High Point’s vTv Therapeutics Licenses Drug Candidate to Biotech Startup​​​​​​​

vTv Therapeutics of High Point has out-licensed worldwide development and commercialization rights to its potential kidney disease drug to a California biotech company in a deal that ultimately could be worth more than $150 million.

Under the terms of the agreement, Anteris Bio will pay vTv $2 million up front and up to $151 million for future development, regulatory and commercial sales milestones, as well as royalties on annual net sales. In addition, vTv will receive a minority equity stake in Anteris.

Anteris is a newly formed portfolio company of Aditum Bio, the biotech investment firm co-founded in 2019 in Oakland, Calif., by former Novartis CEO Joe Jimenez and Mark Fishman, M.D., former president of the Novartis Institutes for BioMedical Research. 

Anteris will focus on developing vTv’s compound, dubbed HPP971, as a new therapy for renal disease. HPP971 is vTv’s most advanced oral, small-molecule activator of the Nrf2 pathway (nuclear factor erythroid 2-related factor 2) within its portfolio of Nrf2 compounds. The compound has completed two Phase 1 studies to date.

“The Nrf2 pathway is a promising, novel target for combating many diseases related to oxidative stress, including renal disease,” said Steve Holcombe, president and chief executive officer of vTv. “We’re thrilled to partner with Anteris to further the development of HPP971. With a focus in renal disease and a strategic partnership with TrialSpark, they will have the ability to efficiently develop HPP971 to ultimately bring a potential new treatment option to patients suffering from kidney disease.”

TrialSpark is a New York-based firm that helps drug companies complete clinical trials faster and at a lower cost than traditional trials, by partnering with doctors to create trial and referral sites within their practices. 

High unmet medical need for kidney disease

Chronic kidney disease (CKD) is a leading cause of mortality, both directly and as a key risk factor for cardiovascular disease. Nearly 700 million people worldwide are estimated to suffer from CKD, and the disease directly causes over 1 million deaths annually.

Therapies have traditionally revolved around treatment of symptoms such as hypertension and renal failure.

“Unmet medical need is high, with few therapies in development that have the potential to be disease modifying," said Jimenez, managing director of Aditum Bio.

HPP971, to be renamed ANT-401, is a small molecule activator of Nrf2. Nrf2 is a transcription factor required for the expression of many antioxidant genes.

"The relentless progression of renal disease has been largely refractory to medical therapies,” said Fishman, chair of Anteris Bio’s medical and scientific advisory boards. “We hope the fundamental mechanism exemplified by ANT-401 will change that for the better." 

vTv said it would continue to explore further internal development and partnership opportunities for the remaining molecules in its portfolio of Nrf2 activators.

vTv is a clinical-stage biopharmaceutical company focused on developing oral small-molecule drug candidates. Its pipeline includes molecules to treat type 1 diabetes, Alzheimer’s disease, and inflammatory disorders. 

The company’s development partners are pursuing additional treatments for type 2 diabetes, chronic obstructive pulmonary disease, and genetic mitochondrial diseases. 

vTv’s shares are traded on the Nasdaq market under the symbol VTVT.