Oncternal Therapeutics

Sonoma Biotherapeutics Strengthens Leadership Team with Appointment of Rajesh Krishnan as Chief Technical Officer

12 days ago

• 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.

Nirogacestat Shows Deepening Long-Term Responses in Desmoid Tumor Patients

2 months ago

• Long-term treatment with nirogacestat (Ogsiveo) demonstrated improved objective response rates reaching 45.7% at 4 years compared to 34.3% at 1 year in patients with desmoid tumors, according to updated DeFi trial data. • Patients experienced significant quality-of-life benefits with nirogacestat, including rapid pain reduction within two weeks of treatment initiation, allowing many to discontinue opioid medications despite minimal initial changes in tumor imaging. • While 75% of female patients experienced reversible ovarian dysfunction with nirogacestat, the study confirmed that ovarian function returned in all patients who discontinued treatment, providing important reassurance for the predominantly young female patient population.

B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025

2 months ago

• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area. • Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025. • Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.

Robust Pipeline for Ewing Sarcoma Treatment: 25+ Companies Advancing Novel Therapies

3 months ago

• 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.

Pipeline Analysis Reveals 85+ Drugs in Development for Metastatic Prostate Cancer Treatment

3 months ago

• DelveInsight's comprehensive analysis identifies over 80 pharmaceutical companies actively developing 85+ pipeline drugs for metastatic prostate cancer treatment. • Novel therapies in development include TAVT-45, a reformulated abiraterone acetate, and Onvansertib, a first-in-class PLK1 inhibitor, demonstrating innovation in treatment approaches. • Multiple clinical trials are underway, including Phase III studies by major players like Bayer, AstraZeneca, and Novartis, evaluating new treatment combinations and targeted therapies.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Aurion Biotech's AURN001 Shows Promise in Phase 1/2 Trial for Corneal Edema

5 months ago

• Aurion Biotech's AURN001, an allogeneic cell therapy, demonstrated statistically significant improvement in visual acuity in patients with corneal edema in a Phase 1/2 trial. • The high-dose AURN001 arm showed that 50% of patients achieved a ≥15-letter improvement in best-corrected visual acuity (BCVA) at 6 months, compared to 14.3% in the Y-27632-only arm. • Key secondary endpoints, including change in BCVA and central corneal thickness, also showed statistically significant improvements in the high-dose AURN001 arm. • AURN001 combines neltependocel (allogeneic human corneal endothelial cells) and Y-27632 (a rho kinase inhibitor) and is intended as a one-time anterior chamber injection.

ROR1-Targeted Therapies Show Promise in Lymphoma and Solid Tumors

5 months ago

• Zilovertamab vedotin combined with R-CHP achieved a 100% complete response rate in untreated diffuse large B-cell lymphoma patients in a Phase 2 trial. • CS5001 demonstrated an overall objective response rate of 48.4% across all dose levels in patients with advanced lymphomas, showing activity in both solid tumors and lymphomas. • ROR1 is a promising target due to its overexpression in various cancers and its role in tumor growth and metastasis, making it a focus for novel therapies. • Clinical trials are underway for multiple ROR1-targeting therapies, including ADCs, bispecific antibodies, and CAR-T cell therapy, offering new options for cancer patients.

Merck's Zilovertamab Vedotin Shows Promise in Phase 2 DLBCL Trial, Phase 3 Initiated

6 months ago

• Merck's zilovertamab vedotin, combined with R-CHP, achieved a 100% complete response rate in previously untreated DLBCL patients in a Phase 2 trial. • The 1.75 mg/kg dose of zilovertamab vedotin was established as the recommended dose for the Phase 3 trial based on efficacy and safety. • A Phase 3 trial, waveLINE-010, has been initiated to evaluate zilovertamab vedotin plus R-CHP versus R-CHOP in previously untreated DLBCL patients. • The waveLINE-010 trial aims to enroll 1,046 patients globally, with progression-free survival as the primary endpoint.

Biotech Industry Adapts to Evolving Challenges: AI and Innovation Key to Clinical Trial Success

6 months ago

• Industry experts at the Outsourcing in Clinical Trials Conference highlight promising signs of recovery in biotech venture financing, while regulatory reforms and pricing policies pose significant challenges. • Clinical trial complexity and recruitment challenges are increasing, with experts noting longer trial durations and higher failure rates, particularly affecting rare disease research and specialty workforce areas. • Artificial Intelligence emerges as a crucial tool for stabilizing operations, with applications in patient recruitment, data analysis, and protocol optimization, driving demand for professionals with advanced analytical skills.

ONCT-534 Shows Promise in Metastatic Castration-Resistant Prostate Cancer

7 months ago

• 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.

Pembrolizumab Approved for Mesothelioma; Patritumab Deruxtecan Shows Promise in NSCLC

8 months ago

• 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 Halts B-Cell Lymphoma Trial and Explores Strategic Alternatives

8 months ago

• 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 Halts Clinical Trials, Initiates Layoffs After Disappointing Results

8 months ago

• 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.

Ractigen's RAG-18 Receives FDA Orphan Drug Designation for Duchenne and Becker Muscular Dystrophy

9 months ago

• Ractigen Therapeutics' RAG-18, a small activating RNA (saRNA) therapy, has been granted Orphan Drug Designation by the FDA for treating Duchenne and Becker muscular dystrophy. • RAG-18 previously received Rare Pediatric Disease Designation, making it the first saRNA therapy to achieve both designations, highlighting its potential for treating rare genetic conditions. • The therapy aims to increase utrophin production by targeting the UTRN gene, offering a functional substitute for the deficient dystrophin protein in DMD and BMD patients. • Preclinical data presented at OTS 2023 demonstrated RAG-18's ability to induce utrophin expression and ameliorate muscle damage in a mouse model of DMD.