Kineta has resumed enrolment in the Phase I/II VISTA-101 clinical trial of its lead cancer therapy, KVA12123, in combination with Merck & Co (MSD)’s Keytruda (pembrolizumab).
It has been a hard year for the biotech after it lost funding in February. The company stated that “certain investors indicated that they would not fulfil their funding obligation due in April 2024 pursuant to the previously disclosed private placement financing”.
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The cash preservation measures saw the company halt enrolment in the Phase I/II VISTA-101 clinical trial (NCT05708950). Kineta also laid off 64% of its workforce, including its CEO, Shawn Iadonato, and the general counsel and secretary, Pauline Kenny.
Washington-based Kineta closed the first quarter of 2024 with $1.8m in cash reserves stating that it is not enough to fund operations for the next 12 months, as per a 15 May press release. The company also noted that it had received $500,000 from an investor as part of private placement. Adding that Kineta is litigating against the other two investors.
KVA12123 is an immunoglobulin (Ig) G1 monoclonal antibody that targets negative immune checkpoint regulatory protein V-domain Ig suppressor of T-cell activation (VISTA). Kineta acquired the therapy as part of a reverse merger of Yumanity in 2022. In July, the company signed an exclusivity and right of first offer agreement for KVA12123 with TuHURA Biosciences. Kineta received $5m in nonrefundable payment as part of the agreement.
The Phase I/II VISTA-101 trial plans to enrol approximately 316 participants with solid tumours, as per ClinicalTrials.gov. According to Kineta, KVA12123 and Keytruda combination therapy has cleared the fifth of six monotherapy dose levels and two of the four cohorts.
In April 2024, the company reported that 30 patients had been enrolled in the trial, with 21 being in the monotherapy escalation arm and the rest in the combination arm. In the combination group, the best overall response was seen in two out of three patients. A partial response in a mucoepidermoid carcinoma patient with a “54% reduction in target lesions and a complete response in non-target lesions”.
