Cullinan Therapeutics, Inc. - CGEM STOCK NEWS

Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. announced the launch of the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation. This trial aims to assess progression-free survival of zipalertinib plus chemotherapy versus chemotherapy in adult patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR exon 20 insertion mutations. Results from a Phase 1/2a clinical trial of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations demonstrated its therapeutic potential and were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

Cullinan Oncology announces positive clinical data for CLN-619 in Phase 1 study of advanced solid tumors. Monotherapy shows anti-tumor activity and acceptable safety profile. Expansion cohorts to be initiated in endometrial and cervical cancers. Combination study with pembrolizumab ongoing.

Cullinan Oncology, Inc. (Nasdaq: CGEM) announced the presentation of initial clinical data for its drug CLN-619 at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. CLN-619 is a novel antibody targeting MICA and MICB, ligands that interact with immune cells to induce anti-tumor responses. The Phase 1 study focuses on evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of CLN-619, both as a standalone treatment and in combination with pembrolizumab, in patients with advanced solid tumors. The clinical data presentation will take place on June 3, 2023, and aims to showcase the therapeutic potential of CLN-619 across various cancer types.

Cullinan Oncology, Inc. (Nasdaq: CGEM) announces its participation in the Stifel 2023 Targeted Oncology Days on April 26, 2023, at 2:30 PM EDT. The event will feature a fireside chat with CEO Nadim Ahmed, focusing on the company's innovative approaches to cancer therapies. A live webcast will be available on the investor relations website.

Cullinan Oncology is a biopharmaceutical firm committed to developing new cancer treatment standards. The company leverages extensive research in immuno-oncology and translational cancer medicine, aiming to create groundbreaking therapies through its diverse pipeline. They seek to activate the immune system or target oncogenic drivers, positioning their assets for potential market leadership in various cancer indications.

Cullinan Oncology (Nasdaq: CGEM) announced that the FDA has cleared its IND application for CLN-617, a fusion protein combining IL-2 and IL-12 for targeted tumor treatment. This innovative therapy aims to enhance efficacy and reduce toxicity by retaining the drug within the tumor microenvironment post-injection. Cullinan will conduct a Phase 1 clinical trial focusing on advanced solid tumors and exploring the combination of CLN-617 with pembrolizumab. This advancement represents Cullinan's commitment to developing diverse cancer therapies, with CLN-617 being their sixth clinical-stage asset.

Cullinan Oncology (Nasdaq: CGEM) announced the presentation of preclinical data for its assets, CLN-619 and CLN-617, at the 2023 AACR Annual Meeting from April 14-17 in Orlando, Florida. CLN-619 is a humanized IgG1 antibody undergoing a Phase 1 trial for advanced solid tumors, with initial data expected mid-2023. CLN-617 is a first-in-class cytokine therapy combining IL-2 and IL-12, for which an Investigational New Drug application has been submitted to the FDA. Presentations will focus on their therapeutic potential and preclinical research outcomes.

Cullinan Oncology, Inc. (Nasdaq: CGEM) reported strong advancements and financial results for 2022, highlighting a net income of $109.2 million compared to a net loss of $67.5 million in 2021. The company expanded its pipeline by licensing U.S. rights to CLN-418, received FDA clearance for CLN-978, and submitted the IND for CLN-617, potentially positioning six clinical-stage programs by year-end 2023. Research and development expenses increased to $91.9 million in 2022, driven by ongoing clinical trials. The cash position stands at $550.1 million, providing runway into 2026 for ongoing development efforts.