Sapience, Intensity, Kazia and Transcenta Tout Early Success at ASCO
Four life sciences companies posted updates on their respective programs ahead of the American Society of Clinical Oncology (ASCO) annual meeting, taking place June 3-7 in Chicago.
Sapience Lead Cancer Asset Shows Early Potential
Sapience Therapeutics shared that its Phase I trial exploring efficacy proof-of-concept for its lead cancer drug ST101 is seeing an ongoing clinical benefit in three of 25 patients who started treating on May 5. ST101, a first-in-class peptide antagonist of C/EBPβ, is being observed in the Phase II part of a Phase I-II clinical trial in people diagnosed with advanced unresectable and metastatic solid tumors.
The primary objective is to assess the drug's tolerability and safety, as well as determine the dose levels for Phase II. The secondary objectives include pharmacodynamic evaluation, pharmacokinetics and preliminary efficacy.
"The Phase II expansion portion of the study is going very well, with all cohorts enrolling and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101's unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer," Dr. Alice Bexon, chief medical officer of Sapience said in a statement.
Intensity Phase I/II Study Validates Proof of Concept
INT230-6, a combination of cisplatin and vinblastine, is being explored either as a monotherapy or in combination with pembrolizumab. It is designed for direct intratumoral injection.
"The biomarker and clinical data generated in this study provide strong proof-of-concept evidence for our approach and underscore the potential of this new, potential treatment. As recent data readout events in the field of oncology have shown, there remains a high unmet need for novel therapeutic approaches. With that in mind, we are planning for later stage studies in order to advance INT230-6 toward potential future commercialization," Lewis Bender, president and CEO of Intensity Therapeutics, said.
INT230-6 is currently being studied in several Phase II cohorts in patients with various types of advanced solid tumors.
Kazia Encouraged by Glioblastoma Data
Kazia Therapeutics announced positive final data from its Phase II trial of paxalisib as a first-line treatment for patients living with glioblastoma.
In a trial involving 30 participants, the researchers observed a median overall survival rate of 15.7 months in those who received paxalisib versus the 12.7 months reported in the temozolomide group. Temozolomide is the only existing FDA-approved product for first-line treatment. In terms of median progression-free survival, the paxalisib group reported 8.6 months compared to the temozolomide group's 5.3 months.
"The directionality of these analyses gives us greater confidence in the efficacy signals observed and appear encouraging for future development. We are immensely grateful to the investigators and patients whose hard work and engagement has ensured the success of this trial," Dr. James Garner, CEO of Kazia, commented.
Transcenta Touts "Encouraging Clinical Response" in Phase I
Transcenta shared promising clinical data for the dose-escalation part of its ongoing Phase I study of TST001 as a first-line treatment for advanced and metastatic gastric cancer or gastroesophageal junction cancer. TST001, a humanized anti-Claudin18.2 monoclonal antibody, is being assessed for its capabilities when used in combination with Capox.
"From the dose-escalation phase, we are very pleased to show that TST001 is well tolerated and displayed encouraging clinical response in combination with chemotherapy in Claudin18.2 unselected first-line gastric cancer patients. We will continue to evaluate the safety and efficacy of this combination and plan to initiate a multi-center global registration enabling trial in Claudin18.2 positive first-line gastric cancer patients," Dr. Michael Shi, EVP, head of global R&D and CMO at Transcenta, noted in a press release.
TST001 already has an Orphan Drug Designation from the FDA.