The Targeted Pulse: New Therapies for Melanoma, Myeloma, and More

FDA Clears LP-184 IND for TNBC Trial as Monotherapy & PARP Inhibitor Combo

The investigational new drug application for LP-184 has been cleared by the FDA. With this clearance, a phase 1b/2 trial of the agent will begin in triple-negative breast cancer (TNBC). The trial will assess LP-184 as monotherapy and in combination with a PARP inhibitor. With an average survival of 10 to 18 months for patients with newly diagnosed metastatic TNBC, LP-184 could address a significant unmet medical need.

"This IND clearance for LP-184 in a phase 1b/2 study represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options," said Panna Sharma, chief executive officer and president of Lantern Pharma, in a press release. "The strategic design of our clinical program reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184's potential in TNBC."

Read more about LP-184 here.

RP1 and the Future of Oncolytic Therapy in Melanoma

In an interview with Targeted Oncology^TM, Mohammed Milhem, MBBS, clinical professor at the University of Iowa Health Care, discussed RP1 (vusolimogene oderparepvec), a genetically engineered next-generation herpes simplex virus. While T-VEC is the only approved oncolytic virus for melanoma, RP1 appears more potent in early data.

“The virus is injectable, so you have to find a location where you can actually put the virus in. The nice thing about the study, the IGNYTE study [NCT03767348], is that they allowed us to basically inject anywhere in the body. You could inject viscera like the liver. You can inject deep lymph nodes like the retroperitoneum. That was a very good part of that design, and it was mostly in patients who were progressing on immunotherapy,” Milhem explained in the interview.

Read the full interview here.

First-in-Human Data Highlight Potential of Intracellular Checkpoint Inhibition in Metastatic Colorectal Cancer

First-in-human data has demonstrated the feasibility and potential efficacy of targeting the intracellular immune checkpoint CISH in patients with heavily pretreated metastatic colorectal cancer.

The phase 1 study (NCT04426669) evaluated the effects of administering autologous neoantigen-reactive tumor-infiltrating lymphocytes with CRISPR/Cas9-mediated knockout of the CISH gene in 12 patients with advanced metastatic colorectal cancer who had progressed through multiple prior lines of therapy, including standard chemotherapy and biologic agents. Notably, the treatment demonstrated a favorable safety profile, with the most common severe adverse events being hematological effects from the lymphodepleting chemotherapy and anticipated effects of IL-2.

Learn more about this study here.

FDA Grants ISB 2001 Fast Track Designation in RRMM FDA Grants ISB 2001 Fast Track Designation in RRMM

The FDA granted ISB 2001 fast track designation for the potential treatment of adult patients with relapsed/refractory multiple myeloma (RRMM). This indication is for patients with RRMM who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

ISB 2001 is a trispecific T-cell engager that targets BCMA and CD38 on myeloma cells and CD3 on T cells. The agent was developed using the proprietary BEAT® protein platform from Ichnos Glenmark Innovation. ISB 2001 was previously granted orphan drug designation by the FDA in July 2023.

Check out the full story here.

CBT Benefits Cancer Patients' Mental Health and Treatment Adherence

In an interview with Targeted Oncology^TM, Sofia Chernoff, PsyD, MSEd, clinical health psychologist, educator, and supervisor overseeing training initiatives and clinical services as Beck Institute’s Director of CBT Programs, discussed the use of cognitive behavioral therapy (CBT) and its specific utility for patients with cancer. Specifically, Chernoff highlighted how oncology health care providers can use CBT with their patients.

“Beyond that, I think that there's so much early-stage fantastic research out there that is popping up that says that not only mental health providers can deliver CBT, but really health care providers [in general] can deliver CBT, and with as much efficacy in a much briefer format,” Chernoff explained. “Training in CBT doesn't have to be this thing. You don't have to get a different degree. It can be quick, as much as 1 or 2 hours [of training]. And CBT tools that our health care providers can use are very much adjusted for their specific setting and role, so they don't have to take on the role of a therapist or psychologist to deliver good care.”

Read the full interview here.