Cullinan Oncology Inc - CGEM STOCK NEWS

Cullinan Therapeutics (Nasdaq: CGEM) announced FDA clearance of its Investigational New Drug (IND) Application for CLN-978, allowing its global Phase 1 clinical trial to proceed in the U.S. for patients with moderate to severe systemic lupus erythematosus (SLE). CLN-978 is the first development stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.

The trial will enroll patients with a SLEDAI score of 8 or greater who have had inadequate response to at least two treatments. It consists of Part A (dose escalation) and Part B (dose expansion). The primary objective is to evaluate CLN-978's safety, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.

Cullinan Therapeutics aims to address the unmet medical need in SLE patients, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978 offers a novel approach with off-the-shelf access and convenient subcutaneous dosing.

Cullinan Therapeutics (Nasdaq: CGEM) has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its global Phase 1 clinical trial for CLN-978, a CD19xCD3 bispecific T cell engager, in treating systemic lupus erythematosus (SLE). The trial will assess safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients, which affects approximately 430,000 individuals globally. The study will be conducted across multiple sites in Australia and other countries worldwide.

CLN-978 is designed to deliver T cell-directed potency with off-the-shelf access and convenient dosing, potentially offering a best-in-class treatment for SLE. This approval marks a significant step in Cullinan's global clinical development strategy for autoimmune diseases. The company has also submitted an Investigational New Drug Application to the U.S. FDA for this study.

Cullinan Therapeutics (Nasdaq: CGEM) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CLN-978, a CD19xCD3 bispecific T cell engager, to treat systemic lupus erythematosus (SLE). This marks a significant step towards advancing their global study of CLN-978 in SLE within the United States.

SLE affects over 160,000 people in the U.S., according to CDC estimates. Current treatments do not typically induce treatment-free remission, with most patients requiring lifelong immune suppression. CLN-978 is a novel, highly potent, half-life extended bispecific T cell engager that could potentially offer a disease-modifying, off-the-shelf option for SLE patients.

Cullinan Therapeutics (CGEM) presented updated data from Module C of the pivotal Phase 2b REZILIENT1 trial for zipalertinib at ESMO 2024. The study focused on patients with NSCLC harboring EGFR exon 20 insertion mutations who progressed after amivantamab treatment. Key findings include:

- 40% objective response rate (ORR) in 30 evaluable patients
- 90% disease control rate (DCR)
- 9.7 months median progression-free survival (PFS)
- Manageable safety profile with mostly grade 1/2 adverse events

The pivotal Phase 2b trial completed enrollment ahead of schedule. Cullinan's partnership with Taiho involves a $275M upfront payment and potential for $130M in additional regulatory milestones, with a 50/50 profit share in the U.S.

Cullinan Therapeutics (Nasdaq: CGEM), a biopharmaceutical company developing targeted therapies, has announced its participation in two upcoming investor conferences. CEO Nadim Ahmed and CMO Jeffrey Jones will engage in fireside chats at:

• The Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 5, 2024, at 4:05 p.m. EDT
• The 2024 Cantor Global Healthcare Conference in New York on September 19, 2024, at 10:20 a.m. EDT

Webcasts of both fireside chats will be accessible on Cullinan's investor relations website under the Events and Presentations section.

Cullinan Therapeutics (CGEM) provided a corporate update and Q2 2024 financial results. Key highlights include:

1. On track to file IND for CLN-978 in SLE in Q3 2024
2. Pursuing rheumatoid arthritis as second autoimmune indication for CLN-978
3. Presented promising CLN-619 combination therapy data at ASCO
4. Appointed Mary Thistle to Board of Directors
5. Cash position of $664.9 million as of June 30, 2024
6. Q2 2024 R&D expenses increased to $36.3 million
7. Q2 2024 net loss of $42.0 million
8. Discontinuing development of CLN-418

The company expects its cash resources to provide runway into 2028 based on current operating plans.

Cullinan Therapeutics has announced positive initial data from its Phase 2b REZILIENT1 study of zipalertinib for non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations. The study involves patients who progressed after amivantamab treatment, showing a 39% objective response rate (ORR) and a 94% disease control rate (DCR). The data, cut off as of January 12, 2024, reflects findings in 31 patients with a median of three prior treatments. Zipalertinib had a manageable safety profile, with no grade 4 or 5 treatment-related adverse events. The company remains on track to complete enrollment by the end of 2024 and retains a 50/50 profit share in the U.S. through its partnership with Taiho. An investor event will be held on June 1, 2024, to discuss this and other data.

Cullinan Therapeutics, a biopharmaceutical company focused on developing targeted therapies, has announced that its CEO, Nadim Ahmed, and CMO, Jeffrey Jones, will participate in a fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit.

The event, which will take place virtually on May 28 and 29, 2024, will feature their chat on May 29 at 11:30 am ET. A webcast of the event will be accessible on the company's investor relations website.

Cullinan Therapeutics announced preliminary data from its Phase 1 trial of CLN-619, an anti-MICA/B antibody, in combination with pembrolizumab, and updated monotherapy results. Among 22 patients treated with the combination, 3 showed partial responses, including in non-small cell lung cancer (NSCLC) and gastric cancer. Monotherapy results showed a 41.4% clinical benefit rate across various tumor types. CLN-619 was well tolerated, with most adverse events being mild. Cullinan is expanding the trial to include more NSCLC patients and has plans for further studies in multiple myeloma.