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Oryzon Genomics

New data support holistic effects of ORY-2001

Update | Pharmaceutical & healthcare | 14 Dec 2017

Recently, Oryzon has published a flurry of fresh preclinical data backing its products ORY-2001 and ORY-3001. Latest data from ORY-2001 expanded the understanding about its diverse effects on Alzheimer's disease (AD) patients, potentially including a disease modifying effect. At ASH in December 2017 Oryzon revealed first preclinical data with ORY-3001 showing that the drug could be effective in sickle cell disease. The company also introduced its plans to continue the development of ORY-1001, its lead oncology asset, once it gets the rights back in early Q118, after Roche completes a dose-finding study with small cell lung cancer patients. Our valuation is EUR 305m or EUR 8.9/share (vs EUR 8.6/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.

Orgenesis

Executive interview - Orgenesis

Edison TV: | Pharmaceutical & healthcare | 28 Nov 2017

• Orgenesis is a vertically integrated biopharmaceutical company with expertise and unique experience in cell therapy development and manufacturing.• Through its Israeli subsidiary, Orgenesis Ltd, Orgenesis is a pioneer in the development of technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, insulin producing cells (IPCs).• Its Belgian subsidiary, MaSTherCell, is a global Contract Development and Manufacturing Organization (CDMO), through which Orgenesis is able to deliver optimised process industrialisation capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market.

Heidelberg Pharma

ATACking cancer cells with novel technology

QuickView | Pharmaceutical & healthcare | 16 Nov 2017

Heidelberg Pharma is building a proprietary pipeline of Antibody Targeted Amanitin Conjugates (ATACs). Lead product, HDP-101, is in preparation to start clinical development at the end of 2018. The company has a back-loaded research and option deal with Takeda that could be worth up to $113m per product. The investment case rests on its current and new partnerships and on the clinical progress of its proprietary ATAC pipeline. Cash at end-9M17 was €4.5m; the company has an additional funding commitment of €5.6m, sufficient into Q218.

CO.DON

Green light for Spherox from the EMA

QuickView | Pharmaceutical & healthcare | 15 Nov 2017

CO.DON is a leading manufacturer of autologous cell therapies for the treatment of cartilage defects. The company's main product, Spherox, is based on the core spheroid technology and can repair cartilage defects of the knee of up to 10cm2 in a minimally invasive procedure. The Phase III clinical trial allowed CO.DON to obtain marketing authorisation from the European Medicine Agency (EMA) in July 2017, which opened access to all European markets. The company is preparing for the roll-out of Spherox and has already received a green light from the UK's National Institute for Health and Care Excellence (NICE).

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.

Hutchison China MediTech

WCLC highlights savolitinib combination potential

ADR Update | Pharmaceutical & healthcare | 19 Oct 2017

Data presented at the World Conference on Lung Cancer (WCLC) on combination approaches to treat resistant EGFR-driven non-small cell lung cancer (NSCLC) highlight a widening of the patient population that could be eligible to receive savolitinib in combination with either Tagrisso or Iressa. Partner AZN now has the data set to make a decision on global Phase III trials and evaluate breakthrough therapy designation (BTD) potential in both 2L and 3L EGFR-resistant NSCLC; in our view, data to date supports both. BTD could offer earlier entry into the US market. Furthermore, Phase II data presented on fruquintinib in combination with Iressa (first line EGFRm NSCLC) showed encouraging efficacy and acceptable safety. We place our forecasts and valuation under review as we revisit our peak sales assumptions.

Hutchison China MediTech

WCLC highlights savolitinib combination potential

Update | Pharmaceutical & healthcare | 18 Oct 2017

Data presented at the World Conference on Lung Cancer (WCLC) on combination approaches to treat resistant EGFR-driven non-small cell lung cancer (NSCLC) highlight a widening of the patient population that could be eligible to receive savolitinib in combination with either Tagrisso or Iressa. Partner AZN now has the data set to make a decision on global Phase III trials and evaluate breakthrough therapy designation (BTD) potential in both 2L and 3L EGFR-resistant NSCLC; in our view, data to date supports both. BTD could offer earlier entry into the US market. Furthermore, Phase II data presented on fruquintinib in combination with Iressa (first line EGFRm NSCLC) showed encouraging efficacy and acceptable safety. We place our forecasts and valuation under review as we revisit our peak sales assumptions.

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.