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Oncology Venture

LiPlaCis focused Phase II interim data

Update | Pharmaceutical & healthcare | 09 Oct 2018

In mid-September, Oncology Venture (OV) provided an update on its focused Phase II study investigating LiPlaCis in heavily pre-treated metastatic breast cancer (mBC) patients. To date, 26 patients have been enrolled in the trial via the drug response predictor (DRP) screening programme. Nine patients were segmented into the top one-third of responders and of these, 55% achieved partial remission. Notably, only the top responders as identified by the DRP achieved this, which may suggest that the DRP could prospectively identify responders.

Mologen

Global lefitolimod partnership close to completion

Outlook | Pharmaceutical & healthcare | 21 Sep 2018

Mologen announced that it has signed term sheets for a global partnership with Oncologie for its lead asset, lefitolimod. The deal is expected to complete in Q119, and in the near term Mologen expects to receive EUR 23m from the agreement in a combination of R&D funding, cash payment and bond issues. Sensitivity remains around Oncologie who are an early stage biotech with $16m in seed funding. Mologen announced a capital raise in which it could receive gross proceeds of EUR 18m. Focus remains on data from the Phase III IMPALA trial in metastatic colorectal cancer (mCRC), expected in 2020. We value Mologen at EUR 188m (EUR 16.6/share).

Herantis Pharma

Innovation at its core

Initiation | Pharmaceutical & 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.

Kazia Therapeutics

GDC-0084 and Cantrixil trials progressing

Update | Pharmaceutical & healthcare | 19 Sep 2018

Kazia Therapeutics has commenced the Phase II programme for GDC-0084 in glioblastoma (GDC-0084 was in-licensed from Genentech in 2016). Initial data from the Phase IIa dose optimisation component are expected in H119, with a subsequent Phase IIb study expected to read out in 2021. The Phase I study of Cantrixil in ovarian cancer is in the final stages of determining the maximum tolerated dose (MTD). Our valuation range is unchanged at A$73m to A$133m (A$1.46–2.65 per share).

ASLAN Pharmaceuticals

Enrolment for China study adjusted

Update | Pharmaceutical & healthcare | 19 Sep 2018

ASLAN announced it would be amending the protocol for its ongoing Chinese pivotal trial of varlitinib in biliary tract cancer (BTC). The patients being enrolled in China had more severe disease than expected based on historical controls, which manifested as a weaker than expected response to treatment on the trial. Due to delays, the Chinese study may not complete before the ongoing TREETOP study, which would then serve as a pivotal study for approval in China and is expected to complete in 2019.

Kazia Therapeutics

GDC-0084 and Cantrixil trials progressing

ADR Update | Pharmaceutical & healthcare | 19 Sep 2018

Kazia Therapeutics has commenced the Phase II program for GDC-0084 in glioblastoma (GDC-0084 was in-licensed from Genentech in 2016). Initial data from the Phase IIa dose optimization component are expected in H119, with a subsequent Phase IIb study expected to read out in 2021. The Phase I study of Cantrixil in ovarian cancer is in the final stages of determining the maximum tolerated dose (MTD). Our valuation range is unchanged at $56m to $101m ($11.10–20.16 per share).

Oncology Venture

Merger with Medical Prognosis Institute finalised

Update | Pharmaceutical & healthcare | 13 Sep 2018

In early September, Oncology Venture AB and Medical Prognosis Institute (MPI) completed their strategic merger and the new entity, Oncology Venture A/S (OV), now trades on the NASDAQ First North Stockholm. Recently, OV’s three highest priority programmes all demonstrated progress. OV reported interim data from the LiPlaCis trial and is increasing enrolment, whereas 2X-121 received an IND from the US FDA in ovarian cancer. Furthermore, OV has a 55% stake in dovitinib, a tyrosine kinase inhibitor that was in-licensed from Novartis.

Immunovia

Exploring new avenues

Update | Pharmaceutical & healthcare | 06 Sep 2018

Immunovia has announced that it needs to optimise the algorithms used in the IMMray PanCan-d test in high-risk patients due to sample collection-related variability, which will delay the first sales of the product for a year from late 2018 to late 2019. Separately, Immunovia has shown the IMMray platform can differentiate between healthy and lung cancer samples with 95% accuracy. On the autoimmune front, IMMray has proven efficacious in detecting patients with rheumatoid arthritis (RA) who tested negative for antibodies against cyclic citrullinated peptides (CCP) with 90% accuracy, allowing a potential increase of up to 30% in detection rate. Both studies will be validated in further trials. Net cash at end H118 was SEK447.2m. Our updated valuation is SEK3.5bn vs SEK3.6bn before.

VolitionRx

Executive interview – VolitionRx

Edison TV: | Pharmaceutical & healthcare | 20 Aug 2018

Volition is a multi-national life sciences company focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers. The tests are based on the technology platform of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

Telix Pharmaceuticals

Targeted radiation to image and treat cancer

Initiation | Pharmaceutical & 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.

4SC

Domatinostat R&D ramp-up in H218

Update | Pharmaceutical & healthcare | 17 Aug 2018

During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).

Celyad

Allogeneic trial approved in colorectal cancer

Update | Pharmaceutical & 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.