Date: 2016-06-13
Type of information: Establishment of a new subsidiary in the EU
Compound:
Company: Bionor Pharma (Norway)
Therapeutic area: Infectious diseases
Type agreement: update
Action mechanism:
Disease:
Details: * On June 13, 2016, Bionor Pharma provided an update on scientific collaborations in relation to the company’s HIV immunotherapy pipeline. On 31 May 2016, the Board of Directors announced a clinical strategy with continued focus on HIV immunotherapy and functional cure (see below). Currently, Bionor’s scientific collaborations include possible extension of the ongoing collaboration with Celgene as well as finalization of research and scientific publication of the work conducted with St. Georges University of London, UK and SCHARP (Statistical Center for HIV/AIDS Research and Prevention) at the Fred Hutchinson Research Institute, USA. In addition, to achieve a functional cure for HIV, a combination of more than two agents will likely be required. Bionor is currently considering which additional immune regulating agents could be relevant, and owing to the encouraging results from the IMiD trial, lenalidomide is a natural part of these considerations. St. Georges University of London (SGUL): Bionor has had a longstanding collaboration with SGUL, and the projects have been partly financed by the Research Council of Norway GLOBVAC and BIA programs. The current project addresses immune activation in HIV infection and the potential role of a specific region on the HIV envelope glycoprotein in this process. Bionor has developed a peptide antigen, Vacc-C5, corresponding to this region. Earlier work has shown that the presence of antibodies to the C5 region of HIV is associated with slowed disease progression. Bionor has extended this work by analyzing the prevalence of antibody responses to Vacc-C5 in HIV patient cohorts. The collaboration with SGUL is addressing the mechanisms by which this region of HIV-1 may contribute to immune activation, and how antibodies to this region may reduce these effects. The study has also carried out preclinical work addressing the potential to use Vacc-4x and Vacc-C5 together. A scientific publication of the results is expected later this year. SCHARP, Fred Hutchinson Research Institute: Bionor has had a collaboration with SCHARP since 2014 with the purpose of performing a post-hoc statistical analysis of data from the large 2007 phase II clinical trial (CT BI-Vacc-4x 2007/1) where Vacc-4x showed a statistically significant reduction in viral load set point compared to placebo patients (Pollard et al., 2014)1. It has been confirmed that Vacc-4x provided a positive effect on both CD4 counts and viral load compared to placebo. These results were published earlier this year in a peer-reviewed journal (Huang et al., 2016)2. In the collaboration with SCHARP, Bionor is also seeking to identify candidate biomarkers and immune correlates of the effect of Vacc-4x. This work is expected to be published in a scientific journal later this year. * On May 31, 2016, Bionor Pharma announced that the Board of Directors has completed its review of the company’s strategy and financing plans in accordance with the considerations presented in stock exchange announcement of 28 April 2016. The company maintains its focus on HIV immunotherapy and overall strategy to further advance Vacc-4x in clinical development in combination with other medicines to develop a functional cure for HIV. The timing and details in the clinical development program have been revised in light of the company’s cash position and market capitalization, and a two-step funding plan is outlined below. Bionor believes that a crucial step in validating this approach was taken with the REDUC clinical trial, which demonstrated that Vacc-4x led to improved control of HIV in the blood after the virus had been “shocked” out of its latent reservoir by romidepsin, and met its primary end point by leading to a reduction of the latent HIV reservoir (See stock exchange announcement of 21 December 2015). Based on the REDUC data, Bionor is currently planning BIOSKILL, a multicenter placebo-controlled proof of concept Phase II clinical trial, as well as an exploratory Phase I/II trial to evaluate an immune regulating agent administered in a triple agent regimen with Vacc-4x and romidepsin (BIONAB). Finally, a trial is planned to document the effect of the adjuvant GM-CSF on Vacc-4x immunogenicity. This is a clinical trial planned to provide data requested by the FDA. As previously announced, Bionor has been granted approximately NOK 20 million from Skattefunn for the BIOSKILL clinical trial, and the Research Council of Norway has granted the company up to NOK 9.2 million to partially fund the BIONAB trial. The company will continue to pursue non-dilutive funding. Capital structure: Based on the clinical strategy outlined above, Bionor’s capital need is now estimated by the Board to approximately NOK 230-270 million, which covers the period from the third quarter of 2016 to the fourth quarter of 2019 (14 calendar quarters); approximately nine months after the expected announcement of BIOSKILL topline results in the first quarter of 2019. Previously, Bionor estimated the capital need until the first quarter of 2019 to NOK 375-425 million (11 calendar quarters). The significantly reduced, estimated capital need is based on a planned, major reduction of the core cost base for the period, a slightly narrowed clinical development plan, and less focus on further expanding the company’s asset pipeline. Bionor will seek to reduce the costs for running the company by relocating to other facilities in Norway, Denmark, and the U.S. In addition, an organizational review is currently ongoing. As part of this review, it has been decided not to replace Søren Keller, SVP and Chief Operating Officer, who will leave the company by 1 June 2016. The Board has considered various transaction structures to fund the continued development of the company’s assets. Taking into account the need for funding, execution risk, transaction costs and cash position of the company as well as the clinical status of Vacc-4x, the Board has decided that the company’s long-term funding initially will be covered by an equity offering to fund the company through the following 6-12 months. Further details on the timing, size, and structure of this transaction will be disclosed in due course. Concurrently, the Board will investigate the possibilities of securing the remainder of the long-term capital need through equity, non-dilutive means, or a combination thereof. Enrollment in each of the clinical trials will only be initiated when funding has been secured to complete the trial. Based on this new funding strategy, enrollment of first patient in BIOSKILL is planned for the first quarter of 2017.
Bionor and Celgene have had a fruitful collaboration since 2011, when the IMiD trial with Vacc-4x and lenalidomide (Revlimid®, supplied by Celgene Corporation) trial was initiated. The collaboration did continue with the successful REDUC trial, for which Celgene provided romidepsin (Istodax®), and expanded in July 2015, where Bionor and Celgene agreed, that Celgene would secure a continued supply of romidepsin for use in the planned BIOSKILL trial.
Bionor deploys a “Shock and Kill” approach for achieving a functional cure for HIV infection. This reflects a prevailing view in the HIV scientific community that a combination of different compound classes is likely required to achieve long-lasting viral control in the absence of ART, the current standard of care for HIV-infected patients. As part of this approach, Bionor will continue investigating the combination of Vacc-4x with a latency reversing agent (romidepsin, supplied by Celgene Corporation; marketed as Istodax®) to first educate the immune system to recognize and kill infected cells, followed by an activation of the latent HIV in infected cells to make them visible to the immune system. It is expected that a third agent will be needed for the purpose of further improving the immune response.
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