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MagForce

NanoTherm US prostate cancer trial initiates

Update | Pharmaceutical & healthcare | 04 Jul 2018

MagForce has announced the enrolment of the first patient in its pivotal clinical trial evaluating NanoTherm focal ablation therapy in the US for prostate cancer. The trial started as expected in Q218 and further patient recruitment is underway at the two clinical sites (CHRISTUS Santa Rosa and the University of Washington). Prostate cancer presents a significant market opportunity in the US (representing ~60% of our rNPV) and makes sense strategically as a first US indication.

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.

Hutchison China MediTech

Jewels in the crown

ADR Outlook | Pharmaceutical & healthcare | 01 Jun 2018

Key near-term value drivers include newsflow from partnered assets savolitinib (AZN globally) and fruquintinib (LLY in China). By year end, we anticipate the China FDA to approve fruquintinib (3L CRC). The molecular epidemiology study (MES) data on savolitinib in PRCC could support a US NDA submission (possible breakthrough therapy designation, BTD). Both products have blockbuster potential; as combination therapies in cancer drive overall uptake of targeted therapies. Beyond this we expect progression in Hutchison China MediTech's (HCM) wholly owned late stage oncology assets to reach value inflection points over the next few years. We have extensively reviewed our financial forecasts and increase our valuation to $47.9/ADS or $6.4bn.

Hutchison China MediTech

Jewels in the crown

Outlook | Pharmaceutical & healthcare | 31 May 2018

Key near-term value drivers include newsflow from partnered assets savolitinib (AZN globally) and fruquintinib (LLY in China). By year end, we anticipate the China FDA to approve fruquintinib (3L CRC). The molecular epidemiology study (MES) data on savolitinib in PRCC could support a US NDA submission (possible breakthrough therapy designation, BTD). Both products have blockbuster potential; as combination therapies in cancer drive overall uptake of targeted therapies. Beyond this we expect progression in Hutchison China MediTech’s (HCM) wholly owned late stage oncology assets to reach value inflection points over the next few years. We have extensively reviewed our financial forecasts and increase our valuation to GBP 71.0/share or $6.4bn.

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.

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.