Oncternal Therapeutics, Inc. engages in the development of novel oncology therapies for the treatment of cancers with critical unmet medical need. Its product pipeline include Zilovertamab, ONCT-216, ONCT-808 and ONCT-534. The company was founded by David F. Hale and James B. Breitmeyer in September 1997 and is headquartered in San Diego, CA.
Clinical Trials
5
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Completed
1
20.0%
Terminated
3
60.0%
Withdrawn
1
20.0%
No approval data available
- Oncternal Therapeutics has sold its zilovertamab monoclonal antibody and ONCT-808 CAR-T cell therapy programs to Ho'ola Therapeutics for $3 million upfront and up to $65 million in milestone payments. - Both investigational therapies target ROR1 (Receptor Tyrosine Kinase-Like Orphan Receptor 1), with zilovertamab being a monoclonal antibody and ONCT-808 an autologous CAR-T therapy using zilovertamab's binding domain. - Following the asset sale completed on June 27, 2025, Oncternal has appointed Craig R. Jalbert to oversee the company's wind-down operations and future distribution of milestone payments. - The milestone structure includes up to $5 million for development achievements, $40 million for regulatory approvals, and $20 million for sales thresholds across major markets including the US, Europe, and Japan.
• Sonoma Biotherapeutics has appointed Rajesh Krishnan, Ph.D., as Chief Technical Officer to advance their engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. • Dr. Krishnan brings over 25 years of industry experience in process development and manufacturing, most recently serving as CTO and CSO at Oncternal Therapeutics with previous leadership roles at Dynavax, Gilead, Merck, Amgen, and Pfizer. • The strategic appointment comes at a crucial time for the clinical-stage biotech company as they continue developing novel treatments aimed at restoring immune system balance through proprietary Treg cell therapy platforms.
- A comprehensive pipeline analysis reveals over 25 pharmaceutical companies actively developing treatments for Ewing Sarcoma, with multiple promising candidates in various clinical stages. - Gradalis's Vigil, a personalized cancer immunotherapy, has advanced to Phase III trials in combination with irinotecan and temozolomide for Ewing Sarcoma treatment. - Key emerging therapies include Oncternal's ONCT216, a first-in-class ETS-family transcription factor inhibitor, and Salarius's SP-2577, currently in Phase I/II trials for multiple sarcoma types.
- Oncternal Therapeutics' ONCT-534 demonstrates potential in treating relapsed or refractory metastatic castration-resistant prostate cancer (mCRPC). - Twice-daily dosing of ONCT-534 was well-tolerated, with one patient experiencing a significant PSA reduction and target lesion decrease at a higher dose. - Circulating tumor cell (CTC) analysis revealed promising effects on androgen receptor (AR)-regulated genes and AR nuclear translocation in some patients. - The company is exploring strategic alternatives to further develop ONCT-534, including potential use in earlier lines of therapy for advanced prostate cancer.
- FDA has expanded the approval of pembrolizumab (Keytruda) in combination with pemetrexed and cisplatin for previously untreated advanced/metastatic malignant pleural mesothelioma. - Patritumab deruxtecan demonstrated a statistically significant improvement in progression-free survival versus doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer. - A novel three-drug regimen yielded an 80% response rate in a small study of patients with advanced chronic myelogenous leukemia or high-risk acute myeloid leukemia.
- Oncternal Therapeutics discontinues its Phase 1/2 trial of ONCT-808, a CAR-T therapy targeting ROR1, for relapsed/refractory aggressive B-cell lymphoma due to strategic considerations. - The decision follows promising early antitumor activity of ONCT-808, including complete metabolic responses, but also a patient death at the highest dose tested. - Oncternal is also halting clinical trials for other pipeline candidates and reducing its workforce while exploring strategic options like asset sales or a merger. - The company cites disappointing early results from the ONCT-534 prostate cancer trial and a challenging financing environment as key factors in the decision.
- Oncternal Therapeutics discontinues clinical trials for ONCT-534 in prostate cancer and ONCT-808 in B-cell lymphoma due to lackluster Phase I results and a patient death. - The company's stock price plummeted by 60% following the announcement, leading to a restructuring that includes laying off 37% of its workforce. - This decision follows previous trial terminations of zilovertamab, a tyrosine kinase inhibitor, in April 2023, compounding financial pressures. - Oncternal plans to explore alternative options for its programs while focusing on cost reduction measures and workforce optimization.
