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Cellular Biomedicine Group

CBMG and Novartis sign manufacturing partnership

Update | Pharmaceutical & healthcare | 05 Oct 2018

Cellular Biomedicine Group (CBMG) announced it has signed an exclusive partnership with Novartis to manufacture the CAR-T therapy Kymriah in China. Novartis retains all marketing responsibility and CBMG will be entitled to both a mark-up on manufacturing costs and an escalating single-digit royalty on sales. Additionally, Novartis will take an equity stake in CBMG of approximately 9%: $40m at $27.43/share. Our valuation is lifted to $535m (from $353.1m).

Oxford BioMedica

Golden age for LentiVector as Axovant signs deal

Update | Pharmaceutical & healthcare | 08 Jun 2018

Oxford BioMedica (OXB) has signed an out-licensing deal with Axovant for its Parkinson’s disease (PD) gene therapy AXO-Lenti-PD (previously OXB-102) worth up to $842.5m. Axovant plans to accelerate it rapidly into the clinic, with a Phase I/II dose escalation study in advanced PD patients to be initiated by year end. In addition to OXB’s numerous other partnerships, notably the recently signed Bioverativ deal and the ongoing collaboration with Novartis on its launched CAR-T Kymriah, this deal demonstrates OXB’s continuing world-leading status in lentiviral technology. We now include the Axovant deal in our model and value OXB at GBP 614m.

Oxford BioMedica

Validation achieved, growth expected

Outlook | Pharmaceutical & healthcare | 10 May 2018

Following the commercial launch in 2017 of partner Novartis’s CAR-T Kymriah (in r/r paediatric ALL), Oxford BioMedica (OXB) has become one of a handful of regulatory approved gene and cell therapy manufacturers worldwide. This validation of its capabilities was most recently demonstrated in signing the GBP 100m+ collaboration with Bioverativ to develop haemophilia gene therapies. We expect OXB to rapidly expand its manufacturing capacity to enable top-line growth. We have reassessed many of our valuation assumptions and now include the partnerships with Immune Design, Orchard and Bioverativ. Moreover, internal asset, OXB-102, will start a Phase II trial shortly. We value OXB at GBP 513m (15.6p/share).

TxCell

Executive interview - TxCell

Edison TV: | Pharmaceutical & healthcare | 30 Nov 2017

TxCell offers a rare investment opportunity as it is the only company applying CAR-T technology to regulatory T-cells (Tregs) for autoimmune and inflammatory therapy. Tregs have very powerful control functions in the immune system. The first CAR-Treg studies are planned in transplantation starting in 2018, followed by possible trials in other indications like multiple sclerosis.

Cellular Biomedicine Group

Cell therapy for China and the US

Initiation | Pharmaceutical & healthcare | 02 Oct 2017

We are initiating coverage on Cellular Biomedicine Group (CBMG), a trans-Pacific cell therapy company developing products in China and the US. It has two ongoing Phase I clinical trials of CD19 chimeric antigen receptor T-cell (CAR-T) therapies for blood cancers in China. Additionally, it is adapting its knee osteoarthritis (KOA) treatment ReJoin as an allogeneic product, AlloJoin, which it hopes to develop in the US after a 2017 or 2018 IND. We arrive at an initial valuation of $191.6m or $13.58 per share.

T‐cell cancer therapies

Looking beyond CD19 for the next opportunities

Comment | Pharmaceutical & healthcare | 27 Sep 2017

CD19 CAR-T therapy gives dramatic responses in some B-cell cancers covering 1.4% of US cancers and about 1% of deaths, 6,500. However, the major T-cell therapy opportunities are in MM, AML and major solid cancers with over 1.2m new US cases and 450,000 deaths a year. CAR-T competes in MM and AML but lacks the antigens to attack solid cancers. Celyad's NKR CAR T-cell therapy targets stress antigens with multi-indication potential in AML, MM and solid cancers. The T-cell receptor approach has high specificity and versatility but with specific patient segmentation. Non-cellular therapies (BiTEs and checkpoint inhibitors) could be synergistic.

