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To Present CAR-T Phase I Clinical Trial Data for Non Small Cell Lung Cancer and Other Solid Tumors at 5th World Congress on Cancer Therapy

On September 16, 2015 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported that it would give an oral presentation to discuss Phase I clinical trial data for EGFR (HER-1)-targeted Chimeric Antigen Receptor-Modified T-Cells (CAR-T) Immunotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) and other solid tumors at the 5th World Congress on Cancer Therapy on September 28, 2015 (Press release, Cellular Biomedicine Group, SEP 16, 2015, View Source [SID:1234507486]).

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Conference: 5th World Congress on Cancer Therapy, September 28-30, 2015 Atlanta, Georgia, USA

Title: EGFR (HER-1)-targeted Chimeric Antigen Receptor-Modified T-Cells Immunotherapy for Patients with Advanced or Relapsed/Refractory Solid Tumors
Oral Presentation: Scientific Program, September 28, 2015 18:05-18:25

Location: Hilton Atlanta Airport

Presenter: Wei Dong Han, MD, PhD, Chinese PLA General Hospital

The presentation expands on the data that will be presented at the European Cancer Congress poster presentation in Vienna on September 26, and will detail PLAGH/CBMG’s Phase I clinical trial data using Chimeric Antigen Receptor-Modified T-Cells (CAR-T) targeting EGFR (HER-1) for the treatment of patients with EGFR (HER-1) expressing advanced relapsed/refractory Non-Small Cell Lung Cancer (NSCLC) as well as other EGFR (HER-1) expressing solid tumors. The CAR-T trial was designed and conducted by Chinese PLA General Hospital ("PLAGH", Beijing, also known as "301 Hospital"), led by Principal Investigator Wei Dong Han, MD, PhD, head of PLAGH’s cancer immunotherapy department. Dr. Han and his research team have authored several CAR-T publications, including "Tolerance and Efficacy of Autologous or Donor-derived T-Cells Expressing CD19 Chimeric Antigen Receptors in Adult B-ALL with Extramedullary Leukemia" and "Effective Response and Delayed Toxicities of Refractory Advanced Diffused Large B-cell Lymphoma Treated by CD20-directed Chimeric Antigen Receptor-modified T-cells". (OncoImmunology (Impact Factor: 6.28). 03/2015; DOI: 10.1080/2162402X.2015.1027469 and Clin Immunol. 2014 Dec;155(2):160-75. doi: 10.1016/j.clim.2014.10.002) The Company previously announced positive clinical data from its Phase I clinical trials using CAR-T constructs against CD19, CD20 and CD30 for late-stage blood cancers.

Company management will attend the conference and be available for discussions. Full detail of the presented data will be available on the Company website following the presentation.

OncoMed Presents Immuno-Oncology Data for GITRL-Fc Candidate at the Inaugural International Cancer Immunotherapy Conference

On September 16, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported preclinical data for the company’s proprietary, wholly owned GITRL-Fc agent during the afternoon poster session of the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (Press release, OncoMed, SEP 16, 2015, View Source [SID:1234507482]).

GITRL is a member of the tumor necrosis factor (TNF) family of ligands and functions to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptors) to enhance T-cell modulated immune responses. OncoMed’s GITRL-Fc agent is engineered using a novel single-gene linkerless GITRL trimer which enables effective GITR activation and robust anti-tumor immune response.

"The single-gene linkerless trimer technology we have created provides a flexible platform for the design of additional immuno-oncology agents, including bispecific agents," said Austin Gurney, PhD, Senior Vice President of Molecular and Cellular Biology. "We observed improved activation of GITR and highly potent single-agent activity using our GITRL fusion protein, and also noted that GITRL-Fc shows strong additivity with other immune checkpoint blockers. These data demonstrate a powerful new class of immunotherapeutic agent."

