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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.

Celyad

Developing a sophisticated clinical strategy

Update | Pharmaceutical & 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.

Celyad

Progressing a broad clinical strategy

Update | Pharmaceutical & 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.

Medigene

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.

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.

Celyad

Revision of clinical strategy after responses seen

Update | Pharmaceutical & healthcare | 30 Oct 2017

Celyad has reported a complete morphological leukaemia-free status (MFLS) response in acute myeloid leukaemia (AML) in the NKR CAR T-cell THINK study. Spontaneous remission in refractory/relapsed AML is extremely rare, so this is a significant result. Importantly, the response was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date. The clinical strategy has been updated to focus on AML and colorectal cancer. Additionally, with the approvals of Yescarta (Gilead) at a price of $373k and Kymirah (Novartis) at $475k, we have increased our expected price for NRK CAR T-cell therapy to $200k, formerly $150k. The revised strategy and price assumption change moves the indicative value to EUR 103 per share, formerly EUR 51.6 per share.

Celyad

Revision of clinical strategy after responses seen

ADR Update | Pharmaceutical & healthcare | 30 Oct 2017

Celyad has reported a complete morphological leukemia-free status (MFLS) response in acute myeloid leukemia (AML) in the NKR CAR T-cell THINK study. Spontaneous remission in refractory/relapsed AML is extremely rare, so this is a significant result. Importantly, the response was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date. The clinical strategy has been updated to focus on AML and colorectal cancer. Additionally, with the approvals of Yescarta (Gilead) at a price of $373k and Kymirah (Novartis) at $475k, we have increased our expected price for NRK CAR T-cell therapy to $200k, formerly $150k. The revised strategy and price assumption change moves the indicative value to $122 per ADR, formerly $61 per ADR.

Celyad

First "clinical validity" for NKR CAR T-cells

Flash note | Pharmaceutical & healthcare | 04 Oct 2017

Celyad has reported a complete morphological leukaemia-free status (MFLS) response in acute myeloid leukaemia (AML) in the NKR CAR T-cell THINK study. Given that spontaneous remission in refractory/relapsed AML is extremely rare, this is an important result for natural killer CAR T-cell therapy. Importantly, the complete remission was achieved with no toxic preconditioning. CYAD-01 has shown limited toxicities to date

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

What comes after CD19 CAR?

Comment | Pharmaceutical & healthcare | 27 Sep 2017

This report forms Part 2 of a detailed review of T-cell therapies. It gives a more detailed and scientific overview of the area to enhance the summary analysis of investment criteria in Part 1. This report has a general technology introduction and four detailed therapy-focused sections.

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.