Compass Therapeutics Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors

Rhea-AI Summary

Compass Therapeutics dosed the first patient in the Phase 1 trial of CTX-8371, a novel dual checkpoint blocker targeting PD-1 and PD-L1 in patients with solid tumors. The study aims to evaluate the drug's efficacy in patients who failed prior checkpoint blocker treatments.

Insights

Oncology Medical Research Analyst

The initiation of CTX-8371's Phase 1 trial marks a proactive stride in oncology therapeutics, specifically targeting advanced solid tumors. The drug's innovation lies in its dual-action mechanism, targeting both PD-1 and PD-L1. This approach could potentially offer a more robust blockade of the immune checkpoint pathway, a method exploited by many tumors to evade immune detection. If successful, CTX-8371 may offer a treatment for patients who have become refractory to existing checkpoint inhibitors. Investors should monitor the patient response data as the trial progresses, as positive outcomes may bolster the company's valuation, while any safety concerns could raise red flags and possibly affect the stock negatively.

Biotech Stock Analyst

From an investment perspective, Compass Therapeutics' progression to a Phase 1 clinical trial is an essential step in validating CTX-8371's commercial viability. The patient population selected for the trial includes those with a range of tumor types, suggesting a broad potential market if the drug proves efficacious. Moreover, a successful development of CTX-8371 could position Compass favorably within the competitive landscape of oncology treatments. A point of interest will be the drug's differentiation from the current market leaders in PD-1/PD-L1 inhibitors, as this unique selling point would be a significant driver of market penetration and stock performance. It is also worth noting that clinical trials are inherently risky and the majority of compounds do not make it to market, which could lead to volatility in the company's stock price as trial results are announced.

• The first patient was dosed in the Phase 1 dose escalation trial of CTX-8371.This study is conducted in patients with advanced solid tumors who progressed on at least one prior regimen containing a checkpoint blocker.  
• CTX-8371 is a novel dual checkpoint blocker that simultaneously targets the programmed death receptor PD-1 and its ligand PD-L1.
• Compass advanced CTX-8371 to the clinic following pre-clinical observations of superior activity when compared with approved checkpoint blockers.
  

BOSTON, April 16, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the first patient has been dosed in its Phase 1 dose-escalation clinical trial of CTX-8371, a PD-1 x PD-L1 bispecific antibody, in patients with solid tumors.

“Dosing the first patient in the CTX-8371 Phase 1 represents the advancement of our third program into the clinic, which is an important milestone for the company,” said Vered Bisker-Leib, PhD, Chief Executive Officer. “We recently published preclinical data in the peer-reviewed journal, OncoImmunology, supporting the novel mechanism of action of CTX-8371: proteolytic cleavage and subsequent loss of cell surface PD-1. We believe this mechanism drives the enhanced anti-tumor activity of CTX-8371 in preclinical models when compared to approved anti-PD-1 and PD-L1 therapies and warrants its evaluation in patients.”

CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1. CTX-8371 received FDA clearance of the IND in October 2023. The Phase 1 CTX-8371 study design includes five ascending doses (0.1, 0.3, 1.0, 3.0, and 10 mg/kg) and the study is enrolling patients with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Hodgkin Lymphoma, and triple negative breast cancer (TNBC) who have progressed on at least one prior regimen containing checkpoint blocker.

About Compass Therapeutics

Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s product candidates, including CTX-8371, and its development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com

Media Contact
Anna Gifford, Senior Communications Manager
media@compasstherapeutics.com
617-500-8099

FAQ

What is the name of the company mentioned in the press release?

Compass Therapeutics, Inc.

What is the ticker symbol for Compass Therapeutics?

CMPX

What is the drug being studied in the Phase 1 trial?

CTX-8371

What is the unique mechanism of action of CTX-8371?

It involves cleavage of cell surface PD-1.

When did CTX-8371 receive FDA clearance of the IND?

October 2023