In a series of preclinical studies presented today, OncoMed’s GITRL-Fc agent activated GITR signaling more effectively than an agonist GITR antibody and promoted robust anti-tumor immune responses, including the potentiation of antigen-specific T-cell Th1 type immunity and a reduction of regulatory T-cell (Treg) immune suppressive activity. In multiple murine tumor graft models GITRL-Fc enabled complete eradication of some tumors as a single agent. The combination of GITRL-Fc with anti-PD1 or anti-PDL1 checkpoint inhibitors demonstrated enhanced anti-tumor activity compared to either agent alone.

"We are pleased to have presented research highlighting one of our proprietary immuno-oncology therapeutic agents," said John Lewicki, Chief Scientific Officer of OncoMed. "OncoMed is actively advancing GITRL-Fc with a goal of filing an Investigational New Drug (IND) application in 2016. This program further demonstrates our commitment to the ongoing discovery of innovative and next-generation anti-cancer therapies."

Fumiko Axelrod, Senior Scientist II, of OncoMed presented these data in a poster titled "GITRL-Fc, an immunotherapeutic agent that stimulates T-cell-mediated anti-tumor immune response" (Abstract number A058) during Poster Session A.

First half of 2015: landmark agreement with AstraZeneca and strong financial position

On September 17, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the first half of 2015 (Press release, Innate Pharma, SEP 16, 2015, View Source [SID:1234507481]).

Hervé Brailly, Chief Executive Officer of Innate Pharma, commented: "This first half of 2015 marked a major milestone in Innate Pharma’s corporate development with the signature of a landmark co-development and commercialization agreement in April with AstraZeneca to broaden and accelerate the development of IPH2201.

This agreement is a major step towards our corporate goal of further maturing the Company and developing capabilities in late stage development and potential commercial stage by keeping some co-development and co-promotion rights.

In the second half of 2015, additional Phase II clinical trials for IPH2201 will be opened and IPH4102 will start a multi-centric Phase I trial, becoming our third first-in-class, clinical-stage asset. With our increased financial flexibility, we are intensifying our efforts in R&D to enrich our pipeline of first-in-class proprietary antibodies.

As important new clinical data on lirilumab is generated, Innate Pharma is on track to leverage its unique positioning in the very promising area of immuno-oncology."

Tokai Pharmaceuticals Augments Commercialization Capabilities through Appointment of Lisa Taylor as Senior Vice President, Commercial Development

On September 16, 2015 Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally-driven diseases, reported the appointment of Lisa Taylor as Senior Vice President, Commercial Development (Press release, Tokai Pharmaceuticals, SEP 16, 2015, View Source;p=RssLanding&cat=news&id=2088218 [SID:1234507479]). Ms. Taylor brings over two decades of experience in biopharmaceutical marketing, and was a member of the launch team for Xtandi (enzalutamide) at Medivation, Inc.

At Tokai, Lisa will lead commercial preparedness for the launch of galeterone, a potential first-in-class Androgen Receptor Degrader. Tokai has commenced screening patients for the presence of the AR-V7 splice variant for enrollment in ARMOR3-SV, the company’s pivotal Phase 3 clinical trial of galeterone in men with metastatic castration-resistant prostate cancer (mCRPC) whose tumors express the AR-V7 splice variant. Top-line data from ARMOR3-SV are expected by the end of 2016.

"Lisa is an astute commercial strategist with deep expertise in prostate cancer, and we are thrilled to have her join Tokai’s management team," said Jodie Morrison, President and Chief Executive Officer of Tokai. "As we look ahead to results from our pivotal trial in late 2016 and prepare to commercialize galeterone, Lisa’s expertise and leadership will be critical to our successful delivery of this important therapeutic advance for men living with certain forms of advanced prostate cancer."

