Home Interviews Fast Track designation facilitates development of Oncoinvent’s Radspherin

Fast Track designation facilitates development of Oncoinvent’s Radspherin


Fast Track designation facilitates development of Oncoinvent’s Radspherin

27 June, 2024

The FDA has granted Fast Track to Oncoinvent for its radiopharmaceutical Radspherin as a treatment for peritoneal metastases originating from ovarian cancer. This designation will facilitate the candidate’s clinical development, with the next step being a phase IIb trial first in ovarian cancer patients, then in colorectal cancer patients.

Oncoinvent is a privately held Norwegian company developing radiopharmaceutical products for treating cancer patients. The company’s lead product candidate, Radspherin, is a novel alpha-emitting radioactive micro particle suspension designed for local treatment of metastatic cancers in body cavities. It is in clinical development for the treatment of peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.

Fast Track accelerates development

Oncoinvent has now received FDA Fast Track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer. Fast Track is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The aim is to potentially bring important medicines to patients earlier.

– Fast Track designation for Radspherin is a key milestone for Oncoinvent, particularly as we are on the verge of initiating a phase IIb trial to evaluate Radspherin in peritoneal metastases from ovarian cancer, and later also in peritoneal metastases stemming from colorectal cancer patients, says Oncoinvent’s CEO Anders Månsson.

Patients with unmet medical need

Fast Track will allow more frequent interactions with the FDA during the clinical development of Radspherin. If relevant criteria are met, Radspherin is also eligible for Accelerated Approval and Priority Review which could bring the radiopharmaceutical faster to the patients, who are in dire need of new treatment alternatives

– The Fast Track designation for Radspherin underscores the importance of bringing forward new first-line treatments in ovarian cancer that prevent or delay relapse and prolong survival after surgery for peritoneal metastases, says Ignace Vergote, Professor Emeritus at the Catholic University Leuven and Scientific Advisor for Oncoinvent.

– The potential of Radspherin to eradicate microscopic residual disease after surgery could address the unmet need for these patients, especially those with negative homologous recombination deficiency (HRD) testing who may not respond as well to therapies. The recognition from the FDA is indeed very encouraging now that recruitment of patients to the phase IIb RAD-18-003 trial in ovarian cancer is about to begin,

Phase IIb trial soon to be initiated

According to Oncoinvent, the phase IIb trial in ovarian cancer patients is expected to start imminently. The trial aims to evaluate the efficacy and safety of Radspherin, focusing on comparing progression-free survival (PFS) between two groups: patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and those who undergo only pre-operative chemotherapy and surgery. The trial will be conducted in both the US and EU.

The company has previously presented encouraging interim data from the ongoing phase I/IIa studies involving both ovarian and colorectal cancer patients, demonstrating that Radspherin is well tolerated with no dose-limiting toxicity observed with the administration of the recommended dose of 7MBq and featuring a promising efficacy signal.

Addressing the need for safer and more effective treatments

With Fast Track in place, Oncoinvent’s CEO is eager to advance the development of the lead candidate:

– We believe we are well positioned to execute the clinical development of Radspherin in our upcoming trial and look forward to advancing this innovative product candidate to benefit patients battling this type of cancer, for whom there are limited treatment options.

Peritoneal metastases have a significant negative impact on life expectancy, underscoring the need for a novel effective treatment that could improve overall survival in these patients.

CEO comments on the Fast Track Designation

Anders Månsson, CEO of Oncoinvent

BioStock reached out to Anders Månsson to learn more about the unmet medical need, and the importance of the Fast Track designation for Radspherin.

Could you first provide more details on the criteria that must be met to receive Fast Track designation?

– There are two criteria that needs to be met in order to qualify for fast track; the drug is developed for a serious condition where there is an unmet medical need. Seriousness is evaluated based on the drugs potential impact on i.a. survival. In order to meet the unmet need criterion, the drug must be developed to treat a condition where current therapy does not exist or where the fast track drug shows an advantage over available therapy.

What are the medical need and specific challenges associated with treating peritoneal metastases, and how will Radspherin potentially address these challenges?

– Peritoneal metastases represent the main cause of death in ovarian cancer and is associated with severely distressing symptoms and poor quality of life. Despite a comprehensive treatment approach, peritoneal recurrences frequently occur. Relapsed advanced ovarian cancer is typically incurable, highlighting the need for effective first-line treatments that prevent or delay relapse and prolong survival. The unmet medical need is particularly high for patients with homologous recombinant proficient (HRP) tumours who have a limited effect of available therapy after surgery. The homologous recombinant repair pathway refers to the ability to accurately repair double-strand DNA breaks. Since HRP tumors can effectively repair DNA damage, they are generally less responsive to treatment.

– The aim of Radspherin treatment is to complement surgery by eradicating micrometastases that are not visible to the surgeon, thereby prolonging the disease-free period leading to an improvement in overall survival.

How will Fast Track benefit the clinical development of Radspherin, particularly as you prepare for the phase IIb trial in patients with peritoneal metastases from ovarian cancer?

– Fast Track is of course only a first step, albeit a necessary first step, in a process that could eventually lead to accelerated approval and priority review. Still, in the shorter term it also helps us as it creates attention and provides further endorsement of our development plans, and as such it can further boost investor interest and interest in scientific collaboration with our company.

Could you provide more details on the expected timeline and key objectives of the phase IIb trial?

– The phase IIb trial in ovarian cancer already has a a few centers initiated, and the first patient could actually be included any week now. The phase IIb study in colorectal cancer is expected to start in the autumn. The objective of both trials is to provide further evidence on both safety and efficacy allowing for properly designed and powered pivotal trials planned to start in 2027.

– With continued good results we also think there is a good chance of conditional approval being granted as there is no currently available therapy that is developed specifically for the treatment of peritoneal metastases, while the survival benefits of avoiding a cancer recurrence after debulking surgery is substantial. In short, there is a dire unmet medical need, impacting many patients, and we think Radspherin can address that unmet need.

With Fast Track designation, there are expectations for Accelerated Approval and Priority Review. How does Oncoinvent plan to leverage these opportunities in advancing Radspherin to market?

– As there is no effective in-label therapy that is available for these patients, it would be in the interest of society to bring an effective therapy to market as soon as possible. However, this can not be the focus of our company. We simply have to focus on delivering the best results possible with the clinical trials currently planned. If the results at the end of the day, meet the criteria for a faster approval, we will for sure do our bit to expedite this.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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