Oncology data dominated the health and biotech news flow as the European Society for Medical Oncology Congress in Madrid drew near, with Faron Pharmaceuticals, GSK and PureTech Health all releasing clinical results ahead of the gathering. Elsewhere, ProBiotix Health reported its first EBITDA profit on surging sales, Hemogenyx Pharmaceuticals struck a deal to explore an off-the-shelf CAR-T delivery route, and smaller names TheraCryf and Nuformix advanced their respective pipelines.
Faron posts final melanoma survival data ahead of ESMO
Faron Pharmaceuticals (AIM:FARN) has reported final results from the metastatic melanoma cohort of its Phase 1/2 MATINS study, with the data accepted as an ePoster at the ESMO Congress running from 23 to 27 October in Madrid. The Turku-based clinical-stage biopharmaceutical company, which develops immune-based cancer treatments, shares fell 2.778% to 35.0p despite the update marking the first complete survival readout across all 25 patients in the cohort, building on interim data presented in 2022 and 2023.
The cohort enrolled 25 patients with checkpoint inhibitor-refractory metastatic melanoma who received single-agent bexmarilimab at doses of 0.3 to 10 mg/kg every three weeks, all having failed prior anti-PD-1 therapy and 48% also having failed anti-CTLA-4 treatment. Disease control rate stood at 20%, with median overall survival of 7.6 months; patients achieving disease control saw median overall survival of 15.2 months versus 6.2 months for non-responders, and 12-month survival rates of 80% against 35% respectively, though Faron cautioned the difference did not reach statistical significance given the cohort's size. Treatment-emergent adverse events affected 96% of patients, with grade 3 or higher events in 56% and serious events in 44%, which the company attributed to the heavily pretreated nature of the population.
"What interests us most is the biology underneath it," said Petri Bono, chief medical officer at Faron Pharmaceuticals.
The exploratory biomarker findings are the real signal here: patients who achieved disease control started with lower baseline serum interferon gamma and saw a median peak rise of 181% on treatment, consistent with reactivation of a suppressed immune response. For a company whose bexmarilimab programme has faced scrutiny over efficacy in heavily pretreated populations, identifying a biomarker that tracks with clinical benefit gives Faron a rationale to prioritise patient selection in future combination trials, potentially sharpening the odds of a cleaner readout than this single-agent cohort delivered.
ProBiotix Health swings to EBITDA profit as sales jump
ProBiotix Health (AQSE:PBX) told investors that sales rose 36% to £2.68m in the nine months to 30 September, up from £1.97m a year earlier, with shares edging up 0.82% to 7.0775p. The AQSE-listed life sciences company, which develops probiotics for cardiometabolic health, posted EBITDA of £0.15m for the period against a £0.25m loss in the prior year, while gross profit nearly doubled to £1.64m from £0.87m, lifting gross margin to 61% from 54%.
The group held a cash balance of £1.2m, which it said is sufficient to fund planned activities. Chief executive Steen Andersen pointed to "the continued expansion of our customer base, growing pipeline of active sales opportunities and increasing commercial interest at key industry events, including CPhI in Milan and Vitafoods in Barcelona" as reinforcing confidence in the business. The group's LPLDL probiotic strain underpins a run of recent regional supply deals, including partnerships with Nutrisan in Belgium and iProbio in Slovakia.
The swing from a six-figure EBITDA loss to profit, paired with margin expansion, marks a credibility milestone for a company whose commercial model depends on licensing a single proprietary strain across multiple geographies. With cash on hand and a widening partner network, ProBiotix now has room to show whether that model scales profitably rather than simply growing top line.
Hemogenyx tests off-the-shelf route for CAR-T therapy
Hemogenyx Pharmaceuticals (LSE:HEMO) has entered a feasibility study agreement with Nitto Denko Corporation, the Tokyo-listed Japanese materials manufacturer, to explore delivering its CAR-T technology without individualised cell manufacturing. Shares in the London-listed, clinical-stage biopharmaceutical group jumped 6.38% to 700.0p as the company outlined plans to test whether Nitto's cell-targeted lipid nanoparticle technology can deliver messenger RNA encoding its FLT3-targeting chimeric antigen receptor directly to a patient's T cells inside the body.
