Faron Pharmaceuticals Oy
("Faron" or the "Company")
MATINS TRIAL UPDATE
Ovarian cancer selected as second expansion cohort
Company announcement, 27 January 2020 at 9.00 AM (EET)
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the second expansion cohort in its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen will be in patients with ovarian cancer.
The ongoing phase I/II MATINS clinical trial is investigating the tolerability, 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.
Initiation of this second expansion cohort follows approval from the MATINS trial's data monitoring committee earlier this month to initiate the study's first expansion cohort in patients suffering from late-stage colorectal cancer (CRC). Ovarian cancer is a tumour type known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). It presents a high unmet medical need with few available treatments for patients. Large transcript analysis of ovarian tumours indicates significant outcome differences between patients with either high or low Clever-1 expression. Patients with high Clever-1 expression have short life expectancies under current treatment options.
Dr. Markku Jalkanen, Faron's CEO, said: "Data collected so far in the MATINS trial are highly encouraging, with Clevegen establishing itself as a potential immunotherapy capable of downregulating a range of major inhibitory immune checkpoints (PD-1, PD-L1, CTLA-4) across several cancers. Initiation of this additional expansion cohort signals our commitment to rapidly progress the development of Clevegen in patients with limited effective treatment options."
Dr. Tyler Curiel, Professor and The Daisy M. Skinner President's Chair in Cancer Immunology Research, UT Health San Antonio, and MATINS trial site investigator and principal investigator for USA, said: "Ovarian cancer is devastating and there remains a huge need for new treatments. Expanding the MATINS trial to include ovarian cancer patients will help us to understand this novel potential immunotherapy in a patient group where we desperately need to improve outcomes. We are very excited to join the MATINS trial and to start US recruitment."
Existing MATINS trial sites in Europe are currently recruiting for the first expansion cohort in late-stage CRC patients and this second cohort, in a total of 10 patients with ovarian cancer, is expected to follow in the coming weeks. With good tolerability and no dose limiting toxicity signals established across all dosing levels explored in the MATINS trial to date, the dosing for this additional cohort is likely to be higher (e.g. 1 mg/kg) than for the first CRC cohort. MATINS trial sites in the US are expected to begin opening in the short term.
Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial has already shown that Clevegen administration promoted immune activation in all of the dosed patients to date. This would potentially make Clevegen a new and effective macrophage immune checkpoint drug for cancer patients, who frequently suffer from supressed immune capacity toward tumour elimination. Previously announced data also indicate that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current immuno-oncology therapies aim to suppress.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
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
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: [email protected]
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 II 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. Colorectal cancer and ovarian cancer have been selected as the first and second expansion cohorts 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.
About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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.
