At Highlight Therapeutics, we continue to take steps to expand the potential of immunotherapy and reach more patients who currently lack effective treatment options.
In this context, we have initiated a second collaboration with MSD (Merck & Co., Inc.) to launch a phase II clinical trial evaluating the combination of BO-112, our lead candidate, with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma who have stopped responding to anti-PD-1 therapies.
The new study, called SPOTLIGHT-203, strengthens the relationship of trust and collaboration between the two companies and focuses on one of the greatest unmet medical needs in oncology: patients with advanced-stage melanoma who no longer respond to conventional immunotherapy.
A challenge in the fight against melanoma
Advanced malignant melanoma remains one of the most difficult forms of skin cancer to treat.
Immunotherapies based on PD-1 or CTLA-4 inhibitors have represented a major breakthrough, but many patients fail to respond initially, while others eventually develop resistance after an initial response.
At Highlight Therapeutics, we are working precisely to overcome this resistance barrier and reactivate the immune system against the tumor.
BO-112: reactivating the body’s natural defenses
BO-112 is a double-stranded RNA agonist designed to stimulate the innate immune system. Its intratumoral administration triggers a local immune response capable of converting so-called “cold tumors”—those not recognized by the immune system—into “hot tumors” that can be detected and attacked by the body’s defenses.
In combination with pembrolizumab, BO-112 aims to improve the efficacy of anti-PD-1 therapies by helping the immune system regain its ability to respond to cancer.
The SPOTLIGHT-203 study
This phase II clinical trial will be conducted at several international centers and is designed to evaluate the safety, tolerability, and antitumor efficacy of the combination of BO-112 with pembrolizumab.
The study will initially enroll 40 patients with refractory advanced melanoma, and a subsequent randomized phase will be incorporated depending on the results obtained.
Evaluation parameters will include:
- objective response rate
- disease control rate
- duration of response
- progression-free survival
- overall survival
- as well as the safety profile of the treatment.
Highlight Therapeutics CEO Marisol Quintero emphasized the importance of this new stage: “SPOTLIGHT-203 is designed to address a major unmet medical need in patients with unresectable stage III or IV melanoma who have failed anti-PD-1 therapy. Previous phase I data suggest that BO-112 has the potential to sensitize the immune system to the tumor, and we believe this combination may be able to overcome treatment resistance.”
An alliance driving the development of new therapies
This new collaboration with MSD will allow us to accelerate the launch of new treatment strategies and continue expanding our understanding of BO-112.
As Marisol Quintero highlighted: “We are pleased to continue this productive collaboration with MSD, whose extensive experience in immuno-oncology makes it the ideal partner. Together, we can accelerate the research of effective therapies for patients with malignant melanoma, a disease that continues to have a very poor prognosis.”
Looking ahead
The launch of the SPOTLIGHT-203 study represents another step forward in our mission: developing innovative immunotherapies capable of offering a second chance to patients who have become resistant to treatment.
We will continue to move forward along this path, convinced that the combination of science, collaboration, and commitment is the key to extending the reach of immunotherapy and benefiting more patients.