Prima BioMed’s incoming CEO to refocus company on CVac

Prima BioMed has cancelled two side programmes and is refocussing its energies on driving its lead product, CVac, towards gaining regulatory approval in the major markets of the US, Europe and Australia.

This represents an emphasis by the incoming CEO, Matt Lehman, who intends to narrow the company’s focus primarily on CVac.

“I believe, and my management believes, that the team’s near-term focus should remain completely on the execution of CVac clinical trials in the major markets,” he stated in a company newsletter.

The company announced it is pulling out of Dubai, where it was offering apheresis services at The City Hospital to fund a CVac pilot project in the country.

According to the company, the revenues from apheresis service were insufficient to fund the pilot programme, and there were also regulatory barriers to importing CVac from Melbourne to Dubai for the pilot.

“The team at Prima made a concerted effort to establish a successful CVac and apheresis program in Dubai, but assumptions about revenue from non-CVac-related apheresis services and the forecast timeline for when CVac could be exported from Australia to Dubai were, in retrospect, too optimistic,” said Lehman.

“We were not able to foresee a situation where the Dubai franchise would be profitable in a reasonable amount of time. While we had started to achieve some initial success in providing therapeutic apheresis, this side of the business would not provide enough revenue to break even.”

The company also announced the termination of preclinical development of an antibody for Cripto-1, a gene associated with tumorigenesis.

The project was a collaboration established in 2010 with Bioceros B.V. (Netherlands), but while the antibody was found to have strong binding capacity, it demonstrated no tumour cell killing ability.

Further development would have required either the generation of new antibodies, or the combination of the existing antibody with a cytotoxic compound. According to a company statement: “neither approach fits in with Prima’s strategic vision at this time.”

“We are disappointed by the outcome of the preclinical testing, but prompt termination of unsuccessful projects is an important part of rational product development,” said Lehman.

“There are no further expenses to be incurred by Prima on the Cripto-1 program and we can refocus resources on clinical stage development of personalized bio-therapeutics such as CVac.”

Lehman has reiterated his commitment to developing CVac not only for its initial indication of ovarian cancer, but for other cancers as well. “We will look at expanding CVac development into other cancer indications,” he said.

“There are opportunities for acquiring additional technology, products, or even companies to complement our existing assets in the personalized bio-therapeutics field. We are continuously looking at incremental innovation in cell therapy to reduce costs of production, enhance the potency of products, improve administration to the patients, and generally streamline processes.”

Lehman also outlined Prima’s future plans, emphasising the need to expand to handle additional development programmes and bring some services in-house.

“When it makes business sense, we may look at some vertical integration steps to bring some activities in-house that we currently contract out. We could also look at more strategic collaborations or risk-sharing endeavours with partners to build capacity while minimizing capital outlay,” he said.

He also stated that the company is beginning intracellular cytokine staining (ICS) analysis of CVac in order to determine how it works biologically. If this is successful, it could lead to Prima pursuing new indications other than ovarian cancer.

The next 12 months will also see the release of some important clinical data on the safety and efficacy of CVac, including the CAN-003 trial measuring safety, and progression-free survival data coming out in mid-2013.

As a part of its global strategy, Prima will list on the NASDAQ and has just listed on the Frankfurt stock exchange.

“In line with our overall philosophy of building a global platform to maximize Prima’s presence in future commercial markets and obtain exposure to potential patients and the scientific community worldwide,” said Lehman.

Lehman, who has been with Prima for two and half years and is currently COO, will take over from Martin Rogers as CEO from 1 September this year. Prior to his time at Prima, Lehman managed a contract research organisation for 10 years, and has worked in Europe and his native US.