SOTIO, a biotechnology company leading the efforts of PPF Group, one of the largest investment groups in Central and Eastern Europe, to build a diverse biotechnology portfolio, has selected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement NBE-Therapeutics, a privately-owned Swiss, Basel-based biotech company, founded in 2012.

SOTIO announced its initial collaboration with NBE-Therapeutics for the development of antibody-drug conjugates in October 2016. The first joint program was to develop an ADC against an undisclosed target is referred to as SO-N102

As part of the collaboration, NBE-Therapeutics and SOTIO will be working together in the discovery, non-clinical development and manufacturing of this second undisclosed target.

The development will be based on NBE’s proprietary antibody-drug conjugate platform, including NBE’s site-specific SMAC-technology™ conjugation and its new, highly potent anthracycline toxin platforms. In turn, SOTIO will take global responsibility for clinical development, registration, and commercialization of the novel ADC.

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Immune-stimulatory ADC
NBE-Therapeutic’s iADCs™ payload platform combines a uniquely effective anthracycline payload with site-specific enzymatic conjugation generating entirely homogeneous iADCs™ with stable linkers.

The company’s technology leverages a highly potent anthracycline-based DNA-intercalating toxin, a highly potent metabolite metabolite of nemorubicin (MMDX), which is related to doxorubicine and termed PNU-159682.[1]

The active drug, PNU-159682, is up to 3-5000 times more potent on selected cancer cell lines than the standard doxorubicin (Adriamycin®, Rubex®) . To be used as a payload in an antibody-drug conjugate, ultra-potent toxins like PNU-159682 require highly stable linkers that covalently attach the toxin to the antibody. To safely use this payload, a well-defined conjugation site with uniform stability is a crucial requirement. Scientists at NBE-Therapeutic have efficiently coupled this payload, modified via a stable amide and peptide bond linker, to the C-termini of antibody heavy and light chains using the company’s SMAC-Technology™.

NBE-Therapeutic’s novel ADCs have shown unprecedented preclinical data in efficacy, as well as safety, in multiple pipeline programs.

Lead Program
The company’s lead program, NBE-002 against ROR1, has successfully passed a Good Laboratory Practice (GLP) toxicology study and is in the final stages of Chemistry, Manufacturing and Controls (CMC). It is expected to begin its first in-human study by mid-2020 for the treatment of patients with triple negative breast cancer (TNBC) and lung cancer (NSCLC), as well as other cancer indications.

Radek Špíšek, MD., Ph.D, joined SOTIO in 2010. He has been a member of the company’s management team responsible for overseeing research and manufacturing. He was appointed Global CEO in March 2018.
Radek Špíšek, MD., Ph.D,
joined SOTIO in 2010. He has been a member of the company’s management team responsible for overseeing research and manufacturing. He was appointed Global CEO in March 2018. Photo Courtesy SOTIO.

Milestone payments
NBE-Therapeutics is eligible for the option exercise fee, as well as milestone payments and royalties based on global net product sales. In addition, NBE will be reimbursed for its R&D expenses incurred in connection with product development in collaboration with SOTIO.

“We are very enthusiastic that SOTIO has nominated a second ADC program under the existing collaboration agreement between SOTIO and NBE-Therapeutics, confirming the high quality of our ADC platform,” noted Ulf Grawunder, Ph.D, Chief Executive Officer of NBE-Therapeutics.

“We have now created a robust and scalable ADC platform that enables us to leverage iADC development in clinical studies for multiple programs. The collaboration with Sotio over the past years has further strengthened our technology and we are very proud to have them on board for a second iADC development program,” Grawunder added.

Encouraging data
“Based on the very encouraging data from our first collaboration target with NBE and the SO-N102 program, as well as the data of NBE’s proprietary program NBE-002, we have now exercised the second target option in the collaboration,” noted Dr. Radek Špíšek, MD., Ph.D, Chief Executive Officer of SOTIO.

“NBE’s product platform addresses the key issues of today’s antibody-drug conjugates and has the potential to provide new and superior treatment options for cancer patients,” Špíšek concluded.

Quintieri L, Geroni C, Fantin M, Battaglia R, Rosato A, Speed W, Zanovello P, Floreani M. Formation and antitumor activity of PNU-159682, a major metabolite of nemorubicin in human liver microsomes. Clin Cancer Res. 2005 Feb 15;11(4):1608-17.

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