Trial to Examine New Immunotherapy, Libtayo in Advanced Solid Cancers

The first patient has been dosed in a phase 1/2 clinical trial evaluating a novel drug, SNS-101, for the treatment of patients with advanced solid cancers. Additionally, according to a press release from Sensei Bio, the manufacturer of the drug, patients can also currently enroll in an arm of the trial that is investigating SNS-101 plus Libtayo (cemiplimab).

There are three parts of the clinical trial:

• Part A is a phase 1 dose escalation trial (meaning that researchers will increase the dose until they determine the best dosing of the agent) of SNS-101 administered alone.
• Part B is a phase 1 dose escalation trial evaluating SNS-101 in combination with Libtayo.
• Phase C is a phase 2 expansion cohort (meaning that more patients will be able to enroll) of SNS-101 alone or in combination with Libtayo.

For parts A and B, the main goals of the trial are to determine the incidence, nature and severity of side effects, as well as the maximum tolerated dose of SNS-101, while the main goal of part C is objective response rate (percentage of patients whose disease shrinks or disappears from treatment) after approximately one year.

Other endpoints of the study include how SNS-101 works in and interacts with the body; number of patients with anti-SNS-101 antibodies in the body after the last administration of the drug; objective response rate; duration of response disease control rate at one year; progression-free survival (percentage of patients whose did not die or experience disease progression) at one year; and side effects.

SNS-101 is an immunotherapy agent that targets the VISTA protein, which plays a role in regulating the immune system. Similarly, Libtayo is also an immunotherapy drug. This agent targets and inhibits the PD-1 protein, which helps cancer cells to essentially hide from the immune system. Once the PD-1/PD-L1 pathway is inhibited, the patient’s immune system can better find and fight the cancer.

“We are pleased with the rapid enrollment of our clinical trial and are excited to evaluate SNS-101 as a combination therapy earlier than anticipated,” John Celebi, president and chief executive officer of Sensei Biotherapeutics, said in a press release. “Sensei is now treating patients at a dose significantly higher than any VISTA antibody for which clinical data have been reported, while dosing less frequently at a rate of once every three weeks. We believe these important differentiators underscore the vast potential of SNS-101 to treat patients with solid tumors.”

To be eligible for participating in the trial, patients must have a locally advanced, unresectable or metastatic solid tumor; be refractory or intolerant standard of care; have measurable disease; be able to perform all or most of their daily activities independently; have a life expectancy of three or more months; provide treatment biopsy samples; have adequate organ function; and be willing to prevent pregnancy.

The pharmaceutical company announced that it expects to have initial pharmacokinetic (how the drug interacts with the body) and safety data within the first few months of 2024, with preliminary anti-tumor data sometime within 2024 as well.

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