreatic Cancer Patients

On April 13, 2016 Celprogen reported they successfully completed their pre-clinical evaluation of CEP1430 and CEP1507 compounds as selectively targeting Pancreatic Cancer stem Cell population that contribute to treatment related resistance (Press release, Celprogen, APR 13, 2016, View Source [SID:1234510892]). Both compounds demonstrated growth inhibition of pancreatic tumors in patient derived xenograft (PDX) cancer models by 80% to 85%. The results of the study will be presented in an abstract format on Monday, April 18, 2016 at American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans. These compounds are Celprogen’s propriety compounds for targeting Pancreatic Cancer Stem Cells (CSC) and Circulating Tumor Cells (CTC) in patients with advanced stages of pancreatic cancer.

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The present invention relates to Drug Discovery programs at Celprogen that identify potential drug candidates for the treatment of pancreatic cancer. At present Celprogen is exploring partnership with Pharmaceutical Industry to move promising drug candidates forward to the clinical development and increasing the armament of drugs against pancreatic cancer. CEP1430 is a selective inhibitor of CSC that can be administrated orally and does not exhibit sign of toxicity. The mechanism of cell death also indicates that these molecules will greatly enhance the efficacy of immune based approaches to improve outcome in pancreatic cancer patients. These pancreatic Stem Cell selective inhibitors are expected to eradicate tumors, improve quality of life and prolong and/or overall survival and patients bearing pancreatic tumors.

OncoSec to Host Webcast and Panel Discussion on New Melanoma Clinical Data

On April 13, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that it will host a webcast to provide an overview and panel discussion regarding new clinical data that will be featured as an oral presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, OncoSec Medical, APR 13, 2016, View Source [SID:1234510751]).

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The webcast will be held on Wednesday, April 20, 2016 at 11:00 AM ET/8:00 AM PT.

The webcast will include a round table discussion to enable key opinion leaders in the fields of melanoma and immuno-oncology to contribute their respective insights on data from the AACR (Free AACR Whitepaper) abstract entitled: "Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma" (Abstract #CT134). Webcast participants will include:

Alain Algazi, MD, Skin Cancer Specialist, Melanoma Center, University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
Adil Daud, MD, Clinical Professor, Department of Medicine (Hematology/Oncology), UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
Robert Andtbacka, MD, CM, Associate Professor, Division of Surgical Oncology, Department of Surgery, University of Utah School of Medicine; Surgeon and Investigator, Intermountain Healthcare and Huntsman Cancer Institute
Sharron Gargosky, PhD, Head of Clinical Development and Operations, OncoSec*
Moderator: Robert Pierce, MD, Chief Scientific Officer, OncoSec
To join via webcast, please use the following link: View Source To listen to the conference call, please dial (877) 731-1960 and enter conference ID number: 84899794. An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: ir.oncosec.com/events.

Tokai Announces Presentations on Galeterone at the AACR Annual Meeting 2016

On April 13, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported that two presentations on galeterone will be made during poster sessions held at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans (Press release, Tokai Pharmaceuticals, APR 13, 2016, View Source;p=RssLanding&cat=news&id=2156705 [SID:1234510747]). Galeterone, Tokai’s lead product candidate, is being developed for the treatment of men with metastatic castration-resistance prostate cancer.

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Title: Galeterone-induced degradation of the androgen receptor involves inhibition of deubiquitinating enzymes
Date/time: Monday, April 18, 2016, 8 a.m. – 12 p.m. CDT
Location: Section 16
Abstract: 1234
Title: The effect of novel CYP17 inhibitor galeterone on gonadal and tumor progestogen and androgen levels in SCID mice bearing LNCaP prostate cancer xenografts
Date/time: Tuesday, April 19, 2016, 1 – 5 p.m. CDT
Location: Section 1
Abstract: 3490
Additional information, including the presentation schedule and full abstracts, may be found at www.aacr.org. A copy of each presentation will be available on the "Publications & Presentations" page of Tokai’s website, www.tokaipharma.com.

About Galeterone
Galeterone is an oral small molecule that utilizes the established pathways, including CYP17 enzyme and androgen receptor inhibition, of the current second-generation hormonal therapies abiraterone and enzalutamide. Galeterone also introduces a distinct third mechanism – androgen receptor degradation – that decreases the sensitivity of androgen receptors to androgen activity, thus leading to reductions in tumor growth. Tokai is developing galeterone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ARMOR3-SV, the company’s pivotal Phase 3 study of galeterone in treatment-naive mCRPC patients whose prostate tumors express the AR-V7 splice variant, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide. Tokai is also evaluating galeterone in mCRPC patients who have shown resistance following treatment with second-generation hormonal agents. Tokai has worldwide development and commercialization rights to galeterone.

TG Therapeutics, Inc. Announces Issuance of Composition of Matter Patent for TG-1101 in the United States

On April 13, 2016 (TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TG-1101, the Company’s novel, glycoengineered monoclonal antibody (Press release, TG Therapeutics, APR 13, 2016, View Source [SID:1234510746]). The patent, U.S. Patent No. 9,234,045 specifically covers the composition of TG-1101, and its use for treating various forms of CD20 expressing leukemia and lymphoma, including chronic lymphocytic leukemia (CLL) and various types of non-Hodgkin’s lymphoma, including follicular lymphoma (FL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

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The patent was issued to LFB SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with LFB SA. The issuance affords patent protection for TG-1101 in the US through July of 2029, exclusive of additional patent term extensions also available. TG-1101 is currently being studied in two Phase 3 clinical trials in patients with CLL, with additional registration directed trials in NHL expected to commence in 2016.

"We are excited to announce the issuance of the first U.S. patent for TG-1101 which affords protection through 2029. With composition of matter patents now in place for both TG-1101 and TGR-1202, and an additional later-filed patent application on the combination of TG-1101 and TGR-1202, we believe we have established a very strong intellectual property position for the two components of our proprietary ‘TG-1303′ regimen that provides a very attractive exclusivity period without the risk of generic competition for many years to come," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We remain focused on continuing to strengthen our intellectual property position through the issuance of additional patents for both TG-1101 and TGR-1202 individually as well as in combination here in the US and abroad."