Faron Pharmaceuticals Oy
("Faron" or the "Company")
Poster discussion presentation at ESMO Congress highlights effective immune switch in MATINS patients with advanced solid tumours
TURKU - FINLAND, 30 September 2019 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces details from a poster discussion presentation held at the European Society of Medical Oncology (ESMO) 2019 Congress to showcase recent data from its ongoing MATINS study.
The phase I/II MATINS clinical trial is investigating the safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. During the session Dr Petri Bono, principal investigator of the MATINS trial, presented data showing Clevegen's potential early efficacy and good tolerability. The discussion highlighted:
· Good tolerability across all dosing levels with no dose limiting toxicity (DLT) observed. Maximally tolerated dose (MTD) has not been reached yet.
· Promising clinical anti-tumour activity, evidenced by the trial's first long-lasting partial responder - a heavily pre-treated metastatic colorectal cancer (CRC) patient, whose tumour had been classified as microsatellite instability (MSI)-low and tumour mutation burden (TMB), and who had previously been treated with six different anti-cancer drugs, which had all failed. MSI-low colorectal patients represent around 90% of all colorectal cancers and over one million annual cases globally.
· Th1 immune activation was observed in all subjects measured following treatment with Clevegen, confirming earlier ex vivo results with human cells (Palani et al., 2016). The patients also increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or had a substantial increase in mobile natural killer (NK) cells in the blood, all signs of this desired immune activation.
· Clevegen's potential to overcome the immunosuppressive environment in difficult-to-treat PD-1/PD-L1- resistant immunologically non-inflamed (cold) tumours, by converting them into inflamed (hot) tumours.
· The ongoing development path investigating Clevegen as a monotherapy in CRC MSI-low patients and other advanced solid tumours (liver, pancreas, ovarian and melanoma), including targeting patients with hormone receptor-positive breast cancer, gastric cancer and uveal melanomas. The potential of Clevegen to bring a synergistic benefit to existing immunotherapies also warrants further investigation through future combination studies.
Commenting on the presented data, Dr. Petri Bono, principal investigator of the MATINS study, said: "We are very encouraged by the progress of this trial. The emerging tolerability profile and early signs of clinical benefit from this novel anti Clever-1 antibody are promising, particularly as the patients enrolled in the MATINS trial had already received several lines of treatment and exhausted all available options for further therapy. Early indications of its potential to convert cold tumours to hot are an important signal for the next wave of immunotherapies in development and we look forward to generating further data as the trial continues."
The poster discussion was held at ESMO 2019, Barcelona, on 28 September 2019. The full abstract and poster are available online at the ESMO Congress website: https://www.esmo.org
Title: Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumours
Presenter: Dr. Petri Bono, MATINS trial principal investigator
Abstract Number: 6587
Further information, including poster and discussion slides, is also available at the company web pages (www.faron.com).
About the MATINS study
The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. Cancer patients with high Clever-1 expression are identified with a simple blood myeloid cell staining with Clevegen ("liquid biopsy").
Part I of the trial deals with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. The Company has already announced that colorectal cancer (CRC) has been selected as the first expansion cohort in Part II. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
[email protected]
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley (Corporate Finance)
James Stearns (Corporate Broking)
Phone: +44 207 886 2500
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: [email protected]
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: [email protected]
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other immune checkpoint molecules. Traumakine, the Company's pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", "hope", "seek", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.
A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.
