Australian biotechnology company Immutep (ASX: IMM) has entered into three agreements with Japanese cancer vaccine development company Cytlimic Inc for its lead product candidate eftilagimod alpha.
A clinical collaboration agreement will enable the two companies to work together on trials to evaluate Immutep’s efti (also known as IMP321) as part of a therapeutic cancer vaccine containing Cytlimic’s innovative cancer peptide vaccine CYT001, first discovered by artifical intelligence.
Therapeutic cancer vaccines are those containing cancer antigens which boost a patient’s own immune cells to recognise and kill cancer cells related to the antigens.
Efti is a first-in-class antigen presenting cell activator proven to induce a sustained immune response in cancer patients when used at low doses.
It can also be used as a cancer vaccine adjuvant or used at higher doses to produce a systemic effect.
Under the terms of the agreements, Cytlimic will conduct, control and fully-fund all development costs relating to the CYT001 / efti trials.
Immutep will receive an upfront payment of US$500,000 and will be eligible to receive up to US$4.5 million in milestone payments upon the achievement of pre-determined milestones by Cytlimic.
During the term of the collaboration, Immutep will retain exclusivity over patent rights covering its own clinical development programs and those being conducted with other partners evaluating efti in combination with either chemotherapy or PD-1/PD-L1 immunotherapy.
Supply and service agreements
In addition to the collaboration agreement, Immutep has entered into a supply agreement to provide efti to Cytlimic for the manufacture of CYT001 for use in the vaccine’s clinical development and commercialisation.
The companies have also signed a service agreement where Immutep will provide technical support services to Cytlimic during the development and commercialisation of of the CYT001 vaccine.
Eftilagimod alpha is a soluble LAG-3Ig fusion protein based on the lymphocyte activation gene-3 (or LAG-3) immune control mechanism which plays an important role in the regulation of T-cell immune response.
T cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer.
Immutep CEO Marc Voigt said efti is generating global interest for its broad therapeutic potential in the development of cancer vaccines.
“Efti it is now being evaluated as part of three different combination therapy types – as part of a therapeutic cancer vaccine, as a chemo-immunotherapy and in an IO combination,” he said.
“We are excited to be working alongside Cytlimic to help evaluate efti as part of an innovative cancer vaccine which has potential as a new therapy.”
Efti is currently being used by Immutep partners in a Phase IIb clinical trial as a chemo-immunotherapy for metastatic breast cancer, and a Phase II clinical trial to evaluate a combination of efti with Keytruda (pembrolizumab) in several different solid tumours.
The drug will also be used in a planned Phase I clinical trial to evaluate a combination of efti with avelumab; and a Phase I combination therapy trial in metastatic melanoma.
In November, the European Patent Office granted Immutep a patent to protect its intellectual property relating to combined preparations comprising efti and a PD-1 or PD-L1 inhibitor, as well as usage of the same preparations for the treatment of cancer or infection.
Last month, Immutep announced it will use the proceeds from a US$5.2 million financing exercise with US specialist healthcare investor Altium Capital to fund ongoing clinical development of efti as well as the pre-clinical development of IMP761 drug candidate as an immuno-suppressive agonist antibody to LAG-3.
At midday, shares in Immutep Limited were trading 9.68% higher at $0.034.