Sanofi invests up to $25 million in Adagene, exercises third option

SAN DIEGO/SUZHOU - Sanofi (Euronext:SAN FP) has agreed to invest up to $25 million in antibody-focused biotech firm Adagene Inc. (NASDAQ:ADAG), currently valued at $92 million, while exercising its option on a third SAFEbody discovery program, according to a press release statement issued Tuesday. According to InvestingPro data, Adagene maintains a healthy balance sheet with more cash than debt, though the company faces significant operational challenges.

The investment will help fund Adagene’s development activities, including a randomized phase 2 trial of muzastotug (ADG126), its anti-CTLA-4 SAFEbody candidate, in microsatellite stable colorectal cancer.

As part of the expanded collaboration, Adagene will supply muzastotug to Sanofi for evaluation in combination with other anticancer therapies in over 100 patients with advanced solid tumors in a phase 1/2 clinical trial. Adagene will retain worldwide commercial rights to muzastotug.

Sanofi has also selected a third SAFEbody discovery program using Adagene’s proprietary masking technology. This bispecific therapeutic with undisclosed targets will be engineered by Adagene and triggers an option exercise fee along with potential milestone payments and royalties under their 2022 partnership agreement.

"Expanding our partnership with Sanofi highlights the potential of our SAFEbody platform and the clinical proof of concept for ADG126," said Peter Luo, Chairman, CEO and President of R&D at Adagene.

Following the investment, a Sanofi representative will join Adagene’s Scientific Advisory Board to provide strategic advice on scientific and clinical activities.

Adagene reported audited cash and cash equivalents of $85.2 million as of December 31, 2024, with a current ratio of 2.3x indicating strong short-term liquidity. The company expects the proceeds from Sanofi’s investment, combined with current cash reserves, to fund planned operations into 2027. For deeper insights into Adagene’s financial health and 12 additional ProTips, visit InvestingPro.

The SAFEbody technology is designed to address safety challenges in antibody therapeutics by using precision masking to shield the binding domain, allowing tumor-specific targeting while minimizing toxicity in healthy tissues.

In other recent news, Adagene Inc. has announced promising results from a clinical trial of its drug ADG126 for the treatment of advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases. The Phase 1b/2 study revealed a confirmed overall response rate of 29% when ADG126 was combined with pembrolizumab, an anti-PD-1 therapy. The trial’s 20 mg/kg dosing regimen every six weeks resulted in less than 20% Grade 3 adverse events, with no treatment discontinuations. Notably, the 20 mg/kg cohorts have not reached a median overall survival, while the 10 mg/kg cohorts showed a median overall survival of 19.4 months. All six responders in the 20 mg/kg cohorts remain on treatment, with some patients participating for over forty weeks. Dr. Marwan Fakih emphasized the reduced treatment-related toxicities and durable responses observed. Adagene plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development. The company utilizes computational biology and artificial intelligence to create novel antibodies, aiming to minimize on-target off-tumor toxicity through its SAFEbody® precision masking technology.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.