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Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek

Trinity Delta Lighthouse: Avacta

Trinity Delta view: Updated SGC data in 30-patients confirm that the efficacy and safety signals seen in Phase Ia are consistent and meaningful. Maturing data from the Phase 1b cohort will guide design of the Phase II/III registration study in SGC. Whilst clearly important, we view the real significance of this encouraging data as providing the proof-of-concept for Avacta’s FAP-targeted pipeline. Although faridoxorubicin has a clear clinical, and commercial, role, the greater value of Avacta’s p...

Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek

Trinity Delta Lighthouse: Oxford BioDynamics

Trinity Delta view: Oxford BioDynamics’ focus is maintaining the building sales momentum, growing PSE test volumes to 500 per month within 12 months. Stated objectives within this timeframe include: (1) signing a partnership or distribution deal for PSE (with an upfront fee, milestones, and royalties); (2) out-licensing or partnering a test (most likely CiRT, NST, or ME/CFS); (3) establishing CiRT in the NCCN guidelines; (4) initiating the monetisation of the 3D genomics platform (EpiSwitch Orio...

Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek

HUTCHMED: Pipeline potential underpins long-term growth prospects

HUTCHMED’s recent R&D update highlighted multiple catalysts expected over the next 12-24 months, including the launches of new products and regulatory decisions on new indications for existing products which will be key for near- and mid-term revenue growth in China. Ex-China, partner AstraZeneca has guided towards Phase III SAFFRON top-line data in H126, with savolitinib remaining on track to become HUTCHMED’s second global asset. Longer-term, the proprietary ATTC platform offers significant po...

Franc Gregori ... (+2)
  • Franc Gregori
  • Lala Gregorek

Trinity Delta Lighthouse: Scancell

Trinity Delta view: The data from the SCOPE study of Scancell’s “off the shelf” cancer vaccine SCIB1/iSCIB1+ continue to show a clinically meaningful and commercially relevant improvement over currently achievable treatments. The safety and tolerability also remain attractive, with the iSCIB1+/CPI combination comparable to SoC alone. Positive discussions with regulatory authorities mean investor attention will now focus on the design, timing, and, importantly, funding of the pivotal Phase III re...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Scancell: Abundant development opportunities in immuno-oncology

Scancell’s investment case centres on the potential of the lead oncology programmes from its highly promising ImmunoBody and Moditope “off the shelf” platforms. Following the successful outcome from the SCOPE trial, iSCIB1+ has been selected as the optimal ImmunoBody candidate to progress into a potentially registrational trial. Forthcoming discussions with the FDA should define the registrational trial design. Other 2025 catalysts include further SCOPE data, plus early data from the RCC (renal ...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Oxford BioDynamics

Trinity Delta view: OBD is at the forefront of exploiting 3D genomics to develop clinically relevant diagnostics that address clear needs. The £7m fundraise, which includes participation from new investors, will allow OBD to remain focused on delivering on the potential of the EpiSwitch platform, which will be achieved by growing existing test volumes, and through securing partnerships, collaborations and/or licensing deals to maximise the revenue potential of its growing portfolio, whilst remai...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Avacta

Trinity Delta view: Although addressing attractive, and commercially relevant, indications, we view faridoxorubicin’s (FAP-Dox, previously AVA6000) primary role as being proof-of-concept demonstration of FAP-targeted biotherapeutics. The versatility and broad potential of Avacta’s pre|CISION platform, with the ability to selectively activate potent drugs in the TME, should lead to a deep pipeline of novel targeted therapeutics. The successful £16m placing removes funding uncertainty and allows m...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Avacta

Trinity Delta view: These preclinical data once again provide valuable insights into the versatility and broad potential of Avacta’s pre|CISION platform. The proof-of-concept of FAP-targeted biotherapeutics will be demonstrated through its lead clinical candidate, faridoxorubicin (FAP-Dox, previously AVA6000), but we believe this should be viewed as the first in a pipeline of novel therapeutics that can be selectively activated in the TME, thus reducing toxicity and improving patient outcomes. W...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: HUTCHMED

Trinity Delta view: Elunate in China is already approved in colorectal and endometrial cancers; kidney cancer, the third indication, is currently under regulatory review. Successfully launching new indications for Elunate and the rest of the marketed portfolio will be key revenue growth drivers in China, with the most notable perhaps the recent Orpathys/Tagrisso approval based on SACHI data (representing a much larger lung cancer indication than the initial approved monotherapy indication). Outs...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Oxford BioDynamics

Trinity Delta view: OBD is at the forefront of exploiting 3D genomics to build a portfolio of clinically relevant diagnostics that address clear needs, are accurate, reproducible, and, importantly, are minimally invasive and easy to perform. The successful development of this CFS test is yet another example that highlights the potential of the EpiSwitch platform. Management’s near-term focus remains on securing one or more partnerships, collaborations and/or licensing deals to maximise the reven...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Avacta: Key faridox data and FAP-EXd Phase I start on the horizon

