Expanded Access Policy

Oncoinvent is developing therapeutics to combat various cancers. 

At Oncoinvent, we are committed to developing new innovative products to provide better treatment options for cancer patients. Currently, our lead candidate Radspherin® is in clinical trials to evaluate its safety and efficacy in patients with metastatic colorectal or ovarian cancer in the peritoneal cavity.

An Expanded Access Policy – sometimes called “compassionate use”, refers to the use of an investigational medicinal product outside of clinical trials. It is a potential pathway for patients to obtain access to investigational therapies under some extraordinary circumstances, in compliance with guidelines on eligibility criteria set out by the US Food and Drug Administration (FDA) and other regulatory agencies. For example, if a patient has a serious or immediately life-threatening disease, and/or the potential benefit to the patient clearly outweighs the collective potential risks, expanded access to a therapy may be considered.

We strive to establish efficacy and safety in controlled clinical trials as early as possible. The scientific evidence generated in these clinical trials is essential to obtain market approvals to make Radspherin® available to as many patients as possible.

At Oncoinvent, we believe that participation in one of our clinical trials is the best way to access Radspherin® in a controlled setting. Our current policy is that Radspherin® will not be available on an expanded access basis. This may change in the future when sufficient safety and efficacy information has been demonstrated in randomized, controlled clinical trials.

Radspherin®

Oncoinvents lead product candidate is designed to treat cancer in the peritoneal cavity

Description of the product

  • Inorganic microparticles as carriers of alpha-emitters
  • High-power radiation with a short range
  • Short half-life of the radionuclide
  • Microparticles which degrade slowly in the body
  • Regional retention of effective radiation dose

Anders Månsson

Chief Executive Officer

mansson@oncoinvent.com

Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.