Oxford BioMedica

Lentiviral vector supply for CTL019 driving revenue growth

Flash note | Pharmaceutical & healthcare | 06 Jul 2017

Oxford BioMedica has today announced a significant agreement with Novartis for the ongoing commercial and clinical supply of lentiviral vectors used to produce CTL019, confirming its status as a major component of Novartis’ future CAR-T plans. The agreement is an extension of the October 2014 collaboration and comes in anticipation of the launch of CTL019 in H217. In deal terms, OXB will receive a $10m upfront payment and could potentially receive $100m+ from Novartis over the next three years. Our forecasts and valuation are under review (in our last published outlook we noted peak royalties of GBP 12.4m). We await the outcome of CTL019’s FDA advisory committee meeting (12 July) to shed more light on its path to approval and likely commercial success.

Cellular Biomedicine Group

A transpacific cell therapy company

QuickView | Pharmaceutical & healthcare | 02 May 2017

Cellular Biomedicine Group (CBMG) has seven preclinical CAR-T programs and two Phase I clinical trials using its CD19 CAR-T therapy in China, making it the only US-traded CAR-T company in this market. It has rights to the Dendristim lung cancer vaccine. In addition, it is adapting its osteoarthritis (OA) treatment ReJoin as an allogeneic product, AlloJoin, which will be developed in the US after an IND in 2017 or 2018.

Oxford BioMedica

Encouraging CTL019 data in paediatric r/r B-ALL

Flash note | Pharmaceutical & healthcare | 05 Dec 2016

At ASH this weekend, Novartis presented data from its global registration trial (ELIANA) of CTL019 in relapsed/refractory (r/r) paediatric and young adults with B-cell acute lymphoblastic leukaemia (B-ALL). In one of the largest CAR-T trials to date, 41 out of 50 (82%) treated patients achieved a complete remission or complete remission with incomplete blood count recovery. These positive results have prompted Novartis to reaffirm its timelines for filing in B-ALL, with a submission to the FDA expected in early 2017 and to the EMA later in 2017. This data, along with the restated timelines, reinforce our forecasts for Oxford BioMedica (OXB), which manufactures and supplies the vectors that are utilised in CTL019. We value OXB at GBP 173m (6.2p/share).

Oxford BioMedica

Harnessing the CAR-T

Outlook | Pharmaceutical & healthcare | 27 Jul 2015

Over the past year, Oxford BioMedica's outlook has been transformed. The near term is now geared to the emerging specialist production capabilities, where the expertise in cell- and gene-based medicine is increasingly appreciated. Progress on the development pipeline, notably the RetinoStat programme and, further out, ProSavin/OXB102, would add to our valuation. The longer term should benefit from additional collaborations for the late-stage projects, license income from the patent estate and other pipeline products. Our valuation is £356.1m (13.9p a share), with OXB Solutions valued at £233.5m (9.2p a share) and the pipeline at £122.6m (4.7p a share).

Medigene

Riding high on immuno-oncology

Update | Pharmaceutical & healthcare | 06 May 2015

Medigene shares have doubled in the last two months, a surge we attribute to renewed investor enthusiasm for its emerging cancer immunotherapy franchise. With a recent flurry of licensing deals over CAR-T technology platforms and products, at a time of widespread excitement about the transformational potential of this approach to treating certain cancers, Medigene's preclinical stage adoptive TCR (T-cell receptor) therapy may be attracting particular interest. We raise our valuation to €175m, or €12.55 per share, on re-evaluation of the cancer immunotherapy franchise.

Oxford BioMedica

New non-dilutive funding to expand production

Flash note | Pharmaceutical & healthcare | 05 May 2015

Oxford BioMedica has secured a $50m loan facility from Oberland Capital. The funds will be used primarily to expand the manufacturing capacity for Novartis' CTL019/CART-019 clinical development programme, with $25m to be drawn down immediately. This production contract is important, not only commercially (worth up to $90m over three years) but in validating the company's expertise. The loan has sufficient headroom to also fund Oxford BioMedica's pipeline development and for product acquisitions.