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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

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

Celyad

Gaining value on stable disease observations

ADR Update | Pharmaceutical & healthcare | 15 Aug 2017

The development of Celyad’s natural killer (NK) receptor-based CAR T-cell therapy (NKR-2/CYAD-01) has taken an important step with the initiation of the SHRINK trial, which moves NK CAR T-cell therapy towards the 90%+ of cancer patients who do not have CD19 or BCMA tumors. CYAD-01 is already being tested in THINK with five solid tumor types plus AML and MM. Promising THINK results have been reported at the lowest dose. Celyad has paid $25m in cash and shares to reduce the royalties payable on potential short-term deals and long-term sales. Our indicative value of Celyad has been revised to $616m or $61 per ADR.

Celyad

Gaining value on stable disease observations

Update | Pharmaceutical & healthcare | 14 Aug 2017

The development of Celyad’s natural killer (NK) receptor-based CAR T-cell therapy (NKR-2/CYAD-01) has taken an important step with the initiation of the SHRINK trial, which moves NK CAR T-cell therapy towards the 90%+ of cancer patients who do not have CD19 or BCMA tumours. CYAD-01 is already being tested in THINK with five solid tumour types plus AML and MM. Promising THINK results have been reported at the lowest dose. Celyad has paid $25m in cash and shares to reduce the royalties payable on potential short-term deals and long-term sales. Our indicative value of Celyad has been revised to EUR 524m or EUR 51.6 per share.

Celyad

Colorectal patient in THINK study

Update | Pharmaceutical & healthcare | 09 Jan 2017

Celyad has enrolled the first patient the Phase Ib THINK study. The THINK Phase Ib trial is a major expansion of CAR therapy with five solid tumours plus AML and MM being explored. The first patient has colorectal cancer, a key move into solid tumours, and will be dosed at 3 x 108 autologous cells. In the previous Phase I study, one patient at the highest 3 x 107 dose showed unexpected signs of efficacy. The US allogenic CAR patent has been confirmed. Our interim indicative value remains at EUR 45 per share.

Celyad

Waiting for the Roman results

ADR Update | Pharmaceutical & healthcare | 08 Jul 2016

Celyad's Phase III CHART-1 study in cardiac regeneration missed its primary endpoint, but a clinically defined subgroup with 60% of patients saw a positive outcome, p=0.015. Celyad management believes data are robust enough to discuss submitting a conditional marketing authorization to the EMA for European approval. Data on the CHART-1 composite endpoint will be presented on 28 August 2016. The US Chart-2 trial with a new endpoint and EDV focus will run if partnered. On the basis of limited data, the indicative value has been revised from $96.8 to $35.2 per 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.

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.

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.

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.

Celyad

Novartis says yes to allogeneic technology

Update | Pharmaceutical & healthcare | 04 May 2017

Novartis has taken a non-exclusive licence to Celyad's granted allogeneic US patent for $96m (an upfront fee, we assume $12m, and milestones) plus single-digit royalties. Novartis, a leading player in the haematological CAR T-cell cancer area, presumably aims to expand out of the limited autologous ALL indication where it has a filed BLA. The $96m deal sends a clear signal to other CAR T-cell companies to license quickly or risk being locked out of any allogeneic mass market until 2031. Celyad already has an allogeneic deal with ONO in Japan and Asia. Our indicative value has moved to €52.25 per share, formerly €45.