IMMUNE Pharmaceuticals is an Israeli and US based emerging leader in the development of antibody therapeutics in cancer and inflammation. IMMUNE has multiple drug candidates based on proprietary cytotoxic formulations, linkers and monoclonal antibodies. A recent presenter at OneMedForum NY 2012, the company is gaining market attention as it progresses in clinical trials for it’s Bertilimumab platform in inflammatory diseases (entering Phase III in ulcerative colitis, Chron’s disease, and severe asthma) and opthalmology (entering Phase III in VKC and AKC). In addition, IMMUNE is entering Phase I with NanomAbs, an Antibody Drug Conjugate exploring indications in cancer.
Recently, CEO Dr. Daniel Teper announced the company is looking to raise $20-$30MM in a series C financing between Q42012 and Q12012. IMMUNE is exploring strategies to list on a major US exchange, and the company is gauging an initial public offering or private funding to further planned clinical trials next year.
OneMedRadio spoke with Dr. Teper about IMMUNE’s unique technology platform, and the market opportunity of monoclonal antibodies in these indications. View the audio and transcript below.
Matthew Margolis: Greetings from OneMedRadio, I’m Matt Margolis. Today, I’m with Dr. Daniel Teper, founder and CEO of Immune Pharmaceuticals, an Israeli-based clinical stage private biotech developing monoclonal antibodies for the treatment of inflammatory diseases and cancer. Thank you for joining us, Dr. Teper.
Dr. Daniel Teper: Good to be with you today.
Matthew Margolis: Excellent. So today, we’re talking about the development of first in class monoclonal antibodies, but first I think we should learn a little bit more about this company. So, Dr. Teper, what is Immune Pharmaceuticals and what makes you unique?
Dr. Daniel Teper: We’re a very young company. We’re founded two years ago and in the past two years, we have assembled a significant portfolio of antibodies in clinical and preclinical stage of development and a very seasoned management team on board to guide us.
MM: Let’s talk a little bit about your lead program entering phase 2 for the treatment of ulcerative colitis, Crohn’s disease, and severe asthma as well as for indications in ophthalmology. So firstly, can you talk about how this technology works?
DT: Sure. You know, we’re privileged to have a potential blockbuster first in class drug. It’s antibody that was developed by Cambridge Antibody Technology, which is now part of AstraZeneca MedImmune. It targets eotaxin-1 which is a regulator of inflammation and it has several publications in major scientific journals such as Nature and the International Academy of Science. It’s been developed all the way to phase 1 by CAT. So we’ve now prioritized indications in particularly ulcerative colitis and to start clinical trials, phase 2 clinical trials after this summer.
MM: Let’s go into some detail about the technology, you know, what is the mechanism of action here?
DT: The eotaxin-1 is involved in the regulations of eosinophils, which increase when you have inflammation in specific tissues and particularly in gastrointestinal tissues as well as in the lungs so to combat Crohn’s disease and ulcerative colitis. It has been demonstrated that the more inflammation you have, the more eotaxin-1 you have and our drug Bertilimumab targets specifically eotaxin-1 and by reducing eotaxin-1 we’re expecting to reduce significantly the inflammation and improve the symptoms of those patients.
MM: So let’s take a step back for a second. What is the market opportunity for monoclonal antibodies in these indications?
DT: It’s quite significant. Remicade from Johnson & Johnson and Humira from Abbott are both monoclonal antibodies and are the market leaders. They’re multibillion-dollar drugs. They have limitations in terms of patients that respond to those drugs and unexpected side effects. So there’s a significant unmet need for new therapies and we expect that Bertilimumab will be one of those alternatives for physicians treating ulcerative colitis and Crohn’s disease.
MM: And I understand that the field of monoclonal antibodies are a particularly hot spot for investors right now. So can you talk a little bit about this?