That would represent a first step toward an "in vivo" CAR-T approach, where an injectable medicine reprogrammes T cells within the patient rather than requiring cells to be engineered externally. Hemogenyx's lead candidate, HG-CT-1, is currently an autologous therapy manufactured from each patient's own cells, collected, engineered and expanded outside the body before being returned, a complex, patient-by-patient process. "This Study with Nitto, a recognized leader in nucleic acid medicine and drug delivery, opens that opportunity for Hemogenyx, considerably extend the value of our CAR-T platform," said Dr Vladislav Sandler, chief executive of Hemogenyx.
If feasibility proves out, the implications for Hemogenyx's cost base and scalability are significant: an in vivo approach would strip out the manufacturing bottleneck that constrains autologous CAR-T economics industry-wide, potentially repositioning HG-CT-1's underlying platform as a licensable technology rather than a single-product bet.
GSK reports early response data for lung cancer drug Ris-Rez
GSK (LSE:GSK) reported the first global data for risvutatug rezetecan (Ris-Rez), its investigational B7-H3-targeted antibody-drug conjugate, in patients with relapsed extensive-stage small cell lung cancer. Shares dipped 0.56% to 1852.0p even as results from the phase Ib dose-optimisation portion of the EMBOLD PanTumour-101 trial showed a confirmed objective response rate of 61% among evaluable patients at the 8mg/kg dose, against 32% at the 6mg/kg dose.
The findings will be presented in a poster session at the ESMO Congress in Madrid and build on positive phase III data reported last month from a Chinese trial of the same drug run by partner Hansoh Pharma. Together, the two datasets supported GSK's selection of the 8mg/kg dose now being tested in its global phase III EMBOLD SCLC-301 study. "As the data for Ris-Rez continues to grow, we remain focused on accelerating development in extensive-stage small cell lung cancer, where patients often relapse quickly and urgently need more treatment options," said Hesham Abdullah, president of oncology at GSK, adding that "today's first global data for Ris-Rez build on the statistically significant overall survival benefit recently reported in Hansoh's pivotal Chinese trial."
The near-doubling of response rate between dose levels gives GSK a clean rationale for its phase III dose choice, reducing a key execution risk heading into the pivotal study. For a pipeline asset partnered with Hansoh in China, consistent global and regional data strengthens the case for Ris-Rez as a future multi-market franchise rather than a regionally confined win.
TheraCryf clears final toxicology hurdle for Ox-1 trial bid
TheraCryf (AIM:TCF), trading at 0.175p, has completed the toxicology work required to support a clinical trial application for its lead candidate Ox-1, clearing a regulatory prerequisite the company needed before it can approach authorities to begin human testing.
Completing toxicology studies is typically the last major preclinical gate before a trial application can be filed, and for a micro-cap developer at TheraCryf's stage, clearing it de-risks the near-term pathway to first-in-human data, a milestone that will shape how the market prices the stock ahead of any filing decision.
Nuformix reports fresh evidence of TGF-β pathway engagement for NXP002
Nuformix (LSE:NFX) shares rose 4.545% to 0.115p after the company reported new evidence that its NXP002 candidate engages the TGF-β signalling pathway, a mechanism implicated in fibrotic disease progression.
Pathway engagement data of this kind gives Nuformix a mechanistic underpinning for NXP002's therapeutic rationale, supporting the scientific case the company will need to make to partners or regulators as it advances the programme toward further clinical development.
PureTech's LYT-200 data to feature in ESMO oral presentation
PureTech Health (LSE:PRTC) will have data on its LYT-200 candidate featured in an oral presentation at the ESMO Congress in Madrid, with shares slipping 0.43% to 114.109p.
Securing an oral presentation slot, rather than a poster, signals that ESMO's selection committee views the LYT-200 dataset as among the more clinically significant results on the conference agenda, raising the programme's visibility among oncologists and potential partners alike.