Phase I data from Avacta’s lead pre|CISION asset, faridoxorubicin (formerly FAP-Dox, AVA6000) continues to mature, with presentation of full Phase Ia dose escalation data upcoming at the European Society of Medical Oncology (ESMO) 2025 meeting. Further data from salivary gland cancer (SGC) patients enrolled in the Phase Ia/Ib dose escalation and expansion cohorts are expected by year-end, with similar data in TNBC (triple negative breast cancer) following in H126. These data, along with addition...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta LIghthouse: Scancell

Trinity Delta view: Scancell continues to advance plans to progress its highly promising ImmunoBody “off-the-shelf” DNA cancer vaccine. Selected candidate iSCIB1+ could offer meaningful benefits to a large, identifiable group of advanced melanoma patients. Critical path meetings with regulators are scheduled, and discussions are also ongoing with potential partners, in order to expeditiously initiate a potentially registrational trial in 2026. Further iSCIB1+ data are expected this year, in addi...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: ANGLE

Trinity Delta view: ANGLE’s strategy centres on growing its Pharma Services as it seeks to widen commercial adoption of its proprietary Parsortix technology for CTC capture and subsequent downstream analysis. The marketing focus shifted a year ago towards the better-resourced large pharma customers where, despite more complex selling cycles, there is the potential to drive significant mid- and longer-term revenues. An analogous approach is addressing medtech diagnostics companies to support deve...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Oxford BioDynamics

Trinity Delta view: EpiSwitch CiRT addresses a clear need in helping guide ICI therapy, accurately differentiating between non-responders and responders, thus avoiding unnecessary side-effects and costs. The further clinical validation provided by PROWES data and the expectation that Oxford BioDynamics will apply for clinical guideline inclusion during 2025 should drive wider CiRT adoption by oncologists, growing test revenues, and making CiRT more attractive to potential partners. OBD’s near-te...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: Avacta

Trinity Delta view: In our view, the amended CB terms indicate management confidence in their ability to secure funds to advance Avacta’s pre|CISION assets through clinical development. This funding is likely to come from a variety of sources including partnerships, strategic investment, and/or an equity raise, and could be catalysed by key data readouts slated for the next 12 months: Phase I FAP-Dox SGC results in H225 (potentially at ESMO 2025) and TNBC data in H126. Appetite for Avacta equity...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: HUTCHMED

Trinity Delta view: The China sales decline, plus lowering of revenue guidance are undoubtedly disappointing. However, China growth is already improving and management is confident this will continue during H225, driven by new indications. In particular, the recent Orpathys/Tagrisso approval based on SACHI data represent a much larger indication; importantly, data from the global SAFFRON trial are expected H126. Furthermore, as the sizeable ATTC opportunities become clearer, these could offer si...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Scancell: SCOPE’ing out iSCIB1+ in advanced melanoma

Data from SCOPE, examining Scancell’s highly promising ImmunoBody “off-the-shelf” DNA cancer vaccine, appear to show that a meaningful, additional benefit can be achieved when added to standard-of-care (SoC) CPIs as a first-line treatment in advanced melanoma. iSCIB1+ has been selected as the candidate for further development; it works in a larger, and easily identifiable, patient group that represents 80% of all advanced melanomas, double that of SCIB1. The benefits of iSCIB1+ will need to be d...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta LIghthouse: Scancell

Trinity Delta view: The positive latest results from the SCOPE study of Scancell’s “off the shelf” cancer vaccine SCIB1/iSCIB1+ are important for three reasons: (1) data consistently show a clinically meaningful and commercially relevant improvement over currently achievable outcomes; (2) the better efficacy can be achieved without worsening SoC safety and tolerability; and (3) the selection of iSCIB1+ should allow a larger group of patients (c 80% of melanoma patients vs c 40% with SCIB1) to be...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Scancell: Key ImmunoBody clinical data imminent

Scancell’s investment case centres on the lead cancer vaccines from its highly promising ImmunoBody and Moditope “off the shelf” platforms. Key data from two programmes will determine future development plans and define the commercial opportunities. The first, and most important, are the imminent SCOPE trial results: a successful outcome will allow selection of the optimal candidate (SCIB1 or iSCIB1+) to take into a potentially pivotal Phase II/III trial. Later in 2025, early data from the renal...

Franc Gregori ... (+3)
  • Franc Gregori
  • Lala Gregorek
  • Philippa Gardner

Trinity Delta Lighthouse: HUTCHMED

Trinity Delta view: The approval of the Orpathys/Tagrisso combination in China is an important element for revenue growth and sustained profitability. The smooth China approval, and near-term launch, in this broader NSCLC patient group should mean that Orpathys makes an increasingly meaningful contribution to domestic sales. This NSCLC indication also underpins the major global commercial opportunity for savolitinib, and recent data support the view that similar approvals will happen in global (...

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