E!113345 Fighting Leukemia with the Original Radioimmunotherapy Alpha37

Nordic Nanovector has developed a CD37-targeting radio-immunoconjugate (RIC), Betalutin®, for treatment of Non-Hodgkin Lymphoma (NHL). Betalutin® is currently in a global, randomized Phase 2b trial. Betalutin® consists of the murine anti-CD37 antibody lilotomab conjugated with a chelator that chelates the beta-particle emitting radionuclide lutetium-177. A chimeric (mouse/human) version of lilotomab, NNV03, has been developed for FLORA. OranoMed has developed a unique and patented lead-212 production process and set-up facilities for the production and distribution of this rare radioisotope in the US and Europe. FLORA?s main goal is to develop a novel product candidate, Alpha37, comprised of NNV003, the chelator TCMC and lead-212 for treatment of CD37-positive R/R CLL. The product is proteccted by two patents. CLL is a cancer originating from B-cells that highly and selectively express CD37. Despite available treatments, the 5-year survival rate for patients with CLL is 83%. Approximately 25% of resistant or refractory CLL patients discontinue therapy in the first year, mainly due to treatment related adverse events. These patients have a median survival of approximately 3.5 months after stopping therapy. Current drugs pose compliance issues since the patients must take the drugs every day until the disease progress, thus making a strong case for therapies with simpler dosing schedules, like Alpha37. Nordic Nanovector and Orano Med have used their combined expertise to develop a new, unique and well characterised RIC towards an investigational new drug (IND) application.

Internal radiation therapy will be optimal for treatment of the radiosensitive CLL cells. This will be disruptive for CLL treatment since there is no external beam radiation therapy developed for CLL. Most available therapies are used in combination regimens and require multiple administrations over time, while Alpha37 can be used alone and requires one single administration. The single injection and the mechanism of action of Alpah37 are disruptive and totally new to market.

Nordic Nanovector has developed a CD37-targeting radio-immunoconjugate (RIC), Betalutin®, for treatment of Non-Hodgkin Lymphoma (NHL). Betalutin® is currently in a global, randomized Phase 2b trial. Betalutin® consists of the murine anti-CD37 antibody lilotomab conjugated with a chelator that chelates the beta-particle emitting radionuclide lutetium-177. A chimeric (mouse/human) version of lilotomab, NNV03, has been developed for FLORA. OranoMed has developed a unique and patented lead-212 production process and set-up facilities for the production and distribution of this rare radioisotope in the US and Europe. FLORA’s main goal is to develop a novel product candidate, Alpha37, comprised of NNV003, the chelator TCMC and lead-212 for treatment of CD37-positive R/R CLL. CLL is a cancer originating from B-cells that highly and selectively express CD37. Despite available treatments, the 5-year survival rate for patients with CLL is 83%. Approximately 25% of resistant or refractory CLL patients discontinue therapy in the first year, mainly due to treatment related adverse events. These patients have a median survival of approximately 3.5 months after stopping therapy. Current drugs pose compliance issues since the patients must take the drugs every day until the disease progress, thus making a strong case for therapies with simpler dosing schedules, like Alpha37. Nordic Nanovector and Orano Med will use their combined expertise to develop a new, unique and well characterised RIC. Main deliverables include preclinical documentation of Alpha37, GMP manufacturing process for antibody conjugate and RIC, bioanalytical assays and the investigational new drug (IND) application.