Data has been so good for Oncology Venture's main asset that the Danish biotech company now aims for a meeting the US Food and Drug Administration (FDA) to get permission to initiate phase II studies on the other side of the Atlantic.
The company recently submitted a meeting request to FDA and if everything goes well, the goal will be realized in November or the beginning of December.
"Taking our studies to the US is an important next step. We already received great interest from US practitioners, who want to participate, os obviously, a potential appointment with FDA is a big deal for us," says Peter Buhl Jensen, CEO in Oncology Venture.
The candidate in question is Liplacis that recently showed good data in the ongoing phase II clinical trials in Denmark. Here, Oncology Venture is testing the efficiency and tolerability of the drug in patients with metastatic breast cancer.
However, the Danish company has further ambitions for the candidate and now aims to initiate the trial in the US, the world's absolutely largest market for cancer drugs like Liplacis.
We want to be in sync with FDA, so our studies are designed in a way that can be easily approved
A meeting with FDA is to open the doors.
"We want to be in sync with FDA, so our studies are designed in a way that can be easily approved so we can get started. At this meeting, we have the opportunity to ask clarifying questions," explains Buhl.
According to the CEO, this type of meetings with FDA usually last for an hour and typically, 10 FDA representatives will be present, including the director of the oncology division and the deputy, a team leader and an oncologist, who will be responsible for the clinical part of the company's application.
"Moreover, there will be representatives from all concerned specialties like manufacturing, toxicology and clinical and pre-clinical pharmacology. we also asked for a representative from the Device group on account of DRP."
DRP - that is, the Drug Response Predictor technology - is the company's diagnostic test comparing genomic information from tumor cells with data on existing drugs' mechanism of action.
Effect in 8 out of 9 patients
In the third quarter of last year, Oncology Venture dosed the first 12 patients in the Danish phase II trial. Since then, 10 more patients have been tested using the DRP technology that, according to the company, can select the patients likely to respond to a certain drug.
Oncology Ventures has followed 18 of the 22 participants long enough to assess the effect of the treatment.
"Eight out of nine patients, the DRP technology found likely to benefit from treatment with Liplacis, experienced a clinical improvement. Six in eight patients experienced an improved response rate or longer durability of the Liplacis treatment compared to previous therapies the patients received," explains Buhl.
These results made him contact FDA, and he is confident that the US authority will welcome Liplacis.
"We already had a very constructive meeting with the Danish drug authorities regarding Liplacis, and we also expect that with FDA," says the CEO.
Been there, done that
Oncology Venture has already been through this part of the process with another candidate, the PARP inhibitor 2X-121 Oncology Venture licensed from Japanese Eisai.
"We have been through the process before with 2X-121 and its DRP, when FDA gave us permission to use it (the DRP technology, ed.) in a phase II trial with 2X-121 against ovary cancer," says Buhl.
Back then, FDA granted Oncology Venture an Investigational Device Exemption (IDE) that a company must obtain to use medical devices not yet approved by the FDA in the US, as is the case for the DRP technology.
FDA meetings are always strictly choreographed - and we are well prepared
Since then, FDA also gave Oncology Venture green light for initiating phase II studies with 2X-121 for treatment of ovary cancer.
Buhl hopes for the same outcome for Liplacis, and he feels ready for the meeting with FDA.
"Already when you request a meeting, you have prepared a comprehensive briefing book. FDA meetings are always strictly choreographed - and we are well prepared," he says.
If the FDA meeting goes well, Oncology Venture plans to file an application, similar to the one of 2X-121, for permission to use the DRP technology on Liplacis and afterwards initiate the phase II trial with US breast cancer patients.
"We are preparing the application already now and expect to submit it within one month after a positive meeting," says Buhl. He adds:
"If there are no further comments, we can begin the studies as early as one month after FDA receives the application."
English Edit: Ida Løjmand
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