Most recently prior to joining Tokai, Ms. Taylor was the Principal and Founder of Packers Falls Group, Inc., a healthcare consulting firm that conducted commercial assessments and provided marketing and strategy consulting to biopharmaceutical companies. She previously served as Vice President, Commercial Development at Medivation, Inc., where she was the company’s first commercially-focused employee and subsequently served on the Xtandi (enzalutamide) launch team. Ms. Taylor began her career in strategy consulting at Booz, Allen and Hamilton and has held a number of strategic planning and marketing roles with in vitro diagnostic and medical device manufacturers. She is also an active patient advocate, serving on the Gynecologic Cancer Steering Committee’s Uterine Task Force at the National Cancer Institute and on the Developmental Therapeutics Committee of the Gynecologic Oncology Group.

"It is an honor to be joining Tokai at such an exciting time in the company’s growth," Ms. Taylor said. "We are developing a commercial strategy that builds from our differentiation as an Androgen Receptor Degrader with the potential to overcome the limitations seen with second-generation hormone therapies currently approved for CRPC. I look forward to applying my expertise in building a world-class commercial organization capable of effectively delivering galeterone to patients."

Idera Pharmaceuticals Presents New Intratumoral IMO-2125 Preclinical Data at CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference

On September 16, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, reported new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2125 alone and in combination with ipilimumab demonstrated potent and systemic anti-tumor activity in preclinical cancer models (Press release, Idera Pharmaceuticals, SEP 16, 2015, View Source;p=RssLanding&cat=news&id=2088264 [SID:1234507478]). IMO-2125 is a synthetic oligonucleotide-based agonist of Toll-like receptor 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Additionally, Idera presented preclinical data which demonstrated that IMO-2125 induces a systemic antitumor immune response with the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors. These data are being presented at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York City, beginning today.

"The body of preclinical data that we have assembled further illustrates the potential of intratumoral IMO-2125 to play an important role in the emerging field of cancer immunotherapy," stated Sudhir Agrawal, D.Phil., President of Research at Idera Pharmaceuticals. "We are looking forward to advancing this approach into clinical development with our first study and exploring additional clinical studies with intratumoral IMO-2125 in other tumor types and with other checkpoint inhibitor combination regimens."

In the presentation, entitled "Intratumoral administration of IMO-2125, a novel TLR9 agonist, modulates the tumor microenvironment and exerts systemic antitumor activity alone and in combination with an anti-CTLA4 monoclonal antibody (mAb)," Idera scientists presented data suggesting that intratumoral IMO-2125 monotherapy led to dose-dependent decreases in treated and distant tumor volume, an increase in infiltrating CD8+ T cells and specific cytotoxic T cell responses against tumor antigens. Combination of intratumoral IMO-2125 and an anti-CTLA4 mAb showed improved inhibition of tumor growth, regression of systemic lung metastases and infiltration of TILs versus monotherapy with either agent. Collectively, these data demonstrate the potent antitumor activity of IMO-2125, a novel immunostimulatory TLR9 agonist, alone and in combination with a checkpoint inhibitor.

Idera expects to initiate the first clinical study of intratumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma in the fourth quarter of this year as part of the previously announced clinical research alliance with MD Anderson Cancer Center.

In the presentation, entitled "Modulation of checkpoint expression in tumor microenvironment by intratumoral administration of a novel TLR9 agonist: Rationale for combination therapy," Idera scientists presented data suggesting that intratumoral IMO-2125 treatment led to antitumor activity in preclinical tumor models of lymphoma, colon carcinoma and melanoma. Specifically, intratumoral IMO-2125 treatment resulted in changes in the tumor microenvironment in both treated and distant tumors, as demonstrated by modulation of immune checkpoint gene expression. These data showed that intratumoral IMO-2125 has the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors.

These presentations are both currently available on Idera’s website at View Source

Additionally, Idera announced that pre-clinical data relating to the combination of intratumoral IMO-2125 and an anti-PD-1 mAb in a murine colon carcinoma model will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston from November 5-9th.

About Toll-like Receptors and Idera’s Immuno-Oncology Research Program

Toll-like receptors (TLRs) are believed to play a central role in the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intratumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs); and potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.

Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company’s proprietary chemistry-based discovery platform. IMO-2125 has been shown to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data from these studies to be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in November in Boston.