ImmunityBio Partners with Accord Healthcare to Expand Anktiva Access Across 33 Countries

ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries, following conditional marketing authorization from the European Commission. The partnership will utilize over 100 Sales, Medical, and Marketing professionals to drive commercialization of Anktiva in the U.K. and Europe. ImmunityBio has also established a Dublin-based subsidiary to support the company's distribution and commercialization strategy in Europe.

Anktiva received conditional marketing authorization from the European Commission, allowing sales across 27 EU member states, Iceland, Liechtenstein, and Norway. The therapy is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, used in combination with Bacillus Calmette-Guérin (BCG).

With approvals now spanning 33 countries, ImmunityBio has expanded global access to Anktiva for those with BCG-unresponsive NMIBC CIS, with or without papillary disease. These approvals include the U.S. and span four major regulatory jurisdictions. The company will submit long-term safety and efficacy data to the European Medicines Agency to meet regulatory requirements and facilitate the widespread use of Anktiva in Europe.

Approximately 157,000 people are diagnosed annually with non-muscle invasive bladder cancer (NMIBC) in the EU and UK, with an estimated 10% to 20% presenting with NMIBC carcinoma in situ, with or without papillary tumors. Accord Healthcare will deploy an 85-person sales force to drive Anktiva commercialization across 30 countries.

Anktiva is a first-in-class interleukin-15 (IL-15) receptor agonist consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. Anktiva binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, Anktiva addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses.

For bladder cancer indication expansion, a response has been submitted to the U.S. FDA for BCG-unresponsive papillary-only disease, and a randomized BCG naïve trial is nearing full enrollment. ImmunityBio shares fell approximately 8% in Thursday's opening trade following the partnership announcement.