cancer therapies

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MagForce

US NanoTherm IDE approval a major milestone

Update | Pharmaceutical & healthcare | 23 Feb 2018

MagForce has received IDE approval to start its first pivotal clinical trial evaluating NanoTherm focal ablation therapy for prostate cancer in the US. This is a major milestone for the company. Prostate cancer in the US presents a significant market opportunity (representing ~60% of our rNPV) and makes sense strategically as a first US indication. The start of this trial will broaden the geographic and therapeutic reach of NanoTherm therapy beyond Europe, where it is already approved for brain cancer. Our updated valuation is EUR 302.6m.

4SC

Steady R&D newsflow

Update | Pharmaceutical & healthcare | 09 Feb 2018

Over the past several months 4SC has reported progress with both its clinical-stage assets – resminostat and 4SC-202. The pivotal trial with resminostat as a maintenance therapy in advanced CTCL passed the first DSMB review and is on track to report data in H119. The Phase Ib/II study with 4SC-202 for melanoma has been initiated, while another Phase II study with 4SC-202 for GI cancer should start in Q118. 4SC-208 completes the core portfolio and is expected to enter the clinic in early 2019. Our valuation is largely unchanged at EUR 347m or EUR 11.3/share (EUR 344m previously).

Viralytics

Looking towards pivotal Cavatak combo studies

Outlook | Pharmaceutical & healthcare | 05 Dec 2017

Viralytics continues to report impressive preliminary data for Cavatak in combination with immune checkpoint inhibitors (ICIs), whether administered intravenously (iv) or by intra-tumoural injection. Viralytics is currently recruiting additional patients in expansion cohorts in melanoma, lung and bladder cancers in order to obtain more robust estimates of tumour response rates. It has announced plans to initiate four Phase I studies in additional indications and has commenced planning for a potential pivotal study of Cavatak plus Yervoy in melanoma patients who had failed prior single-agent, anti-PD1 ICI therapy, a serious unmet medical need. Updates on MITCI, CAPRA and Keynote 200 are expected in Q218. We increase our valuation to A$469m or A$1.95/share (vs A$408m and A$1.70/share).

Targovax

Priming immune response in anticancer combos

Initiation | Pharmaceutical & healthcare | 08 Nov 2017

Targovax is an immuno-oncology (IO) company specialising in two distinct, but complementary approaches. ONCOS-102 is a genetically engineered adenovirus being tested in advanced melanoma, mesothelioma and three other indications run by partners. From the TG platform two mutant RAS-specific, neo-antigen cancer vaccines are in development for colorectal and pancreatic cancers, for which interim Phase I/II results with positive survival data were presented at ASCO in June 2017. Targovax’s core proposition is to use its products as immune response primers and combine with other anticancer therapies, such as checkpoint inhibitors, for increased efficacy. We value Targovax at NOK1.69bn or NOK32.1 per share.

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.

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.

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.