July 9, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Paris-based immunotherapy biotech Neovacs has seen a rollercoaster ride over the last year. In December, the company was hammered by critics and bears alike when it announced its experimental therapeutic vaccine for rheumatoid arthritis had flunked a Phase IIb study—but the company began seeing more upside this spring as it shifted its focus towards a promising treatment for Lupus.
So what’s next for the firm, as biotech’s bull run continues? BioSpace sat down with Miguel Sieler, chief executive officer of Neovacs, as part of our continuing coverage of BIO2015, to talk about what the company has on the horizon—and how it expects to rare back into the crowded immunotherapy space in 2015.
Can you talk a little bit about your Lupus compound and how it is unique?
Our lead product candidate, IFNa-Kinoid (interferon alpha Kinoid), originates from Neovacs’ breakthrough proprietary immunotherapy platform, which couples inactivated target cytokines with an immunogenic carrier protein to elicit the production of polyclonal antibodies against pathogenic, over-expressed, cytokines e.g. IFNa in the case of lupus as well as dermatomyositis, an orphan skin and muscular condition. It is an active immunotherapy which acts as a vaccine.
The production of a self, polyclonal response from the patients’ immune system holds significant advantages over the monoclonal antibodies currently on the market and/or in the clinic for the treatment of lupus: it is safe, highly-efficient, long-lasting and can be produced at significantly lower costs compared to monoclonal antibodies. The treatment administration of IFNa-Kinoid also represents an improvement over monoclonal antibodies, with 5 intramuscular injections over a year instead of monthly intravenous injections for years.
What are your partnership objectives in 2015?
Neovacs is currently seeking regional partners to advance the development of IFNa-Kinoid –notably in Asia and the U.S.. We are engaged in advanced discussion with potential partners, which could result in licensing agreements in the coming months.
What’s your timeline for clinical trials?
We are very excited to be starting our phase IIb trial of IFNa-Kinoid in lupus this summer in Europe, Latin-America and Asia. Results for this study are expected H1-2017. Thanks to the €7.5 million raised in June with U.S. investors, we will initiate two additional clinical trials with IFNa-Kinoid in the short-to-mid-term: a phase I/IIa trial of IFNa-Kinoid in lupus in the U.S. and a phase I/IIa trial for IFNa-Kinoid in dermatomyositis in Europe. Both of these trials are expected to initiate in early 2016.
What sort of regulatory approvals are you seeking and when?
Although it is a rare disease, lupus is not considered an orphan disease, except in South Korea; therefore a full phase III registration program is required. In South Korea, depending on the results of our upcoming Phase IIb trial, we could obtain market approval within the next few years. Regarding dermatomyositis, which is an orphan disease, we will request an orphan drug designation for IFNa-Kinoid in Europe and in the U.S. and take advantage of fast-track development plans to obtain an accelerated approval in this indication.
Will you be expanding staff at all?
We are currently fully staffed, working with highly qualified and motivated professionals to advance our clinical programs. But as IFNa-Kinoid progresses in the clinic, notably in the U.S., we will start thinking about adding new members to our team to support our US development.
What’s the size of the market (both patient population and dollar amount) you’re hoping to target?It is estimated today that a minimum of 450,000 patients are diagnosed and treated for lupus in the seven major global markets, but the prevalence is likely much higher. According to the Lupus Foundation of America, there are about 1.5 million people suffering from the disease in the U.S. alone. The disease has also a high prevalence in emerging markets, including China and Latin America. Lupus affects mostly young women.
The current standard of care for lupus consists of treating flares, mainly with corticosteroids and immune-suppressants. One biological treatment, Benlysta, has been approved by the FDA and EMA over the last 50 years, but is marginally effective leaving an unmet medical need. For these reasons, market estimates for this disease are still evolving – but according to our estimates the market could reach $5 million by 2020.
As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.
The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.
The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.
But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.
That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?
