iCo Therapeutics Inc: Conference & Catalyst

Summary

• Phase 2 trial for the treatment of diabetic macular edema (DME).
• ICo-007 Potential advantages, insight from a M.D. PhD, Medicine, Immunology.
• Conference Preview (OTCQX:ICOTF).
• IDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation.

iCo Therapeutics (OTCQX:ICOTF), is a company focused on the identification, development, and commercialization of drug candidates to treat diseases of sight and life threatening diseases. iCo currently has multiple products undergoing clinical testing in the pipeline. The Company's lead program (iDeal Study) is a phase 2 trial for the drug iCo-007, the drug aims to treat diabetic macular edema or (DME) for short. The iDeal trial has been conducted across multiple sites throughout the US. Data on the primary end point is set be unveiled in the coming weeks.

Facts About Diabetic Macular Edema

All patients with diabetes are at risk of developing DME. The onset is usually insidious and painless, and manifest with blurring of central visual acuity. The Severity of DME varies between mild to profound loss of vision.

* DME among US diabetics approaches 30% in adults who have had diabetes for 20 or more year.

* It can occur at any stage in a person diagnosed with diabetes

* Untreated 20% to 30% of patients with DME will experience a doubling of the visual angle within 3 years.

* 500,000 new case of DME occur every year worldwide.

iCo Therapeutics Drug iCo-007: Potential Solution and Advantage

For commentary on the topic I have turned to Dr. Philip Scumpia M.D. PhD, Medicine, Immunology, for his thoughts on the science behind iCo-007. Dr. Scumpia is my go to source when it comes to biotech and medicine related topics. Dr. Scumpia is non affiliated with iCo therapeutics trials or company.

(The following has been taking in direct correspondence with Dr. Philip Scumpia.)

Therapies for DME are limited. Laser photocoagulation remains the mainstay of treatment, but is not without its risks. Steroid implants have recently been approved, and can help prevent new blood vessel growth (neovascularization), but a major limitation of this approach is the development of cataracts and increased intraocular pressure. Use of VEGF inhibitors including Avastin, Lucentis, and Eylia has shown similar efficacy to laser photocoagulation, but requires monthly to every other month intraocular injections, which can be burdensome to patients. iCO Therapeutics is using antisense technology originally developed by Isis Pharmaceuticals, to target the c-Raf kinase, which is the signaling molecule used by VEGF and other growth factors. Blocking c-Raf may provide similar effects to the VEGF inhibitors. Importantly, iCO Therapeutics is hoping to accomplish similar effects with only two intraocular injections for an 8 month- 12 month period, which is considerably better for patients. Local, intraocular injections of antisense RNA has already been proven to be effective by Isis, as they had an approved therapy for CMV retinitis, Fomiversin, in the late 1990s. It never took off, because improvement in HIV therapies and HAART therapy has considerably decreased the incidence of CMV retinitis.

These factors make ICO-007 an intriguing option for DME.

Conclusion

DME treatment options are limited and only 1 drug has been approved for therapeutic treatment of DME. The potential for iCo Therapeutics to break into this market demonstrates the upside obtainable through successful clinical results and possible future product development. I would never attempt to predict clinical results and urge caution when considering investments in the biotech sector. This article is intended to be informative, and to raise much deserving awareness in my opinion of iCo Therapeutics potential future roll in the treatment of DME. Please do your own due diligence and manage your risk accordingly. All early stage biotech companies financial position should be taken into consideration. iCo Therapeutics as balance sheet data reported September 30th, 2013 reads as follows.

Financials

Invested Capital to Date (as of Jan 31, 2014) $33.25 million

Cash & Equivalents (as of Q3 2013) $2.1 million

Raised $6.75M on January 27, 2014

Cash Runway (as of Jan 31, 2014) Q4 2015

Share Capital (as of Jan 31, 2014) 84 M (SO) 115 M (FD)

For a more detailed look at iCo's financial statements see link.

Conference Update

iCo therapeutics will be presenting Phase 2 trial data at the ARVO 2014 annual meeting. See link for conference description.

Through the ARVO conference website abstract search page, I was able to gather this information to be presented May 5th, 2014.

Presentation time- 11 AM- 12:45 PM

TITLE: Demographics and Baseline Characteristics of the iDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema with Involvement of the FoveAL Center

Inovio (INO) new abstract tuesday march 25th

Click link here to INO abstract Co-administration of Molecular adjuvants

Inovio (INO) New Interview with Dr. Kim about Inovio's research and treatment for cancer.

