Breakthrough Therapy Designation for RP1 and RP1 BLA submitted to the FDA under the Accelerated Approval Pathway November 26, 2024
Further positive data announced from SCOPE trial of SCIB1 with double CPIs for Advanced Melanoma November 19, 2024
Highly Significant Results In Ph 3 Study Of Ameluz®-Photodynamic Therapy (PDT) in Superficial Basal Cell Carcinoma (sBCC) Announced November 5, 2024
Updated Ph 1b Data on ACTengine® IMA203 TCR-T Targeting PRAME in Melanoma Patients announced; upcoming SUPRAME Ph 3 Trial to be registrational study October 15, 2024
First Patient Dosed in Ph 1b Trial, MELODY-1 of MB097 Precision Microbiome Co-Therapy in Advanced Melanoma October 8, 2024
TIL-based cNeT program to be discontinued and Ph 1/2a CHIRON and THETIS clinical trials to be closed September 24, 2024
FDA Approves IDE to Initiate Multi-Center Investigator-Initiated Study of Alpha DaRT® in Immunocompromised Patients with Recurrent cSCC September 24, 2024
Successful pre-BLA meeting with the US FDA to support BLA for RP1 (vusolimogene oderparepvec) in anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024 announced September 17, 2024
Scancell and PharmaJet to use Stratis® IM Needle-free delivery System for SCIB1/iSCIB1+ vaccine for Advanced Melanoma September 17, 2024
IDMC recommends continuing Ph 3 trial (IOB-013/KN-D18) of IO102-IO103 following a per-protocol interim analysis September 10, 2024
Fast Track Designation Granted for VMT01 for the Diagnosis & Treatment of MC1R-Positive Melanoma September 10, 2024
GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 + KEYTRUDA in Patients with IO-Resistant HCC, Melanoma, and RCC September 3, 2024
Ph 3 KEYNOTE-867 trial in NSCLC and KEYNOTE-630 Trial in cSCC to be discontinued based on DMC recommendations September 3, 2024
Ph 3 Trial of IO102-IO103 + KEYTRUDA as 1L Treatment in Advanced Melanoma to be continued without modifications based on DMC recommendations September 3, 2024
Ph 2 results from LTX-315 skin cancer (BCC) trial show an 86% overall reduction of tumor size, complete clearance in half of the patients August 22, 2024
Positive Topline Ph 2 Results Announced for mRNA Immunotherapy BNT111 in Patients with Advanced Melanoma August 6, 2024
FDA Accepts BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma July 30, 2024
Update Provided from iSCIB1+ Clinical Advisory Meeting to Strengthen Plans for Ph 2/3 Registration Clinical Trial July 27, 2024
BLA resubmitted to the FDA for cosibelimab for patients with metastatic or locally advanced cSCC not candidates for curative surgery or curative radiation July 9, 2024
SEACRAFT-2 Pivotal Ph 3 Trial of Naporafenib + Trametinib Initiated in Patients with NRAS-Mutant Melanoma June 25, 2024