DT: It basically came 15 years ago from a non-existing commercial market to today it’s over $15B in sales. Four of the top 10 pharmaceuticals are monoclonal antibodies. The success rate in developing is significantly higher than small molecules so as a result the partnering deals between monoclonal antibodies and big pharma are quite rich even at preclinical or early clinical stage and the valuations of the companies in the market are quite significant. I will cite a company like Merrimack, which did an IPO in March this year. It was a lead monoclonal antibody in phase 2 and did an IPO at $600M and now has a valuation, I believe the latest valuation was $670M. That’s one example among several very promising new companies.
MM: Dr. Teper and I discussed before the interview that among the top ten drugs sold worldwide, four are monoclonal antibodies. So Dr. Teper, in regards to your clinical development, how are you planning to position yourself in this market and in terms of dollars what does your market penetration look like?
DT: What’s very interesting is that eotaxin-1 it’s a chemokine substance that can be dosed both in the blood and in the tissue of patients. So it allows us to take a personalized medicine approach to the treatment of ulcerative colitis and Crohn’s disease and select patients that have a high eotaxin level and therefore have a much more significant response rate. What we expect is that Bertilimumab once it’s in the market will be used not only in patients not responding to anti-TNF but potentially in patients that do not respond well enough to steroids and [treatments related to] anti-TNF. So the market penetration could support a multibillion-dollar drug just in the ulcerative colitis and Crohn’s disease indication.
MM: So let’s circle back now to your clinical development and what data can you report from your clinical trials?
DT: The phase 2 clinical study that’s starting after the summer is a proof of concept study and aims to demonstrate that by selecting those patients with moderate to severe ulcerative colitis and high level of eotaxin-1, you can actually reduce the inflammation and reduce the disease index, which is called the major clinic ulcerative colitis index significantly. That would lead to phase 2b and phase 3 trials towards approval.
MM: And can you talk a little bit more about your R&D and other areas that you’re exploring with other platforms?
DT: Yes. You know, beyond Bertilimumab, we have a significant pipeline, which is primarily oncology. Our focus is on the next generation of antibody drug conjugates. You probably would be familiar with companies like Seattle Genetics and ImmunoGen who have demonstrated with their drugs significant clinical results beyond those of traditional antibodies or traditional chemotherapeutics.
We’ve licensed from the Hebrew University in Jerusalem a new technology, a next generation ADC technology, which basically conjugates antibodies with drug-loaded nanoparticles. That’s a two-level targeting. The nanoparticle allow us to target the tumor tissue and then the antibody works like a key to the cell and allows the internalization of the drug-loaded nanoparticle which then biodegrades into the cell. So it’s basically guided missiles going directly into the cancer cells and destroying the cancer cell and delivering safely a micro dose of cytotoxic to the cancer cells. There are two other companies developing similar technologies, second-generation technology. One of them is Merrimack, which I mentioned earlier and the other one is BIND Bioscience, which is a private company with technology from MIT Professor Langer.
MM: Great. I want to shift gears a little bit now to your financing efforts. On July 10, 2012, it was announced that Immune Pharma would seek to raise $20M to $30M in series C financing. So can you go into some detail about this and some strategies for the future?
DT: Yes. You know, we have been supported by private investor and we’ve been very capital efficient now. But we’ve reached a stage where to realize the full potential of our pipeline goes to multiple indications from Bertilimumab and then NanomAb, you know, pipeline in oncology, we feel that we need to raise significantly more capital. We feel that most likely we’ll do it in public markets and we’re in advanced discussion with a major New York investment bank to discuss options to get into a major market here in New York.
MM: So lastly, do you have partnering strategies and what can we expect from Immune Pharma in the second half of 2012?
DT: Immune recently announced that Suzy Jones who was at Genentech for over 20 years and the last 10 years in senior business development positions has joined us as chief business officer. She’s leading our partnering efforts and we expect to have at least one partnering deal on the NanomAb before the end of the year.
MM: That was a company snapshot with Daniel Teper founder and CEO of Immune Pharmaceuticals. With OneMedRadio, this is Matt Margolis signing off.