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Co-operation agreement for Phase I IIT TCR trial

Update | Pharmaceutical & healthcare | 05 Jul 2016

Medigene has announced it has entered into a co-operation agreement to conduct a Phase I investigator-initiated TCR therapy trial (IIT), with grant funding, in patients with relapsed/refractory multiple myeloma. This is an important step forward in the process of bringing its TCR therapy to patients, a potentially transformational approach to treating certain cancers. The final aspect is the regulatory approval for the trial, to which Medigene is contributing. We expect the Phase I trial to initiate at end 2016/early 2017. We maintain our rNPV-based valuation at €214m, or €10.8 per share, with upside expected when the Phase I trial is initiated.


Continuing to progress its clinical pipeline

Update | Pharmaceutical & healthcare | 19 May 2016

Medigene's Q1 results continue to underpin its transformation to a cancer immunotherapy-focused company. Progress across its clinical pipeline continues to create further focus on clinical development and future commercialisation. Alongside management changes, this indicates that the company is executing its strategy. It is well funded, with a net cash position of €46.3m (Q116).


bluebird bio back for more

Update | Pharmaceutical & healthcare | 17 May 2018

Medigene has announced an expansion of its bluebird partnership, giving significant external validation of its T-cell receptor (TCR) technology platform. The full partnership now covers six targets and is worth potentially US$1.5bn in development and commercial milestones, in addition to royalties on any future sales. Medigene’s own internal pipeline continues to advance with its MDG1011 Phase I/II TCR clinical trial now enrolling patients. Additionally, we forecast that the Phase I part of the TCR trial and the now fully enrolled Phase I/II DC vaccine trial will read out in 2019. We have updated our forecasts and now value Medigene at EUR 416m (EUR 18.65/share) vs EUR 396m (EUR 17.8/share) previously.


TCR enters the clinic

Outlook | Pharmaceutical & healthcare | 27 Mar 2018

Medigene has started its TCR Phase I/II clinical trial, making it one of the few clinical TCR companies globally. Combined with the completed enrolment of the Phase I/II DC vaccine trial, Medigene is positioning itself at the forefront of the next wave of cell and gene therapies. We expect initial data packages from both trials in 2019. We have updated our MDG1011 assumptions, rolled forward our model, adjusted for the sale of the US rights to Veregen, and delayed our assumed DC vaccine out-license to 2019. We value Medigene at EUR 396m vs EUR 316m previously.


TCR clinical trial initiation imminent

Update | Pharmaceutical & healthcare | 09 Nov 2017

Medigene’s Q3 results are in line with our forecasts. The company has submitted its Phase I/II clinical trial application for its lead TCR cellular immunotherapy product candidate MDG1011 and anticipates initiation of the trial by year end. In addition to the upcoming trial initiation, Medigene has made numerous scientific and technological achievements in 2017, including presentations on its automated TCR identification platform and preclinical data on MDG1011. Partners have presented compassionate use data on DC vaccines in AML. We value Medigene at EUR 316m (EUR 14.3/share).


Transition to prominent immunotherapy player

Update | Pharmaceutical & healthcare | 03 Aug 2017

Medigene’s H1 results are in line with our expectations and represent the completion of its transformation into a prominent T-cell immunotherapy player. Highlights from H1 include submission of a clinical trial authorisation (CTA) to begin its first clinical T-cell trial and a fund-raising of EUR 20.7m (gross). We maintain our valuation at EUR 315m, but expect upside as it executes on its strategy over the next 12-18 months.


Next step taken toward its first TCR clinical trial

Update | Pharmaceutical & healthcare | 11 Jul 2017

Medigene has announced that it has submitted a clinical trial authorisation application (CTA) to begin its first clinical trial with its proprietary T-cell receptor (TCR) modified T cells. If approved, the trial will evaluate it as an immunotherapy to treat a range of blood cancer indications and will be one of the first in Germany of TCR-modified cells. The trial is expected to start by the end of 2017. This submission triggers a final milestone payment of EUR 2m for the Trianta acquisition (January 2014). We maintain our valuation of EUR 315m but note the company is well-funded to deliver important milestones from progressing its clinical programme.


Funded to execute clinical development strategy

Update | Pharmaceutical & healthcare | 12 May 2017

Medigene recently announced a placing of €20.7m gross (issuing 1.96m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This leaves it well funded (pro forma cash €67.7m) to advance both its DC vaccine programmes and TCR programme. We expect 2017 to be a year of important progress for Medigene, in particular the start of its first company-initiated TCR clinical study. We have increased our rNPV-based valuation to €315m (vs €293m), as we now include the cash from the fund-raising and have rolled the model forward.


Fund-raising to accelerate clinical programme

Flash note | Pharmaceutical & healthcare | 05 May 2017

Medigene has announced a placing of €20.7m gross (issuing 2m new shares at €10.55) to intensify its R&D through the expansion of its planned T-cell receptor (TCR) modified T-cells clinical programme. This was achieved with an accelerated book build process and became effective today. The fund-raising was over-subscribed and included both existing institutional shareholders and new specialised healthcare investors. We place our financial forecasts and valuation under review to assess the full impact, but see this as a significant and positive step.


Becoming an increasingly prominent player

Outlook | Pharmaceutical & healthcare | 24 Apr 2017

Medigene is well funded (FY16 cash €52.6m) to advance both its DC vaccine programmes and TCR programme. We expect a number of important milestones in 2017; specifically, we expect newsflow from its most advanced technology (DC vaccines) in Phase I/II studies for AML (complete enrolment) and the start of its first company-initiated T-cell receptor (TCR) clinical study. We have increased our rNPV-based valuation to €293m (vs €233m), to reflect the increase in the TCR programme probability to 13% (vs 5%), rolling the model forward and using FY16 cash.


Continuing to take steps to focus on core

Update | Pharmaceutical & healthcare | 21 Dec 2016

Medigene has announced that it has granted an exclusive worldwide licence for the development and commercialisation of its preclinical-stage adeno-associated virus-like particles (AAVLP) technology to 2A Pharma, a Swedish biotech company. The financial details of the agreement are not disclosed, although Medigene has indicated that it will receive clinical, regulatory and commercial milestone payments, as well as royalties on net sales based on the technology. This is another positive development, with Medigene continuing to streamline its focus on its immunotherapy programmes, while retaining potential value from its non-core assets. We maintain our valuation at EUR 233m.


Strategic alliance validates TCR technology

Update | Pharmaceutical & healthcare | 05 Oct 2016

Medigene has announced an alliance with bluebird bio, a prominent T-cell immunology company. It is Medigene's first commercial partnering agreement based on its proprietary T-cell receptor (TCR) technology platform. The collaboration will seek to identify four TCR therapeutic candidates against four targets. This is a positive development as it validates Medigene's TCR technology and makes use of technological synergies to develop new immuno-oncology products, which could prove beneficial. Importantly, it does this while retaining all rights for its proprietary TCR development programme and TCR library. We have increased our valuation to €233m (vs €219m), as we have rolled the model forward to an estimated Q3 position and included the upfront payment.