announced encouraging results from its phase I/II clinical trial for Clevegen, the company’s wholly-owned novel precision cancer immunotherapy, in selected metastatic or inoperable solid tumours.
Shares are up nearly 18% following the news.
The study, which administered 10mg/kg of the drug to nine patients, found Clevegen is well tolerated at high doses. Moving forward, the company intends to test even higher doses. And should this dosage also be well tolerated in patients, it would change the course of Clevegen’s commercialization.
A successful and safe administration of this higher dosage would “demonstrate a high tolerability and an unusually wide safety margin for Clevegen compared to other immuno-oncology (IO) products.”
Essentially, Clevegen would be able to begin new clinical studies and accelerate both its time-to-market and its market potential.
Clevegen is currently marketed as having a high potential for patients who “have exhausted all other treatment options.” This, along with the safety proven in the recent study, has led Faron to believe it will have the data necessary to apply for initial regulatory approval by 2022.
As Dr. Markku Jalkanen, CEO of Faron, commented on the update, “We are thrilled with the progress the MATINS study has made during the last few months. We believe we have the first macrophage immune checkpoint drug in clinical development promoting immune activation and are encouraged by the latest data indicating potential early efficacy and good tolerability.
We expect to progress the cohort expansion phase of the study in Q3 2019 in patients with late-stage colorectal cancer and as more data are generated we will seek guidance from regulators regarding the best and fastest pathway to secure initial approval of Clevegen as a single-agent treatment.
We also hope to conclude partnering discussions during H2-2019, which should enable us to expand clinical development to include combination studies exploring the potential of Clevegen in combination with existing immunotherapies."
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