EnVivo Pharma: “It is going to be a big year for us”
Kees Been, CEO, EnVivo
Kees Been is building a company; he arrives in Milan for BIO-Europe Spring® looking for partners who can help bring the lead central nervous system (CNS) products for EnVivo Pharmaceuticals to market.
“This year at EnVivo we are reading out on the Phase IIb results for EVP-6124, our lead product, an Alpha 7 agonist for schizophrenia, in April and then the Phase IIb results for Alzheimer’s disease by year end,” said Been, EnVivo’s chief executive.
“We are taking our gamma secretase modulator into the clinic in several months, our PDE-10 inhibitor into the clinic at the end of the year, and we plan to start a Phase II trial with our HDAC inhibitor while also exploring opportunities to exploit the whole platform,” he continued.
“We have the financing to reach these stages of development with each of our candidates, and we are unique as a company for having such a long term vision with an intent to building a broad CNS pipeline and the goal of becoming a commercial stage company,” said Been.
“It is going to be a big year for us, but we need help,” he said. “We are small as a company and we need partners to realize our ambitions.”
In an interview with partneringNEWS, CEO Been outlined his approach to seeking potential partners for different products and his strategy for dealmaking in different geographies.
“EnVivo aims to be a leader in CNS diseases by building a pipeline that attacks schizophrenia and Alzheimer’s from several angles, addressing the underlying disease with different mechanisms of action.
“These are multifactorial diseases, such that no one is going to solve Alzheimer’s, for example, with a single drug. Even if we found a drug that is truly disease modifying, capable of stopping or slowing the progression of the disease, we believe there will remain strong medical needs for therapeutics we are developing that improve the patient’s cognition.
“EnVivo is building a large footprint in CNS to address these opportunities, and to an extent we are also hedging our bets,” he said.
“We are fortunate in having a committed investor in Fidelity Biosciences, which has been with us since the beginning in 2002, and which enables us to build this broad pipeline.”
“So I will not be in Milan looking for financing,” he said. “We are going there looking for partners and to meet with companies we have already been in touch with. It is safe to say they will want to see the upcoming EVP-6124 Phase IIb trial data, and with the Phase IIb results of this Alpha 7 agonist imminent, a lot of people are becoming interested.”
“The key message is that we are building a company. For our lead compound, EVP 6124, we intend to establish a commercial presence in certain key markets.”
“It is safe to say that our biggest interest is the United States, which is, and will remain, the largest and most attractive pharmaceutical market for CNS. Yet to maximize our value in the USA, we need help with the later stages of clinical development, the launch, the regulatory dealings, and with sales and marketing. This means we are willing to share risk and benefit with a partner,” he said.
“It is heavy lifting, and big pharma is good at that.
“There are certain other markets we have targeted for commercialization where we want to collaborate, but other markets’ geographies are out of our reach right now, such as in Asia or Eastern Europe. In these areas we are looking at a straight licensing deal.
“Being prepared to take a risk with a major partner means that we want to participate in a Phase III trial that is global in scope. We only would want to run this once and then have data that can be applied for regulatory approvals around the world.”
“We are ready to collaborate and fund some of those Phase III studies which will affect the licenses we intend to negotiate in the rest of the world. The more EnVivo participates in the Phase III trials, the higher the price of the license for other countries, of course, especially as we expect other partners will be able to use the Phase III results to file and sell in their specific licensed geography.
“China remains a special case for discussion. Everyone is predicting the dementia market in China will be one of the biggest markets in the world five years from now. But no one is going to partner a deal today based on what it may be in five years. So we are going slow on China until the opportunity becomes clearer.”
According to CEO Been, EnVivo has purposefully pushed its lead product, the EVP 6124 Alpha 7 agonist, very far into Phase IIb studies, “because we have the resources to do so. Proving cognitive effects is not as complicated and expensive as proving disease modification.”
Different products require different partners.
EnVivo is pursuing a similar partnering strategy for EVP-0638, a PDE-10 inhibitor that will enter a Phase I clinical trial by the end of this year.
“It potentially affects the positive symptoms of schizophrenia, the hallucinations and the delusions, but with a totally different mechanism from the current therapies using antipsychotics. “Here again we are able to take the candidate through to advanced clinical development ourselves, because developing an antipsychotic is a well trodden path and does not require long and expensive clinical trials. Although the mechanism is entirely novel, we do not need to be innovative, we only need to apply the kind of clinical design that is familiar.
“We expect to be very far along before we contemplate a partnering agreement, yet we are always willing to talk, of course.”
EnVivo is also developing a disease modifying compound and an HDAC platform that present a different challenge for partnering.
“Our gamma secretase modulator EVP 0962 is scheduled to go into the clinic in the next few months. Full development of this drug will require that we seek a partner earlier as it is a disease modifying agent. Development of these drugs is more expensive, time consuming and much more complicated.
“It is a different challenge that quickly becomes expensive with early requirements for extensive biomarker work, with studies that are longer and therefore more complicated, and ultimately requiring pivotal clinical studies over many years enrolling over 2,000 patients.
“We also have a broad HDAC inhibitor platform from which we have developed a lead compound, EVP-0334, that has completed a Phase I trial with good tolerability and safety in humans. We are currently trying to find a home for it, conducting experiments to determine what would be the best indication to test in a full Phase II trial. It is highly likely that this will be an orphan disease indication.
“From a partnering perspective, the opportunity is for a dual approach where we jointly develop EVP-0334 in several orphan indications, and meanwhile also seek opportunities to further exploit the HDAC platform, generating new compounds, making selective inhibitors, and then putting them into the clinic.”
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