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SAN DIEGO and SUZHOU, China - Adagene Inc. (NASDAQ: ADAG), a biotechnology firm with a market capitalization of $85 million focused on antibody-based cancer therapies, has revealed encouraging clinical data from a trial involving its novel drug, ADG126, for treating microsatellite stable colorectal cancer (MSS CRC). The announcement came following a presentation at the ASCO Gastrointestinal Cancers Symposium in San Francisco. According to InvestingPro analysis, the company's stock appears slightly undervalued despite falling over 50% in the past year.
The Phase 1b/2 study examined the combination of ADG126 with pembrolizumab, an anti-PD-1 therapy marketed as KEYTRUDA® by Merck (NSE:PROR). The trial reported a 33% overall response rate with a 20 mg/kg loading dose of ADG126, followed by a maintenance dose of 10 mg/kg every three weeks (Q3W), in combination with pembrolizumab administered to patients without liver and peritoneum metastases. While the clinical results are promising, InvestingPro data shows the company maintains a healthy current ratio of 2.5, though it's quickly burning through cash - one of 13+ insights available to subscribers.
Out of twelve patients, four confirmed partial responses were observed, and importantly, no Grade 4 or 5 treatment-related adverse events were reported. Additionally, no treatment discontinuations have occurred to date, suggesting a favorable safety profile for the drug combination.
The study's results are seen as a positive development in the treatment of MSS CRC, a condition that typically has limited treatment options. ADG126 is a masked anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment. This targeted approach is designed to minimize toxicity while maintaining efficacy.
The absence of severe safety events and the management of lower-grade treatment-related adverse events through dose modification highlight the potential of ADG126 as a therapeutic option for MSS CRC patients. The most common adverse event noted was pruritus, affecting 25% of participants.
Adagene plans to extend its trial to a broader patient population, including those with liver metastases, and to assess the drug's performance in combination with standard care treatments.
The company's SAFEbody technology, which utilizes precision masking to shield the binding domain of the therapy, allows for tumor-specific targeting while reducing off-tumor toxicity. This technology, along with the drug's novel epitope targeting, positions ADG126 as a potential best-in-class CTLA-4 inhibitor.
Adagene's commitment to innovation in cancer immunotherapies is supported by its proprietary Dynamic Precision Library platform, which includes NEObody, SAFEbody, and POWERbody technologies. The company continues to collaborate with global partners to advance its pipeline of novel immunotherapy programs.
As the clinical data matures throughout 2025, further endpoints, including time to event, will be reported, providing additional insight into the treatment's efficacy and durability. This update is based on a press release statement from Adagene Inc. With analyst price targets ranging from $3.50 to $19.06 and an overall "Weak" Financial Health score according to InvestingPro, investors should closely monitor both clinical and financial developments. The company's next earnings report is expected on March 27, 2025.
In other recent news, Adagene has presented new clinical data regarding its product, ADG126, at the ASCO-GI symposium. The data highlighted results from a study combining ADG126 with Merck's KEYTRUDA® in MSS CRC. This follows Adagene's commitment to developing innovative antibody-based cancer immunotherapies, leveraging computational biology and artificial intelligence in its Dynamic Precision Library platform.
Adagene has also faced a downgrade from Jefferies, shifting the stock rating from Buy to Hold with a reduced price target of $3.50. This comes after observations of ADG126's efficacy in a specific patient subset, excluding those with liver and peritoneal metastases. Despite the downgrade, analysts from H.C. Wainwright maintain a Buy rating on Adagene, reinforcing confidence in ADG126's potential.
Recent developments also include significant findings presented at the Society for Immunotherapy of Cancer (SITC) and the European Society of Medical (TASE:PMCN) Oncology (ESMO) Congress. The research focused on Adagene's proprietary SAFEbody® technology platform and the anti-CTLA-4 antibody, ADG126. The combination of ADG126 with pembrolizumab demonstrated a confirmed overall response rate of 24% and a disease control rate of 88% in recent studies.
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