Biotecnol’s is developing its products, up to and including clinical proof of concept in man through development milestones that represent key value inflection points with the aim of subsequently license or selling them to a pharmaceutical partner.
Biotecnol is developing various products, some under collaborations with undisclosed partners. The company is commited to explore the design of treatments using combinations of novel agents in this exciting, dynamic and constantly emerging space of cancer immunotherapy, which could contribute significantly to fighting highly heterogeneous and agressive cancers.
Biotecnol has various undisclosed candidates being tested both in solid and non-solid tumours. Furthermore, these products are being investigated as dual-targeting agents, making the most out of the trispecific features of the versatile Tribody™ Platform. Our first product moving to the clinic is Tb535, which is described below.
Tb535 a T-cell engager Tribody™ with a pan-cancer application potential for treating solid tumours expressing 5T4/WAIF1
Tb535 is Biotecnol's first candidate entering clinical development in a collaboration with Cancer Research UK (CRUK). Tb535 is a Tribody™, against the well-validated oncofoetal tumour-associated antigen,5T4/WAIF1, originally isolated from trophoblasts. The 5T4/WAIF1 tumour antigen is a protein found on many different solid tumours and is thought to contribute to the spread of cancer cells.
Tb535 binds to the tumour antigen on the surface of the tumour cell. Upon accumulation of Tb535 it triggers primed CD8+ CTLs, to engage and kill the target tumour cells.
5T4/WAIF1 is expressed on a majority of solid tumours including colorectal (40-80%), renal (>95%), breast (85-90%), ovarian (70%), Malignant Mesothelioma (98%), gastric (50-70%), non-small cell lung (>99%), prostate (>80%) and cervix (86-90%) cancers.
Expression of 5T4/WAIF1 on a patient tumour cells is a negative prognostic factor in several malignancies. Furthermore, 5T4/WAIF1 expression has been associated with the cancer stem cell phenotype. By contrast, expression levels of 5T4/WAIF1 in normal tissues generally absent or are very low. Immunohistochemistry of normal tissues from healthy donors showed no 5T4/WAIF1 staining in major tissues (adrenal, blood, marrow, breast, brain, colon, heart, kidney, liver, uterus cervix, lung, lymph nodes, pancreas, parathyroid, prostate, skin, spinal cord, spleen, muscle, testis, thyroid, stomach, ileum or eye). Clear positive staining was found in placenta only. Weak expression was seen in some samples of normal bladder, fallopian tube, endometrium, pituitary, ureter and duodenum.
A two-centre open label, dose escalation clinical study for evaluation of the tolerability and safety of Tb535, in various patients with tumours expressing 5T4/WAIF1 is planned. The study will assess safety, maximum tolerated dose (MTD), recommended phase two dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity including biomarkers of anti-tumour activity. It will be a dose escalation study to establish a recommended dose and schedule, for the continued clinical development of Tb535.