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Celyad

Allogeneic trial first dose given

Update | Pharmaceuticals & healthcare | 03 Dec 2018

The allogeneic version of NRK CAR T-cell therapy, CYAD-101, is underway with the first patient dosed. The study mirrors the current colorectal SHRINK trial in combining NKR CAR cell therapy with FOLFOX chemotherapy. This gives Celyad the lead in a potential high-value mass-market solid cancer where allogeneic therapy is likely to be essential. The indicative value is EUR 1,090m (EUR 89 per share) pending further data.

Immutep

A big year ahead for efti

ADR Update | Pharmaceuticals & healthcare | 22 Nov 2018

We expect Immutep to deliver on a number of important milestones in the year ahead. The AIPAC Phase II study of its APC activator eftilagimod alpha (efti) plus chemo in breast cancer is expected to complete recruitment in H119 and report top-line data before the end of the year. The TACTI-002 study of efti plus Keytruda in lung and head and neck cancers in collaboration with US Merck will start shortly and report first data mid-year, whereas TACTI-mel will report first data from melanoma patients dosed with efti from the start of Keytruda therapy. Other in-house and partnered programs are also likely to produce significant news. We maintain our valuation of $387m ahead of these milestones.

Immutep

A big year ahead for efti

Update | Pharmaceuticals & healthcare | 21 Nov 2018

We expect Immutep to deliver on a number of important milestones in the year ahead. The AIPAC Phase II study of its APC activator eftilagimod alpha (efti) plus chemo in breast cancer is expected to complete recruitment in H119 and report top-line data before the end of the year. The TACTI-002 study of efti plus Keytruda in lung and head and neck cancers in collaboration with US Merck will start shortly and report first data mid-year, whereas TACTI-mel will report first data from melanoma patients dosed with efti from the start of Keytruda therapy. Other in-house and partnered programmes are also likely to produce significant news. We maintain our valuation of A$510m ahead of these milestones.

Medigene

Successful manufacturing of first TCR therapy

Update | Pharmaceuticals & healthcare | 19 Nov 2018

Medigene’s MDG1011 trial in MM, AML and MDS is ongoing and the first MDG1011 TCR cell product has been successfully produced. Additionally, procedures to speed up patient enrolment are being rolled out, including the simplification of enrolment criteria and the addition of new trial centres. We continue to forecast that clinical data from both the Phase I part of the MDG1011 Phase I/II clinical TCR trial and the now fully enrolled Phase I/II dendritic cell (DC) vaccine trial will be available in 2019. Financials for 9M18 were above guidance, driven by a reduction in expected R&D costs. We now forecast a net loss of EUR 16.9m in FY18 vs EUR 18.4m previously. Additionally, Medigene announced an exclusive licence agreement with Leiden University to develop a TCR against HA-1, an antigen expressed in a range of cancers. We value Medigene at EUR 457m.

Herantis Pharma

Innovation at its core

Initiation | Pharmaceuticals & healthcare | 20 Sep 2018

Herantis Pharma is focused on the development of innovative regenerative medicines targeting unmet needs. Its two lead assets are cerebral dopamine neurotrophic factor (CDNF), a potential disease-modifying treatment for Parkinson’s disease (PD), and Lymfactin, the only gene therapy in development for breast cancer-related associated (BCAL) secondary lymphedema. The underlying science for both is novel and positive efficacy/safety data from ongoing proof-of-concept clinical trials expected in 2019–20 would serve as validation of the research efforts and additionally could crystallise value through partnering opportunities for these unique assets. We value Herantis Pharma at EUR 9.3/share.

Telix Pharmaceuticals

Targeted radiation to image and treat cancer

Initiation | Pharmaceuticals & healthcare | 20 Aug 2018

Telix has assembled a portfolio of promising molecularly targeted radiation (MTR) therapeutic and imaging products for three different cancers. Each product has been validated by clinical studies or compassionate use in patients, thus reducing development risk. Telix is positioned to add significant value, such as by refining the products or developing them as a combination therapy. Preparations for a confirmatory Phase III study for kidney cancer imaging agent TLX250-CDx and for multiple Phase I/II studies of other agents are underway. It has begun commercialisation of an investigational prostate cancer imaging kit in the US, and plans are being developed for a short pivotal study to allow full approval. Our initial valuation is A$303m or A$1.39 per share.

