Valo Therapeutics Oy (ValoTx) has selected CDMO Exothera to develop a large-scale production process for clinical development of its oncolytic adenovirus, VALO-D102.

ValoTx’s VALO-D102 is an oncolytic adenovirus, which the firm says is an essential component of its immuno-oncology platform PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus).

“We take an oncolytic adenovirus (VALO-D102) and add immunogenic positively charged tumor peptides, which are adsorbed onto the negatively charged viral capsid to create PeptiCRAd,” a spokesperson for ValoTx told us.

Image: DepositPhotos/Julia_Tim

The platform works by using a technology that the company says can create electrostatic interactions between positively charged, tumor-specific peptides as well as negatively charged surface oncolytic adenoviruses. In turn, the adenoviruses can then be used as immunogenic carriers for the tumor-specific peptides and create systemic tumor-targeted killer T-cell responses.

“We will grow the virus in an adherent/suspension mode bioreactor, using a A549 cell line and purify the virus harvest using conventional purification process before filling into single dose vials.  The synthetic peptide cancer antigens are also supplied as single dose vials and coated on the virus surface by simply mixing the virus (negative charge on surface) and poly-lysine extended cancer specific peptides (positive net charge) to create PeptiCRAd,” the spokesperson said.

No financial details have been disclosed but contract development manufacturing organization (CDMO) Exothera will perform tech transfer, analytical development, and initiate a scale-up to start manufacturing clinical material for EU Phase II clinical trials of VALO-D102 at its facility in Jumet, Belgium.

“ValoTx’s platform has the potential to turn the tide in the fight against cancer,” said Hanna Lesch, chief technology officer at Exothera.

“At Exothera, we are excited to put our extensive viral vector expertise at Valo’s service for the process development and manufacturing of such a revolutionary oncolytic virus-based immunotherapy. We’re proud to be one of the leaders laying down the roadmap for viral vector production to deliver exciting new cancer therapies like PeptiCRAd-1.”

Exothera added 22,600 square feet to relieve its capacity constraints at the Jumet plant in March 2022 and ValoTx said the facility can accommodate programs from development stage through to manufacturing scale.

“We are reinventing cancer immunotherapy to make it more effective and accessible to cancer patients. This important work with Exothera will enable us to develop a large-scale manufacturing process for VALO-D102 to support our future clinical development plans and pave the way for future commercial-scale manufacturing,” Petri Priha, vice president of CMC at ValoTx said.

The time-limit will not be divulged.