ROCKVILLE, Md. - I-Mab (NASDAQ: IMAB), a biotech firm specializing in cancer immunotherapies, has disclosed pharmacokinetic and pharmacodynamic (PK/PD) modeling data from three Phase 1 studies for its drug uliledlimab. The data, presented at the World Conference on Lung Cancer in San Diego, supports dosing for future clinical trials.
Uliledlimab, an antibody targeting CD73, has shown promise in treatment-naïve metastatic non-small cell lung cancer (mNSCLC) patients. CD73 is an enzyme that hampers immune responses against tumors. By inhibiting CD73, uliledlimab aims to enhance anti-tumor immunity.
Chief Medical Officer Phillip Dennis stated that the PK/PD analysis affirms uliledlimab's potential as a leading CD73 inhibitor. The data guides dose selection for upcoming studies, including a randomized Phase 2 trial with pembrolizumab and chemotherapy slated for the first half of 2025.
The studies, conducted in China, evaluated uliledlimab alone and in combination with checkpoint inhibitors. Findings indicate a positive correlation between uliledlimab concentration and overall response rates in mNSCLC patients. A dose of 30 mg/kg achieved target trough concentrations in 95% of the simulated population, suggesting a favorable safety profile and clinical efficacy.
A complete version of the poster presentation is accessible on I-Mab's website under the "Innovation, Publications & Presentations" section.
I-Mab is a global company with operations in Maryland, dedicated to developing unique immunotherapies for cancer treatment. The company's forward-looking statements, such as expected trial commencement and drug efficacy, are subject to risks and uncertainties that could cause actual results to differ. The information contained in this article is based on a press release statement.
In other recent news, I-MAB Biopharma announced significant updates on its financial health and drug development progress during an earnings call. The company revealed a focus on three oncology programs, with uliledlimab (uli) as the leading candidate. I-MAB Biopharma plans to initiate a frontline combination study for uli in the first half of 2025 and underscored the potential of its other drug candidates, givastomig (giva) and ragistomig (ragi).
The recent developments also include the divestiture of its operations in China and a restructuring that led to a new U.S.-based leadership team. As of mid-2024, I-MAB's cash balance was reported at $207.5 million, with the company estimating its cash reserves to support operations until 2027.
Furthermore, the company has received FDA clearance for a combination study of uli with pembrolizumab and chemotherapy, and early Phase I results for ragi indicated an objective response rate of 27%. These recent developments reflect I-MAB Biopharma's strategic focus on advancing cancer immunotherapy.
InvestingPro Insights
As I-Mab (NASDAQ: IMAB) progresses with its clinical trials for uliledlimab, a potential new therapy in the fight against cancer, the company's financial health and market performance provide a backdrop for its scientific endeavors. I-Mab holds more cash than debt on its balance sheet, which could be a strategic advantage in funding ongoing research and development activities without the immediate need for external financing. According to InvestingPro Tips, this is a positive sign for potential investors looking for companies with a solid financial foundation.
Despite the potential of uliledlimab, I-Mab's financial metrics reflect the challenges typical of biotech firms in the development stage. The company's market capitalization stands at $87.95 million, and it has not been profitable over the last twelve months. This is echoed by a negative P/E ratio of -5.6, indicating that the company does not have positive net earnings at the moment. The price of I-Mab's stock has also seen a significant decline over the past three months, with a 3-month price total return of -41.78%, underscoring the volatility and risk associated with investing in biotech stocks. It's worth noting that I-Mab does not pay a dividend to shareholders, which is common for companies focused on reinvesting earnings into research and development.
For readers interested in deeper financial analysis and additional InvestingPro Tips, including insights on shareholder yield and liquidity, more information can be found on InvestingPro's dedicated page for I-Mab at https://www.investing.com/pro/IMAB. With a total of seven InvestingPro Tips available, investors can gain a comprehensive understanding of I-Mab's financial landscape and potential investment risks and opportunities.
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