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Linnaeus’ new investigational drug gets FDA clearance to treat cancer
Patient Assistance Programs (PAPs), growing initiatives from governments from various countries for cancer awareness, surging prevalence of cancer across the globe, and robust R&D initiatives and clinical trials from key players in the medical industry is driving the cancer therapy market. Several global firms are increasingly working towards the development of treatments for cancer.
An instance of this was recently observed when, Linnaeus Therapeutics, a New Jersey based biotechnology company focused on the identification and development of small-molecule agents for cancer treatment, reportedly announced that its new investigational drug, LNS8801, has been cleared by the Food and Drug Administration (FDA).
LNS8801 is a small molecule agonist of the GPER (G protein-coupled estrogen receptor). LNS8801 is being developed for the treatment of hematologic and solid cancer.
Chief Executive Officer at Linnaeus, Patrick Mooney, MD stated that the FDA clearance of LNS8801 enables Linnaeus to start human testing of this IND and also represents the outcome of an incredible effort by the company’s research and development team. IND LNS8801 is a highly selective and potent small-molecule agonist of G protein-coupled estrogen receptor (GPER).
Mooney added that based on epidemiological evidence and the compelling preclinical data, the company believes that IND LNS8801 has the true potential to offer lasting and meaningful clinical benefits for patients suffering from cancer. The company is thrilled to enroll its first patient in the upcoming weeks.
LNS8801 is a highly specific, orally bioavailable, agonist of GPER with its activity being dependent on the GPER expression. Activation of GPER suppresses recognized tumor-associated genes like PD-L1 and c-Myc. In the preclinical cancer models, IND LNS8801 shows potent antitumor activities in a wide varied array of tumors, quickly shrinking tumors as well as inducing immune memory. The LNS8801 monotherapy has substantial antitumor activity, which includes responses that are immune to re-challenge.
FDA allowance of the LNS8801 IND allows Linnaeus to further begin its planned phase 1/2 clinical study in patients suffering from advanced cancers. The phase 1 dose-escalation portion of this study would assess the safety, pharmacokinetics, tolerability as well as LNS8801’s preliminary antitumor activity.
After the establishment of a recommended phase 2 dose, dose extension cohorts are anticipated. The company expects the enrollment of the first patient in the trial conducted during October 2019.
Source credit: https://linnaeustx.com/linnaeus-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-lns8801/