On Wednesday, Candel Therapeutics, Inc. CADL introduced outcomes from a part 3 trial of CAN-2409 viral immunotherapy in intermediate-to-high-risk, localized prostate most cancers sufferers.
The trial met its major endpoint and demonstrated statistically important enchancment in disease-free survival in sufferers who acquired CAN-2409 plus the prodrug (valacyclovir) mixed with the usual of care in comparison with the usual of care alone.
CAN-2409, when administered with valacyclovir, is designed to induce immunogenic cell demise of tumor cells by exposing them to tumor antigens within the context of an activated tumor microenvironment.
Key topline outcomes embrace:
- Statistically important enchancment in disease-free survival (DFS) for CAN-2409 plus radiation remedy (n=496) vs. radiation remedy alone (n=249) (p=0.0155; HR 0.7) within the intent-to-treat inhabitants.
- At 54 months, the CAN-2409 therapy arm noticed a 14.5% relative enchancment in DFS in comparison with the placebo management arm.
- DFS enchancment was noticed in sufferers receiving short-term ADT and people not receiving ADT.
- In an evaluation that targeted on prostate-specific outcomes, CAN-2409 confirmed a extremely important impact on prostate cancer-free survival.
- A big improve within the proportion of sufferers reaching a prostate-specific antigen (PSA) nadir (<0.2 ng/ml) was noticed within the therapy arm in comparison with the placebo management arm (67.1% vs. 58.6%, respectively; p<0.0164).
- CAN-2409 induced 80.4% pathological full responses (pCRs) within the 2-year post-treatment biopsies in comparison with 63.6% noticed within the management arm (p=0.0015).
- The median follow-up time for the recruited inhabitants was 50.3 months.
The security profile of CAN-2409 was typically according to earlier research, with no new security alerts recognized. The commonest CAN-2409-related opposed occasions had been flu-like signs, fever and chills, which had been typically delicate to average in severity and self-limited.
The corporate additionally reported that the part 2 scientific trial of monotherapy CAN-2409 in 190 sufferers with low-to-intermediate threat localized prostate most cancers present process lively surveillance.
The trial confirmed numerical enchancment in time to radical therapy and the share of sufferers reaching damaging (prostate cancer-free) biopsies at 1-year post-treatment. Nonetheless, these variations didn’t attain statistical significance.
Value Motion: CADL inventory is up 167.70% at $12.34 through the premarket session finally verify Wednesday.
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