Celyad

Allogeneic trial approved in colorectal cancer

Update | Pharmaceuticals & healthcare | 02 Aug 2018

The FDA’s sign off on Celyad’s first clinical trial design for its allogeneic NRK CAR T-cell therapy (CYAD-101) is an important milestone. The study, possibly staring in Q4 2018, mirrors the current colorectal SHRINK trial a combination of autologous CYAD-01 therapy with FOLFOX chemotherapy. This gives Celyad the lead in a mass-market solid cancer where allogeneic therapy is likely to be essential. The indicative value has been increased to EUR 1,090m (EUR 89 per share) from EUR 1,040m (EUR 84 per share) pending further data.

MagForce

NanoTherm US prostate cancer trial initiates

Update | Pharmaceuticals & healthcare | 04 Jul 2018

MagForce has announced the enrolment of the first patient in its pivotal clinical trial evaluating NanoTherm focal ablation therapy in the US for prostate cancer. The trial started as expected in Q218 and further patient recruitment is underway at the two clinical sites (CHRISTUS Santa Rosa and the University of Washington). Prostate cancer presents a significant market opportunity in the US (representing ~60% of our rNPV) and makes sense strategically as a first US indication.

Celyad

Developing a sophisticated clinical strategy

Update | Pharmaceuticals & healthcare | 21 Jun 2018

Celyad has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at EUR 1,040m, EUR 84 per share.

Hutchison China MediTech

Jewels in the crown

ADR Outlook | Pharmaceuticals & healthcare | 01 Jun 2018

Key near-term value drivers include newsflow from partnered assets savolitinib (AZN globally) and fruquintinib (LLY in China). By year end, we anticipate the China FDA to approve fruquintinib (3L CRC). The molecular epidemiology study (MES) data on savolitinib in PRCC could support a US NDA submission (possible breakthrough therapy designation, BTD). Both products have blockbuster potential; as combination therapies in cancer drive overall uptake of targeted therapies. Beyond this we expect progression in Hutchison China MediTech's (HCM) wholly owned late stage oncology assets to reach value inflection points over the next few years. We have extensively reviewed our financial forecasts and increase our valuation to $47.9/ADS or $6.4bn.

Hutchison China MediTech

Jewels in the crown

Outlook | Pharmaceuticals & healthcare | 31 May 2018

Key near-term value drivers include newsflow from partnered assets savolitinib (AZN globally) and fruquintinib (LLY in China). By year end, we anticipate the China FDA to approve fruquintinib (3L CRC). The molecular epidemiology study (MES) data on savolitinib in PRCC could support a US NDA submission (possible breakthrough therapy designation, BTD). Both products have blockbuster potential; as combination therapies in cancer drive overall uptake of targeted therapies. Beyond this we expect progression in Hutchison China MediTech’s (HCM) wholly owned late stage oncology assets to reach value inflection points over the next few years. We have extensively reviewed our financial forecasts and increase our valuation to GBP 71.0/share or $6.4bn.

Celyad

Progressing a broad clinical strategy

Update | Pharmaceuticals & healthcare | 30 May 2018

The placing has given Celyad a cash boost of EUR 46.1m gross adding to the EUR 34m on 31 December 2017. Celyad is designing a set of sophisticated clinical trials to expand understanding of its novel NKR CAR T-cell therapy. The THINK study, focused on AML and colorectal cancers, showed a near complete response (CR) in AML in Q417 plus two other AML responses and two colorectal stable disease cases. The highest THINK dose range should complete in H218. The SHRINK study, NKR CAR T-cells plus chemotherapy in metastatic colorectal cancer (mCRC), has dosed its first patient. The indicative value has been adjusted to EUR 1040m, EUR 85 per share.