Type of information: Licensing agreement
Compound: Zalmoxis® - TK cell therapy
Company: Molmed (Italy) TTY Biopharm
Therapeutic area: Cancer - Oncology
Type agreement: licensing - commercialisation - distribution
- cell therapy. Zalmoxis® is a cell therapy product, based on the use of genetically engineered donor T cells with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2). Zalmoxis® is based on genetically engineering donor immune system T cells to carry an inducible “suicide gene”. Administered to patients following HSCT from partially compatible donors (haploidentical HSCT), these cells foster an anti-leukaemia effect by eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution. The suicide gene in the modified T cells makes them susceptible to ganciclovir or valganciclovir. If the patient develops graft-versus-host disease, ganciclovir/valganciclovir is given, which kills the modified T cells that have the suicide gene, so preventing further development of the disease. Zalmoxis® is an advanced therapy medicinal product (ATMP).
- Zalmoxis® is conditionally authorised by the European Commission for adult patients affected by leukaemia or
other high-risk haematological malignancies, and is the first patient-specific cell therapy used in combination
with haplo-identical haematopoietic stem cell transplant (haplo-HSCT).
Disease: hematological cancers
- • On June 30, 2017, MolMed and TTY Biopharm announced that they signed an exclusive license and distribution agreement which defines all terms and conditions to import, use, market, sell and/or distribute Zalmoxis® for the treatment of haematological malignancies in Taiwan, Hong Kong, Singapore, Thailand, Philippines, Vietnam and Malaysia, as anticipated on February 7, when the companies signed a term sheet defining the main terms and conditions.
- Under the terms and conditions of this agreement, the application of Marketing Authorization of Zalmoxis® in the interested territories will be carried-out by and at the cost of TTY which will eventually perform further clinical studies, if needed to obtain regulatory approval, and will conduct all associated regulatory activities after marketing authorization including market access and price & reimbursement. Furthermore, TTY may promote TK008 study enrolment and, possibly, be responsible for engaging hospitals and authorities to allow the performance of it in the interested territories.
- • On February 7th, 2017, MolMed and TTY Biopharm announced they signed a term sheet defining the main terms and conditions under which MolMed will grant TTY an exclusive license agreement for the commercialization of Zalmoxis® in certain Asian territories. Within June 30th, 2017, the terms contained in this agreement shall be incorporated into a definitive contract, pursuant to which TTY, under certain terms and conditions, will be granted an exclusive, non-transferable, revocable, sub-licensable license to import, use, market, sell and/or distribute Zalmoxis for the treatment of hematological malignancies in Taiwan, Hong Kong, Singapore, Thailand, Philippines, Vietnam and Malaysia.
- Under this agreement, MolMed will receive an upfront payment, potential regulatory and sales milestone payments up to € 13.5 million, as well as royalty payments in the range of 10% to 20% on annual net sales generated in each country covered by the agreement.