Cullinan Management, Inc. is a biopharmaceutical company engages in developing oncology and immuno-oncology therapies. The company was founded by Patrick R. Baeuerle on 15 September, 2016 and is headquartered in Cambridge, MA.
Clinical Trials
17
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
4
23.5%
Not yet recruiting
2
11.8%
Recruiting
9
52.9%
Terminated
2
11.8%
No approval data available
- The Phase 3 REZILIENT3 trial met its primary endpoint, showing zipalertinib plus platinum-based chemotherapy extended median progression-free survival to 14.5 months versus 8.5 months with chemotherapy alone. - The combination reduced the risk of disease progression or death by 50% (HR 0.50; 95% CI, 0.34-0.73; P=0.00015) in previously untreated advanced EGFR exon 20 insertion NSCLC. - Objective response rate rose to 65.0% with the combination versus 40.3% with chemotherapy alone, with median duration of response of 14.2 versus 9.9 months. - Interim overall survival data at 30% maturity showed a hazard ratio for death of 0.72 (95% CI, 0.42-1.23), with follow-up ongoing and no new safety signals reported.
- Cullinan Therapeutics' Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy met its primary progression-free survival endpoint at a planned interim analysis in first-line EGFR exon 20 insertion NSCLC. - Interim results will be presented in Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer on September 13, 2026, in Seoul, South Korea. - Cullinan will host a virtual analyst and investor event on September 14, 2026, at 8:00 a.m. ET, featuring CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones, MD, MBA. - The company is a clinical-stage biopharmaceutical developer of T cell engagers for autoimmune diseases and cancer, with zipalertinib representing its lung cancer program.
- The Phase 3 REZILIENT3 trial met its primary endpoint of progression-free survival at a planned interim analysis, showing a statistically significant and clinically meaningful improvement for zipalertinib plus chemotherapy versus chemotherapy alone. - The global, multicenter, randomized, open-label trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations. - Observed safety for the zipalertinib-containing arm was manageable, and the Independent Data Monitoring Committee recommended unblinding the study. - Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics plan to pursue U.S. regulatory approval for the combination in the first-line setting pending FDA discussions.
- Cullinan Therapeutics, Inc. (CGEM) reported a second-quarter loss of $53.7 million, or 81 cents per share, for the Cambridge, Massachusetts-based company. - The results missed Wall Street expectations, as five analysts surveyed by Zacks Investment Research had forecast a loss of 71 cents per share. - The earnings report reflects the company's quarterly financial performance and its position relative to consensus analyst estimates.
- A sharp rotation out of overvalued AI and semiconductor stocks is driving capital into biotechnology, healthcare, and other previously overlooked sectors. - The Nasdaq 100 fell 3.2% while semiconductors dropped around 7%, yet market breadth remained positive as investors sought safer, less extended positions. - Biotech names including Definium Therapeutics, Xeris Biopharma, and Cullinan Therapeutics are benefiting from rotational momentum ahead of key clinical and earnings catalysts. - Definium Therapeutics (DFTX) surged 50% in a single day and is holding gains as the market anticipates its upcoming Phase 3 data readout for Generalized Anxiety Disorder.
- The global EGFR inhibitors market reached USD 7 billion in 2025 across the 7MM, with the United States accounting for approximately 60% of total market share. - A wave of emerging therapies including zipalertinib, firmonertinib, ivonescimab, and multiple ADC candidates is expected to reshape the treatment landscape for EGFR-mutated cancers. - The FDA has set PDUFA action dates for ivonescimab (November 14, 2026) and zipalertinib (February 27, 2027), signaling imminent regulatory decisions for two novel agents. - EGFR exon 20 insertion mutations have emerged as a key competitive arena, with approvals of amivantamab and sunvozertinib creating a distinct market segment.
- The FDA has granted Orphan Drug Designation to CLN-049, a novel FLT3xCD3 T cell engager developed by Cullinan Therapeutics for treating relapsed/refractory acute myeloid leukemia. - CLN-049 targets both mutated and non-mutated FLT3-expressing leukemia cells, making it applicable to a broad population of AML patients regardless of FLT3 mutational status. - The designation provides development incentives including tax credits, FDA user fee exemptions, and potential seven years of market exclusivity following approval. - Currently, there are no approved immunotherapies for AML, highlighting the significant unmet medical need that CLN-049 aims to address.
- Cullinan Therapeutics' CLN-049, a novel FLT3xCD3 bispecific T cell engager, demonstrated a ~30% composite complete response rate in heavily pretreated patients with relapsed/refractory acute myeloid leukemia. - The therapy showed anti-leukemic activity regardless of FLT3 mutational status, with responses observed even in patients with poor-prognosis TP53-mutated AML at the highest dose level. - Initial safety data from 40 patients indicated a manageable profile with cytokine release syndrome limited to Grade 1 or 2, and no treatment discontinuations due to immune-related adverse events. - Updated clinical results will be presented in an oral presentation at the American Society of Hematology Annual Meeting on December 8, 2025.
- Cullinan Therapeutics has licensed velinotamig, a BCMAxCD3 bispecific T cell engager from Genrix Bio for $20 million upfront, with potential milestone payments totaling up to $692 million. - Velinotamig demonstrated potential best-in-class efficacy at Phase 2 target dose in nearly 50 patients with relapsed/refractory multiple myeloma and will now be developed for autoimmune diseases. - The licensing agreement advances Cullinan's T cell engager portfolio for autoimmune diseases, complementing their existing CD19 TCE program CLN-978. - Genrix Bio plans to initiate a Phase 1 study in China by end of 2025 for autoimmune diseases, with Cullinan conducting all subsequent global development.
- The European Medicines Agency has approved Cullinan Therapeutics' Clinical Trial Application for CLN-978, a CD19xCD3 bispecific T cell engager, to begin Phase 1 trials in rheumatoid arthritis patients. - CLN-978 offers potential advantages over existing therapies, including deeper B cell depletion, convenient subcutaneous administration, and off-the-shelf accessibility for patients with difficult-to-treat rheumatoid arthritis. - The company-sponsored trial will commence in Q2 2025 at leading European research institutions, while Cullinan simultaneously advances CLN-978 studies for systemic lupus erythematosus across global sites.
