Article | December 12, 2013

A Q&A With Novadigm

Source: Life Science Leader
wayne koberstein

By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein

This is extra content from the blog "3 Companies To Watch - Part 3."

Excerpts from an interview with M. Timothy Cooke, Ph.D., CEO of Novadigm Therapeutics

COOKE: Our mission is to bring this antigen forward, out of the academic setting into clinical trials. So last year we had our first Phase 1 trial, in 40 subjects. It was safe and well-tolerated. We also had very rapid and broad immune responses after a single dose, because almost everyone has been exposed to Candida or Staph aureus at some point in their life. When we expose people to the antigen, they get a booster response; even though it’s the first dose, because of the previous exposure, they get a strong immune memory response. Within seven days, we see huge increases in antibodies. At day 14, we had a 100% seroconversion, which means 100% of the people got four-fold or higher increase in their antibody levels. You don’t see that with a typical single-dose vaccine if you’re just priming the person for the first time. That’s actually really important because one of the ways that the vaccine against staph and Candida could be used is in the hospital setting where patients are at near-term risk of serious infections.

WHAT KIND OF PARTNERSHIP ARE YOU LOOKING FOR?
The vaccine world’s pretty small. It’s Big Pharma, right? Although it’s increasing. When I started in the vaccine industry 20 years ago, it was basically The Big Four — GSK, Pfizer, which was Wyeth at the time, Sanofi, and Merck. Now Novartis is in, AstraZeneca bought MedImmune. J&J bought Crucell, so now it’s the Big Seven, which is great for companies like us. Those are the likely suspects for partnering for us or any other vaccine company. And Staph aureus is really a consensus target for Big Pharma vaccine companies.

IS IT A CHALLENGE TO INTRODUCE TO THEM THE UNIQUE CONCEPT OF YOUR VACCINE — TARGETING TWO MICROBES WITH A SINGLE ANTIGEN?
Yes, it can be a challenge. If people can’t get their head around the basic concept, they don’t hear anything else we have to say. That is true on both the VC and the pharma sides. It is the first of a kind, so people are intrigued. People in the field are now probably wondering what other antigens out there might be cross-protective. Another difficult concept for people is that the vaccine is a potential anti-adherence vaccine. It’s a vaccine not against a single pathogen, but against a function of pathogens – adherence to host cells, a key step in the pathogenesis of infection. Both pathogens have wide-spread community infections as well. For staph, it’s skin and soft tissue infections which are very widespread. Candida is the biggest cause of vaginal yeast infections in women, including recurrent vulvovaginal candidiasis, RVVC, which impacts about 5 million American women. We think that’s a great target for a vaccine. There is a potential of about $600 - 700 million potential in the U.S. alone for the vaccine, aside from hospital-associated infections. We will be doing a Phase 2 efficacy study next year in the RVVC population.

HOW DID YOU ARRIVE AT THE DECISION TO LOCATE IN NORTH DAKOTA?
The company was founded at UCLA but Los Angeles isn’t the greatest place for lab space, and North Dakota had built a new lab set on the UND campus in Grand Forks. So the company decided to start its lab there. Now we have a beautiful lab, and that’s where we have our company operations. And then we have myself, the CEO, in the Boston area; my head of R&D, John Hennessey, who worked for 20 years at Merck in vaccine development, is in Philadelphia. Our head of Corporate Development Tuomas Holmberg lives in the San Francisco area. It means there’s a fair amount of travel for us, but it works extremely well — this semi-virtual model.

ARE THERE STILL OPERATIONAL CHALLENGES?
Virtual models are much more challenging in the biologics field than on the small molecule side, where you can in-license a compound, put a small team together, and it’s much easier to find parties that can manufacture reliably. We are doing recombinant yeast fermentation and purification, so it is much harder to find and manage the skilled people we need for that. But our head of R&D is a CMC (chemistry manufacturing control) expert with 20 years in vaccines. He is like a conductor of this orchestra of people outside the company. We have a network of different service providers that become pretty close partners because we depend on them so much for various activities. We’ve also benefited greatly from a lot of exodus of people from big pharma, many who are just newly retired but have deep expertise in vaccines and so we hire them on an as-needed basis, which is extremely cash-efficient.

DO YOU HAVE PLANS OR A PIPELINE BEYOND THE VACCINE?
The NDV3 (Als3 antigen) program is our main asset. We do have another antigen from Candida that’s at an earlier stage from our founders at UCLA called Hyr1.  But, to a large extent, we’re a single-asset company because we would envision bundling the two antigens together. Any partner that wanted into buy the vaccine would want the other antigen to put in the kitty ultimately. We intend to bring this product from the academic stage through to proof of concept in humans, and then to sell the asset. It is very hard to take a vaccine from Phase 2 to Phase 3, because of the cost of capital required and time to build your own manufacturing source, even if the clinical studies themselves aren’t that expensive. When we do that, we don’t know. We have a good amount of money now to take us through the Phase 2 efficacy study in RVVC. We’re looking to raise a Series B, and we’re talking to corporate partners all in parallel to see what would be more attractive for our shareholders.

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