SEATTLE, WA and LUND, SWEDEN - Aptevo Therapeutics (NASDAQ:APVO) and Alligator Bioscience AB (NASDAQ STOCKHOLM:ATORX) announced interim results from a Phase 1 trial of their drug ALG.APV-527, showing clinical activity in patients with solid tumors. The data, presented at the European Society for Medical Oncology Congress on September 14, 2024, revealed that 60% of evaluable patients achieved stable disease, with one breast cancer patient maintaining this state for over 11 months.
ALG.APV-527, a bispecific antibody targeting 4-1BB and the tumor antigen 5T4, is currently being tested in a multi-center, dose escalation trial. The trial has not yet reached a maximum tolerated dose, and the drug has demonstrated favorable pharmacokinetics and safety across all patient cohorts.
The trial includes 18 patients who have undergone multiple prior therapies for solid tumor types. Nine of the 15 patients evaluable for efficacy showed a best overall response of stable disease. In addition to the breast cancer patient with prolonged stable disease, a colon cancer patient has also remained on the study for more than four months.
Dr. Thomas Marron from the Icahn School of Medicine at Mount Sinai, a participating investigator, expressed optimism about the drug's potential to benefit patients with solid tumors, highlighting the positive safety profile and signs of clinical activity.
ALG.APV-527 is designed to stimulate immune cells involved in tumor control while minimizing systemic immune activation. Preclinical studies have suggested its potential for highly efficacious tumor-specific responses.
Aptevo Therapeutics focuses on developing bispecific immunotherapies for cancer treatment, while Alligator Bioscience develops tumor-directed immuno-oncology antibody drugs. Both companies are advancing their portfolios with several promising drug candidates.
This report is based on a press release statement and aims to present the key facts without endorsing the claims or potential of the drug. Further studies are necessary to confirm the preliminary findings and to determine the drug's long-term efficacy and safety.
In other recent news, Aptevo Therapeutics and Alligator Bioscience reported positive interim results from their ongoing Phase 1 clinical trial for ALG.APV-527, a bispecific antibody aimed at treating advanced solid tumors. In other developments, Aptevo's stockholders rejected a charter amendment but approved the issuance of more than 19.99% of outstanding common stock upon the exercise of common warrants, according to a recent SEC filing. The company also faced a potential delisting from Nasdaq due to non-compliance with the exchange's minimum bid price requirement, but it has a grace period to regain compliance.
Furthermore, Aptevo secured $2.3 million in a direct offering with the sale of over 5.3 million shares and warrants, facilitated by Roth Capital Partners and Dawson James Securities. The company also set terms for a $4.6 million public offering to further support its corporate purposes and the clinical development of its product candidates. All these recent developments provide an insight into Aptevo's ongoing activities and strategic decisions.
InvestingPro Insights
Aptevo Therapeutics (NASDAQ:APVO) has shown promising interim results in their Phase 1 trial, which could be a significant milestone for the company. However, it's important for investors to consider the financial health and market performance of APVO when evaluating its potential. According to InvestingPro data, Aptevo Therapeutics currently holds a modest market capitalization of $3.34 million, reflecting the size of the company within the biotech industry.
InvestingPro Tips suggest that Aptevo Therapeutics trades with high price volatility, which could be indicative of the market's reaction to trial results and other news. Additionally, the company does not pay a dividend to shareholders, which is common in the biotech sector where companies often reinvest earnings into research and development. With a negative P/E ratio of -0.02 and a price/book ratio of 0.75 as of the last twelve months ending Q2 2024, the financial metrics highlight that the company is not currently profitable and has a market price lower than the book value of its assets.
Investors should be aware that the stock has experienced significant price declines over various timeframes, including a 95.54% drop year-to-date and a 97.99% decrease over the past year. This underscores the InvestingPro Tip that the stock price movements are quite volatile, which could be a risk factor for investors. Despite these challenges, Aptevo Therapeutics' cash position is stronger than its debt, which could provide some financial stability as it continues to develop its drug candidates.
For those interested in further analysis, there are additional InvestingPro Tips available on the platform that provide more in-depth insights into Aptevo Therapeutics' performance and prospects.
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