The drug Omomyc, created at the Vall d’Hebron Institute of Oncology (VHIO), has begun to be tested in patients with pancreatic cancer with metastasis after the good results obtained in its first clinical trial in people.
Omomyc acts differently from any previous therapy, since it is the first drug capable of inactivating the MYC protein of cancer cells, so it is expected that it can be effective in patients in whom other therapies are not.
The results of the first trial, which are presented today in the journal Nature Medicine, indicate this. The trial involved 22 volunteers who had different types of cancer with metastases and in which the disease progressed after exhausting all treatment options.
In a person with pancreatic cancer, the volume of the tumors was reduced by half, there was an 83% decrease in the amount of tumor DNA detectable in the blood and the disease stabilized for seven months.
In another patient with a type of sarcoma, who had not responded to the last two treatments he had been given, the cancer stopped progressing for eight months.
A third patient with salivary gland cancer remained stable 26 months after starting treatment and continued receiving Omomyc after completing the clinical trial.
Other types of cancer that have temporarily stopped progressing with Omomyc include lung and colorectal cancer.
These data expand the initial results of Omomyc presented 15 months ago at a conference. “Now we have proof that this treatment has long-term clinical benefit,” declares Laura Soucek, Icrea researcher at VHIO and leader of the project. “The challenge is to ensure that it reaches patients as soon as possible and to the maximum possible number of patients.”
A priori, Omomyc can be effective against multiple types of tumor, since it inactivates the MYC protein, which is altered in most cancers. This protein, which accelerates the proliferation of tumor cells, has classically been considered undruggable, that is, impossible to attack with drugs. “Everyone said it was impossible,” Soucek told La Vanguardia in 2002. But “where others saw an impossible problem, I saw technical difficulties that I hoped could be solved.”
She teamed up with pharmacologist Marie-Eve Beaulieu to develop a drug capable of accessing the interior of the cell nucleus, where MYC acts, and they founded the company Peptomyc.
To get the drug approved and reach patients, the Peptomyc team has decided to now focus on pancreatic cancer because “it is a type of tumor in which there is a great need to develop new therapies and in which we have had two patients who have responded in the first clinical trial,” declares Soucek. And also “because we have to focus on a concrete indication to move forward; In the future we hope to study the potential of Omomyc in other types of tumor.”
The first three participants in the pancreatic cancer clinical trial have already received the first dose of Omomyc, Soucek reports. In the coming months, up to thirty patients from the Vall d’Hebron, ICO-Bellvitge, Miguel Servet hospitals in Zaragoza and Gregorio Marañón in Madrid will be enrolled.
Patients will receive Omomyc in combination with chemotherapy, rather than receiving it as a single therapy like participants in the first clinical trial. Therefore, the effectiveness of the treatment is expected to be higher, since Omomyc can have a synergistic effect with chemotherapy and prevent the cancer from becoming resistant to treatment.
Additionally, in the first clinical trial, a biomarker has been identified that predicts which patients will respond to Omomyc. This is making it possible to select for the second trial patients who a priori can benefit from the drug.
If the results are positive as expected, “our goal is to partner with a large pharmaceutical company to continue the development of the treatment, because a small biotech like Peptomyc does not have enough resources to reach a large number of patients,” he declares. Soucek.
The development of the drug Omomyc has been financed with contributions – among others – from the European Research Council, the Ministry of Science, Innovation and Universities, the Carlos III Health Institute and the Worldwide Cancer Research, la Caixa, BBVA, Cellex, Fero and La Marató from TV3.
