Pipeline Highlights - ONCT-534, a Dual-Action Androgen Receptor Inhibitor (DAARI), is in Phase 1/2 clinical study for prostate cancer, with initial data expected in Q3 2024[8, 86] - ONCT-808, an autologous CAR T cell therapy targeting ROR1, is in Phase 1/2 clinical study for aggressive B-cell NHL, with a clinical data update expected in Q3 2024[8, 86] - Zilovertamab, a monoclonal antibody targeting ROR1, is seeking partnerships for further clinical trials in hematological malignancies and solid tumors[15, 81] ONCT-534 Key Points - The sixth cohort (1200 mg once daily) is fully enrolled in the Phase 1/2 dose escalation study in R/R mCRPC[8, 90] - ONCT-534 has shown activity in preclinical prostate cancer models of androgen receptor inhibitor resistance[8, 90] ONCT-808 Key Points - In the ONCT-808-101 study, 2 out of 3 patients achieved complete metabolic response (CMR) and 1 out of 3 patients achieved partial response (PR) in the 1x10^6 CAR T cells/kg cohort[72] - ONCT-808 CAR T cells expand and are persistent in all three patients from the 1 x 10^6 CAR T cells/kg dose cohort and the first patient from the 03 x 10^6 CAR T cells/kg dose cohort[75] Zilovertamab Key Points - In a pooled analysis with a median follow-up of 40 months, PFS for p53 mut/del(17p) was 100% for zilovertamab + ibrutinib[79, 80] Financial Highlights - As of March 31, 2024, Oncternal Therapeutics had $270 million in cash and short-term investments, providing a cash runway into Q1 2025[8, 87, 90] - The company anticipates $40 million in non-dilutive support through NIH grants[87]

Oncternal cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on Oncternal's current ...

Core Insights - Merck (MRK) announced positive data from the dose confirmation phase of the phase II/III waveLINE-003 study for zilovertamab vedotin, an antibody drug conjugate (ADC) targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] Study Results - The waveLINE-003 study showed a 56.3% objective response rate (ORR) for zilovertamab vedotin (1.75 mg/kg) in combination with standard-of-care rituximab and gemcitabine-oxaliplatin (R-GemOx), with eight patients achieving complete response (CR) and one partial response [2][6] - The phase II portion of the study indicated a promising response rate and manageable safety profile for zilovertamab vedotin in combination with standard care [3] Development Activities - Zilovertamab vedotin is a first-in-class ADC targeting ROR1, a protein overexpressed in various hematologic malignancies, representing a potential innovation in cancer treatment [4] - The ADC is being evaluated in additional mid-to-late-stage studies for DLBCL, including phase III waveLINE-010 and phase II waveLINE-007 studies for previously untreated DLBCL patients [7] - A new phase II waveLINE-011 study has been initiated to compare zilovertamab vedotin plus rituximab and R-CHP against polatuzumab vedotin with R-CHP for DLBCL treatment [8] Other Developments - Merck also reported data from the phase I KANDLELIT-001 study for its KRAS G12C inhibitor candidate, MK-1084, showing manageable safety and antitumor activity in advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients [9][10] - The phase III KANDLELIT-012 study is evaluating MK-1084 in combination with cetuximab and mFOLFOX6 for first-line treatment of KRAS G12C-mutant CRC, while the phase III KANDLELIT-004 study is investigating its use with Keytruda for metastatic NSCLC [11]