Earlier today, NanoValent Pharmaceuticals, a privately-held development-stage cancer-focused pharmaceutical company advancing antibody-drug conjugate or ADC therapeutics, confirmed signing a licensing agreement with Children’s Hospital Los Angeles, giving the company exclusive global access to all uses of a novel platform technology called Hybrid Polymerized Liposomal Nanoparticle or HPLN.

The novel, targeted, technology was developed in collaboration with Children’s Hospital Los Angeles (CHLA), one of the few freestanding pediatric hospitals in the United States. The hospital is counted among America’s premier teaching hospitals through its affiliation with the Keck School of Medicine of the University of Southern California, and has been ranked the top children’s hospital in California and sixth in the nation for clinical excellence with its selection to the prestigious U.S. News & World Report Honor Roll.

“Having collaborated so closely with Children’s Hospital Los Angeles to achieve scientific validation of our platform technology, the completion of this agreement moves us towards the clinical phase of development with our lead candidate NV103 (irinotecan-anti-CD99) for patients with Ewing sarcoma,” noted Timothy Enns Chief Executive Officer of NanoValent Pharmaceuticals.

NanoValent’s HPLN-based ADC platform promises to be able to provide a wide variety of therapeutic applications to improve care for pediatric and adult cancer patients…

Ewing sarcoma is a type of tumor that forms in bone or soft tissue and is most common in adolescents and young adults. Although childhood cancer mortality decreased by more than 50% between between 1975 and 2010, and the 5-year survival rate for Ewing sarcoma has increased over the same time from 59% to 78% for children younger than 15 years and from 20% to 60% for adolescents aged 15 to 19 years, the incidence of the disease has remained unchanged for 30 years.[1]

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In addition, due to the poor specificity of cancer therapies almost two-third of childhood cancer survivals experience side effects such as secondary cancers, heart or lung damage, infertility or chronic hepatitis. Therefore a reliable, non-toxic high therapeutic window targeted therapy is urgently needed to treat childhood cancer patients.[2]

Platform technology
NanoValent’s HPLN-based ADC platform promises to be able to provide a wide variety of therapeutic applications to improve care for pediatric and adult cancer patients.

“The company’s approach to targeted therapeutics should increase the potency of current and emerging therapies and has the potential to impact outcomes for relapsed cancer patients such as individuals with Ewing sarcoma,” explained Timothy Triche, MD, PhD, co-founder of NanoValent and co-director of the Center for Personalized Medicine at CHLA.

“We are pleased that our collaboration is progressing and getting closer to moving our science into the clinic and hopefully improving outcomes for patients with cancer,” Triche added.

In addition to the licensing agreement, NanoValent also confirmed an initial wave of financing from management and angel investors, which places the company in position to engage commercial manufacturers in preparation for Investigational New Drug (IND) and Biologics Licensing Application (BLA) preclinical studies.

As part of this process, NanoValent completed a convertible note financing to enable the initiation of contract manufacturing. The financing combined both external angel investors and new management investment. “This [important step] has allowed us to engage external manufacturers, laying the foundation for formal IND/BLA studies and enabling us to initiate clinical trials in 2019,” Enns explained.

“Once NV103 is clinically validated in Ewing sarcoma, we will explore additional indications in patients with hepatocellular carcinoma, prostate cancer and neuroendocrine tumors as well as advancing other developmental candidates,” he concluded.

NanoValent also confirmed that it will continue to work with Triche to use the pre-clinical capabilities available at The Saban Research Institute, one of the largest and most productive pediatric research facilities in the United States. The licensing agreement provides for CHLA to receive additional milestones and royalty payments relating to products commercialized by NanoValent or its partners.

Product development pipeline
NanoValent Pharmaceuticals, is developing and commercializing of a truly targeted, nanoparticle-based, antibody-drug conjugate (ADC) technology, called NanoMod™. The platform technology is based on a next generation Hybrid Polymerized Liposomal Nanoparticle (HPLN) targeted with specific human antibodies and loaded with therapeutic anticancer agents. Working in close collaboration with Children’s Hospital Los Angeles, NanoValent has focused scientific validation in Ewing sarcoma and leukemia’s, but will be working to expand this approach to other areas of high unmet clinical need.[2]

The company’s proprietary platform technology, which has been validated pre-clinically with a variety of targeting agents and can potentially be used to create additional novel therapeutic or diagnostic agents, offers flexibility of payload drug and targeting.  NanoValent’s leading drug candidates, including NV101 (doxorubicin-anti-CD99), NV102 (doxorubicin-anti-CD19) and NV103 (irinotecan-anti-CD99), are preparing for phase I clinical trials with initial validating programs in Ewing sarcoma and expansion into hepatocellular carcinoma, neuroendocrine tumors, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

NanoValent Pharmaceuticals has received funding for their research from direct management investment and significant grants from the National Science Foundation, the National Cancer Institute and the Montana Chamber of Commerce.

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