RE: Shasqi13 Jul 2024 17:25
I think Shasqi should be much more worried about Avacta than Avacta need be about Shasqi. Extracts from the poster:
• Shasqi's unique CAPAC® (Click Activated Protodrugs Against Cancer) platform uses Nobel Prize winning technology, click chemistry, to selectively activate high doses of cancer drugs directly at the site of the tumor (Figure 1).
• CAPAC is made up of two separate components: a tumor targeted activator and a payload; payloads are activated by a click chemistry reaction occurring at the tumor.
• SQ3370 combines SQL70 (tetrazine-modified sodium hyaluronate) a biopolymer used as the intratumoral activator with SQP33 protodrug (trans-cyclooctene-modified and attenuated payload) that results in release of active Dox at the tumor.
• We have previously reported on the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SQ3370 in a phase 1 dose escalation study in patients with locally advanced or metastatic STS.
• Here we report data from a planned interim analysis of the phase 2a open-label dose expansion study (NCT04106492); the RP2D selected is equivalent to 12x the standard dose of Dox.
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• Two treatment groups were enrolled: Group 1 had unresectable and/or metastatic extremity STS and were treatment naïve; patients in group 1 [N=2] received an injection of the biopolymer activator followed by 5 days of Dox protodrug dosing every 21 days. Group 2 had unresectable and/or metastatic STS and were Dox naïve. Patients in group 2 received an injection of the biopolymer activator followed by ether 3 [N=6] or 5 [N=6] days of Dox protodrug dosing every 21 days. Total N=14.
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• The enrolled population were 50% female, 79% white, with a median age (range) of 58 years (32-89).
• Patients had predominantly (79%) metastatic disease; 86% had prior surgery, 50% prior radiotherapy, and 21% had previously received a checkpoint inhibitor.
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• SQ3370 was well-tolerated at the phase 2a dose of 12x standard Dox, with no dose-limiting toxicities.
• Nausea and fatigue were the most common AEs, all grade ≤ 2; myelosuppression was mild, with 7% anemia, 7% thrombocytopenia, and 29% neutropenia. There was one case of febrile neutropenia; G-CSF use 47%.
• Patients with TEAE grade ≥ 3 was 29%.
• There were three TEAE-related discontinuations, one due to zoster, one due to Palmar-Plantar Erythrodysesthesia Syndrome and one due to pneumonia, that resulted in death.
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• There were 2 unconfirmed partial responses, 8 patients with stable disease, and 4 with progressive disease; the overall response rate (95% CI) was 14% (1.7- 41%).
• Reductions in tumor size were seen in both the injected and non-injected lesions.
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