Money Matters 14-11

Hosts:   David Ebner of Merrill Lynch & Charlie Shields of Wells Fargo Advisors, LLC

Guests:   J. Joseph Kim, Ph. D., CEO, of Inovio Pharmaceuticals

Description:   Dave & Charlie talk about investing and then interview Dr. Kim about Inovio's research and treatment for cancer.

Click link here to watch now-Watch Interview

INOVIO (INO) CANCER ANTIBODIES CONFERENCE

CANCER ANTIBODIES VACCINES/ADJUVANTS & DELIVERY
17-19 September 2014, Switzerland (INOVIO will co-sponsor this conference)

"This CAVAD 2014 conference brings together 
experts in both fields of mabs and vaccines to address these important issues.
CAVAD 2014 will offer a new international forum to review the current state of research and development of monoclonal antibodies and vaccines for cancer therapy". 

SCIENTIFIC ADVISORY PANEL
Conference Co-Chairs: 
Niranjan Sardesai (Inovio Inc., Blue Bell, Pennsylvania, USA) 
(other co-chairs listed on conference site)

CAVAD 2014 will include keynote presentations from leading researchers, submitted oral and poster presentations, and special discussion/panel sessions

CONFERENCE SESSIONS
1-Abstracts for both oral and poster presentation are called for in the principal topics to be covered at CAVAD 2014 which include:

2-Autoimmunity and cancer
Both mabs and vaccines are trying to harness the immune system to recognise and 
attack self/modified antigens on cancer cells. As autoimmunity does this very effectively, 
inducing both T cell and antibody responses, there are good lessons to learn for cancer 
immunotherapy.

3-Novel targets
As vaccines target intracellular antigens, presented as peptides on MHC molecules, and 
Mabs target cell surface proteins there is obvious synergy in combining these approaches. 
Indeed both cellular and humoral immunity are used in the successful attack on pathogens.

4-Adjuvants
There are still very few approved adjuvants for vaccines that stimulate cellular immunity, 
however new TLR agonists are being developed and the recent approval of a mab targeting 
CTLA-4 and trials with anti-PD.1 mabs suggest novel approaches/combinations.

5-Cytotoxicity
High avidity CD8 T cells, cytotoxic CD4s and direct killing/growth inhibiting mabs have all 
been shown to mediate potent anti-tumour responses. 

Source-Conference Website

OncoSec (ONCS)June 26-27th, 2014 4th European Post Chicago Melanoma/ Skin Cancer Meeting

Results and Interpretations of ASCO presentations 2014 
(Global confernce on news in melanoma/skin cancer) 

Friday, June 27th 2014

Session- New drugs and trials: An update on immunotherapy and chemotherapy 

9:36- Electroporation (Adil I. Daud)

In addition Punit Dhillion will be in attendance.

Gold sponsors for conference 

Merck, Bristol Myers, GSK, Roche

Further Sponsors

Amgen, Celgene, Delcath, Medac, OncoSec 

Conference Description 

The interactive congress offers a comprehensive overview on all new developments in skin cancer and in particular melanoma therapy and a direct communication with the world´s leading experts in these fields. After being held as a joint meeting with the 8th World Congress on Melanoma and the 10th EADO annual conference 2013 in Hamburg, the congress will return to its origins in Munich in June 2014.
Presently there is an exciting time for the development of new drugs for skin cancer / melanoma treatments. New immunotherapies, selective kinase inhibitors, new vaccines, and other innovative strategies for the intratumoral and systemic use are under development and are approaching the market for melanoma rapidly. Some have already been approved in the recent years. Non-melanoma skin cancer has become an exciting arena for clinical research as well. Several new drugs as hedgehog inhibitors for basal cell carcinomas are currently used in the routine and in innovative trials.
However, it will be the main target for all of us to choose the right patients for the right drugs! The aim of the Interdisciplinary Global Conference on Developing New Treatments for Melanoma / Skin Cancer in Munich is to grant a deep overall insight into the development of new drugs for melanoma and other cutaneous malignancies. The lively interaction of clinicians, as well as experts in translational and basic research, and representatives of the pharmaceutical industry, guarantees a successful outcome for every participant.
International key opinion leaders on melanoma, non-melanoma skin cancer and cutaneous lymphomas will be invited to give an overview throughout specified presentations, to present latest clinical trial results, and to discuss on exciting new drugs with the audience. In addition to the scientific value of this meeting, every participant may seize the given opportunity to interact with experts in a familiar setting in one of the most interesting cities of Germany.   Link-http://www.melanomaglobal2014.org/

