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Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a forward-thinking biopharmaceutical company dedicated to establishing new standards of care for patients through innovative cancer and autoimmune therapies. The company specializes in a modality-agnostic approach, targeting key drivers of disease and harnessing the immune system to eradicate diseased cells.
With a highly experienced team of oncology professionals and drug developers, Cullinan boasts a diversified portfolio of clinical-stage assets sourced from both internal and external collaborations. This includes therapies aimed at inhibiting disease drivers or activating the immune system to address various oncology and autoimmune indications.
Recent Achievements:
- CLN-617: A first-in-class cytokine therapy combining IL-2 and IL-12 for intratumoral injection, shown to activate a broad immune response.
- CLN-619: A first-in-class monoclonal antibody for relapsed/refractory multiple myeloma, aimed at restoring immune recognition of tumor cells.
- CLN-978: A novel CD19xCD3 bispecific T cell engager being developed for systemic lupus erythematosus.
- Zipalertinib: An EGFR inhibitor for non-small cell lung cancer, with promising efficacy and a manageable safety profile.
Financially, Cullinan is well-positioned, having announced a $280 million private placement to support ongoing research and development activities. This funding, combined with current assets, is expected to sustain the company's operations into 2028.
For more detailed insights and updates, visit Cullinan’s website or follow them on LinkedIn and Twitter.
Cullinan Oncology (NASDAQ: CGEM) announced updated results from its Phase 1/2a study of CLN-081 for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Key findings include a median duration of response exceeding 21 months and a median progression-free survival of 12 months at the 100 mg BID dose. The overall response rate was confirmed at 41% among treated patients. The drug displayed favorable safety and tolerability in heavily pre-treated patients. Further data will be presented at the 2022 ASCO Annual Meeting.
Cullinan Oncology (Nasdaq: CGEM) announced an investor briefing on June 4, 2022, at 8:00 a.m. EDT during the ASCO Annual Meeting to discuss updated data from the Phase 1/2a study of CLN-081/TAS6417 for non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. This briefing follows a presentation of the data on June 3, 2022, during an ASCO oral abstract session. CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor specifically targeting EGFR exon 20 insertion mutations. A strategic collaboration has been established with Taiho Pharmaceutical for its development.
Cullinan Oncology (NASDAQ: CGEM) announced that CFO Jeff Trigilio will present at the H.C. Wainwright Global Investment Conference from May 23-25, 2022, in Miami and online. The presentation will be available on-demand starting May 24 at 7:00 a.m. ET on the company’s investor relations website.
Cullinan focuses on developing targeted therapies for cancer, leveraging unique partnerships and a diverse pipeline aimed at enhancing patient care.
Cullinan Oncology (CGEM) announced a significant co-development agreement with Taiho Pharmaceutical for CLN-081, receiving $275 million upfront and potential regulatory milestone payments of $130 million. The company reported cash and investments totaling $685 million, ensuring operational funding through 2026. Key pipeline updates include ongoing Phase I trials for CLN-049 and CLN-619, with initial data expected mid-2023, and IND submissions for CLN-617 and CLN-978 anticipated in the first half of 2023. The net loss for Q1 2022 was reduced to $12.9 million from $34.2 million in Q4 2021.
Cullinan Oncology and Taiho Pharmaceutical have entered a strategic agreement for the co-development and commercialization of CLN-081/TAS6417, an innovative treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 mutations. Under the deal, Cullinan will receive an upfront payment of $275 million and may obtain an additional $130 million in milestone payments. The partnership allows Cullinan to retain a share of profits in the U.S. while Taiho commercializes the drug globally. The deal strengthens both companies’ oncology portfolios.
On May 2, 2022, Cullinan Oncology (CGEM) granted stock options for 207,000 shares to two new employees outside its 2021 Stock Option and Incentive Plan. The options, exercisable at $10.53 per share, correspond to the stock's closing price on the grant date. Each option has a ten-year term and vests over four years, with 25% vesting after one year and the remainder in equal installments monthly over three years. This initiative follows Nasdaq Listing Rule 5635(c)(4) and aims to attract talent in the competitive biopharmaceutical industry.
Cullinan Oncology (Nasdaq: CGEM) presented updated findings from its Phase 1/2a clinical trial of CLN-081 at the 2022 ASCO Annual Meeting in Chicago. This oral presentation focused on the drug’s efficacy in patients with EGFR exon 20 insertion mutation positive non-small cell lung cancer (NSCLC). CLN-081, which received Breakthrough Therapy Designation from the FDA, aims to address the limited treatment options available. The trial highlights the potential of CLN-081 as a promising therapy amidst ongoing unmet needs for patients.
Cullinan Oncology (Nasdaq: CGEM), a biopharmaceutical firm, announced its participation in virtual conferences in April 2022. Key events include the Needham Healthcare Conference on April 13, featuring CFO Jeff Trigilio, and the Canaccord Genuity Horizons in Oncology Virtual Conference on April 14, with CEO Nadim Ahmed. Investors can access live webcasts via the investor relations website. One-on-one investor meetings are also available upon request.
Cullinan Oncology (CGEM) announced the granting of stock options for 279,100 shares to four new employees as an inducement for employment. The options were awarded outside the 2021 Stock Option and Incentive Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). Three employees received options for 129,100 shares at an exercise price of $10.99, and one employee received options for 150,000 shares at $12.04, both reflecting the closing prices on their respective grant dates. Each option vests over four years upon continued service.
Cullinan Oncology (Nasdaq: CGEM) provided updates on CLN-081, its lead program targeting EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC). The latest Phase 1/2a trial data shows a confirmed overall response rate of 41% at the 100mg BID dose with a favorable safety profile, including no Grade 3 or greater treatment-related adverse events. The FDA granted CLN-081 Breakthrough Therapy Designation, enabling a small food effect study before a pivotal trial expected to begin in 2H 2022. Further data will be presented at medical conferences later this year.
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