Clinical Phase II colorectal cancer study with SCO-101 to continue as planned

As announced Monday, March 23, Scandion Oncology has, together with its clinical partners, decided not to put the clinical Phase II colorectal cancer study with SCO-101 (our main candidate against cancer drug resistance) on hold and continue the study. However, it will be at the total discretion of the clinical investigators to decide the rate of patient enrolment after taking the COVID-19 situation into account.

 

Clinical recommendations from top authorities

We have all now been informed about recent guidelines released from the Danish Medicines Agency, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) that all First in Man (FIM) clinical studies with novel single agents or novel combinations, should be considered postponed until the COVID-19 pandemic is under control.

The reasons for this recommendation are

1. The staff at the hospitals are extremely stressed and overworked due to the COVID-19-infected patients;
2. All clinical studies testing novel agents/novel combinations will require the trial sites to be able to provide patients with intensive medical care, e.g., respiratory support in case of serious unexpected adverse events, and this may not be possible during the extraordinary circumstances caused by COVID-19;
3. Any severe adverse event, which could potentially influence the study results, may be due to COVID-19 and not related to the drug being studied, and thus impact the validity of trial results;
4. Due to the increased risk of bringing further COVID-19 infections into the hospitals, we should restrict the number of individuals who visit the hospitals.

 

Reason for study continuation

However, as described in the COVID-19 guidance from the EMA: "Sponsors should be mindful of the current pressure on the medical profession and should carefully assess the pertinence of adding new subjects in ongoing clinical trials. Absolute priority should be given to clinical trials on treatments for COVID-19 and COVID-19 related illnesses, or trials on serious diseases with no satisfactory treatment option."

 

Patients being enrolled in our colorectal cancer study with SCO-101 have a serious disease with no satisfactory treatment option. Thus, in accordance with the EMA guidance stated above, this is why we will continue the study. We have previously announced that we will publish a press release when the first three patients have finalized SCO-101 treatment, and this is still the plan.

 

Scandion Oncology is doing what it can to facilitate patient recruitment as soon as possible.

We do know from our clinical partners that several eligible colorectal cancer patients are waiting to be included in the study. Moreover, to ensure the continuation of speedy, yet smooth patient recruitment, Scandion Oncology is doing the following:

1. Having several weekly video meetings with our Clinical Research Organization, which is responsible for the monitoring of the Phase II colorectal cancer study with SCO-101;
2. Weekly contact with current clinical partners to monitor the status of our clinical trial;
3. Video conferences between Scandion Oncology employees on a daily basis (we have closed the office temporarily and all employees are working from home);
4. In talks with additional clinical sites to see whether they can join the study, thereby increasing patient enrolment when possible.

 

Taking extraordinary steps to stay on track once pandemic subsides

In the meantime, Scandion Oncology is also taking steps to optimize time while waiting for the COVID-19 pandemic to be under control in order to come out of the gate strong once things get back to normal. These steps include:

1. Working to make the next clinical protocol ready for submission to the Danish Medicines Agency and the Ethical Committee. This protocol includes treatment with taxane (a common cancer chemotherapy) supplemented with SCO-101 in patients with inoperable pancreatic cancer. It is a randomized study and will allow us to determine the effect of the SCO-101 addition to taxane treatment with regard to patient survival. We have identified four clinical sites that will participate in enrolling and treating the patients. A press-release will be published once the applications are submitted and again when they are approved. The plan is to initiate the study in early Q3, 2020;
2. Initiating the formulation process of more SCO-101 tablets;
3. Developing and analytically validating predictive biomarkers for SCO-101 effects on cancer cells;
4. Continuing to apply for national and international soft money to support future clinical studies;
5. Proceeding with SCO-201 preclinical studies in order to bring this drug forward to clinical studies;
6. Standing ready to perform the third and last animal experiment with SOM-001, our candidate targeting antibiotic resistant bacteria. All the needed animals for these experiments are already at the facilities of the State Serum Institute in Copenhagen, and we are just waiting for permission to initiate the study which takes about 2-3 days to finalize. When we have the animal results, Scandion Oncology will decide on the future business development plans for SOM-001. Information will be provided through a press release;
7. Intensifying Business Development efforts:
   1. Presenting data at National and International meetings
   2. Continuing ongoing discussions and negotiations with potential partners
   3. Hiring a Business Development specialist
   4. Considering the inclusion of American Cancer Centers in the clinical pancreatic cancer study; having American patients included will greatly facilitate later applications to the US Food and Drug Administration.  

Patience and optimism are key

In light of such unprecedented circumstances, we sincerely hope for your understanding - the COVID-19 pandemic is serious and has already affected clinical trials being run not only by many biotech companies, both small and medium-sized, but also by Big Pharma companies. As reported above, Scandion Oncology is taking extraordinary steps not only to make sure our work stays on track and proceeds in the smoothest way possible during this difficult time, but also to ensure that we are at the top of our game when the situation subsides. For the time being, we can only hope that all the measures being taken now will result in a fast return to normality.

 

With my warmest regards; take care

 

Nils Brünner

CEO, Scandion Oncology

 

For further information regarding Scandion Oncology, please contact:

Nils Brünner, CEO

Phone: +45 26 14 47 08

E-mail: nb@scandiononcology.com

 

Scandion Oncology A/S is a biotechnology company that addresses and tackles one of the greatest challenges in modern oncology - the effective treatment of cancer which contains chemotherapy-resistant cells or which has developed resistance to a previously prescribed cancer-fighting drug. In preclinical in vitro-studies SCO-101 restores chemotherapy sensitivity in resistant cancer cells. Moreover, in animal studies, the company's leading candidate drug, SCO-101, significantly enhances the efficacy of certain standard cancer treatments when given in combination. Scandion Oncology is now in clinical phase II trials with its lead compound, SCO-101, in patients with chemotherapy-resistant colorectal cancer. In addition to SCO-101 the Company has two other drug candidates, SCO-201 and SCO-301. Scandion Oncology was listed on Spotlight Stock Market, Sweden in November 2018.