Inovio (INO) March 2014 Protective immunity to H7N9 influenza viruses elicited by synthetic DNA vaccine

Protective immunity to H7N9 influenza viruses elicited by synthetic DNA vaccine [Epub ahead of print]

• Jian Yan^a, 
• Daniel O. Villarreal^b, 
• Trina Racine^c, 
• Jaemi S. Chu^b, 
• Jewell N. Walters^b, 
• Matthew P. Morrow^a,
• Amir S. Khan^a, 
• Niranjan Y. Sardesai^a, 
• J. Joseph Kim^a, 
• Gary P. Kobinger^c, 
• David B. Weinerb
• 
  

• 1Inovio Pharmaceuticals, Inc., 1787 Sentry Parkway West, Building 18, Suite 400, Blue Bell, PA 19422, USA.
• 2Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
• 3Special Pathogens Program, National Microbiology Laboratory, Winnipeg, Manitoba R2E 3R2, Canada.
• 4Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: dbweiner@mail.med.upenn.edu.

Abstract

Despite an intensive vaccine program influenza infections remain a major health problem, due to the viruses’ ability to change its envelope glycoprotein hemagglutinin (HA), through shift and drift, permitting influenza to escape protection induced by current vaccines or natural immunity. Recently a new variant, H7N9, has emerged in China causing global concern. First, there have been more than 130 laboratory-confirmed human infections resulting in an alarmingly high death rate (32.3%). Second, genetic changes found in H7N9 appear to be associated with enabling avian influenza viruses to spread more effectively in mammals, thus transmitting infections on a larger scale. Currently, no vaccines or drugs are effectively able to target H7N9. Here, we report the rapid development of a synthetic consensus DNA vaccine (pH7HA) to elicit potent protective immunity against the H7N9 viruses. We show that pH7HA induces broad antibody responses that bind to divergent HAs from multiple new members of the H7N9 family. These antibody responses result in high-titer HAI against H7N9. Simultaneously, this vaccine induces potent polyfunctional effector CD4 and CD8T cell memory responses. Animals vaccinated with pH7HA are completely protected from H7N9 virus infection and any morbidity associated with lethal challenge. This study establishes that this synthetic consensus DNA vaccine represents a new tool for targeting emerging infection, and more importantly, its design, testing and development into seed stock for vaccine production in a few days in the pandemic setting has significant implications for the rapid deployment of vaccines protecting against emerging infectious diseases.

Copyright © 2014 Published by Elsevier Ltd.

Note to users: Uncorrected proofs are Articles in Press that have been copy edited and formatted, but have not been finalized yet. They still need to be proof-read and corrected by the author(s) and the text could still change before final publication.

Although uncorrected proofs do not have all bibliographic details available yet, they can already be cited using the year of online publication and the DOI, as follows: author(s), article title, journal (year), DOI. Please consult the journal's reference style for the exact appearance of these elements, abbreviation of journal names and use of punctuation.

When the final article is assigned to an issue of the journal, the Article in Press version will be removed and the final version will appear in the associated published issue of the journal. The date the article was first made available online will be carried over.

Click link for data source-Link

OncoSec Medical (ONCS) May 21-24, 2014 ASGCT 17th Annual Meeting

Scientific Symposium 213

Thursday May 22, 2014

Richard Heller, PHD

Non-Viral Gene Transfer of pIL-12 for the Treatment of Melanoma: Results from Phase 1 and 2 Trials

Electrotransfer of plasmids encoding cytokines directly to tumors has been shown to generate a local and systemic anti-tumor effect in both preclinical and clinical studies. In the clinical studies, patients with in-transit cutaneous melanoma recevied at least one treatment cycle (days 1,5,8) of intratumor pIL-12 delivered by electrotransfer in up to four lesions per cycle. In both Phase 1 and 2 trials increases in IL-12 levels and enhanced immune activity were observed and the therapy was well tolerated. Intratumor treatment with pIL-12 electrotransfer exhibited a systemic antitumor immune response with activity in both treated and non-treated sites of disease and objective response to treatment. These postive results provide the rationale for an expanded study.    

To visit the conference website follow the link ASGCT