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At the 2019 European Society for Medical Oncology (ESMO) conference, Transgene presented the first efficacy data for TG4001 in combination with avelumab (Bavencio) in patients with human papillomavirus (HPV) positive cancers. In the Phase I trial, three out of nine patients treated demonstrated a durable partial response, and no dose-limiting toxicities were observed among the nine patients. All patients had metastatic disease and had previously undergone multiple lines of therapy. The tumour ty
Companies: Transgene SA
Edison
The cancer burden is growing globally. Each year >18 million people are diagnosed, nearly 10 million die and the estimated economic cost exceeds $1 trillion. From early diagnosis to late-stage disease, cancer care often involves inappropriate or unnecessary interventions that drive costs but provide limited clinical benefit. Coupled with an increased understanding of cancer biology and rapid technological advances, this has been driving momentum for precision medicine, leading to patient and soc
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goetzpartners securities Limited
The recent failure of the Phase III PHOCUS trial is disappointing but we do not feel is critical to Transgene’s future. The company’s potential pipeline combined with ICIs remains the key driver of long-term value. Focus now turns to the rest of the pipeline, particularly the expected readout by year end of the Phase II trial of TG4010 + nivolumab in first-line non-small cell lung cancer (NSCLC). Early-stage development continues with the announcement of the Invir.IO collaboration with AstraZene
Key inflection points from lead assets Pexa-Vec, TG4010 and TG4001 by year-end will continue to inform the validity of Transgene’s IO strategy. Notably, a futility analysis expected mid-year for the Phase III trial with Pexa-Vec (+sorafenib) in first-line hepatocellular carcinoma (HCC) and efficacy data from the Phase II TG4010 (+nivolumab + chemotherapy) trial in first-line non-small cell lung cancer (NSCLC) will be key to driving value in 2019. Early-stage development continues with both the e
Transgene develops virus-based product candidates for use in oncology and infectious diseases, its five clinical products are currently in 11 clinical trials across a variety of indications, its most advanced is Phase III trial with Pexa-Vec in first-line Hepatocellular Carcinoma with data anticipated in 2019. Its strategy remains to develop its candidates in combination with approved treatments, notably immune checkpoint inhibitors (ICIs). It anticipates eight clinical readouts across its five
We anticipate nine of Transgene’s ongoing clinical trials to read out data later this year. This will be the first major test of the company’s strategy for combining its products with approved therapies. In our view, data packages from two trials testing the combination of TG4010 and Opdivo in advanced first- and second-line NSCLC will be key inflection points. Cash as of FY17 results will be sufficient to fund operations into 2019. We value Transgene at €236m (€3.8/share) vs €207m (€3.7/share)
Transgene’s strategy is focused on combining its products with approved therapies with the aim of improving response rates in patients. The company now has nine ongoing clinical trials, which are expected to readout in the next 12-18 months, and data will inform Transgene’s future strategy. In addition to numerous trial initiations, Transgene recently presented data on TG1050 in hepatitis B patients, launched its next generation oncolytic virus platform Invir.IO and signed a collaboration agreem
Combinations with immunotherapies are key to Transgene’s strategy. The company is focused on combining its main assets, TG4010 (cancer vaccine) and Pexa-Vec (oncolytic virus), with immune checkpoint inhibitors (ICIs), ipilimumab (Yervoy) and nivolumab (Opdivo). ICIs as monotherapies have proven successful in patients; however, positive efficacy has been limited to certain cancers and long-term responses remain difficult. Combinations with other immunotherapies may improve both addressable popula
Transgene announced a collaboration with Bristol Myers Squibb ("BMY" - BMY US - NC) to evaluate the combination of its therapeutic vaccine TG4010 with the immune checkpoint inhibitor ("ICI") Opdivo (nivolumab) and chemotherapy as first line treatment for non-small cell lung cancer ("NSCLC"). The trial is sponsored by Transgene with BMS supplying the drug. The first read-out due in 2018 is one of several ICI combination Phase II proof-of-concept trials that Transgene is initiating with its late s
Transgene has announced the initiation of two clinical trials of its main assets in combination with immune checkpoint inhibitors (ICIs). A Phase I trial of oncolytic virus Pexa-Vec in combination with Yervoy in solid tumours has started. Additionally, a Phase II study of the therapeutic vaccine TG4010 with Opdivo in second-line advanced lung cancer has started at UC Davis in collaboration with Bristol-Myers Squibb; initial results from both trials are expected later this year. Cash and equivale
Trangene's FY2016 results reveal progress and cash burn in-line with expectations. With €56m in cash, TNG is financed through a series of potential inflection points over the next 12 months. Supported in part by large pharma, Transgene is initiating a series of proof-of-concept trials combining its diverse pipeline of late stage cancer-targeted vaccines and oncolytic viruses with immune checkpoint inhibitors ("ICI"). Three of these trials are due first read out during 2017, providing a significa
Transgene has announced the signing of a collaboration with UC Davis Medical Centre to evaluate the combination of its therapeutic vaccine TG4010 with the immune checkpoint inhibitor ("ICI") Opdivo (nivolumab) as second line treatment for non-small cell lung cancer ("NSCLC") in response to progression after chemotherapy. The trial will be jointly supported by Transgene and Bristol Myers Squibb ("BMY" - BMY US - NC). While it was already known this trial was in preparation, BMY has now revealed i
The advent of immune checkpoint inhibitors ("ICI") has firmly established immunotherapy in the treatment of late stage cancer. While sometimes spectacular, responses to ICIs on their own are limited to a minority of patients. The search is on to identify ICI combination therapies that can boost and / or extend these benefits to more patients. With demonstrated safety and efficacy, Transgene's therapies are compelling candidates. Transgene is initiating several ICI combination proof-ofconcept tri
Transgene has further expanded on its new strategy announced in January 2016 and clarified timelines for combination trials of its product candidates with immune checkpoint inhibitors. Six clinical trials are due to start before 2017 year end; its lead product candidates, Pexa-Vec (oncolytic virus) and TG4010 (therapeutic vaccine) in combination with Yervoy and Opdivo respectively should start phase II trials by year end. Restructuring in 2015 has significantly reduced costs and it is now financ
Research Tree provides access to ongoing research coverage, media content and regulatory news on Transgene SA. We currently have 19 research reports from 3 professional analysts.
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Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
Companies: BIRD MBH CHRT INSE KMK FNTL HDD JNEO CCS
Hybridan
Companies: Aptamer Group Plc
Turner Pope Investments
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
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The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
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Hardman & Co
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
Companies: NTQ KMK JNEO DCTA
LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
Companies: NBPE ICGT ARBB CSN RECI CLIG HAT AVO STX VTA APAX
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