LUND, Sweden, April 28, 2020 /PRNewswire/ --
Promising progress reported for BI-1206 in combination with
rituximab
"We have made a strong start to 2020 and remain on track to
deliver on our goals. Our lead candidate, BI-1206, continues to
make good progress, while we are developing promising preclinical
assets and continuing the good work with our partners."
Martin Welschof, CEO BioInvent
Financial information first quarter
2020
- Net sales SEK 16.7 (17.4)
million.
- Loss after tax SEK -32.6 (-27.8)
million.
- Loss after tax per share before and after dilution SEK -0.07
(-0.08).
- Cash flow from operating activities and investment activities
SEK -35.4 (-40.5) million. Liquid
funds as of March 31, 2020:
SEK 117.1 (28.5) million.
Events in the first
quarter
- BioInvent and Transgene announced that the first clinical trial
application for BT-001 was submitted and that the first-in-human
trial is expected to start before the end of 2020 in Europe and the
US.
- BioInvent announced an agreement with SkylineDx to characterize
the gene expression and immunological signatures in tumors of
patients pre- and post-treatment with BI-1206.
Events after the reporting
period
- In April 2020, promising progress
was reported in the Phase I/lla trial of lead program BI-1206 in
combination with rituximab. A complete response was observed in one
follicular lymphoma patient and complete depletion of circulating
tumoral cells in a mantle cell lymphoma patient. (R)
(R)= Regulatory event
Comments from the CEO
BioInvent has made a strong start to 2020 and remains on track
for delivery on our goals. Our lead candidate, BI-1206, continues
to make good progress, while we are developing promising
preclinical assets and continuing the good work with our
partners.
It was very pleasing to report promising progress in the Phase
I/lla trial of BI-1206 in combination with rituximab for the
treatment of Non-Hodgkin Lymphoma (NHL). Three separate responses
have been observed across different subtypes of NHL at doses of
BI-1206 below what is believed to be optimal. Particularly notable
was that one patient in the 70mg cohort achieved a complete
response and another patient had complete depletion of circulating
mantle cell lymphoma cells. Of course, this is a very early stage
in the study, and this part of it is designed to evaluate safety
and tolerability. All the same, these initial signs of efficacy are
very encouraging.
We have also concluded an agreement with SkylineDx, a molecular
diagnostics company focusing on discovery of novel gene-based
biomarkers, to characterize the gene expression and immunological
signatures in tumors of patients pre- and post-treatment with
BI-1206. This is particularly interesting because identifying the
right patients who are likely to respond to treatment with BI-1206
will constitute a major asset in the development of this promising
treatment and, along with FcγRIIB expression levels, should support
the extension of its use to other malignancies.
Further along our pipeline, BioInvent and our partner Transgene
have submitted the first clinical trial application for BT-001, a
multifunctional oncolytic virus which was engineered to encode a
Treg-depleting, anti-CTLA4 antibody from our proprietary
n-CoDeR®/F.I.R.S.TTM platforms. The
first-in-human trial is expected to start before the end of 2020 in
Europe and the U.S. and we believe
that the potential to combine anti-CTLA4, anti-PD-1/PD/L1 and
oncolytic immunotherapy could change the treatment paradigm for
multiple solid tumors.
Thus, our technology platform continues to produce exciting
potential new treatments, ready for developing through clinical
trials and to address important unmet medical needs.
As BioInvent continues to bring new programs towards clinical
development, financing is of course a priority and we will continue
to use a combination of sources for funding. Firstly, we are
engaged in several business development discussions with the aim of
partnering one or more of the programs in our portfolio. Secondly,
the collaboration with Pfizer, which is also a model for other
potential collaborations which commercialize our platform. Thirdly,
our manufacturing capabilities generate revenue, with the most
recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become
a long-term strategic partner, as it works with a number of small-
to mid-sized companies that need manufacturing support. And our
fourth option is to use capital markets for financing. Based on the
support from our large institutional investors and increased
interest in our programs we feel optimistic that a combination of
these four sources will continue to support BioInvent financially.
The Board of Directors follows the financing situation and is
working on a plan to ensure the Group's continued financing.
The spread of COVID-19 has changed all our lives and BioInvent
is no exception. We are taking all the necessary precautions and
continue to monitor its spread and associated measures closely.
BioInvent has clinical trials in process and clinical trials soon
to be initiated and the global measures against COVID-19 and the
need to prioritize healthcare resources will likely affect the
timelines for these studies.
The precise impact is difficult to assess at this stage, given
the rapidly developing situation. Currently, we still expect the
early results from the Phase I open label study with a combination
of BI-1206 and rituximab for treatment of NHL in H2 2020. Early
clinical trial results for BI-1206 in combination with
pembrolizumab and clinical trial initiations in other programs also
remain on track. As the situation is still evolving, timelines are
still subject to potential changes and we will provide updates as
necessary.
BioInvent is delivering consistently on its strategy as we
progress through 2020, despite the disruption caused to the world
by the spread of COVID-19. We wish you and your families the best
of health, and will continue to keep you up to date on our exciting
progress.
Martin Welschof, CEO
Contact
Any questions regarding this report will be answered by Martin
Welschof, CEO, +46 (0)46 286 85 50, martin.welschof@bioinvent.com.
The report is also available at www.bioinvent.com.
BioInvent International AB (publ)
Co. reg. no. 556537-7263
Address: Sölvegatan 41, 223 70 Lund
Tel.: +46 (0)46 286 85 50
Forward looking information
This financial statement contains statements about the future,
consisting of subjective assumptions and forecasts for future
scenarios. Predictions for the future only apply as of the date
they are made and are, by their very nature, in the same way as
research and development work in the biotech segment, associated
with risk and uncertainty. With this in mind, the actual out-come
may deviate significantly from the scenarios described in this
press release.
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The following files are available for download:
https://mb.cision.com/Main/583/3098759/1237688.pdf
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Bioinvent Interim
Report January 1 â€" March 31, 2020 (PDF)
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