Game-Changing Breakthrough in Colorectal Cancer Treatment: Adagene's Groundbreaking SAFEbody Therapy Doubles Patient Response Rate!

Exciting new developments in the realm of cancer treatment have emerged, as Adagene Inc. has unveiled promising results from its ongoing phase 1b/2 clinical trial for its innovative masked anti-CTLA-4 SAFEbody, ADG126. This cutting-edge therapy, which is being administered in conjunction with Merck & Co., Inc.'s renowned anti-PD-1 treatment KEYTRUDA (pembrolizumab), has exhibited unprecedented efficacy in combating advanced and metastatic microsatellite-stable (MSS) colorectal cancer (CRC).

In a remarkable breakthrough, the trial has shown that the confirmed partial response rate in patients without liver and peritoneal metastases has doubled to four, translating to a notable 24% overall response rate (four out of 17 patients). Furthermore, the median progression-free survival in this subgroup has reached 8.5 months, highlighting the therapy's incredible potential in stalling disease progression. Moreover, the 12-month overall survival rates in these patients have been a remarkable 74% for those without liver metastases, and an astonishing 82% for those without liver and peritoneal metastases.

The findings, which were announced at the esteemed ESMO Congress in Barcelona, Spain, have generated immense excitement within the medical community, as they portend a groundbreaking shift in the treatment landscape for MSS CRC. MSS CRC is the most prevalent subtype of colorectal cancer and is notoriously resistant to immunotherapy. As such, the emergence of Adagene's ADG126 as a potent and potentially game-changing treatment paradigm has sent shockwaves of optimism throughout the oncology world.

According to Daneng Li, MD, the principal investigator of the trial and an Associate Professor in the Department of Medical Oncology & Therapeutics Research at the City of Hope Comprehensive Cancer Center, "I am delighted that these ESMO data demonstrate a promising overall response rate, progression-free survival, and early survival benefit from treatment with the immunotherapy doublet of ADG126 in combination with pembrolizumab for patients with advanced/metastatic MSS CRC, the largest segment of colorectal cancer with few treatment options." Dr. Li added that "With a much higher dosing level than available anti-CTLA-4 therapies, these data reinforce the encouraging safety and efficacy profile for ADG126 administered repeatedly in MSS CRC."

The groundbreaking results of the trial have been attributed to the unique properties of ADG126, which, as a masked anti-CTLA-4 SAFEbody, has demonstrated unparalleled safety and efficacy in targeting regulatory T cells in tumor tissue. By targeting a specific epitope on CTLA-4, ADG126 has shown promise in minimizing immunogenicity and anti-drug antibodies, while simultaneously maintaining a robust pharmacokinetic profile.

Perhaps the most promising aspect of Adagene's novel therapy is its potential to be used in conjunction with standard-of-care treatments to address broader patient populations, including those with liver metastases. As noted by Dr. Li, "Given the best-in-class potential for ADG126, this combination with pembrolizumab could address even broader patient populations, such as those with liver metastases, particularly if combined with standard of care to control early disease progression. Further, the safety profile of this immunotherapy doublet enables repeat cycles to achieve and sustain sufficient drug exposure that maximizes potential for a long-term survival benefit."

The Adagene study's revelations hold immense promise for the estimated millions of patients worldwide battling MSS CRC. As researchers continue to refine and expand upon these remarkable findings, the possibilities for a game-changing breakthrough in the treatment of this devastating disease have never been more palpable.

Adagene's mission to transform the discovery and development of novel antibody-based therapies has taken a significant leap forward, and the expectations surrounding this trailblazing research are higher than ever before. As oncologic innovators, scientists, and patients eagerly anticipate further developments, the excitement surrounding the tremendous therapeutic potential of Adagene's ADG126 SAFEbody continues to radiate through the corridors of the scientific community.